UNIVERSITY OF CALGARY Exploring the Relationships between Yoga Practice, Affect and Attention Regulation, Health Outcomes and Program Adherence in Cancer Survivors by Michael John Mackenzie A DISSERTATION SUBMITTED TO THE FACULTY OF GRADUATE STUDIES IN PARTIAL FULFILMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY FACULTY OF KINESIOLOGY CALGARY, ALBERTA NOVEMBER, 2012 © Michael John Mackenzie 2012 Abstract Yoga practice has been reported to lead to improvements in health-related quality of life (HRQL), psychological functioning, and symptom indices in cancer survivors. Yoga is defined in the Yoga Sutras of Patanjali as a path towards, “stilling the fluctuations of the mind (YS I.2).” Importantly, meditative states experienced within yoga practice are correlated to neurophysiological systems that moderate both positive affect and internalised attention. Despite preliminary findings, little attention has been paid to the psychophysiological mechanisms by which benefits are accrued via yoga practice. The impetus for the present studies was to explore the mechanisms by which yoga practice stills the fluctuations of the mind in cancer survivors. Three studies examined: 1) the clinical significance of patient–reported outcomes in yoga interventions for cancer survivors; 2) longitudinal associations between yoga participation, affect, and mindfulness as predictors of mood, stress and HRQL outcomes in an ongoing community-based yoga program; 3) associations between valence, activation, attention, perceived exertion, cardiac activity, and participant descriptions of a single yoga session for cancer survivors. The clinical significance review confirmed yoga practice was related to clinically significant improvements in HRQL, psychological health, and symptom experience. Longitudinal findings suggest improvements in mood, stress and HRQL were related to affect and attention (mindfulness) regulation, but not previous yoga experience. Previous yoga experience, affect and mindfulness were related to yoga practice maintenance. Lab study findings suggest both affect and attention improved in a single yoga session and were related to cardiac activity. Participant descriptions confirmed these findings and ii further suggested regulation of attention via breath awareness elicited positive affective responses to yoga. This research develops current theory in yoga practice, affect and attention regulation by modelling processes and outcomes, resulting in a detailed exploration of yoga in cancer settings. Examining these proposed theoretically-based mechanisms for yoga’s salutary effects enables greater understanding not only of “if” yoga works, but also “how.” This knowledge can be used to develop innovative yoga interventions with the express aim of improving mental health and HRQL in cancer survivors. iii Preface In the course of this dissertation, Chapter 2 was prepared and published in Evidence-Based Complementary and Alternative Medicine (www.hindawi.com/journals/ecam/2012/642576/abs/). The idea for the manuscript was initially conceptualised by Drs. Culos-Reed and Danhauer and Michael Mackenzie was brought in as a collaborator. Mr. Mackenzie was subsequently responsible for completing the literature review, methods, data analysis and results section and significantly contributing to both the introduction and discussion. This was completed under the guidance of Drs. Culos-Reed and Danhauer. All authors provided critical reviews of the manuscript and contributed intellectual content. The published article was reproduced in its entirety and included as a chapter in this document with permission from the publisher. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (creativecommons.org/licenses/by/3.0/). Culos-Reed SN, Mackenzie MJ, Sohl SJ, Jesse MT, Ross-Zahavich AN, Danhauer SC. Yoga & Cancer Interventions: A review of the clinical significance of patient-reported outcomes for cancer survivors. Evidence-Based Complementary and Alternative Medicine: eCAM 2012; 1-17. iv Acknowledgements I am incredibly grateful to many people for their varied contributions and support of this work over the past few years. Thank you to my dissertation committee for all their work in moving this project forward. Particular thanks go to Dr. Nicole Culos-Reed for her mentorship, patience and gentle hand in guiding this work. Dr. Linda Carlson has been my mentor for many years and someone I still grow with and learn from. Dr. Dave Paskevich has also been a wonderful mentor these past three years. His thoughts and opinions have always been welcome additions to this work. I also thank Dr. Telles and Dr. Page for taking time out of their extremely busy schedules to be part of this process. The Health and Wellness Lab has been my home the past three years. Thanks to Dr. Carolina Chamarro, Lauren Capozzi, Amanda Wurz, Kathryn Wytsma, Katie Krenz, Jessica Danyluk, Tanya Williamson, Lynette Stephenson, and Marni Armstrong for being an integral part of this journey. Thanks also to Tyla Arnason, Anne Cox, Sophie Dufresne, Jeanine Goranson, Catherine Townley, Heather Jackson, Helen Cheung and Linda Crawford, our amazing Yoga Thrive teachers who have been so central to the research process. My greatest debt is to those cancer survivors and their support persons who chose to be a part of our research program. They have shared so much and asked for little in return. Thank you. Linda Carlson’s Lab has also been a place of great learning and friendship. Dr. Laura Labelle, Dr. Sheila Garland and Kristin Zernicke have been indispensible to this work and are always good for a fresh viewpoint and a warm beverage. Many thanks to Linda, Laura and Sheila for reading drafts of Chapters 3 and 4. v In the Human Performance Lab Dr. David Smith, Dr. Neil Eves, Dr. Eric Groves, Rosie Neil, have opened my eyes to the beauty of exercise physiology and human performance. There is no going back now. Thank you. Many thanks to Brandon Hisey for his artistic flair and MATLAB expertise in creating the Affect Circumplex 3D models in Chapters 3 and 4. To Gisela Engels, Queen of Stats and lover of basketball, go my deepest thanks. I literally could not have done this without you. To Panteleimon Ekkekakis, Julian Thayer and Shirley Telles, your work has allowed for my work. Thank you. Behind every great learning institution there are administrative assistants that ensure everything runs smoothly. Rosalie Kolstad and Sherri Simpson are impeccable in their work and have been indispensible in my work. Many thanks to you both. I would be neglectful if I also didn’t mention Drs. Michael Speca, Barry Bultz and Tavis Campbell, all long-term mentors and colleagues. Gentlemen I thank you. To yoga friends Robin Rothenberg, Maggie Reagh, Robert Birnberg, Jan’net Barchard-Smith, Manon Bussieres, the Desikchar family, the Krishnamacharya Yoga Mandiram, and Gita Thalashvar’s mom, wherever you may be, thank you for my ongoing introduction to yoga. To friends and family, thanks for letting me disappear for three years. With any luck, I’ll soon be back in the Land of the Living. Tim Seinen deserves an extra shout-out as the “best man” behind the scenes. You were always up for a chat and a workout and infinitely patient when, on more than one occasion, neither happened. Many thanks also vi to Scott Haggins and Cedarglen Homes for allowing me to use their fitness facilities with Tim gratis over the past three years. It has been a pleasure. Kristin what can I say? You’ve been a trooper for three-whole years. Thank you, I love you and look forward to our new life in Illinois together as husband and wife. Many thanks go to Dr. Edward McAuley and members of his Exercise Psychology Lab at the University of Illinois in Urbana-Champaign for this exciting new opportunity as a postdoctoral fellow. Finally, my thanks to SSHRC, AIHS and the University of Calgary for supporting this research. It has been my greatest privilege and I thank you. vii Table of Contents Abstract.............................................................................................................................. ii Preface............................................................................................................................... iv Acknowledgements ............................................................................................................v Table of Contents ........................................................................................................... viii List of Appendices .......................................................................................................... xiii List of Tables .................................................................................................................. xiv List of Figures...................................................................................................................xv List of Symbols, Abbreviations and Nomenclature .................................................... xvi Epigraph ........................................................................................................................ xvii CHAPTER 1: INTRODUCTION .....................................................................................1 1.1 Cancer ........................................................................................................................3 1.1.1 Prevalence ...........................................................................................................3 1.1.2 Yoga and Exercise ..............................................................................................4 1.2 Yoga ...........................................................................................................................6 1.2.1 Yoga in Cancer Settings......................................................................................6 1.2.2 Yoga and Exercise ..............................................................................................7 1.2.3 What is Yoga? .....................................................................................................7 1.3. Mechanisms of Action ..............................................................................................9 1.3.1 Positive Affect ..................................................................................................10 1.3.1.1 Circumplex Model of Affect ......................................................................12 1.3.1.2 Dual Mode Theory .....................................................................................13 1.3.2 Attention ...........................................................................................................14 1.3.2.1 Effort-Related Attention Model .................................................................15 1.3.3 Mindfulness.......................................................................................................16 1.3.4 Autonomic Nervous System and Heart Rate Variability ..................................17 1.3.4.1 Neurovisceral Integration Model ..............................................................19 1.3.5 Neurophenomenology ......................................................................................20 1.4 Research Objectives .................................................................................................21 1.4.1 Study 1 (Systematic Review) ............................................................................22 1.4.2 Study 2 (Longitudinal Study)............................................................................22 1.4.3 Study 3 (Lab Study) ..........................................................................................22 1.5 Significance..............................................................................................................23 viii CHAPTER 2: YOGA AND CANCER INTERVENTIONS: A REVIEW OF THE CLINICAL SIGNIFICANCE OF PATIENT REPORTED OUTCOMES FOR CANCER SURVIVORS ..................................................................................................24 2.0 Abstract ....................................................................................................................25 2.1 Introduction ..............................................................................................................26 2.2 Methods....................................................................................................................30 2.2.1 Selection of Publications...................................................................................30 2.2.2 Data Synthesis...................................................................................................31 2.3 Results ......................................................................................................................33 2.3.1 Description of Studies .......................................................................................33 2.3.1.1 Study Designs ............................................................................................33 2.3.1.2 Instruments Reviewed ................................................................................34 2.3.2 Quality of Life Outcomes .................................................................................34 2.3.2.1 Overall HRQL ............................................................................................34 2.3.2.2 Physical HRQL ..........................................................................................35 2.3.2.3 Mental HRQL ............................................................................................36 2.3.2.4 Emotional HRQL .......................................................................................36 2.3.2.5 Social HRQL ..............................................................................................37 2.3.2.6 Functional HRQL.......................................................................................37 2.3.3 Psychosocial Outcomes ....................................................................................38 2.3.3.1 Depression..................................................................................................38 2.3.3.2 Anxiety.......................................................................................................39 2.3.3.3 Positive Affect ...........................................................................................39 2.3.3.4 Negative Affect ..........................................................................................40 2.3.3.5 Spiritual Well-Being ..................................................................................40 2.3.4 Symptom Outcomes ..........................................................................................41 2.3.4.1 Fatigue........................................................................................................41 2.3.4.2 Sleep...........................................................................................................41 2.3.5 Clinical Significance Criteria ............................................................................41 2.3.5.1 Consistency between SEM and SD............................................................41 2.4 Discussion ................................................................................................................42 2.4.1 Baseline Cut-Offs Reported in Literature .........................................................44 2.4.2 MIDs Reported in Literature.............................................................................45 2.4.3 Limitations and Future Research ......................................................................45 2.4.4 Conclusion ........................................................................................................48 CHAPTER 3: MODELLING ASSOCIATIONS BETWEEN YOGA PARTICIPATION, AFFECT, MINDFULNESS AND HEALTH OUTCOMES .....62 3.1 Introduction ..............................................................................................................63 3.1.1 Yoga in Cancer Settings....................................................................................63 3.1.2 Theoretical Mechanisms of Action ...................................................................64 3.1.2.1 Affect Regulation .......................................................................................64 3.1.2.2 Circumplex Model of Affect ......................................................................65 3.1.2.3 Dual Mode Theory .....................................................................................65 3.1.2.4 Effort-Related Attention Model .................................................................66 ix 3.1.3 Mindfulness.......................................................................................................66 3.1.3.1 Facets of Mindfulness ................................................................................67 3.2 Objectives ................................................................................................................68 3.2.1 Acute Class Effects ...........................................................................................69 3.2.2 Longitudinal Program Effects ..........................................................................69 3.2.3 Yoga Practice Maintenance ..............................................................................69 3.3 Methods....................................................................................................................70 3.3.1 Participants........................................................................................................70 3.3.2 Program .............................................................................................................70 3.3.3 Recruitment .......................................................................................................71 3.3.4 Instruments ........................................................................................................72 3.3.4.1 Baseline ......................................................................................................72 3.3.4.2 Acute Effects ..............................................................................................72 3.3.4.3 Longitudinal Effects...................................................................................73 3.3.4.4 Yoga Practice Maintenance .......................................................................75 3.3.5 Data Analysis ....................................................................................................75 3.3.5.1 Multilevel Models ......................................................................................75 3.3.5.2 Clinical Significance ..................................................................................76 3.3.5.3 Acute Effects ..............................................................................................77 3.3.5.4 Longitudinal Effects...................................................................................77 3.3.5.5 Yoga Practice Maintenance .......................................................................78 3.4 Results ......................................................................................................................78 3.4.1 Demographics ...................................................................................................79 3.4.2 Acute Class Effects ...........................................................................................79 3.4.2.1 Valence ......................................................................................................80 3.4.2.2 Activation...................................................................................................80 3.4.2.3 Attention ....................................................................................................80 3.4.3 Longitudinal Program Effects ...........................................................................81 3.4.3.1 Covariates ..................................................................................................81 3.4.3.2 Affect .........................................................................................................81 3.4.3.3 Mindfulness................................................................................................82 3.4.3.4 Mood Disturbance, Stress Symptoms and Quality of Life ........................82 3.4.3.5 Mood Disturbance......................................................................................83 3.4.3.6 Stress Symptoms ........................................................................................83 3.4.3.7 Quality of Life............................................................................................83 3.4.4 Yoga Practice Maintenance ..............................................................................84 3.5 Discussion ................................................................................................................85 3.5.1 Acute Class Effects ...........................................................................................86 3.5.2 Longitudinal Program Effects ...........................................................................88 3.5.3 Yoga Practice Maintenance ..............................................................................91 3.5.4 Limitations ........................................................................................................92 3.5.5 Conclusion ........................................................................................................93 x CHAPTER 4: MODELLING ASSOCIATIONS BETWEEN AFFECT, ATTENTION AND HEART RATE VARIABILITY IN A SINGLE YOGA SESSION: A NEUROPHENOMENOLOGICAL APPROACH ..............................118 4.1 Introduction ............................................................................................................119 4.1.1 Affect ..............................................................................................................120 4.1.2 Attention .........................................................................................................120 4.1.3 Heart Rate Variability .....................................................................................122 4.1.4 Neuro-Affective Theories and Approaches ....................................................124 4.1.4.1 Circumplex Model of Affect ....................................................................124 4.1.4.2 Dual Mode Theory ...................................................................................125 4.1.4.3 Effort-Related Attention Model ...............................................................125 4.1.4.4 Neurovisceral Integration Model .............................................................126 4.1.4.5 Neurophenomenology ..............................................................................126 4.2 Objectives ..............................................................................................................127 4.3 Methods..................................................................................................................128 4.3.1 Subject Recruitment ........................................................................................128 4.3.2 Procedures .......................................................................................................128 4.3.3 Instruments – Baseline ....................................................................................130 4.3.4 Instruments – In-Task Measures .....................................................................131 4.3.5 Instruments – Pre-post Supine Meditation and Post Yoga Supine Resting ....132 4.3.6 Data Analysis ..................................................................................................132 4.3.6.1 Multilevel Modelling ...............................................................................133 4.3.6.2 Clinical Significance ................................................................................134 4.3.6.3 Qualitative Analysis .................................................................................135 4.3.6.4 Mixed Methods ........................................................................................136 4.4 Results ....................................................................................................................136 4.4.1 Demographics .................................................................................................137 4.4.2 Valence, Activation, Attention, Perceived Exertion and Cardiac Activity During Yoga Session ...............................................................................................137 4.4.2.1 Valence ....................................................................................................137 4.4.2.2 Activation.................................................................................................138 4.4.2.3 Attention ..................................................................................................139 4.4.2.4 Rating of Perceived Exertion ...................................................................139 4.4.2.5 Cardiac Activity .......................................................................................140 4.4.3 In-Task Yoga Session Qualitative Findings ...................................................141 4.4.3.1 Description of Events...............................................................................141 4.4.3.2 Explanatory Mechanisms .........................................................................145 4.4.4 Pre-Post Yoga Session Affect Regulation ......................................................146 4.4.4.1 Energy ......................................................................................................146 4.4.4.2 Tension.....................................................................................................147 4.4.4.3 Tiredness ..................................................................................................147 4.4.4.4 Calmness ..................................................................................................147 4.4.5 Pre-Post Yoga Session Qualitative Findings ..................................................148 4.4.5.1 Energy ......................................................................................................148 4.4.5.2 Tension.....................................................................................................148 4.4.5.3 Tiredness ..................................................................................................148 xi 4.4.5.4 Calmness ..................................................................................................149 4.5 Discussion ..............................................................................................................149 4.5.1 In-Task Effects ................................................................................................150 4.5.1.1 Valence ....................................................................................................150 4.5.1.2 Activation.................................................................................................151 4.5.1.3 Attention ..................................................................................................151 4.5.2 Pre-Post Yoga Session ....................................................................................152 4.5.3 Integration .......................................................................................................152 4.5.4 Limitations ......................................................................................................154 4.5.5 Conclusion ......................................................................................................155 CHAPTER 5: GENERAL DISCUSSION ..................................................................174 5.1 The Present Studies ................................................................................................175 5.1.1 Integration of Theoretical Models, Constructs and Approaches ....................175 5.2 Study Findings .......................................................................................................176 5.2.1 Study 1 (Systematic Review, Chapter 2) ........................................................177 5.2.2 Study 2 (Longitudinal Study, Chapter 3) ........................................................177 5.2.3 Study 3 (Lab Study, Chapter 4) ......................................................................178 5.3 Theoretical Integration ...........................................................................................178 5.3.1 Acute Effects ...................................................................................................178 5.3.2 Longitudinal Measures of Affect ....................................................................179 5.3.3 The Role of Attention in Affective Experience ..............................................180 5.3.4 Autonomic Concomitants of Affect and Attention .........................................182 5.3.5 Integration of Neurophenomenological Approach .........................................183 5.4 Yoga’s Role in Exercise Settings...........................................................................184 5.4.1 Yoga as Cardiovascular Exercise....................................................................184 5.4.2 Yoga as Relaxation .........................................................................................186 5.4.3 Yoga as Yoga ..................................................................................................186 5.5 Concluding Thoughts .............................................................................................187 BIBLIOGRAPHY ..........................................................................................................190 xii List of Appendices Appendix A. Consent Forms........................................................................................232 Appendix B. Demographics Questionnaire .................................................................238 Appendix C. Medical Information Questionnaire .......................................................239 Appendix D. Previous Yoga Experience Questionnaire ..............................................240 Appendix E. Beliefs about Yoga Scale (BAYS) .........................................................241 Appendix F. Feeling Scale (FS) ...................................................................................242 Appendix G. Felt Arousal (FAS) .................................................................................242 Appendix H. Associative-Dissociative Scale (A/D S) .................................................242 Appendix I. Godin Leisure Time Exercise Questionnaire (GLTEQ) ..........................243 Appendix J. Activation-Deactivation Adjective Questionnaire (AD ACL) ................244 Appendix K. Five Facet Mindfulness Questionnaire (FFMQ) ....................................245 Appendix L. Profile of Mood States – Short Form (POMS-SF) .................................247 Appendix M. Functional Assessment of Cancer Therapy (FACT-G) .........................249 Appendix N. Calgary Symptoms of Stress Inventory (SOSI-C) .................................251 Appendix O. Borg Rate of Perceived Exertion (RPE) .................................................255 Appendix P. Qualitative Research Questions ..............................................................256 Appendix Q. Yoga Class Attendance Log ...................................................................257 Appendix R. Yoga 3 and 6 Month Follow-Up ............................................................258 Appendix S. Yoga for Cancer Survivors 7-Week Protocol (Longitudinal Study) ......259 Appendix T. Study 3 Yoga Protocol (Lab Study)........................................................267 xiii List of Tables Table 2.1 Studies Reviewed from the Yoga-Cancer Literature – Control Design .....50 Table 2.2 Studies Reviewed from the Yoga-Cancer Literature – Single Group Design ............... 52 Table 2.3 Health-Related Quality of Life Measures – Control Design.......................................... 54 Table 2.4 Psychosocial Measures – Control Design ..................................................................... 56 Table 2.5 Symptom Measures – Control Design ........................................................................... 57 Table 2.6 Health-Related Quality of Life Measures – Single Group Design ................................ 58 Table 2.7 Psychosocial Measures – Single Group Design............................................................. 60 Table 2.8 Symptom Measures – Simple Group Design ................................................................. 61 Table 3.1 Demographics ................................................................................................................ 95 Table 3.2 Pre-Post Class Estimated Marginal Means Models ....................................................... 96 Table 3.3 Acute Associations: Pre-Post Class Multilevel Regression Model ............................... 97 Table 3.4 Longitudinal Estimated Marginal Means Model ........................................................... 98 Table 3.5 Longitudinal Multilevel Regression Model ................................................................. 100 Table 3.6 Yoga Practice Maintenance Estimated Marginal Means Model .................................. 102 Table 3.7 Predictors of Yoga Practice Maintenance .................................................................... 103 Table 4.1 Demographics .............................................................................................................. 156 Table 4.2 Estimated Marginal Means Model – Valence, Activation, Attention and Rating of Perceived Exertion ...................................................................................................................... 157 Table 4.3 Estimated Marginal Means Model – Heart Rate, HF HRVnu, SDNN, RMSSD and SamEn .......................................................................................................................................... 158 Table 4.4 Multilevel Regression Analyses – Valence, Activation, Attention and Rating of Perceived Exertion ....................................................................................................................... 159 Table 4.5 Estimated Marginal Means Model – AD ACL ............................................................ 161 Table 4.6 Multilevel Regression Analyses – AD ACL ................................................................ 162 xiv List of Figures Figure 3.1 Circumplex Model of Affect ...................................................................................... 104 Figure 3.2 Participant Recruitment Flow Diagram ...................................................................... 105 Figure 3.3 Affect Circumplex 2D Model (valence, activation) ................................................... 106 Figure 3.4 Affect Circumplex 3D Model (valence, activation, attention) ................................... 107 Figure 3.5 Continuous Moderators: total physical activity (LSI), moderate-vigorous physical activity (GLTEQ) and previous Yoga Thrive experience ............................................................ 108 Figure 3.6 Longitudinal Changes in Affect (AD ACL) ............................................................... 110 Figure 3.7 Longitudinal Changes in Mindfulness (FFMQ) ......................................................... 112 Figure 3.8 Longitudinal Changes in Mood Disturbance (POMS), Stress Symptoms (C-SOSI) and Quality of Life (FACT-G) ........................................................................................................... 115 Figure 3.9 Yoga Practice Maintenance ........................................................................................ 117 Figure 4.1 Circumplex Model of Affect ...................................................................................... 163 Figure 4.2 Simple Slopes of the Regression for Dissociative Attention on Condition at Low, Medium and High Levels of Sample Entropy ............................................................................. 164 Figure 4.3 Estimated Marginal Means Models for Valence, Activation, Attention and Perceived Exertion ........................................................................................................................................ 165 Figure 4.4 Estimated Marginal Means Models for Heart Rate, HF HRVnu, SDNN, RMSSD and Sample Entropy............................................................................................................................ 167 Figure 4.5 Estimated Marginal Means Models for Activation-Deactivation Adjective Checklist ..................................................................................................................................................... 170 Figure 4.6 Affective Response (Mean FS and FAS) to a Single Yoga Session Plotted on a TwoDimensional Circumplex Model .................................................................................................. 172 Figure 4.7 Affective Response (Mean FS, FAS, ADTS) to a Single Yoga Session Plotted on a Three-Dimensional Circumplex Model ....................................................................................... 173 Figure 5.1 Yoga Mechanisms Integrated Model .......................................................................... 189 xv List of Abbreviations, Symbols and Nomenclature Symbol Definition ACSM AD ACL A/D S ANS BMI Bpm BAYS CI CSEP C-SOSI ES FACIT-F FACIT-Sp American College of Sports Medicine Activation-Deactivation Adjective Checklist Association / Disassociation Scale Autonomic Nervous System Body Mass Index Beats Per Minute Beliefs about Yoga Scale Confidence Interval Canadian Society of Exercise Physiology Calgary Symptoms of Stress Inventory Effect Size Functional Assessment of Chronic Illness Therapy Functional Assessment of Chronic Illness Therapy – Spiritual Wellbeing Functional Assessment of Cancer Therapy Functional Assessment of Cancer Therapy – General Felt Arousal Scale Five Facet Mindfulness Questionnaire Feeling Scale Generalized Estimated Equation Godin Leisure Time Exercise Questionnaire High Frequency Heart Rate Variability normalized units Heart Rate Health-Related Quality of Life Heart Rate Variability Intraclass Correlation Coefficient Leisure Score Index (total physical activity) Mindfulness-Based Stress Reduction Minimally Clinically Important Difference Physical Activity Profile of Mood States Profile of Mood States – Short Form Patient Reported Outcomes Measurement Information System Quality of Life Root Mean Square of Successive Differences Rate of Perceived Exertion Sample Entropy Standard Deviation of NN (normal-to-normal) heart rate intervals Short Form Health Survey (12-item) Symptoms of Stress Inventory Visual Analog Scale FACT FACT-G FAS FFMQ FS GEE GLTEQ HF HRVnu HR HRQL HRV ICC LSI MBSR MCID PA POMS POMS-SF PROMIS QoL RMSSD RPE SamEN SDNN SF-12 SOSI VAS xvi Epigraph Yoga is the stilling of the fluctuations of the mind. Yoga Sutras of Patanjali, Chapter 1, Verse 2 xvii 1 CHAPTER 1: INTRODUCTION 2 Yoga appears to be a promising complementary exercise choice for cancer survivors. Positive effects have been seen on indices of mood, stress-related symptoms, health-related quality of life (HRQL), fatigue and sleep (1-3). Despite preliminary findings, little attention has been paid to the psychological mechanisms by which benefits are accrued via yoga practice. The current research examines: 1) the clinical significance of patient–reported outcomes from yoga interventions for cancer survivors; 2) associations between yoga participation, affect, mindfulness and mood, stress and HRQL outcomes in cancer survivors longitudinally in an ongoing community-based yoga program; and 3) associations between valence, activation, attention, perceived exertion and cardiac activity in a single yoga session for cancer survivors. The larger aim of this set of studies was to develop new models to better describe the mechanisms underlying how yoga practice elicits improvements in HRQL and psychological outcomes in cancer survivors. The present chapter provides a concise overview of the role of exercise in improving mental health and HRQL in cancer survivors, a brief introduction to the use of yoga in cancer settings, a survey of models, constructs, and approaches helpful to the present work and a synopsis of study objectives. Chapter 2 is a systematic review of yoga interventions for cancer survivors with an emphasis placed on the clinical significance of these outcomes. This chapter was published in its entirety in Evidence-Based Complementary and Alternative Medicine. Chapter 3 is an original longitudinal study examining the effects of yoga on measures of mood disturbance, stress symptoms and HRQL and the associations between these outcomes, affect, mindfulness and yoga practice. Chapter 4 is an original laboratory study examining the effect of yoga on 3 valence, activation, attention and perceived exertion during a single yoga session and the relations between these measures and cardiac activity, particularly heart rate and heart rate variability (HRV). Chapter 5 summarises and integrates the research findings from the previous three chapters to provide an encompassing model of how yoga elicits change in cancer survivors. 1.1 Cancer 1.1.1 Prevalence Over 500 Canadians are diagnosed with cancer daily and 200 die from cancer each day. There will be an estimated 186,400 new diagnoses of cancer and an estimated 75,700 cancer-related deaths in Canada in 2012, with 69% of new cases and 62% of cancer deaths occurring among those 50 to 79 years of age. Of new diagnoses, over half will be either lung, colorectal, prostate or breast cancers (4). Receiving a cancer diagnosis, undergoing treatment and subsequent recovery takes a great toll on many cancer survivors. The cancer experience is associated with high emotional distress and lowered HRQL (5). HRQL can be defined as a state of wellbeing comprised of two components: 1) the ability to perform daily activities that reflect physical, functional, psychological and social wellbeing 2) individual satisfaction with levels of functioning and control of disease and/or treatment-related symptoms. HRQL usually includes functional (e.g., whether a patient is able to engage in activities of daily living), physical (e.g., pain, shortness of breath, fatigue), psychological (e.g., depressive symptoms, positive affect), and social (e.g., involvement with others) domains (6). Distress stemming from the cancer experience is a significant problem for up to half of all cancer patients (7). Cancer survivors may exhibit signs of clinical psychological 4 disorders and a host of more general mood, stress, fatigue and sleep-related symptoms (812). In addition, there are often chronic and late-appearing effects of illness and/or treatment, and increased risk of cancer recurrence or other diseases (13). 1.1.2 Cancer and Exercise An ever-growing area of research highlights the positive role physical activity (PA) and exercise may play in alleviating many of the negative side-effects of cancer and its subsequent treatments. PA can be defined as any movement of the body resulting in increased energy expenditure (6). PA encompasses all bodily movements, from sports to activities of daily living. Exercise is a specific type of PA consisting of planned, structured bodily movement with the express goals of improving or maintaining physical fitness (6). Regardless of intervention specifics, exercise has been shown to improve a variety of HRQL, psychosocial and health outcomes in various cancer survivor groups both during and after cancer treatment, and may also help to manage the long-term effects of treatment (14,15). In a national survey (16), those meeting American Cancer Society recommendations for exercise had higher HRQL. A literature review of 25 intervention studies indicated increased exercise led to increased HRQL (17). Those with greater exercise-related PA reported higher HRQL and better mental health outcomes throughout the cancer experience as opposed to their sedentary counterparts (18). Current research evidence also suggests exercise improves cancer-related fatigue across several types of cancer (9,19). Moreover, increased PA may decrease the risk of cancer recurrence and extend survival (20-22). The sooner cancer survivors maintain, re-establish or improve 5 upon pre-diagnosis PA and body composition within their cancer experience; the more likely they are to report improved HRQL and mental health outcomes. Within the broad scope of oncology, there is a growing interest in promoting PA in general and the development of exercise interventions specifically to ameliorate cancer’s destructive role in survivors’ overall HRQL and mental health. The ACSM roundtable on Exercise Guidelines for Cancer Survivors (23) concluded exercise is safe both during and after cancer treatments, resulting in improvements in HRQL, physical functioning, and cancer-related fatigue in several cancer survivor groups. ACSM Guidelines suggest cancer survivors, regardless of where they are in the treatment continuum, should avoid inactivity and that any level of PA carries with it some benefit (23). Current recommendations suggest an overall volume of weekly activity of 150 minutes of moderate-intensity exercise, or 75 minutes of vigorous-intensity exercise, or an equivalent combination. These recommendations are not dissimilar from general population guidelines and have been shown to be associated with a variety of health outcomes (24). These cancer-specific guidelines are embedded within the proviso that exercise programs must be adapted for the individual on the basis of their health status, treatments, and anticipated disease trajectory (23). Despite reported benefits and recommendations, it is widely acknowledged many cancer survivors never return to either initial rates or healthy levels of PA (24). Data suggests only 22% of cancer survivors are active enough to achieve health benefits (25) and only 50% of cancer patients offered an exercise program will undertake and complete the intervention (26). Even in the general population, the amount of time spent engaged 6 in PA declines across the lifespan and the amount of time spent in sedentary activities increases (27,28). Given poor exercise adoption, adherence and maintenance in cancer and general populations, determinants of health behaviours are considered paramount. These include physiological, psychosocial and environmental factors (6). Addressing these issues often leads to improved health outcomes. Current research advocates for the translation of research on the HRQL and mental health benefits of PA into optimal theoretical models of behaviour change in which determinants of PA, including exercise preferences, are incorporated into exercise interventions (29). 1.2 Yoga 1.2.1 Yoga in Cancer Settings Within the growing body of cancer and exercise research, there have been calls to examine modes of exercise from the area of complementary medicine (30,31). In this regard, yoga has emerged as an important complementary therapeutic approach in cancer settings, often considered a gentle, low-intensity form of exercise (22,32). Preliminary results from the emerging literature on yoga and cancer are promising and provide support for the utility of yoga interventions for cancer survivors. Research examining the effects of these interventions on cancer patients suggest yoga participants compared to waitlist controls or those in supportive therapy groups show greater improvements in overall HRQL, psychological health, stress-related symptoms, fatigue and sleep indices (1,2,33-36), though reported improvements have not been uniform (37). 7 1.2.2. Yoga and Exercise Recent reviews suggest yoga has positive effects on general physical and mental health (38-41), fitness in older adults (42), mood (43-45), symptoms of stress (46), and HRQL in older adults (47). Studies comparing the effects of yoga and exercise indicate that in both healthy individuals and those with various health conditions, yoga may be as effective as walking, cycling, jogging or aerobics at improving a variety of health-related outcome measures and may carry added effects in the alleviation of stress (48). 1.2.3 What is Yoga? The term yoga stems from traditional philosophies from the Indian subcontinent. Most commonly referenced are the Yoga Sutras of Patanjali, an ancient meditation text of indeterminate origin (49) and its various commentaries. The Yoga Sutras four chapters outline both a philosophical and pragmatic path to enlightenment, including attendant ethical prescriptions (yamas), personal observances (niyamas) and the development of various accomplishments (siddhis) along the way. In the 21st century, yoga practice as a system of physical exercise has become prominent (50). This unique integration of both moving and static sequences (asana), breathing exercises (pranayama), and different meditation tools to withdraw the senses (pratyahara), concentrate the mind (dharana) and develop abilities of impartial awareness (dhyana) have all been used in modern settings as means of increasing performance and recovery in both general and clinical populations (40). These practices are routinely modified based on desired outcomes as well as participant health status (51). Yoga’s transition from a system designed for those seeking enlightenment to contemporary yoga, a system comprised of physical, breathing and meditation 8 techniques, remains controversial. There are those that maintain today’s yoga is part of an extant system passed down from antiquity, to those that suggest contemporary yoga is largely a modern invention (50,52-54). Given the complexity of yoga, both in terms of its wide and varied practices and the historical complexity from which it emerged, it is perhaps best thought of as the “source” of a variety of different practices based on geography, historical origins, lineage and purpose (55). From this viewpoint yoga practice may have numerous applications, ranging from enlightenment (IV.34), as per the Yoga Sutras, to ordinary physical and mental training (55). A common definition of yoga is to link or “yoke” things together. This definition has been widely interpreted, from the linking of The Universal (Brahman) and the personal (atman) (56), to linking the mind to an object of attention (57). In contemporary yoga practice, the object of attention could include movement of the body, sensation of the breath, the contents of the mind, a mantra, or a variety of other tools. Perhaps a clearer definition of what yoga “is” or “does” is that found in the Yoga Sutras of Patanjali, which characterises yoga as the “stilling of the fluctuations of the mind (YS 1.2).” Control of these mental fluctuations comes from persevering practice aimed at both attaining and maintaining states of mental stability over long, uninterrupted periods of time (YS 1.12-1.14). Importantly, meditative states experienced within yoga practice are correlated to neurophysiological systems that mediate both positive affect and internalised attention (58,59). The Yoga Sutras trace all benefits of yoga to developing mastery over ones’ mind (60), regardless of whether the personal goals of those practicing yoga are to increase flexibility, relax more, alleviate health concerns or, in the present case, cope with cancer diagnosis, treatment and/or recovery. 9 The previous section has provided a brief overview of yoga in cancer settings, the relationship between yoga and exercise and a working definition of what yoga “is” or “does.” Further details on yoga practice in cancer settings are provided in Chapter 2. The next section examines potential mechanisms for yoga’s health-related effects. 1.3 Mechanisms of Action Therapies like yoga, directed toward addressing functional links between mind and body, may be particularly effective in treating symptoms associated with chronic illness (61). As research in the use of yoga in cancer settings continues to grow and yoga is integrated into cancer care, it is imperative the clinical benefits of yoga for cancer survivors are better understood. Identifying mechanisms that explain how yoga leads to clinically significant outcomes is the next step in understanding the ability of yoga to target desired outcomes. In this capacity, there have been recommendations to integrate patient-reported outcomes with biomedical endpoints as a means of better describing the complexity of these measures (62). While these outcomes may purport treatment effect, they do little in explaining patients’ baseline characteristics, the interventions themselves, and purported mechanisms of action. Recent recommendations from the UK Medical Research Council (63) suggest time spent examining these mechanisms, both theoretically and practically, helps to strengthen the causal chain of evidence and further refine both the interventions themselves and research design. Reviews in the area of exercise and cancer also advocate for further research to define the relations between the psychology and physiology of exercise and their respective contributions to health outcomes (15,22,26,29,64-66). 10 Future research must explore the complementary psychophysiological mechanisms by which exercise and yoga improve cancer survivor health outcomes. In the following studies, three primary mechanisms for yoga’s benefits are suggested. They are: 1) positive affect; 2) attention-mindfulness; 3) cardiac activity as measured via heart rate and heart rate variability (HRV). Within each proposed mechanism, supportive theories, models, constructs, and approaches are described and serve as a foundation for the subsequent research. 1.3.1 Positive Affect A current area of clinical research interest is the study of positive affect as an independent, adaptive pathway in the cancer experience. Positive affect can be broadly defined as feelings that elicit pleasurable experience and may include descriptors such as happiness, joy, contentment, and peacefulness among others (67). Positive affect provides a resource for cancer survivors to cope with the demands of cancer diagnosis, treatment and recovery (68). In a study examining 215 recently diagnosed colorectal cancer patients, those reporting lower positive affect reported higher anxiety and depression. In addition, changes in positive affect significantly moderated associations between increased symptom distress, anxiety and depression (68). A study examining both positive affect and negative affect in a sample of 133 lung cancer patients (69) further suggested negative affect was associated with impaired physical and social functioning, emotional problems, pain and poorer general health, while positive affect was associated with adaptive social functioning, fewer emotional problems, less severe pain and greater general health. In a study of 50 early-stage breast and prostate cancer patients receiving radiotherapy, patients with higher levels of positive affect had an improved acute 11 inflammatory response to radiation treatment, believed to enhance the tissue repair process (70). In sum, reduction of negative affect and maintenance or improvement of positive affect are important therapeutic goals, likely to lead to enhanced HRQL and perhaps improved treatment outcomes. In general, exercise of low- to moderate-intensity increases positive affect and reduces negative affect (71,72). Positive affect tends to increase pre- to post-exercise following exercise intensities that are not exhaustive (73). While a majority of research examining psychological changes associated with exercise is focused on reductions in negative emotions (depression, anxiety), actual exercise recommendations tend to focus on making activity more enjoyable rather than on surmounting mental health concerns (74). The assumption is that if exercise is pleasant and enjoyable, adoption and adherence rates might improve and exercise benefits will be more readily experienced (74). Positive affect experienced during exercise is a strong predictor of future exercise engagement and may enhance adherence to exercise programs, further solidifying the benefits obtained through regular exercise (73). For example, in a sample of 37 healthy adults, affect experienced during an acute bout of moderate-intensity exercise was predictive of exercise participation 6 and 12 months later (75). This evidence suggests the influence of affective responses resulting from exercise may be important with respect to longer term exercise maintenance. In cancer settings, fostering positive affective reactions after a structured exercise program is an important target for interventions designed to facilitate post-program exercise adherence (76). Clinical research has begun to further explore the specific relations between yoga and positive affect. In two nonrandomized studies, single yoga sessions were associated 12 with significant improvements in positive affect and reductions in negative affect and perceived stress, comparable to changes seen with aerobic exercise (77,78). A pilot RCT examining the effects of restorative yoga in 44 breast cancer survivors either on or off treatment also reported significant benefits favouring the yoga group for positive affect, mental health, depression and spirituality outcomes (79). A second pilot RCT examining the effects of an integrated yoga program in 88 breast cancer outpatients undergoing adjuvant radiotherapy reported significant improvement in positive affect, emotional and cognitive function, and decreased negative affect in the yoga group as compared to controls (80). These findings suggest yoga practice is associated with increased positive affect, reduced negative affect and improved health outcomes. 1.3.1.1 Circumplex Model of Affect. Given the proposed importance of positive affect and yoga’s influence on this phenomenon, the Circumplex Model of Affect (81) offers an important parsimonious explanatory approach. At the heart of mood and emotion are underlying psychophysiological states experienced as simply feeling good or bad, energized or fatigued. According to this model, affect is best understood as an underlying state comprised of two orthogonal dimensions: 1) valence, or whether states are perceived as good or bad, and 2) activation, or whether states are experienced as energizing or fatiguing (82). These two dimensions of valence and activation, termed core affect, underlie all affective states. Upon this affective base are layered various cognitive processes that interpret and refine emotions and moods (81). Affect attributed to an immediate cause is considered an emotion. For example, emotion is directed at something (Ted was afraid of the bear). Emotion requires an antecedent event, which elicits core affect. This core affect is then attributed to its 13 antecedent, requiring further appraisal of the antecedent itself and action to be taken in the direction of the antecedent (in the case of the bear, one might consider running...) (81). Mood is described by Russell (2003) as “long-term core affect” and is objectless in the sense that mood is not outwardly directed toward anything. However, based on the principle of mood congruency, what we attend to and cognize in the field of consciousness is based on these underlying affective states (81). Independent of the temporal nature of affect, at the intersection of valence and activation, lay four affective quadrants which can be described as: high activation pleasure (energy), low activation pleasure (calmness), high activation displeasure (tension), and low activation displeasure (tiredness) (83). Based on these two dimensions and four quadrants, a host of affective responses, emotions and moods are possible. 1.3.1.2 Dual Mode Theory. The Circumplex Model has been further developed for exercise settings utilising Dual Mode Theory (84), which postulates changes in core affect, valence and activation, within a bout of exercise are regulated via the continuous interplay of two mechanisms: 1) cognitive processes, including exercise goals, selfefficacy, expectations (75); and 2) interoceptive cues, or physical sensations from the body. The relative importance of these two factors in the regulation of core affect is hypothesized to shift systematically as a function of exercise intensity, with cognitive factors being dominant at low and moderate intensities and interoceptive cues becoming more prominent at higher intensities (85). Intensities above the lactate or ventilatory threshold often lead to negative affective experiences of exercise, as workload increases to a point that exercise cannot be physiologically maintained and interoceptive cues indicate one should stop. Exercise below this threshold is said to lead to positive affective 14 experiences, as individuals are able to maintain this workload, which bolsters cognitive factors including increased self-efficacy and positive exercise beliefs (86). There is large inter-individual variability close to the ventilatory or lactate threshold (73). The lactate threshold is the point at which lactate concentrations in blood exceed the rate at which lactate can be removed, resulting in excess lactate and a shift towards anaerobic metabolism, while the ventilatory threshold is the point at which ventilation (air in and out of the lungs) deviates from a linear sequence and carbon dioxide cannot be removed from the body at the rate it is produced. Ventilatory threshold is closely related with lactate threshold, reflecting the same basic shift toward anaerobic metabolism during greater exercise intensity (87). The previous section provided an overview of the role of affect in cancer settings and the relations between affect, exercise and exercise adherence. The Circumplex Model of Affect provides a dimensional model of affective processes and Dual Mode Theory suggests how affect is regulated in exercise settings. These two theories figure prominently in Chapters 3 and 4 of the present work. 1.3.2 Attention Within the exercise psychology field, the role of attention in performance has been researched extensively. A seminal study in this field by Morgan and Pollock (88) examines the attention strategies of distance runners. Athletes could be subdivided into elite and non-elite based on these attention strategies. Non-elite runners were characterized by dissociative strategies designed to dissociate from painful running stimulus, while elite runners utilized an associative attention strategy, paying attention to physiological cues to monitor running pace and other running-specific cues. 15 Individual focus of attention during exercise can influence changes in affective responses (89). Associative attention is defined as focusing attention on present-moment physical sensations related to exercise, in which exercisers seek to monitor sensory input and adjust their effort accordingly. Dissociative attention is defined as focusing on nonexercise related stimuli that divert attention away from internal sensations and present moment exercise experience, including listening to music, watching TV, talking on the phone or attending to other thoughts and feelings unrelated to exercise (90). For fit individuals, associative attention allows for better regulation of effort, while dissociative strategies have been recommended for individuals beginning exercise programs and unused to the physiological strain of exercise (89). 1.3.2.1 Effort-Related Attention Model. The Effort-Related Attention Model spearheaded by Morgan (88) and refined by Tenenbaum (91), suggested attention strategies during exercise vary based on intensity. Specifically, during low or moderate intensity workloads, attention is voluntary and can switch between dissociative and associative attentional strategies, as external stimuli do not compete with internal stimuli. At higher exercise intensities, increased physiological cues demand attention. As a result, attention narrows, shifts internally and becomes associative (92). Based on exercise intensity, dissociative attention strategies may make exercise “feel easier” at low tomoderate intensities (91), but this coping strategy is “load dependent” and ineffectual at higher intensities (93). The previous section provides an overview to associative and dissociative attention strategies in exercise settings and suggests focus of attention is related to affective experiences of exercise. The Effort-Related Attention Model proposes attention 16 and affect are linked via exercise intensity. The Effort-Related Attention Model was used to build upon the Circumplex Model of Affect and Dual Mode Theory and is featured in both Chapters 3 and 4 of the current work. 1.3.3 Mindfulness Mindfulness is the systematic development of the ability to direct attention towards events in the field of consciousness non-judgementally in the present moment (94). Salmon and colleagues (2010) suggested mindful awareness is similar to associative attentional processing, but that the inclusion of these non-judgmental qualities enhance accurate observation and acceptance of both one’s internal bodily cues, the content of thoughts and the external environment (95). Within exercise settings, mindfulness builds upon associative attention by refining perceptions of perceived exertion on a moment-bymoment basis, via increased sensitivity to a host cognitive and interoceptive cues. Mindfulness concurrently limits emotional reactivity to these cues via acceptance (95). It is hypothesised the strong mind-body interaction within contemporary yoga practice adds a unique contemplative dimension to exercise and has been referred to as ‘mindfulness in motion’ (96). The practice of yoga provides an opportunity for sustained attention to the body, breath and mind through a progressive sequence of dynamic movements, restful postures, breathing exercises and periods of meditative awareness. Froeliger and colleagues (97) suggest the object of mindfulness in contemporary yoga practice comes from both physical sensations of the body moving and awareness of breath. However, research evidence linking yoga in eliciting these changes in mindfulness remains equivocal. Lengacher and colleagues (98) found total minutes of 17 yoga practice as part of an overall MBSR program was not significantly related to positive changes in psychosocial status and HRQL. These findings are in contrast to the work of Carmody and Baer (99), whose research in a non-cancer heterogeneous medical population found the yoga component of a mindfulness program to be most strongly related to improvements of mindfulness measures, psychological symptoms and perceived stress. These findings have more recently been corroborated in a study by Sauer-Zavala and colleagues (100), which reports yoga practice was associated with greater psychological wellbeing independent of body scan and sitting meditation practices. The previous section has provided a brief introduction to mindfulness, the link between mindfulness and associative attention strategies, and the role of mindfulness in exercise settings. It is hypothesized yoga practice is a form of mindfulness but findings in this area are preliminary and equivocal. The construct of mindfulness in relation to yoga practice features prominently in Chapter 3 of the current work. 1.3.4 Autonomic Nervous System & Heart Rate Variability A commonly reported neurophysiological mechanism for relations between yoga practice, positive affect and improved attention regulation via mindfulness lies in the Autonomic Nervous System (ANS). The ANS is the most prominent physiological factor in determining heart functions and is comprised of both parasympathetic and sympathetic input. The amount of input received from each is examined through the study of heart rate variability (HRV), the modulation of the heart rate about its mean value (101). Primarily, the heart is under tonic inhibitory control by parasympathetic influences, and resting cardiac autonomic balance favours energy conservation by parasympathetic 18 dominance over sympathetic influences (102). The basic data for calculating HRV measures is the sequence of time intervals between heart beats, also known as the R-R interval. Increases in sympathetic activity, which cause the time between heart beats to become shorter, are associated with heart rate increases, while increases in parasympathetic activity cause the heart rate to decrease by increasing the R-R interval. Sympathetic effects, usually taking seconds to respond, are slow in comparison to the parasympathetic effects, which take milliseconds. Therefore, parasympathetic influence is responsible for making the rapid changes in the timing of the heart (102). An increase in parasympathetic activity is also expected with deep breathing and low respiration rates (103). HRV offers a non-invasive quantitative method of investigating autonomic effects on the heart and has been increasingly used as an index of affect regulation (104-106). In general, higher vagally-mediated HRV is associated with positive health outcomes (106,107). Yoga programs are reported to result in increased parasympathetic nervous system (PNS) activity and significantly improved cardiac autonomic function (108). Streeter and colleagues (2012) hypothesize yoga practice corrects PNS under-activity via stimulation of the vagus nerves to ameliorate stress-related illness symptoms (109). One potential mechanism of action is that the conscious regulation of breathing practiced in yoga may influence autonomic function by regulating the balance of sympathetic and parasympathetic activation, the latter increasing as the breath deepens and slows (110,111). Yoga practice also appears to result in increased vagal modulation and control over autonomic responses such as heart rate (112,113). During active poses, heart rate and respiration may increase consistent with exercise (114). However, during and 19 following the restful supine and seated meditative postures that conclude most yoga classes, parasympathetic activity consistent with a reduction in physiological arousal is apparent (115). 1.3.4.1 Neurovisceral Integration Model. The Neurovisceral Integration Model integrates affective, attentional and autonomic systems into a theoretical structure that aids in understanding affect regulation (106). This model suggests attention, valence and activation are vagally mediated. Specifically, the Neurovisceral Integration Model links the dimensions of valence, activation and attention via cardiac autonomic function, specifically PNS function, as measured by heart rate and HRV. Research utilising the Neurovisceral Integration Model has demonstrated those with lower HRV are at risk for both psychological and physiological dysfunction (116) and, ultimately, increased morbidity and mortality (117). In exercise settings, evidence suggests sedentary lifestyles result in negative mood symptoms, especially feelings of fatigue and depressive symptoms, which are related to decreases in PNS function (118). Conversely, regular exercise induces training adaptation in ANS, particularly greater parasympathetic modulation of cardiac function (119). Daily exercise also improves positive affect by shifting autonomic balance to parasympathetic predominance (118). We chose to examine the Neurovisceral Integration Model for two reasons: 1) given the linkage between yoga’s benefits and HRV, it was important to include a model which used HRV as its primary indicator; and 2) both Dual Mode Theory and the EffortRelated Attention Model suggest affective experiences in exercise settings are driven by the physiological intensity of exercise. Common physiological indices of this intensity are ventilatory and lactate thresholds. However, from an exercise physiology perspective, 20 yoga practice is generally considered low-intensity and occurs below lactate or ventilatory threshold (120). Given this intensity, we required an additional theoretical model and accompanying physiological measure sensitive to lower-intensity exercise changes. The Neurovisceral Integration Model figures prominently in Chapter 4. 1.3.5 Neurophenomenology The current research is concerned with the phenomenological lived experience of contemporary yoga practice, related psychosocial health outcomes and potential mechanisms of action. We are particularly interested in examining these phenomena within the practice of yoga via the lens of neurophenomenology, a convergent mixed methods research approach that combines qualitative subjective first-person narratives, quantitative self-reports and physiological data to develop a layered descriptive research approach to conscious experience (121). Specifically, the inclusion of subjective first-person descriptions of the phenomena in question are with the express aim of further describing these events of consciousness and how they pertain to the quantitative measures (122). These reports are useful for identifying physiological variability in responses to stimuli from moment to moment. It is believed these descriptions provide unique information that aid in the interpretation of physiological processes. The strategy of neurophenomenology is to provide mutually informative insights between first-person and neurophysiological accounts as a means of generating new data in the exploration of consciousness (123). The importance of contemplative mental training is central to this novel research approach and has been used extensively in examining contemplative practices (55) using fMRI and EEG investigative methods (124-128). 21 Despite use of neurophenomenology in the field of meditation and contemplative studies (129), this approach had not been used previously in a yoga setting prior, nor had HRV been used as the primary neurophysiological indices. This overarching methodological approach features prominently in Chapter 4. 1.4 Research Objectives Taking Patanjali’s definition that yoga is the, “stilling of the fluctuations of the mind (YS 1.2)” as a guide, we suggest the benefits of yoga practice experienced in cancer settings are related to mechanisms of affect, attention-mindfulness and regulation of the autonomic nervous system. The Circumplex Model of Affect, Dual Mode Theory, EffortRelated Attention Model, construct of Mindfulness, Neurovisceral Integration Model, and Neurophenomenology helped further encapsulate these mechanisms of action. Based on the premise that: 1) yoga’s primary purpose is to control the mind via 2) affect and attention regulation and its autonomic correlates, leading to 3) improved HRQL and mental health outcomes, three studies were developed to examine the relations between yoga practice, affect and attention regulation in cancer settings. The current research examines: 1) the clinical significance of patient–reported outcomes from yoga interventions for cancer survivors; 2) associations between yoga participation, affect, mindfulness and health outcomes in cancer survivors longitudinally in an ongoing community-based yoga program; and 3) associations between core affect, attention, perceived exertion and cardiac activity in a single yoga session for cancer survivors. Study objectives were as follows: 22 1.4.1 Study 1 (Clinical Significance Review) Objective 1a: Examined how yoga programs have been offered in cancer settings and what outcomes were measured. Objective 1b: Examined whether yoga improved measured outcomes and by what magnitude using measures of clinical significance. 1.4.2 Study 2 (Longitudinal Study) Objective 1a: Examined potential changes in valence, activation, and attention pre-post each class of a seven-week yoga intervention. Objective 1b: Examined whether potential changes in valence, activation and attention were related to one another or moderated by baseline affect or mindfulness Objective 2a: Examined changes pre-post and at three- and six-month follow-up, in measures of mood disturbance, stress symptoms and HRQL as well as proposed predictor variables, including affect and mindfulness Objective 2b: Examined whether potential improvements in mood disturbance, stress symptoms and HRQL were longitudinally associated with concurrent changes in affect and mindfulness Objective 3a: Examined whether participants maintained their yoga practice longitudinally, pre-post and three- and six-month follow-ups. Objective 3b: Examined whether maintenance of yoga practice was associated with mood disturbance, stress symptoms and HRQL as well as proposed predictor variables, including affect and mindfulness. 1.4.3 Study 3 (Lab Study) Objective 1a: Examined changes in valence, activation, attention and perceived exertion during a single yoga session as well as associated measures of cardiac activity, including heart rate and HRV. Objective 1b: Examined whether changes in valence, activation, attention and perceived exertion are related to one another and/or changes in 23 cardiac activity. Objective 1c: Examined whether changes in valence, activation, attention, perceived exertion and cardiac activity were related to subjective first-person descriptions of the single yoga session. Objective 2a: Examined whether significant changes in dimensions of affect, including measures or energy, tension, tiredness and calmness, occur pre-post yoga class. Objective 2b: Examined whether changes in dimensions of affect were related to one another and/or to concurrent changes in valence, activation, attention, perceived exertion, and cardiac activity. Objective 2c: Examined whether changes in affect were related to subjective first-person descriptions of the yoga session. 1.5 Significance Little attention has been paid to the mechanisms by which health benefits from yoga practice accrue and the experience of yoga has not been studied within these theoretical frameworks or using this integrated methodology to date. This research develops current theory in yoga practice, affect and attention regulation by modelling processes and outcomes, resulting in a detailed exploration of yoga in cancer settings. Examining these proposed theoretically-based mechanisms for yoga’s salutary effects enables understanding not only of “if” yoga works, but also “how.” This research provides a foundation to more fully examine the use of yoga in cancer settings. This knowledge can then be transferred directly back into the community to further develop innovative yoga programs and best practices, with the express aim of improving HRQL and mental health in cancer survivors. 24 CHAPTER 2: YOGA AND CANCER INTERVENTIONS: A REVIEW OF THE CLINICAL SIGNIFICANCE OF PATIENT REPORTED OUTCOMES FOR CANCER SURVIVORS 25 2.0 Abstract Limited research to date suggests yoga may be a viable gentle physical activity option with a variety of health-related quality of life, psychosocial and symptom management benefits. The purpose of this review was to determine the clinical significance of patient-reported outcomes from yoga interventions conducted with cancer survivors. A total of 25 published yoga intervention studies for cancer survivors from 2004-2011 had patient-reported outcomes, including quality of life, psychosocial or symptom measures. Thirteen of these studies met the necessary criteria to assess clinical significance. Clinical significance for each of the outcomes of interest was examined based on 1 standard error of the measurement, 0.5 standard deviation, effect sizes and their respective confidence intervals. This review describes in detail these patientreported outcomes, how they were obtained, their relative clinical significance and implications for both clinical and research settings. Overall, clinically significant changes in patient-reported outcomes suggest yoga interventions hold promise for improving cancer survivors’ well-being. This research overview provides new directions for examining how clinical significance can provide a unique context for describing changes in patient-reported outcomes from yoga interventions. Researchers are encouraged to employ indices of clinical significance in the interpretation and discussion of results from yoga studies. 26 2.1 Introduction Physical activity is widely accepted as beneficial for cancer survivors both on and off treatment (130). It is recommended adult cancer survivors engage in the same amount of physical activity as healthy older adults, with adaptations made as necessary (23). This recommendation is supported by a substantive amount of evidence documenting the beneficial effects of physical activity on quality of life, psychosocial and physical/symptom outcomes (130). Within this growing body of physical activity and cancer research, there have been calls to examine modes of physical activity from the area of complementary medicine as a means of improving participation rates and longterm adherence (29). This approach is particularly important when considering potential additional barriers experienced during a cancer diagnosis, its subsequent treatments, and ongoing recovery (29,131). Yoga is quickly emerging as an important complementary medicine therapeutic approach for cancer survivors. Ross and Thomas’ (48) review of exercise and yoga highlights that yoga is as beneficial as more traditional types of physical activity at improving a variety of health-related outcome measures (with the exception of physical fitness outcomes) in both healthy individuals and those with various health conditions (e.g., cancer). It concludes that yoga is a potentially beneficial gentle form of physical activity for cancer survivors and continues to receive growing research attention in cancer populations (48). Additionally, four recent reviews have summarized findings specifically on yoga for cancer (2,33,51,132). Smith and Pukall (33) conducted the first systematic review of the yoga and cancer research to date. This review reported both the characteristics and 27 effect sizes of ten studies, including six randomized controlled trials. The authors documented large variability across studies (i.e., yoga type, population, sample size, intervention duration) as well as methodological limitations. Despite these issues, generally positive results, especially in terms of psychological outcomes, were noted based on a calculation of effect sizes and narrative summary of reported results. In addition, a recently published meta-analysis aimed to determine effects of yoga on quality of life, psychological and physical health in cancer survivors (2). Ten studies were examined, including both yoga and mindfulness-based stress reduction (MBSR) interventions, due to the inclusion of yoga in MBSR. Although the results are preliminary and should be interpreted cautiously, intervention groups showed significantly greater improvements in psychological health than waitlist or supportive therapy control groups (2). Results were inconclusive for quality of life and physical health outcomes. Undoubtedly, research examining yoga for cancer survivors is in its infancy. However, as research in this area continues to rapidly grow and yoga is increasingly integrated into cancer care, it is imperative the clinical benefits of yoga for cancer survivors are better understood and emphasized within clinical and post-treatment survivorship care. Thus the focus of the current study is to better determine the implications of the existing research on yoga for cancer survivors by evaluating additional indicators of clinical significance. Reviews of the research on yoga for cancer survivors to date have relied on the interpretation of effect sizes and subjective observation of trends. Subjective interpretation of trends is often heavily influenced by reporting of the p-value, which is commonly used as a statistical indicator of the benefits of an intervention. However, the P-value, often set at .05, indicates only whether or not observed changes are large enough 28 to conclude that such differences were not caused by chance (133). In addition, the Pvalue is largely contingent on sample size, with larger studies more likely to report statistical significance. Clinical significance, or minimal clinically important difference (MCID), may not involve statistical significance (134) and is considered a marker of the effectiveness of interventions that takes into account the practical importance of treatment effects (135). Clinical significance also gives meaning to observed changes in terms of their implications for patient care (136,137). In the case of the current review, clinical significance may also be used as a comparative metric of treatment effects between studies. There are a number of widely accepted assessments of the clinical significance of change in an intervention, using both anchor-based (i.e., clinical) and distribution-based (i.e., statistical) assessments (135,137). Anchor-based approaches are methods that relate change to an external event, rating, or condition, while distribution-based methods link clinical significance to a statistical parameter of group or individual data (137). Examination of the yoga and cancer intervention literature reveals minimal reporting of anchor-based metrics. Given this an anchor-based approach for understanding clinical significance was not employed in the current overview of the literature. Commonly reported distribution-based methods include one standard error of the measurement (1 SEM), 0.5 standard deviation (0.5 SD), and effect sizes. The SEM provides an index that incorporates both the variation and reliability of a sample on any measure expressed in the original metric of the measure it describes (138). When examining the mean difference from pre to post intervention, a value greater than 1 SEM is considered clinically significant. One SEM has been shown to consistently correlate 29 with anchor-based measures of important difference and with an effect size of 0.5, if the reported reliability is ≥0.75 (138). Caution must be used in interpreting the SEM, as this criterion is often predetermined from other studies and may not be derived directly from the study sample. Second, the assessment of the clinical significance is often determined using 0.5 SD of the baseline measure as a “rule of thumb” or guideline (139,140). Specifically, prepost mean differences larger than 0.5 SD on that scale are considered clinically significant. It has been suggested (135) the 0.5 SD is best used as an indicator of “meaningful difference” versus “minimal difference,” suggesting a change that cannot be ignored. Third, effect size (ES) is a simple way of quantifying the differences between two groups, and by association, how large a clinical response is observed (141). Helpful exploratory criteria are Cohen’s convention of 0.20 for a small effect, 0.50 for a moderate effect and 0.80 for a large effect (142). Of note, 0.5 SD of the pre-intervention score (in the case of pre-post within subjects) or 0.5 of control baseline (in the case of betweengroups) can equate with 0.50 ES (provided these measures are calculated using these same baseline measures as the denominator). Finally confidence intervals (CI) provide a range of possible scores for a population parameter. Thus, in the case of the oft reported 95% CI, we can be 95% confident that the CI includes the population parameter (143). The width of the CI reflects the precision of the data, with more narrow confidence intervals being more precise. CIs are not just a surrogate for P-value reported statistical significance, as they also give us a window into both the size of the difference and precision in estimating the true difference (144). 30 In all cases, it is important not to use these indices (1 SEM, 0.5 SD, ES, CI) in the way P-values often are: as arbitrary cut-off values of a study’s given significance (145). Rather, these values should be used concurrently to triangulate on and describe the range of one’s findings, their relative magnitude of effect and generalizability. Such a thorough examination of the clinical significance of published studies on yoga for cancer survivors has not been completed to date. The purpose of this paper was to clarify how findings from yoga interventions for cancer survivors should be interpreted by implementing multiple methods for calculating clinical significance of patient-reported outcomes, including measures of general quality of life, psychosocial factors and symptoms. Interpretation of the studies’ findings consisted of examining both within group pre-post change in both control and pre-post design studies, as well as determining the magnitude of difference between treatment and control groups in control design studies. Factors that may influence clinical significance related to the study design, sample, specific intervention and method of measurement were also documented. 2.2 Methods 2.2.1 Selection of Publications. This literature review of yoga interventions for cancer survivors, both on and off treatment, was completed in July 2011. To this end, a systematic search was conducted of the relevant databases, including PubMed, PsychInfo, Medline, Annotated Bibliography of Indian Medicine, Cochrane Library, Web of Science, and Google Scholar. Key search terms included yoga, cancer, survivor, patient, intervention, quality of life, well-being, clinical significance, important change(s), important difference(s), and/or patient reported outcomes. The following inclusion criteria were applied to the search: (1) must 31 include a yoga intervention; (2) have a sample of exclusively adult cancer survivors (on or off treatment); (3) report at least pre- and post-intervention assessments; and (4) include patient-reported outcomes related to quality of life, psychosocial and/or symptom outcomes. Publications were excluded if they incorporated intervention components in addition to yoga (e.g., MBSR, comprehensive lifestyle change programs, physiotherapy), were published in a non peer-reviewed journal, or were not written in English. 2.2.2 Data Synthesis The common indices of clinical significance used in the current overview were: (1) 1 standard error of the measurement (1 SEM); (2) 0.5 standard deviation (0.5 SD); and (3) both within and between-group difference effect sizes (ES - Hedge’s g) and their respective confidence intervals (CI). In order to examine the clinical significance of findings for each yoga intervention study, both pre-post means and the SDs or SEs had to be available in order to calculate 1 SEM, 0.5 SD, ES and CI. No follow-up time periods (if included) were analyzed, and only published data were accessed. From the initial 19 eligible publications, a further six were dropped because: (a) SDs or SEs were not available; or (b) the same data were reported in duplicate publications. Data were extracted to examine changes pre-post intervention in both the yoga and control groups, as well as the relative difference between groups in the case of control design studies. Clinical significance was determined using the following criteria. First, the SEM was calculated as (pre-intervention SD * √1 – Cronbach’s alpha). If the Cronbach’s alpha was not cited in the study it was derived from either a clinically relevant population, or from prior psychometric evaluations of the instrument. Second, 0.5 SD values were calculated from the baseline SD. Third, ES were calculated using Hedges g for both within-groups 32 effects (post-pre/pooled SD) and between-groups effects (treatment mean differencecontrol mean difference/pooled change SD). These effects were interpreted following Cohen’s convention of small (0.2), medium (0.5), and large (0.8) (142). Fourth, CIs were calculated for both treatment and control within-subjects mean differences, betweengroups mean differences and their accompanying ES. ES and CIs were calculated using Comprehensive Meta-Analysis (Version 2) software (146). Pre-post differences were evaluated based on their respective 1 SEM, 0.5 SD ES, and CI, while between-group differences were evaluated based on the control group 1 SEM, 0.5 SD and the betweengroups calculated ES and CI. Finally, given the aforementioned correlation between 1 SEM and an effect size of 0.5 if the reported reliability is ≥ 0.75 (138), the Pearson product-moment correlation coefficients were calculated to determine the strength of the linear dependence between the 1 SEM and 0.5 SD. As the primary purpose was to evaluate patient-reported outcomes in the yoga literature and given the comparatively small number of studies, no computation of study quality was completed in the current review. In addition, given the focus on a number of different indices of clinical significance, the small number of studies and heterogeneity in terms or type of yoga, dose-response, length of intervention and outcome measures, average effect sizes across studies were not calculated nor meta-analyses performed. Although we intended that the literature search be inclusive of all existing studies, it did not follow other methods necessary to be considered a systematic review so as not to be redundant with other recent publications (2,33). 33 2.3 Results 2.3.1 Description of Studies The initial literature search resulted in a total of 25 publications. A review of abstracts reduced the final number to 19 publications based on the inclusion and exclusion criteria. Of the 19 publications reviewed, 14 contained enough data to be included in this review and are summarized in Tables 2.1 and 2.2. Note that Vadiraja 2009a (80) and Vadirja 2009b (147) are from the same study sample and are therefore reported as one study. The resulting 13 studies included a variety of yoga interventions (with respect to type of yoga and duration), cancer types, and timing and content of assessments. Seven of the 13 studies employed a randomized controlled trial design, including a control group for comparison to the yoga intervention (n=6 with a waitlist control group, n=1 with an active control group). Six studies were single-group pre-post designs. Tables 2.3 through 2.8 details all study results. 2.3.1.1 Study Designs. In the randomized controlled trial studies, mean age ranged from 46-60 years. Sample size in the treatment group at time 2 ranged from 13-45 participants. Cancer diagnoses were comprised primarily of breast cancer, with one study focused on lymphoma. Many participants were on active treatment or, in some cases, three months or more post-treatment. In the case of Moadel et al. (148) we reported on their secondary analysis that focused on women with breast cancer who were not receiving chemotherapy. Yoga classes were 60-90 minutes in length, and programs lasted 6 to 26 weeks. Yoga styles included Hatha, Integral, Iyengar, Tibetan, Viniyoga, and Vivekananda. The majority of control designs employed a waitlist control group except 34 the Vadiraja study (80,147), which utilized an active supportive therapy with education control group. In the single group design studies, mean age ranged from 41-59 years. Sample size at time 2 ranged from 10-43 participants. Cancer diagnoses were comprised primarily of breast cancer, with one study focused on ovarian cancer. Many participants were on active treatment or, in some cases, six months or more post-treatment. Yoga classes were 60-90 minutes in length and programs lasted 6 to 10 weeks. Yoga styles included Integral, Iyengar, and “classical” yoga. 2.3.1.2 Instruments Reviewed. A total of 18 different instruments, assessing patient-reported outcomes in health-related quality of life (HRQL; six instruments), psychosocial (eight instruments) and symptom domains (four instruments) were reviewed. We acknowledge there is some overlap in HRQL and psychosocial constructs. For the sake of simplicity and parsimony, we left HRQL subscales in the HRQL category even if they capture psychosocial constructs such as social or emotional well-being. Further, in order to minimize the number of categories of patient-reported outcomes, we included spiritual well-being in the psychosocial category. Tables 2.3 through 2.8 present a summary of the clinical significance for the patient-reported outcomes in the 13 reviewed studies and is divided into control design and pre-post single group design studies. Each table further distinguishes between patient-reported outcome categories – HRQL, Psychosocial and Symptom variables. 2.3.2 Quality of Life Outcomes 2.3.2.1 Overall HRQL. Two control design studies, Danhauer et al. (79) and Culos-Reed et al. (149) met the 1 SEM and 0.5 SD criteria both pre-post and between 35 yoga intervention and waitlist control. Medium between-group ES, ranged from 0.49 [95% CI -0.25, 1.24; p=NS] (79) to 0.67 [95% CI 0.01, 1.32; p<.05] (149). Moadel et al. (148), while showing no evidence of clinically significant change pre-post, met the 1 SEM criteria with an overall small ES of 0.43 [95% CI -0.05, 0.91; p=NS], reflecting improvement in overall HRQL in the yoga group versus a worsening in the control group. Littman et al. (150) showed no significant differences either pre-post or between-groups. In single group design studies (151-156) clinically significant outcomes ranged from a small ES of 0.39 [95% CI -0.08, 0.86; p=NS] meeting the 1 SEM criteria (155), to a large ES of 0.81 [95% CI 0.14, 1.48; p<.05] (154), that met both 1 SEM and 0.5 SD criteria. Interestingly, overall HRQL in Danhauer et al. (152), while statistically significant (p<.05) with a small ES of 0.32 [95% CI 0.02, 0.63], met neither the 1 SEM nor 0.5 SD criteria. 2.3.2.2 Physical HRQL. Only two control design studies, Chandwani et al. and Danhauer et al. (79,157), showed evidence of clinically significant differences. While both studies did not exhibit clinically significant pre-post changes, both studies showed clinically significant effects between groups that met the 1 SEM criteria, with small ES, ranging from 0.36 ES [95% CI -0.38, 1.10; p=NS] (79) to 0.46 ES [95% CI -0.06, 0.97; p=NS] (157). Interestingly, although there was clinically significant change on the FACT physical wellbeing subscale in Danhauer et al. (79), there was no significant change on the SF-12 physical wellbeing subscale. Several other control design studies (80,148,150) exhibited no clinically significant differences in physical HRQL, either pre-post or between groups. Within the single-group design studies, only the Ülger and Yağli study (156) showed a large ES of -0.92 [95% CI -1.43, -0.41; p<.001] and met both the 1 SEM 36 and 0.5 SD criteria, indicating significant improvements in physical HRQL pre-post yoga intervention. Speed-Andrews et al. (155) met the 1 SEM criteria with a small ES of 0.32 [95% CI -0.14, 0.79; p=NS]. Interestingly, Danhauer et al. (152) met neither 1 SEM nor 0.5 SD but was statistically significant (p<.05) with an effect size of 0.38 [95% CI 0.07, 0.68] on the FACT physical wellbeing subscale. There was no significant change on the SF-12 physical wellbeing subscale. 2.3.2.3 Mental HRQL. Large effects were seen in control group designs for Danhauer et al. (79) with pre-post and between-group mean differences meeting both 1 SEM and 0.5 SD criteria, with a between group ES of 1.00 [95% CI 0.22, 1.78; p<.01]. Vadiraja et al. (80) did not meet the 1 SEM or 0.5 SD criteria but reported a statistically significant (p<.05) ES of 0.30 [95% CI 0.00, 0.61] pre-post yoga intervention. There were no clinically significant differences between groups. There were also no significant differences either pre-post or between groups in Chandwani et al. (157). In single group designs, Danhauer et al. (152) pre-post differences did not meet the 1 SEM or 0.5 SD criteria but reported a statistically significant (p<.01) ES of 0.41 [95% CI 0.11, 0.72]. Speed Andrews et al. (155) demonstrated a small clinically significant difference meeting the 1 SEM criteria with an effect size of 0.45 [95% CI -0.03, 0.93; p=NS]. 2.3.2.4 Emotional HRQL. Values ranged from meeting both the 1 SEM and 0.5 SD criteria pre-post and between groups, with ES from 0.53 [95% CI 0.07, 0.99; p<.05] (80), to 0.61[95% CI -0.15, 1.35; p=NS] (79), between groups. There were no clinically significant differences pre-post for either Moadel et al. (148) or Culos-Reed et al. (149), however both exhibited between-group differences. Culos-Reed et al. (149) exhibited a small ES of 0.48 [95% CI -0.16, 1.13; p=NS] between groups that met both the 1 SEM 37 and 0.5 SD criteria. Moadel et al. (148) met neither 1 SEM nor 0.5 SD criteria but demonstrated a small statistically significant (p<.01) pre-post ES of 0.40 [95% CI 0.10, 0.70]. There were no differences between groups. Littman et al. (150) demonstrated no clinically significant differences either pre-post or between groups. Within single subject designs, Ülger and Yağli (156) reported large pre-post differences that met both 1 SEM and 0.5 SD with an effect size of -1.15 [95% CI -1.70, -0.60; p<.001]. There was no clinically significant differences pre-post yoga intervention for either Danhauer et al. (152) or Speed-Andrews et al. (155). 2.3.2.5 Social HRQL. The majority of control design studies (79,80,150) report no clinically significant differences either pre-post or between yoga and waitlist control groups. Interestingly, Moadel et al. (148) demonstrated a moderate, clinically significant decline in the waitlist control group, with an ES of -0.60 [95% CI -1.00, -0.19; p<.01]. This led to a moderate between group difference of 0.60 ES [95% CI 0.11, 1.09; p<.05], which met both the 1 SEM and 0.5 SD criteria, indicating a relative improvement in social HRQL for the yoga group versus a worsening of the waitlist control group. Within the single group designs, Ülger and Yağli (156) demonstrated a moderate clinically significant difference of -0.74 ES [95% CI -1.22, -0.26; p<.01], meeting both the 1 SEM and 0.5 SD criteria, while Danhauer et al. (152) and Speed-Andrews et al. (155) demonstrated no clinically significant differences in social HRQL pre-post yoga intervention. 2.3.2.6 Functional HRQL. Only Danhauer et al. (79) reported pre-post improvement in Functional HRQL, with a moderate between-group ES of 0.58 [95% CI 0.17, 1.34; p=NS] that met both 1 SEM and 0.5 SD criteria. Littman, Moadel, and 38 Vadiraja, (80,148,150) indicated no clinically significant differences either pre-post or between yoga and waitlist control groups. Similarly no clinically significant differences are reported pre-post within single group designs (152,155). 2.3.3 Psychosocial Outcomes 2.3.3.1 Depression. Clinically significant differences ranged from small, with a between-groups ES of -0.39 [95% CI -1.04, 0.25; p=NS], that met the 1 SEM criteria (149) to medium, with a between groups ES of -0.69 [95% CI -1.45, 0.06; p=NS], meeting both 1 SEM and 0.5 SD criteria (79). Interestingly in the case of Vadiraja et al. (147) large clinically significant differences within the yoga group, -0.89 ES [95% CI 1.25, -0.54; p<.001], and small clinically significant differences within the supportive therapy control group, -0.40 ES [95% CI -0.74, -0.05; p<.05], indicated significant depression reduction in both groups. This led to a medium overall ES, -0.52 ES [95% CI -0.98, -0.06; p<.05] that met both the 1 SEM and 0.5 SD criteria, favoring overall depression reduction in the yoga group relative to the supportive therapy control. Within the Chandwani et al. study (157), small clinically significant differences in the yoga group, -0.48 ES [95% CI -0.86, -0.09; p<.05], and small clinically significant differences in the waitlist control group, -0.32 ES [95% CI -0.67, 0.03; p=NS], also indicated significant depression reduction in both groups. However, there were no overall clinically significant differences in depression reduction between yoga and waitlist control groups. Within the Cohen et al. (158) study there were no clinically significant differences in depression reduction pre-post or between groups. Within single group designs, ES ranged from small, -0.36 ES [95% CI -0.66, -0.05; p<.05] meeting the 1 SEM criteria (152), to large, -1.00 ES [95% CI -1.69, -0.32; p<.01] meeting both the 1 SEM and 0.5 SD (151). 39 In the case of Speed-Andrews et al. (155) no clinically significant differences in depression were indicated pre-post yoga intervention. 2.3.3.2 Anxiety. Within the control designs, Vadiraja et al. (147) indicated moderate clinically significant differences, with an overall between-groups ES of -0.51 [95% CI -0.97, -0.05; p<.05] that met the 1 SEM criteria. Chandwani et al. (157) indicated moderate clinically significant differences within the yoga group, -0.63 ES [95% CI -1.04, -0.23; p<.01] and small clinically significant differences in the waitlist control group, ES -0.20 [95% CI -0.55, 0.15; p=NS], indicating anxiety reduction in both groups. Overall, small clinically significant differences between yoga and waitlist control, with an ES of -0.46 [95% CI -0.98, 0.05; p=NS] that met both the 1 SEM and 0.5 SD criteria, suggest relative overall anxiety reduction in the yoga group relative to the waitlist control. Interestingly, within the Cohen et al. study (158), small clinically significant differences, with an ES of -0.30 [95% CI -0.80, 0.21; p=NS] that met the 1 SEM criteria; indicate significant overall anxiety reduction in the waitlist control versus the yoga group. Within single group designs Ülger and Yağli (156) demonstrated large clinically significant reductions in anxiety, -1.51 ES [95% CI -2.14, -0.88; p<.001] that met both the 1 SEM and 0.5 SD criteria. Danhauer et al. (152) indicated small clinically significant reductions in anxiety, with an ES of -0.22 [95% CI -0.52, 0.08; p=NS] that met the 1 SEM criteria. No clinically significant differences were reported in SpeedAndrews et al. (155). 2.3.3.3 Positive Affect. Danhauer et al. (79) demonstrated a small clinically significant effect of 0.45 ES [95% CI -0.29, 1.19; p=NS] that met the 1 SEM criteria between yoga and waitlist control groups. Vadiraja et al. (80)reported a moderate 40 clinically significant effect pre-post yoga intervention of 0.52 ES [95% CI 0.20, 0.84]. However, although statistically significant (p<.001), the between-group difference met neither the 1 SEM nor 0.5 SD criteria. Within the single group designs, there were no significant differences in positive affect pre-post yoga intervention. 2.3.3.4 Negative Affect. Within the Danhauer et al. study (79), moderate clinically significant differences between groups, -0.73 ES [95% CI -1.49, 0.03; p=NS] meeting both the 1 SEM and 0.5 SD criteria, indicated significant overall reduction in negative affect in the yoga group. Within the Vadiraja et al. study (80), large clinically significant differences within the yoga group, -0.86, ES [95% CI -1.21, -0.51; p<.001] and small differences within the supportive therapy group, -0.33 ES [95% CI -0.67, 0.01; p=NS] suggested there was a clinically significant reduction of negative affect in both groups. However, moderate clinically significant differences between groups, -0.57 ES [95% CI -1.03, -0.11; p<.05], that met both the 1 SEM and 0.5 SD criteria, suggest a significant overall reduction of negative effect in the yoga group relative to the supportive therapy control group. In the single group study designs, Danhauer et al. (152) met neither the 1 SEM nor 0.5 SD criteria but did exhibit a statistically significant (p<.05) ES of -0.35 [95% CI - 0.65, -0.04]. 2.3.3.5 Spiritual Well-Being. In Danhauer et al. (79) moderate clinically significant differences, 0.56 ES [95% CI -0.19, 1.30; p=NS] meeting both the 1 SEM and 0.5 SD criteria, indicated an increase in spiritual well-being in the yoga versus waitlist control group. Within the Moadel et al. study (148) there were no clinically significant differences in spiritual well-being pre-post or between groups. Within the single group designs moderate clinically significant differences, 0.60 ES [95% CI 0.16, 1.04; p<.01] 41 were reported pre-post yoga intervention (153). There were no clinically significant differences in spiritual well-being pre-post yoga intervention in Danhauer et al. (152). 3.4 Symptom Outcomes 2.3.4.1 Fatigue. Within the control group designs (79,148,150,157,158) clinically significant differences between the yoga intervention and control groups ranged from small ES, -0.17 ES [95% CI -0.68, 0.34; p=NS], meeting the 1 SEM criteria (157) to medium ES, 0.71 ES [95% CI -0.04, 1.47; p=NS], meeting both the 1 SEM and 0.5 SD criteria (79). In the case of Cohen et al. (158) there were no clinically significant differences in fatigue pre-post or between yoga and control groups. Within the single group designs, effect sizes ranged from small, 0.22 ES [95% CI -0.08, 0.52; p=NS] meeting the 1 SEM criteria (152), to very large, -2.34 ES [95% CI -3.47 to -1.22; p<.001] meeting both the 1 SEM and 0.5 criteria (151). 2.3.4.2 Sleep. In the case of Danhauer et al. (79) despite small clinically significant differences pre-post, ES -0.46 ES [95% CI -1.00, 0.08; p=NS] there were no overall clinically significant differences in sleep between the yoga and waitlist control groups. There were no clinically significant differences in sleep pre-post or between groups in the Chandwani or Cohen studies (157,158). In the single group designs, there was a large effect, -0.88 ES [95% CI -1.38, -0.38; p<.001] meeting both 1 SEM and 0.5 SD requirements, for sleep pre-post yoga intervention (156). In the case of Bower et al. (151) there were no clinically significant differences in sleep pre-post yoga intervention. 3.5 Clinical Significance Criteria 2.3.5.1 Consistency between SEM and SD. Within the control group designs, the correlation between the 1 SEM and 0.5 SD criteria for HRQL indices was r=.92, p<.01 42 for the treatment group and r=.93, p<.01 for the control group. For the single group designs the correlation between 1 SEM and 0.5 SD was r=.92, p<.01, indicating these criteria are highly correlated. For psychosocial indices within the control group designs, the overall correlation between the 1 SEM and 0.5 SD criteria was r=.74, p<.01for the treatment group and r=.83, p<.01 for the control group. For the single group designs the correlation between 1 SEM and 0.5 SD was r=.80, p<.01, indicating these criteria are also highly correlated. Similarly, for the symptom indices, within the control group designs, the overall correlation between the 1 SEM and 0.5 SD criteria was r=.91, p<.01for the treatment group and r=.91, p<.01 for the control group. Finally, for the single group designs the correlation between 1 SEM and 0.5 SD was r=.97, p<.05, indicating these criteria are highly correlated. 2.4 Discussion The yoga and cancer literature is rapidly growing. This literature is characterized by studies published with small sample sizes and variability in the type and length of interventions, populations studied (e.g., cancer type, time during the treatment continuum), and measures used to assess the patient-reported outcomes of interest. Thus, to accurately characterize the results of the current literature in this area, reporting multiple indicators of clinical significance is of great value (159). Studies evaluated for clinical significance show some consistency across this research, demonstrating the positive impact of yoga on quality of life, psychosocial and, to a lesser degree, physical symptom indices. Since this area of research is in its infancy, it is helpful to utilize multiple criteria of clinical significance to explore the clinical efficacy of results from each study. The use 43 of not only ES and CIs, but also validated metrics such as the 1 SEM and 0.5 SD criteria is recommended. A cursory look at the summary tables would indicate that to examine any of these studies by one criterion alone, particularly in the case of P-values, much information and insight into the results would be lost. Based on the current review, we see emerging beneficial findings from yoga interventions in the areas of HRQL, including overall HRQL and its mental and emotional domains, and in psychosocial measures in the areas of anxiety, depression, negative affect and spiritual well-being. There may also be some preliminary evidence for yoga’s role in fatigue. Findings for the role of yoga in physical, functional and social domains of HRQL remain far more inconclusive, as is the role of yoga in positive affect and sleep indices for cancer survivors. Thus, considering clinical significance indicates stronger support than previous reviews of the literature for the preliminary efficacy of yoga for improving overall HRQL and its mental and emotional domains, in addition to psychosocial outcomes (2,33). The present review highlights that yoga for cancer survivors results in a number of clinically significant improvements in select patient-reported outcomes. Specifically, multiple criteria, including a mean difference from pre- to post-intervention greater than or equal to 1 SEM and/or 0.5 SD, and the respective ES and CI, were met for quality of life and psychosocial outcomes (e.g., anxiety, depression, positive and negative affect, spiritual well-being), and for some limited symptom outcomes (e.g., fatigue, sleep). These results suggest that indices vary in their sensitivity / conservatism for reporting clinical significance. For example, in cases where research participants patient-reported outcome pre-scores are sub-clinical or it has been established that smaller changes in patient-reported outcomes would be beneficial (e.g., palliation), using the mean 44 difference criterion of greater than 1 SEM may be a more pragmatic index of clinically significant change. In addition, researchers may want to employ the respective smaller ES with the SEM when smaller changes would be considered meaningful. 2.4.1 Baseline Cut-offs Reported in Literature One consideration for the discrepancies between clinical significance and statistical significance found for HRQL and psychosocial patient-reported outcomes may be participant baseline characteristics. Baseline health status, as reflected in patientreported outcome scores, has been shown to affect the overall responsiveness of an instrument (160). For example, if participants are several months post treatment, they may report pre-intervention scores that are relatively high (positive). Thus, there is less “room” for improvement and a ceiling effect is encountered on a given outcome. The patient cannot score any higher and so a given level of change necessary for clinical significance is not obtained (137). Therefore, improvements in patient-reported outcomes must be contextualized within participant baselines scores. While beyond the scope of this manuscript, the baseline values of all HRQL, psychosocial, and symptom measures varied for each study in comparison to established clinical cut-offs, where available. Clinical cut-off values are established to distinguish between people who have a clinically important level of the construct and to enable comparison between studies. Thus studies that had more room for improvement at baseline, which can be judged in comparison to clinical cut-off values, may have resulted in higher levels of clinical significance. 45 2.4.2 MIDs Reported in Literature In addition to the 1 SEM, 0.5 SD and ES measures reported in the results, for some instruments, MIDs currently exist in the literature. Thus it may also be of value to compare current results to literature-reported MIDs. Utilizing a combination of distribution-based methods and MIDs reported in the literature, as they are available, allows for unique insights into both the interventions and study members. While literature-based MIDs may allow for additional ease in comparing changes across studies, they are developed based on a large cross-section of studies and may not always be appropriate given any one study (159). 2.4.3 Limitations & Future Research The current review has some limitations. First, it is important to note calculations of clinical significance do not account for elements that can be controlled by the original study design. Differences between the studies – type of yoga, duration, assessment periods, number of assessments, type of control group (waitlist vs. active comparison control), sample size, and cancer type – are all issues that should be considered in the interpretation of the results. For example, some studies may show clinically significant changes as a function of a longer duration (i.e., a time effect improvement in patientreported outcomes) rather than a direct benefit of yoga. In addition, small sample sizes may also miss important clinical differences and mask significant improvement following an intervention. In contrast, studies with large sample sizes may produce significant findings that are clinically meaningless (161). Future studies will be strengthened by the recruitment of larger, more homogenous samples to minimize this variability and lead to more consistent results. In addition, the research clearly has relied primarily on 46 participation from breast cancer survivors, and minimal published work on yoga in other groups of cancer survivors exists to date. The relative dearth of symptom-focused patient-reported outcomes illustrates a gap in the evaluation of the potential physical effects of yoga for cancer survivors. Whereas it is certainly important that yoga consistently demonstrates a positive influence on quality of life and psychosocial outcomes, research evaluation may be missing an important component of the potential benefits that may be gained in symptom alleviation, be it fatigue, sleep disturbance or pain. Future research that focuses more in-depth on assessment of symptom patient-reported outcomes, in addition to fatigue and sleep, is warranted. Comparing yoga to other types of interventions, either physical activity or psychosocial, may elucidate comparable effects or unique outcomes of yoga on patientreported outcomes in cancer survivors. Notably, yoga was not originally intended to target specific outcomes. Thus, choosing which of the many yoga practices to implement (e.g., movement, breath, meditation) and, based in part on these decisions, which psychophysiological outcomes to assess, will be an ongoing challenge in the attempt to explore this holistic ancient practice with contemporary methods of scientific exploration (48). Within this review paper a total of 18 different instruments were used to assess patient-reported outcomes, including six instruments for HRQL alone. Recent research has advocated for a more coordinated use of measures to increase validity of constructs measured as well as to ensure the reliability of comparisons (162). In this capacity, recent work by the Patient Reported Outcomes Measurement Information System (PROMIS) 47 cooperative group provides new direction in collectively and parsimoniously measuring these phenomena (163). Independent of the PROMIS initiative, the literature on yoga for cancer survivors is beginning to use some of the same measures within multiple interventions. This practice of consistent use of measures is valuable for furthering the evidence on yoga for cancer survivors. For example, recent studies have found clinically significant changes using the FACT-G and subscales, FACT-F, FACIT-Sp (79,153,155). Thus, we now have the benefit of inferring that it was not likely the measure alone, but perhaps other intervention-dependent factors, that influenced the results. In this capacity, we also strongly recommend the use of disease-specific instruments in future research. Identifying mechanisms that explain how yoga leads to clinically significant outcomes is another next step in understanding the ability of yoga to target specific desired outcomes. Little research attention has been paid to the psychophysiological mechanisms by which benefits are accrued via yoga practice. In this capacity, there have been recommendations to integrate patient-reported outcomes with biomedical endpoints as a means of better describing the complexity of these measures (62). Before yoga can be broadly applied within oncology, both a strong theoretical understanding of how yoga practice causes change and carefully designed and executed research that convincingly evaluates not only the efficacy of yoga in clinical settings but also posits potential mechanisms of action underlying these interventions are required (164). Finally, since the timing of the assessment of a patient-reported outcome may influence clinical significance, it is important for future studies of yoga to include measures that look at change before and after a single yoga practice session. Assessing 48 these more acute effects of yoga would allow for documentation of the potential immediate impact of yoga on outcomes of interest (165). 2.4.4 Conclusion There is a need across the research literature to assess a variety of indices that speak to a given study’s clinical significance, a metric relevant to researchers, clinicians, and patients alike. The current analysis supports preliminary evidence of the clinical significance of yoga for improving quality of life, psychosocial, and limited symptom outcomes in cancer survivors. It behooves researchers to take these preliminary findings as a starting point to begin to explore, report and revise these purported indices of clinical significance further (139). Identifying the clinical significance in studies of yoga for cancer survivors adds further description to the existing literature and highlights the promising intervention benefits of a yoga intervention. While this study focused specifically on one type of intervention in a defined group (i.e., cancer survivors), there is the broader issue of the need to examine and present clinical significance data for other types of intervention studies in order to ensure that “significant” findings are truly meaningful to people, impacting various health outcomes and behaviors that are important to them. Acknowledgements This work was supported by Alberta Health Services, University of Calgary Research Grant funding, the Wake Forest School of Medicine Translational Science Institute, and the National Cancer Institute (R25 CA122061-01A1). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health. Michael J. Mackenzie 49 acknowledges Social Sciences and Humanities Research Council of Canada (SSHRC) and Alberta Innovates-Health Solutions (AIHS) for funding of his doctoral program of research. Author Chandwani et al., 2010 (157) Cohen et al., 2004 (158) Culos-Reed et al., 2006 (149) Danhauer et al., 2009 (79) Sample Cancer Type and Treatment Yoga Intervention Control Group Outcome Measures Reported in Current Review Quality of Life -SF-36 Psychosocial -CES-D, STAI Symptom -BFI, PSQI Treatment: T1=30, T2=27 Control: T1=31, T2=31 Age range: 31-68 Mean age = 53 Breast (Stages 0-3) Chemotherapy (n=47) Radiation therapy (n=61) 60-minute classes twice weekly for 6 weeks Type: Vivekananda Yoga Wait-list control Treatment: T1=19, T2=16 Control: T1=19, T2=14 Age range: NR Mean age = 51 Lymphoma (Stages I - IV) Previous 12 months receiving chemotherapy Weekly classes for 7 weeks (class length not reported) Type: Tibetan Yoga Wait-list control Treatment: T1=20, T2=18 Control: T1=18, T2=18 Age range: NR Mean age = 51 Breast (n=32), Other (n=6) ≥ 3 months post-treatment 75-minute weekly classes for 7 weeks Type: Iyengar Yoga Wait-list control Treatment: T1=22, T2=13 Control: T1=22, T2=14 Age range: 38-79 Mean age = 55 Breast (Stages I-IV) Radiation therapy (n=9) Chemotherapy (n=11) 75-minute weekly classes for 10 weeks Type: Integral Yoga Wait-list control Psychosocial -CES-D, STAI Symptom -BFI, PSQI Quality of Life -EORTC QLQ-C30 Psychosocial -POMS Quality of Life -FACT-B, SF-12 Psychosocial -CES-D, PANAS, FACIT-Sp Symptom -FACT-F, PSQI Table 2.1 Studies Reviewed from the Yoga-Cancer Literature – Control Design 50 50 Author Littman et al., 2011 (150) Moadel et al., 2007 (148) Vadiraja et al., 2009a & b (80,147) Sample Treatment: T1=32, T2=27 Control: T1=31, T2=27 Age range: 33-74 Mean age = 60 Treatment: T1=45, T2=45 Control: T1=26, T2=26 Age range: 28-75 Mean age = 54 Treatment: T1=44, T2=42 Control: T1=44, T2=33 Age range: 30-70 Mean age = 46 Cancer Type and Treatment Yoga Intervention Breast (Stages 0-III) > 3 months postchemotherapy and/or postradiation 75-minute classes five times per week for 26 weeks (combination in-facility and home-based practice) Type: Viniyoga Breast (Stages I-III) Surgery (n=95) Radiation Therapy (n=10) Chemotherapy (n=27) Anti-estrogen Therapy (n=30) 90-minute weekly classes for 12 weeks. Home practice encouraged Type: Hatha Yoga Breast (Stages II-III) Radiation therapy (n=88) Minimum of 3 in-person 60minute individual yoga sessions per week for 6 weeks. Home practice encouraged. Type: Integrated Yoga Program Control Group Wait-list control Wait-list control 3-4 sessions of brief supportive therapy w/ education Outcome Measures Reported in Current Review Quality of Life -FACT-G Symptom -FACT-F Quality of Life -FACT-G Psychosocial -FACIT-Sp Symptom -FACT-F Quality of Life -EORTC QoL C30 Psychosocial -PANAS, HADS Table 2.1 – continued 51 51 Author Bower et al., 2011 (151) Sample T1=12, T2=11 Age range: 46-65 Mean age = 54 Danhauer et al., 2008 (152) T1=51, T2=43 Age range: 34-82 Mean age = 59 Duncan et al., 2008 (153) T1=24, T2=22 Age range: NR Mean age = 49 Galantino et al., 2011 (154) T1=10, T2=10 Age range: 50-71 Median age = 58 Cancer Type and Treatment Breast (Stages 0-2) All had completed radiation therapy or radiation therapy + chemotherapy Yoga Intervention 90-minute classes twice weekly for 12 weeks Type: Iyengar Yoga Outcome Measures Reported in Current Review Quality of Life -SF-36 Psychosocial -BDI-II Symptom -PSQI, FSI 75-minute weekly classes for 10 weeks Type: Integral Yoga Quality of Life -FACT-G, SF-12 Psychosocial -CES-D, FACIT-Sp, PANAS, STAI Symptom -FACT-F Breast (42%) Gynecologic (16.6%) Lymphoma (12.5%) Currently on or < 6 months post treatment 90 minute weekly classes for 10 weeks Type: Iyengar Yoga Quality of Life -FACT-G Psychosocial -FACIT-Sp Breast (Stages I-III) > 4 weeks post-chemotherapy and/or post-radiation, all women taking aromatase inhibitors 90-minute classes twice weekly for 8 weeks, home practice encouraged Type: Iyengar-inspired Quality of Life -FACT-B Ovarian (n=37) Breast (n=14) Radiation therapy (n=5) Chemotherapy (n=29) Table 2.2 Studies Reviewed from the Yoga-Cancer Literature – Single Group Design 52 52 Author Sample Cancer Type and Treatment Yoga Intervention Outcome Measures Reported in Current Review Speed-Andrews et al., 2010 (155) T1=17, T2=17 Age range: NR Mean age = 54 Breast (Stages I-III) Surgery (n = 23) Radiation therapy (n = 19) Chemotherapy (n = 18) Hormone therapy (n = 10) Two different sessions; 90 minute classes twice weekly for 6 weeks and 90 minute classes 22 times over 12 weeks Type: Iyengar Yoga Quality of Life -FACT-B, SF-36 Psychosocial -CES-D, STAI Ülger &Yağli, 2010 (156) T1=20, T2=20 Age range: 30-50 Mean age = 41 Breast > 6 months post-chemotherapy 60 minute weekly classes for 8 weeks Type: Not specified (“Classical Yoga”) Quality of Life -NHP Psychosocial -STAI Abbreviations: T1, baseline; T2, follow-up; SF-36 & SF-12, Medical Outcomes Study Short-Form Health Survey; EORTC QLQ C30, European Organization for Research and Treatment of Cancer- Quality of Life C30; FACT-B , Functional Assessment of Cancer Therapy –Breast; FACT-G, Functional Assessment of Cancer Therapy –General; NHP, Nottingham Health Profile; BDI, Beck Depression Inventory; CES-D 20, Center for Epidemiologic Studies Depression Scale – 20 Item; STAI, State/Trait Anxiety Inventory; POMS, Profile of Mood States; PANAS, Positive & Negative Affect Schedule; FACIT-Sp, Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being; HADS, Hospital Anxiety & Depression Scale; BFI, Brief Fatigue Inventory; PSQI, Pittsburgh Sleep Quality Index; FSI, Fatigue Symptom Inventory; FACT-F, Functional Assessment of Cancer Therapy-Fatigue. NR=Not Reported. Table 2.2 – continued 53 53 Study Outcome measure SF-36 PCS Chandwani (Physical) et al., 2010 SF-36 MCS (157) (Mental) EORTC-QoL Culos-Reed (Overall) et al., 2006 EORTC-Emo (149) (Emotional) FACT-B (Overall) FACT-SWB (Social) FACT-FWB (Functional) Danhauer et FACT-EWB al., 2009 (Emotional) (79) FACT-PWB (Physical) SF-12 PCS (Physical) SF-12 MCS (Mental) FACT-B (Overall) FACT-SWB (Social) Littman et FACT-FWB al., 2011 (Functional) (150) FACT-EWB (Emotional) FACT-PWB (Physical) SEM (Baseline Internal SD x √1 – consistency Cronbach α) (Cronbach α) Baseline 0.5 SD Yoga Control Yoga Control .90 2.60 3.40 4.10 5.30 .90 3.80 3.50 6.00 5.60 .89 8.50 4.26 12.82 6.43 .80 9.01 6.64 10.07 7.43 .90 6.30 7.70 10.00 12.20 .69 2.60 3.00 2.60 2.70 .86 2.60 3.10 2.90 3.50 .69 2.00 2.70 2.00 2.60 .81 3.00 2.20 3.50 2.60 .86 4.50 3.80 6.1 0 5.10 .81 4.40 4.50 5.10 5.10 .90 2.97 4.49 4.70 7.10 .69 2.84 3.01 2.60 2.70 .86 1.23 1.46 1.70 2.60 .69 1.56 1.45 1.40 1.30 .81 1.00 1.70 1.20 2.00 Baseline Mean (SD) Yoga 41.50 (8.20) 47.80 (12.00) 64.58 (25.63) 79.58 (20.14) 104.90 (19.90) 23.30 (4.70) 18.70 (5.70) 18.10 (3.90) 19.70 (7.00) 42.70 (12.10) 43.40 (10.10) 89.00 (9.40) 21.70 (5.10) 22.70 (3.30) 19.80 (2.80) 24.70 (2.30) Control 41.8 (10.6) 48.0 (11.1) 62.04 (12.85) 75.00 (14.85) 101.1 (24.4) 21.4 (5.4) 18.0 (6.9) 18.5 (5.2) 20.7 (5.1) 40.6 (10.1) 49.9 (10.2) 87.8 (14.2) 21.7 (5.4) 21.6 (5.1) 20.3 (2.6) 24.2 (3.9) Within-Groups Mean Difference (95% CI) Yoga 1.60 [-1.74, 4.94] 1.90 [-2.16,5.96] 13.66 [2.85,24.47]ab 4.22 [-4.05,12.49] 9.90 [-0.71,20.51]a -0.20 [-2.84,2.44] 3.20 [0.33,6.07]ab 2.70 [0.74,4.66]ab 2.80 [-1.18,6.78] 2.10 [-4.56,8.76] 8.80 [3.97,13.63]ab 1.30 [-2.58,5.18] 0.40 [-1.51,2.31] -0.10 [-1.47,1.27] 0.50 [-0.84,1.84] 0.70 [-0.08,1.48] Control -2.80 [-6.35, 0.75] 1.90 [-1.76,5.56] 0.46 [-6.16,7.08] -4.17 [-11.57,3.23] -2.70 [-17.80,12.40] -1.00 [-4.26,2.26] -0.60 [-4.38,3.18] -0.30 [-3.29,2.69] 0.40 [-2.44,3.24] 2.10 [-3.68,7.88] -2.40 [-8.90, 4.10] -0.10 [-5.61,5.41] -0.80 [-2.96,1.40] 0.10 [-1.75,1.95] 0.50 [-0.59,1.59] 0.10 [-1.47,1.67] Within-Groups Effect Size - Hedges’ g (95% CI) Yoga 0.18 [-0.19,0.54] 0.17 [-0.19,0.54] 0.56 [0.08,1.04]* 0.23 [-0.22,0.67] 0.48 [-0.06,1.02] -0.04 [-0.55,0.47] 0.57 [0.01,1.12]* 0.70 [0.13,1.28]* 0.36 [-0.17,0.89] 0.16 [-0.35,0.67] 0.93 [0.30,1.55]** 0.12 [-0.24,0.49] 0.08 [-0.29,0.44] -0.03 [-0.39,0.34] 0.14 [-0.23,0.51] 0.33 [-0.05,0.71] Control -0.27 [-0.62,0.08] 0.18 [-0.17,0.52] 0.03 [-0.41,0.47] -0.25 [-0.70,0.20] -0.09 [-0.58,0.41] -0.15 [-0.65, 0.35] -0.08 [-0.57,0.42] -0.05 [-0.54,0.44] 0.07 [-0.42,0.56] 0.18 [-0.32,0.68] -0.18 [-0.68,0.31] -0.01 [-0.37,0.36] -0.14 [-0.50,0.23] 0.02 [-0.35,0.39] 0.17 [-0.20,0.54] 0.02 [-0.34,0.39] Between Groups Mean Difference (95% CI) 4.40 [-0.52, 9.32]c 0.00 [-5.45,5.45] 13.20 [0.52,25.88]cd 8.39 [-2.71,19.49]cd 12.6 [-6.12,31.32]cd 0.80 [-3.43,5.03] 3.80 [-1.00,8.60]cd 3.00 [-0.63,6.63]cd 2.40 [-2.44,7.24]c 0.00 [-8.79,8.79] 11.20 [3.01,19.39]cd 1.40 [-5.34,8.14] 1.20 [-1.68,4.08] 0.20 [-2.11,2.51] 0.00 [-1.73,1.73] 0.60 [-1.16,2.36] Between Groups Effect size – Hedges’ g (95% CI) 0.46 [-0.06,0.97] 0.00 [-0.51,0.51] 0.67 [0.01,1.32]* 0.48 [-0.16,1.13] 0.49 [-0.25,1.24] 0.14 [-0.60,0.87] 0.58 [-0.17,1.34] 0.61 [-0.15,1.35] 0.36 [-0.38,1.10] 0.00 [-0.73.0.73] 1.00 [0.22,1.78]** 0.11 [-0.42,0.64] 0.22 [-0.31,0.75] 0.05 [-0.50,0.57] 0.00 [-0.53,-0.53] 0.18 [-0.35,0.71] Table 2.3 Health-Related Quality of Life Measures – Control Design 54 54 Study Moadel et al., 2007 (148) Vadiraja et al., 2009 (80) Outcome measure FACT-G (Overall) FACT-SWB (Social) FACT-FWB (Functional) FACT-EWB (Emotional) FACT-PWB (Physical) EORTC-Phys (Physical) EORTC-Role (Role) EORTC-Emo (Emotional) EORTC-Cog (Cognitive) EORTC-Soc (Social) SEM (Baseline Internal SD x √1 – consistency Cronbach α) (Cronbach α) Baseline 0.5 SD Yoga Control Yoga Control .89 5.96 8.11 8.99 12.23 .69 3.47 3.46 3.12 3.11 .80 2.85 3.45 3.19 3.86 .74 2.43 3.03 2.39 2.97 .82 2.24 2.98 2.64 3.52 .71 12.49 16.68 11.60 15.49 .52 24.15 25.22 17.43 18.20 .80 8.84 7.80 9.89 8.72 .73 9.35 10.97 9.00 10.56 .77 12.73 11.72 13.28 12.22 Baseline Mean (SD) Yoga 76.53 (17.98) 20.98 (6.23) 18.33 (6.38) 16.36 (4.77) 20.87 (5.28) 73.20 (23.20) 72.72 (34.86) 56.45 (19.77) 85.29 (18.00) 52.82 (26.55) Control 77.54 (24.45) 22.12 (6.22) 18.19 (7.72) 16.50 (5.94) 20.73 (7.03) 62.72 (30.98) 71.59 (36.40) 51.58 (17.44) 82.67 (21.12) 52.41 (24.43) Within-Groups Mean Difference (95% CI) Yoga 1.54 [-3.60,6.68] -0.30 [-1.99,1.39] -0.16 [-2.08,1.76] 1.83 [0.51,3.14]** 0.16 [-1.51,1.83] 0.06 [-7.30,7.42] 7.16 [-3.32,17.64] 18.67 [12.47,24.87]ab 5.28 [0.13,10.43] 2.14 [-5.53,9.81] Within-Groups Effect Size - Hedges’ g (95% CI) Control Yoga Control -7.16 0.09 -0.30 [-16.25,1.93] [-0.20,0.37] [-0.68,0.09] -3.95 -0.05 -0.60 [-6.41,-1.49]ab [-0.34,0.24] [-1.00,0.19]** -1.98 -0.02 -0.26 [-4.88,0.92] [-0.31,0.26] [-0.63,0.12] -0.41 0.40 -0.07 [-2.65,1.83] [0.10,0.70]** [0.44,0.31] -0.82 0.03 -0.12 [-3.39,1.75] [-0.26,0.32] [-0.49,0.26] 6.24 0.00 0.20 [-4.19,16.66] [-0.29,0.30] [-0.14,0.54] 1.26 0.20 0.03 [-11.81,14.33] [-0.10,0.50] [-0.30,0.37] 7.65 0.89 0.36 [0.48,14.82] [0.54,1.25]*** [-0.01,0.70]* -1.90 0.30 -0.08 [-9.66,5.86] [0.00,0.61]* [-0.42,0.25] -2.48 0.08 -0.10 [-10.78, 5.82] [-0.22,0.38] [-0.43,0.23] Between Groups Mean Difference (95% CI) 8.70 [-0.96,18.36]c 3.65 [0.75,6.56]cd 1.82 [-1.53,5.17] 2.24 [-0.19,4.67] 0.98 [-1.96,3.91] 6.18 [-6.24,18.60] 5.90 [-10.64, 22.44] 11.02 [1.57,20.47]cd 7.18 [-1.83,16.19] 4.62 [-6.74,15.98] Between Groups Effect size – Hedges’ g (95% CI) 0.43 [-0.05,0.91] 0.60 [0.11,1.09]* 0.26 [-0.22,0.74] 0.44 [-0.05,0.92] 0.16 [-0.32,0.64] 0.23 [-0.23,0.68] 0.16 [-0.29,0.61] 0.53 [0.07,0.99]* 0.36 [-0.10,0.82] 0.18 [-0.27,0.64] Table 2.3 – continued 55 55 Study Chandwani et al., 2010 (157) Cohen et al., 2004 (158) Culos-Reed et al., 2006 (149) Outcome measure CES-D 20 (Depression) STAI-State (Anxiety) CES-D 20 (Depression) STAI – State (Anxiety) POMS-D (Depression) CES-D 20 (Depression) PANAS-P (Positive Danhauer Affect) et al., 2009 PANAS-N (Negative (79) Affect) FACIT-Sp (Spiritual Well-Being) FACIT-Sp Moadel et al., (Spiritual 2007 (148) Well-Being) PANAS-P (Positive *Vadiraja Affect) et al., 2009 PANAS-N (80) (Negative Affect) HADS-A *Vadiraja (Anxiety) et al., 2009b HADS-D (147) (Depression) SEM (Baseline Internal SD x √1 – consistency Cronbach α) (Cronbach α) Baseline 0.5 SD Baseline Mean (SD) Yoga 11.60 (9.30) 36.30 (13.70) 10.20 (11.00) 34.30 (12.30) Within-Groups Mean Difference (95% CI) Yoga Control Yoga Control Control Yoga Control 10.50 -5.00 -3.50 (6.70) [-8.85,-1.15]ab [-7.23,0.24]a 32.70 -8.30 -2.50 (10.00) [-13.09, -3.51]ab [-6.75,1.75]a 9.60 -1.20 .10 (8.57) [-5.91,3.51] [-3.79,4.00] 37.80 -0.20 -4.00 (14.60) [-5.54,5.14] [-10.65,2.65]a .87 3.35 2.42 4.65 3.35 .94 3.36 2.45 6.85 5.00 .93 2.91 2.27 5.50 4.29 .95 2.75 3.26 6.15 7.30 .95 1.76 1.14 3.93 2.55 4.70 (7.86) 5.44 (5.10) -2.48 [-5.68,0.72]a .93 2.57 3.89 4.85 7.35 16.30 (9.70) 16.60 (14.70) .87 3.17 3.53 4.40 4.90 32.70 (8.80) .87 2.99 3.39 4.15 4.70 .87 2.38 2.60 3.30 .87 3.33 3.99 .87 2.62 .87 Within-Groups Effect Size - Hedges’ g (95% CI) Yoga -0.48 [-0.86,-0.09]* -0.63 [-1.04,-0.23]** -0.12 [-0.58,0.35] -0.02 [-0.48,0.45] Control -0.32 [-0.67,0.03] -0.20 [-0.55,0.15] 0.01 [-0.48,0.51] -0.30 [-0.80,0.21] 0.06 [-2.54,2.66] -0.34 [-0.80,0.11] -8.20 [-13.27,-3.17]ab 1.20 [-7.14,9.54] 30.60 (9.80) 5.50 [1.16,9.84]ab 19.00 (8.30) 18.50 (9.40) 3.60 23.30 (6.60) 4.62 5.53 2.66 3.64 3.82 3.18 .79 1.77 .87 1.45 Between Groups Mean Difference (95% CI) Between Groups Effect size – Hedges’ g (95% CI) -1.50 [-6.87,3.87] -5.80 [-12.18,0.58]cd -1.30 [-7.52,4.92] -3.80 [-12.24,4.64]c -0.14 [-0.65,0.37] -0.46 [-0.98,0.05] -0.15 [-0.85,0.55] -0.31 [-1.02,0.39] 0.01 [-0.43,0.45] -2.54 [-6.66,1.58]c -0.39 [-1.04,0.25] -0.82 [-1.42,-0.22]** 0.07 [-0.42,0.57] -9.40 [-19.34,0.54]cd -0.69 [-1.45,0.06] 1.20 [-4.21,6.61] 0.64 [0.08,1.21]* 0.11 [-0.39,0.60] 4.30 [-2.71,11.31]c 0.45 [-0.29,1.19] -5.00 [-8.91, -1.09]ab 1.40 [-3.63,6.43] -0.65 [-1.22,0.08]* 0.14 [-0.36,0.63] -6.40 [-12.84,0.04]cd -0.73 [-1.49,0.03] 23.20 (7.20) 2.70 [-0.92, 6.31]a -1.70 [-6.16,2.76] 0.38 [-0.15,0.91] -0.19 [-0.69,0.31] 4.40 [-1.40,10.20]cd 0.56 [-0.19,1.30] 37.87 (9.24) 34.58 (11.06) -1.02 [-3.59,1.55] -1.83 [-6.49,2.83] -0.11 [-0.40,0.17] -0.15 [-0.52,0.23] 0.81 [-4.08,5.70] 0.08 [-0.40,0.56] 3.69 24.05 (7.28) 21.81 (7.37) 3.80 [1.62,5.98]ab 1.52 [-1.17,4.21] 0.52 [0.20,0.84]*** 0.19 [-0.15,0.53] 2.28 [-1.14,5.70] 0.30 [-0.15,0.76] 5.30 4.41 22.15 (10.60) 25.22 (8.82) -9.24 [-12.41,-6.07]ab -3.37 [-6.78,0.04]a -0.86 [-1.21,-0.51]*** -0.33 [-0.67,0.01] -5.87 [-10.56,-1.18]cd -0.57 [-1.03,-0.11]* 1.82 1.94 1.99 1.25 2.01 1.74 8.05 (3.87) 7.57 (4.02) 9.35 (3.98) 8.00 (3.47) -3.17 [-4.27,-2.07]ab -3.43 [-4.57,-2.29]ab -1.23 [-2.56,0.10] -1.47 [-2.71,-0.23]a -0.86 [-1.21,-0.51]*** -0.89 [-1.25,-0.54]*** -0.31 [-0.65,0.03] -0.40 [-0.74,-0.05]* -1.94 [-3.65,-0.23]c -1.96 [-3.65.-0.27]cd -0.51 [-0.97,-0.05]* -0.52 [-0.98,-0.06]* Table 2.4 Psychosocial Measures – Control Design 56 56 Study Internal Outcome measure consistency (Cronbach α) SEM (Baseline SD x √1 – Cronbach α) Baseline 0.5 SD Baseline Mean (SD) Within-Groups Mean Difference (95% CI) Yoga Control Yoga Control Yoga Control Yoga Control Within-Groups Effect Size - Hedges’ g (95% CI) Yoga Control Between Groups Mean Difference (95% CI) Between Groups Effect size – Hedges’ g (95% CI) BFI (Fatigue) .94 0.39 0.54 0.80 1.10 2.30 (1.60) 2.30 (2.20) -0.40 [-1.58,0.78]a 0.20 [-1.17,1.57] -0.12 0.05 [-0.49,0.24] [-0.29,0.39] -0.60 [-2.44,1.24]c -0.17 [-0.68,0.34] PSQI (Sleep) .84 1.52 1.56 1.90 1.95 7.30 (3.80) 7.10 (3.90) -0.70 [-2.46,1.06] -0.40 [-2.15,1.35] -0.15 -0.08 [-0.51,0.22] [-0.42,0.27] -0.30 [-2.79,2.19] -0.06 [-0.57,0.45] BFI (Fatigue) .96 0.48 0.44 1.20 1.10 3.10 (2.40) 2.80 (2.20) 0.00 [-1.03,1.03] 0.30 [-0.72,1.32] 0.00 0.15 [-0.47,0.47] [-0.35,0.64] -0.30 [-1.76,1.16] -0.14 [-0.84,0.56] PSQI (Sleep) .84 2.00 1.88 2.50 2.35 6.50 (5.00) 7.20 (4.70) -0.70 [-2.82,1.42] 0.90 [-1.23,3.03] -0.16 0.21 [-0.62,0.32] [-0.29,0.71] -1.60 [-4.62,1.42] -0.37 [-1.07,0.34] FACT- F (Fatigue) .95 3.00 2.64 6.70 5.90 30.10 (13.40) 32.70 (11.80) 9.70 [2.87,16.53]ab -0.10 [-7.45,7.25] 0.72 -0.01 [0.14,1.30]* [-0.50,0.49] 9.80 [-0.27,19.87]cd 0.71 [-0.04,1.47] PSQI (Sleep) .84 1.88 2.12 2.35 2.65 8.30 (4.70) 8.60 (5.30) -2.20 [-4.65,0.25]a -1.60 [-4.14,0.94] -0.46 -0.31 [-1.00,0.08] [-0.81,0.20] -0.60 [-4.14,2.94] -0.12 [-0.86,0.61] Littman et al., 2011 (150) FACT-F (Fatigue) .95 1.30 1.90 2.90 4.25 43.10 (5.8) 43.20 (8.50) 1.9 [-0.20,4.00]a -0.10 [-3.69,3.49] 0.33 -0.01 [-0.05,0.71] [-0.38,0.36] 2.00 [-2.16,6.16]c 0.25 [-0.27,0.78] Moadel et al., 2007 (148) FACT-F (Fatigue) .95 2.75 3.22 6.16 7.21 34.27 (12.31) 35.88 (14.42) 2.29 [-1.11,5.69] -1.11 [-6.50,4.30] 0.19 -0.08 [-0.10,0.48] [-0.45,0.30] 3.40 [-2.66,9.46]c 0.27 [-0.21,0.75] Chandwani et al., 2010 (157) Cohen et al., 2004 (158) Danhauer et al., 2009 (79) Table 2.5 Symptom Measures – Control Design 57 57 Study Outcome Measure Bower et al., 2011 (151) SF-36 Gen Health (Overall) Danhauer et al., 2008 (152) FACT-G (Overall) FACT-SWB (Social) FACT-FWB (Functional) FACT-EWB (Emotional) FACT-PWB (Physical) SF-12 PCS (Physical) SF-12 MCS (Mental) Duncan et al., 2008 (153) Galantino et al., 2011 (154) FACT-G (Overall) FACT-B (Overall) Internal consistency (Cronbach α) SEM (Baseline SD x √1 – Cronbach’s α) Baseline 0.5 SD Within-Groups Baseline Mean Mean Difference (SD) (95% CI) Within-Groups Effect Size- Hedges’ g (95% CI) 50.50 (22.10) 14.50 [1.44, 27.56]ab 0.61 [0.00,1.21]* 75.90 (10.70) 24.00 (4.30) 18.00 (4.30) 14.00 (2.10) 20.00 (5.70) 41.20 (11.40) 48.40 (8.60) 3.50 [0.33,6.67] 0.80 [-0.53,2.13] 0.80 [-0.44,2.04] -0.20 [-0.81,0.41] 2.10 [0.47,3.73] 2.30 [-0.98,5.58] 3.60 [1.04,6.16] 0.32 [0.02,0.63]* 0.18 [-0.12,0.47] 0.19 [-0.11,0.49] -0.10 [-0.39,0.20] 0.38 [0.07,0.68}* 0.21 [-0.09,0.50] 0.41 [0.11,0.72]** 7.30 64.6 (14.16) 10.63 [4.44,16.82]ab 0.69 [0.24,1.14]** 10.09 89.33 (20.18) 16.72 [-5.07,28.37]ab 0.81 [0.14,1.48]* .81 9.63 11.05 .89 3.55 5.35 .69 2.39 2.15 .80 1.92 2.15 .74 1.07 1.05 .82 2.42 2.85 .86 4.27 5.70 .81 3.75 4.30 .89 4.70 .90 6.38 Table 2.6 Health-Related Quality of Life Measures – Single Group Design 58 58 Study SpeedAndrews et al., 2010 (155) Ülger&Yağli, 2010 (156) Outcome Measure FACT-B (Overall) FACT-SWB (Social) FACT-FWB (Functional) FACT-EWB (Emotional) FACT-PWB (Physical) SF-36 PCS (Physical) SF-36 MCS (Mental) NHP-Total (Overall) NHP-Social (Social) NHP-Emotion (Emotional) NHP-Physical (Physical) Internal consistency (Cronbach α) SEM (Baseline SD x √1 – Cronbach’s α) Baseline 0.5 SD .90 6.67 10.55 .69 2.95 2.65 .86 1.83 2.45 .69 2.67 2.40 .81 2.31 2.65 .90 3.38 5.35 .90 2.85 4.50 .70 12.64 11.54 .56 20.01 15.08 .83 9.68 11.74 .72 11.86 11.21 Within-Groups Baseline Mean Mean Difference (SD) (95% CI) 108.20 8.90 (21.10) [-1.51,19.31]a 20.70 0.70 (5.30) [-1.84,3.24] 19.90 1.80 (4.90) [-0.29,3.89] 15.80 2.10 (4.80) [-0.37,4.57] 20.90 2.00 (5.30) [-0.37,4.37] 45.50 3.70 (10.70) [-1.41,8.81]a 44.40 4.20 (9.00) [-0.01,8.41]a 103.23 -17.32 (23.08) [-26.70,-7.94]ab 43.01 -20.56 (30.16) [-32.24,-8.88]ab 61.37 -26.61 (23.47) [-36.35,-16.87]ab 44.51 -20.41 (22.41) [-29.77,-11.05]ab Within-Groups Effect Size - Hedges’ g (95% CI) 0.39 [-0.08,0.86] 0.13 [-0.33,0.58] 0.39 [-0.08, 0.86] 0.39 [-0.09,0.86] 0.38 [-0.09,0.85] 0.32 [-0.14,0.79] 0.45 [-0.03,0.93] -0.77 [-1.26,-0.29]** -0.74 [-1.22,-0.26]** -1.15 [-1.70,-0.60]*** -0.92 [-1.43,-0.41]*** Table 2.6 – continued 59 59 Study Bower et al.,2011(151) Danhauer et al., 2008 (152) Duncan et al., 2008 (153) Speed-Andrews et al., 2010 (155) Ülger &Yağli, 2010 (156) Outcome Measure BDI (Depression) CES-D 20 (Depression) STAI-State (Anxiety) PANAS-P (Positive Affect) PANAS-N (Negative Affect) FACIT-Sp (Spiritual WellBeing) FACIT-Sp (Spiritual WellBeing) CES-D 10 (Depression) STAI – State (Anxiety) STAI-State (Anxiety) Internal consistency (Cronbach α) SEM (T1 SD x√1 – Cronbach’s α) Baseline 0.5 SD Baseline Mean (SD) 15.40 (8.00) 12.30 (8.60) 34.20 (10.70) 34.70 (8.60) Within-Groups Mean Difference (95% CI) -7.90 [-12.20,-3.60]ab -3.10 [-5.66,-0.54]a -2.40 [-5.57,0.77]a 1.50 [-1.06,4.06] Within-Groups Effect Size – Hedges’ g (95% CI) -1.00 [-1.69,-0.32]** -0.36 [-0.66,-0.05]* -0.22 [-0.52,0.08] 0.17 [-0.12,0.47] .81 3.49 4.00 .93 2.27 4.30 .95 2.39 5.35 .87 3.10 4.30 .87 1.80 2.50 15.80 (5.00) -1.70 [-3.14,-0.26] -0.35 [-0.65,-0.04]* .87 2.56 3.55 38.70 (7.10) 1.40 [-0.74,3.54] 0.19 [-0.10,0.49] .87 3.65 5.07 30.83 (10.13) 5.88 [1.93,9.83]ab 0.60 [0.16,1.04]** .85 0.23 0.30 .85 2.59 3.35 .95 1.75 3.92 31.00 (0.60) 45.20 (6.70) 55.05 (7.83) -0.20 [-0.47,0.07] 1.80 [-1.48,5.08] -11.70 [-14.96,-8.44]ab -0.34 [-0.81,0.13] 0.25 [-0.21,0.71] -1.51 [-2.14,-0.88]*** 2.7 Psychosocial Measures – Single Group Design 60 60 Study Outcome Measure Internal consistency (Cronbach α) SEM (Baseline SD x √1 – Cronbach’s α) Baseline 0.5 SD Within-Groups Baseline Mean Mean Difference (SD) (95% CI) Within-Groups Effect Size - Hedges’ g (95% CI) FSI Average (Fatigue) .97 0.19 0.55 6.3 (1.1) -3.6 [-4.44,-2.76]ab -2.34 [-3.47,-1.22]*** PSQI (Sleep) .84 1.64 2.05 7.1 (4.1) -0.7 [-2.99,1.59] -0.17 [-0.72,0.38] Danhauer et al., 2008 (152) FACT-F (Fatigue) .95 2.71 6.05 34.6 (12.1) 2.7 [-0.83,6.27]a 0.22 [-0.08,0.52] Ülger&Yağli, 2010 (156) NHP-S (Sleep) .72 15.64 14.78 43.50 (29.55) -23.47 [-34.69,-12.25]ab -0.88 [-1.38,-0.38]*** Bower et al., 2011 (151) *p<.05, ** p<.01, ***p< .001 (Reported between group p-values) a Within-Group mean difference exceeds 1SEM b Within-Group mean difference exceeds Baseline 0.5 SD c Between-Group mean exceeds control group 1 SEM d Between-Group mean exceeds control group Baseline 0.5 SD Abbreviations: α, alpha; SD, standard deviation; CI, confidence interval; SF-36 & SF-12, Medical Outcomes Study Short-Form Health Survey; EORTC QLQ C30, European Organization for Research and Treatment of Cancer-Quality of Life C30; FACT-B, Functional Assessment of Cancer Therapy–Breast; FACT-G, Functional Assessment of Cancer Therapy-General; NHP, Nottingham Health Profile; BDI, Beck Depression Inventory; CES-D 20, Center for Epidemiologic Studies Depression Scale – 20 Item; STAI, State/Trait Anxiety Inventory; POMS, Profile of Mood States; PANAS, Positive&Negative Affect Schedule; FACIT-Sp, Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being; HADS, Hospital Anxiety & Depression Scale ; BFI, Brief Fatigue Inventory; FSI, Fatigue Symptom Inventory; PSQI, Pittsburgh Sleep Quality Index; FACT-F, Functional Assessment of Cancer Therapy-Fatigue Table 2.8 Symptom Measures – Single Group Design 61 61 62 CHAPTER 3: MODELLING ASSOCIATIONS BETWEEN YOGA PARTICIPATION, AFFECT, MINDFULNESS AND HEALTH OUTCOMES IN CANCER SURVIVORS 63 3.1 Introduction Receiving a cancer diagnosis, undergoing treatment and the subsequent recovery takes a great toll on many cancer survivors. Research demonstrates psychosocial distress stemming from the cancer experience is a significant problem for up to half of all cancer patients, and many survivors experience lowered overall health-related quality of life (HRQL) both during and following active treatment (7). In some cases, cancer survivors exhibit signs of clinical psychological disorders and a host of more general mood, stress, sleep, and fatigue symptoms (8-12). In this capacity, regardless of intervention specifics, exercise has been shown to improve almost all aspects of physical and psychological functioning in cancer survivors (14,15). Specifically, exercise enhances a variety of HRQL, health, functional and psychosocial outcomes in various cancer survivor groups both during and after cancer treatment, and may also help to manage the long-term effects of treatment (20-22). However, current data suggests only 22% of cancer survivors are active enough to achieve health benefits (25) and only half of cancer patients offered an exercise program will undertake and complete the intervention (26). 3.1.1 Yoga in Cancer Settings Within the growing body of PA and cancer research, there have been calls to examine modes of exercise from the area of integrative medicine (29). In this regard, yoga is quickly emerging as an important integrative therapeutic approach in oncology. Within the larger field of exercise and cancer, yoga is often considered a gentle, lowintensity form of exercise (22,32). Studies comparing the effects of yoga and exercise indicate that, in both healthy individuals and those with various health conditions, yoga 64 may be as effective as more contemporary western forms of exercise, including walking, jogging, cycling, and aerobics, at improving a variety of health-related outcome measures (48). Within oncology, yoga groups compared to waitlist control groups or supportive therapy groups show greater improvements in overall HRQL, psychological health, stress-related symptoms, sleep and fatigue indices (1,2,33). 3.1.2 Theoretical Mechanisms of Action Despite preliminary findings, little attention has been paid to the psychological mechanisms by which benefits are accrued via yoga practice. Proposed mechanisms tested in the current study include affect regulation and mindfulness. 3.1.2.1 Affect Regulation. Positive affect is an independent, adaptive pathway in the cancer experience (68). Both baseline positive affect and enhancement of positive affect are important components of symptom management and cancer recovery (166). In general, exercise increases positive affect and reduces negative affect (71,72). Specifically, positive affect tends to increase pre- to post-exercise following exercise intensities that are not exhaustive (73). Individuals tend to choose and adhere to activities associated with positive affective experiences (71,72,167). Fostering positive affective experiences via a structured exercise program is an important target for interventions designed to facilitate post-program exercise adherence in cancer settings (76). In two recent nonrandomized trials, a single session of yoga was associated with significant improvements in positive affect and reductions in negative affect, comparable to changes seen with aerobic exercise (77,78). A pilot RCT examining the effects of a 10week restorative yoga in breast cancer survivors on or off treatment reported significant benefits favouring the yoga group for positive affect, mental health, depression and 65 spirituality outcomes (79). A second pilot RCT examining the effects of a 12-week yoga program in breast cancer outpatients undergoing adjuvant radiotherapy reported significant improvement in positive affect, emotional function and cognitive function, and decreased negative affect in the yoga group as compared to controls (80). 3.1.2.2 Circumplex Model of Affect. Given the proposed importance of positive affect and yoga’s influence on this phenomena, the Circumplex Model of Affect (81) offers a parsimonious explanatory approach. According to this model, affect is best understood as an underlying state comprised of two orthogonal dimensions: feeling good or bad (valence), and feeling energized or enervated (activation). These two dimensions of valence and activation, termed core affect, underlie all affective states and specific affective states are considered combinations of these two dimensions. Four quadrants can be described as: energy (high activation pleasure), calmness (low activation pleasure), tension (high activation displeasure), and tiredness (low activation displeasure) (83) (see Figure 3.1). 3.1.2.3 Dual Mode Theory. This Circumplex approach can be further contextualised within exercise settings utilising Dual Mode Theory (168) which suggests exercise experiences, including yoga, are regulated by affect via the continuous interplay of two mechanisms; 1) cognitive processes, and 2) interoceptive cues. The relative importance of these two factors in the regulation of core affect is hypothesized to shift systematically as a function of exercise intensity, with cognitive factors being dominant at low and moderate intensities and interoceptive cues becoming more prominent at higher intensities (85). 66 3.1.2.4 Effort-Related Attention Model. Individual attention during exercise can influence changes in affective responses. Associative attention is defined as focusing attention on present-moment physical sensations related to exercise, where exercisers seek to monitor sensory input and adjust their effort accordingly. Dissociative attention is defined as focusing on non-exercise related stimuli that divert attention away from internal sensations and present moment exercise experience (90). The Effort-Related Attention Model suggests these attention strategies during exercise vary based on intensity (91). During low or moderate intensity workloads attention is voluntary and can switch between dissociative and associative attentional strategies, as external stimuli do not compete with internal stimuli, while at higher exercise intensities increased physiological cues demand attention. As a result attention narrows, shifts internally and becomes associative (92). 3.1.3 Mindfulness Mindfulness is the systematic development of the ability to non-judgmentally direct attention towards events in the field of consciousness in the present moment (169). Research reveals both trait and state mindfulness, as specific forms of attention, are related to affect regulation (170). The various extant measures of mindfulness have been associated with higher positive affect and lower negative affect, perhaps through engagement of attention upon immediate experience (94). Research in the field of psychosocial oncology further indicates cancer survivors who participate in mindfulness-based programs, of which yoga is a significant component, with higher mindfulness scores report less mood disturbance and symptoms of stress as well as report significantly improved self-regulated emotion and behaviour, 67 all of which contribute to enhanced HRQL (171-174). These changes in mindfulness mediate changes in psychological outcomes including perceived stress and positive states of mind (175). These psychological benefits have been maintained up to a year at followup (176-179). It has been suggested yoga adds a contemplative element to exercise and can be conceptualised as ‘mindfulness in motion’ (96). Specifically, the practice of yoga provides an opportunity for sustained attention to the body, breath and mind through progressive sequences of dynamic movements, restful postures, breathing exercises and periods of meditative awareness, facilitating a strong mindfulness practice. However, research evidence linking yoga in eliciting these changes in mindfulness remains equivocal. Lengacher and colleagues (98) found minutes of yoga practice as part of the overall MBSR program was not significantly related to positive changes in psychosocial status and HRQL. These findings are in contrast to the work of Carmody and Baer (99), whose research in a non-cancer heterogeneous medical population found the yoga component of the mindfulness program to be most strongly related to improvements of mindfulness measures, psychological symptoms and perceived stress. These findings have more recently been corroborated in a study by Sauer-Zavala and colleagues (100), which reports 105 minutes in yoga practice was associated with greater psychological wellbeing independent of equivalent amounts of body scan or sitting meditation practices. 3.1.3.1 Facets of Mindfulness. The Five Facet Mindfulness Questionnaire was chosen to examine mindfulness in yoga settings (180). These five facets of mindfulness have been described as follows: the ability to1) observe and 2) describe experiences in the present moment while 3) acting with awareness 4) without judgment or 5) prolonged 68 reaction (181). In cancer settings, work by Branstrom and colleagues (175) suggests prepost changes in facets of mindfulness mediate changes in psychological outcomes both post-MBSR program and at a three- but not six-month follow-up (182). Recent work by Garland and colleagues (183) is consistent with these findings, indicating significant relationships between increased facets of mindfulness and reductions in mood and stress symptoms. In a mediation analyses by Labelle and colleagues (184), while significant changes in facets of mindfulness were observed, they did not mediate treatment change in depression. It has also been suggested the five facet mindfulness questionnaire does not measure mindfulness per se, but rather sequalae of mindfulness (185). In sum, cancer-related distress and lower HRQL are prevalent among many cancer survivors. Exercise has proven effective in ameliorating this distress and improving HRQL. Despite these benefits, only a fraction of cancer survivors engage in enough exercise to receive these benefits and over half of cancer survivors who engage in an exercise program will not maintain it. Yoga is considered a low-intensity form of physical activity that has been shown to independently improve HRQL, psychosocial outcomes and symptom indices. Two mechanisms by which this may occur are via increased positive affect and mindfulness. 3.2 Objectives Given preliminary evidence that yoga practice is associated with, 1) positive affect, 2) mindfulness, and 3) improved HRQL and mental health outcomes in cancer survivors, the present study sought to examine: 69 3.2.1 Acute Class Effects Objective 1a: To examine potential changes in valence, activation, and attention pre-post each class of a seven week yoga intervention. Objective 1b: To examine associations among changes in valence, activation and attention within the yoga classes and whether these changes were moderated by proposed predictor variables, including baseline affect and mindfulness. Covariates included baseline demographics, physical activity, previous yoga experience, beliefs about yoga, affect, mindfulness, or psychological functioning. 3.2.2 Longitudinal Program Effects Objective 2a: To examine changes longitudinally pre-post yoga program and at three- and six-month follow-ups, in measures of mood disturbance, stress symptoms and HRQL as well as proposed predictor variables, including affect and mindfulness. Objective 2b: To examine whether improvements in mood disturbance, stress symptoms and HRQL were associated with concurrent changes in proposed predictor variables including affect and mindfulness. Covariates included age, time since diagnosis, physical activity, previous yoga experience and beliefs about yoga. 3.2.3 Yoga Practice Maintenance: Objective 3a: To examine whether participants maintain their yoga practice longitudinally, pre-post and three- and six-month follow-ups. Objective 3b: To examine whether maintenance of yoga practice was associated with mood disturbance, stress symptoms and HRQL as well as proposed predictor variables, including affect and mindfulness. Covariates included age, time since diagnosis, physical activity, previous yoga experience and beliefs about yoga. 70 3.3 Methods 3.3.1 Participants Ethical approval was obtained from the Conjoint Health Research Ethics Board of the University of Calgary/Alberta Health Services (Ethics ID # 23313). Program participants were comprised of a heterogeneous group of cancer survivors enrolled in the ongoing “Yoga Thrive: Therapeutic Yoga for Cancer Survivors” program. Participants were eligible for study inclusion if they were: 1) age 18 years or older; and 2) had received a cancer diagnosis at any time in the past. Previous participation in the Yoga Thrive program was not an exclusion criterion, but was evaluated as part of the study. Yoga Thrive is offered in several community locations throughout the city of Calgary, Alberta, Canada. Participants were informed of the research study at the time of class registration, either via telephone or online. Those that indicated interest in participating in the research study were contacted by the study coordinator. Participants completed inclass measures before and after each yoga class in the seven-week program. Baseline, post-program and the three- and six-month follow-up surveys were completed online. 3.3.2 Program The Yoga Thrive program is a research-based, therapeutic yoga program for cancer survivors and their support persons. This gentle, seven-week yoga program is based on contemporary yoga practices modified for cancer survivors. Details of the program have been previously described (149,186). A typical 75-minute class was broken down as follows: 0–10 minutes - gentle breathing and movement, laying supine, with legs flexed at the hip and supported by a wall; 10–60 minutes - a series of 6–10 modified yoga postures / sequences comprised of gentle stretching and strengthening exercises with 71 attention to breath and bodily sensations; 60–75 minutes – guided supine meditation with attention placed on both breathing and bodily sensations. The yoga classes became progressively more challenging over the seven-week course, as participant flexibility and strength improved. 3.3.3 Recruitment Power calculations were derived using GPower 3.1. The sample size / power calculation was based on a clinically significant (135) change in score pre-post program on the Profile of Mood States (POMS) Total Mood Disturbance (TMD) score as the primary outcome (Cohen’s d = .50). With an α of .05 and power of .80, a minimum of 34 participants were to be recruited from the Yoga Thrive program. During the eight-month recruitment period, 125 people enrolled in the program over 233 times in 23 separate seven-week sessions over four waves (Fall, Winter, Spring, Summer). Of these 125 participants, 100 expressed an interest in participating in the research component of the program at the time of enrollment. Of these 100 interested participants, 18 had not received a cancer diagnosis and were attending the program as support persons, eight subsequently declined study participation when contacted by the study coordinator, three consented but their seven-week session was later cancelled due to lack of enrollment and the study coordinator was unable to contact one interested participant. Subsequently, 70 participants were eligible for the current study, 66 of who completed baseline measures used in the current analyses (see Figure 3.2). 72 3.3.4 Instruments 3.3.4.1 Baseline Demographics: Demographic information included age, education, marital status and current employment status. Medical history included self-reported cancer diagnosis, date of diagnosis and type(s) of cancer treatment. Beliefs about Yoga Scale. The BAYS (187) is an 11-item self-report measure developed to examine common positive and negative beliefs about yoga in order to: 1) inform promotion of yoga to diverse populations; 2) frame yoga programs to retain participants; and 3) help yoga instructors understand participant expectations related to yoga (baseline α = .78). 3.3.4.2 Acute Effects (objectives 1a & 1b). Feeling Scale. The FS (188) is an 11-point, single-item, bipolar measure of affective valence (pleasure-displeasure). The scale ranges from -5 to +5. Anchors are provided at zero (‘Neutral’) and all odd integers, ranging from ‘Very Good’ (+5) to ‘Very Bad’ (-5). Instructions were to, “estimate how good or bad you feel right now.” The FS is commonly used for the assessment of affective responses during exercise (189). Felt Arousal Scale. The FAS (190) is a 6-point, single-item measure of perceived activation. The scale ranges from 1 to 6, with anchors at 1 (‘Low Arousal’) and 6 (‘High Arousal’). Instructions were to, “estimate how aroused you feel right now (low arousal = calm or fatigued, high arousal = anxious or energized). Association / Dissociation Scale. The A/D S (191) is a single-item 10 point bipolar scale designed to measure to what extent attention is primarily associative or dissociative. The scale ranges from 1 to 10, with anchors at 1 (very associative) and 10 73 (very dissociative) (192). Instructions were to, “estimate your present state of attention right now (associative = focused in present moment, dissociative = unfocused in past or future). 3.3.4.3 Longitudinal Effects (objectives 2a & 2b). Godin Leisure Time Exercise Questionnaire . The GLTEQ (193) was used to assess physical activity levels. The LSI contains three questions that assess the frequency of mild, moderate, and strenuous physical activity performed for at least 15 minutes duration during free time in a typical week within the past month. A weekly total of moderate-vigorous physical activity can also be computed from this scale (baseline α: LSI = .88; moderate + vigorous physical activity = .86). Activation-Deactivation Adjective Check List. The AD ACL (194) is a 20-item measure of the four quadrants of circumplex affective space. The Energy pole is theorized to map the high activation pleasure quadrant of the circumplex, Tension maps the high-activation displeasure quadrant, Tiredness maps the low-activation displeasure quadrant, and Calmness maps the low-activation pleasure quadrant (83) (baseline α: energy = .88; tired = .84; tension = .79; calm = .80). Five Facet Mindfulness Questionnaire. The FFMQ (180) is a 39-item five-point Likert scale designed to measure five factors that represent elements of trait mindfulness as it is currently conceptualized. The five facets are observing, describing, acting with awareness, non-judging of and non-reaction to inner experience. Higher scores indicate higher levels of mindfulness (baseline α: observing = .85; describing = .87; acting with awareness = .89; non-judging = .91; non-reacting = .88). 74 Profile of Mood States - Short Form. The POMS-SF (195) is a widely used instrument in the study of psychological aspects of cancer. It is a 37-item five point Likert scale designed to assess fluctuating affective states over a one-week period. The instrument provides a total mood disturbance score as well as six factor-based subscale scores including tension-anxiety, depression-dejection, anger-hostility, vigour-activity, fatigue-inertia, and confusion-bewilderment. Higher scores indicate more mood disturbance, except on the vigour-activity subscale, where higher scores indicate more vigour. Due to high multicollinearity (r >.7) between the POMS-SF total score and six subscales at all time points, only the POMS-SF total score was used (baseline α = .93). Calgary Symptoms of Stress Inventory. The C-SOSI (196) was designed to measure physical, psychological, and behavioural responses to stressful situations. It is a 56-item five-point Likert scale inventory. The instrument provides a total stress score as well as 10 subscale scores including peripheral manifestations, cardiopulmonary symptoms, central-neurological symptoms, gastrointestinal symptoms, muscle tension, habitual patterns, depression, anxiety/fear, emotional irritability, and cognitive disorganisation. Higher scores indicate higher reported levels of stress symptoms. Only the SOSI total stress score was used (baseline α = .91). Functional Assessment of Cancer Therapy – General Version. FACT-G (version 4) (197) is a 27-item questionnaire that measures four domains of HRQL (physical wellbeing, functional well-being, social well-being, emotional well-being) in patients undergoing cancer treatment. The FACT-G employs a five-point Likert scale for all questions. Due to high multicollinearity (r >.7) between the FACT-G total score and four subscales at all time points, only the FACT-G total score was used (baseline α = .93). 75 3.3.4.4 Yoga Practice Maintenance (objectives 3a & 3b). Participants were asked to report weekly frequency of ongoing yoga practice via the Yoga Thrive program, community-based yoga programs, home yoga practice or combinations thereof. 3.3.5 Data Analysis All data analyses were conducted using IBM SPSS version 19. Demographics and medical history were described using frequency and descriptive statistics to characterize study participants. This investigation used a repeated measures design in which participants served as their own control. Before beginning primary analyses, all continuous variables were checked for normality (skewness, kurtosis) and corrected where necessary. Statistical analyses were conducted on the entire sample (n = 66). 3.3.5.1 Multilevel Models. In examining both the acute pre-post effects of each yoga session (objectives 1a & 1b) and the longitudinal effects of yoga practice (objectives 2a & 2b), two sets of multilevel (mixed model) analyses were conducted: 1) estimated marginal means (piecewise) models to examine effects over time; and 2) multilevel regression analyses to examine associations between outcomes and predictor variables. Multilevel models were appropriate for analyzing data with dependent observations (such as within-subject repeated measures). That is, each time measurement of a given variable (level 1) was nested within each participant (level 2). These models take into account this hierarchical structure by modelling at both levels (198). In addition, multilevel models retain cases for which missing data is present and provide a valid analysis when data are assumed missing at random (199). Correlations among observations from the same individual were modeled using an unstructured covariance matrix across all time points. 76 In each multilevel regression model time was measured continuously and included linear, quadratic and cubic terms (200). All models were tested step by step. An initial unconditional model was developed for each outcome variable (data not shown) followed by unconditional growth models (data not shown). Based on these growth models, predictor variables were tested individually for main effects and for interaction effects with each time term (data not shown). Significant predictors and their time interactions, if also significant, were then tested together as part of their respective overall scale (data not shown). A final trimmed model was developed by entering all significant predictors and their interactions to test overall prediction of outcome variables across time (exclusion p >.1). This method of model development has proven robust with smaller sample sizes and ensures these models do not tax the “carrying-capacity” of the dataset (201). If interaction terms were not significant, it could be assumed the relationships between predictor and outcome variables were constant throughout the study. In each model, the time variable was centered at initial status; therefore the intercept of the regression model can be interpreted as participant reports of the outcome variable at baseline. To enhance interpretability of the model intercept parameters, all predictor variables were grand-mean centered. 3.3.5.2 Clinical Significance. Clinical significance, or meaningful clinically important difference, a marker of the effectiveness of programs, was assessed using multiple criteria including: 1) An effect size using Cohen’s interpretation of >.20 as a small effect >.50 as a moderate effect and >.80 as a large effect (142). Effect sizes were calculated using Cohen’s d for each outcome variable between baseline and a) post 77 program (8 weeks), b) three-month, and c) six-month follow-up (T1-Tx / T1 SE * √N). 2) A standard mean difference between baseline and follow-up time points ≥ 1 standard error of the measure (SEM) (138). SEM was calculated as baseline (T1 SE * √n) * (√1 – Cronbach’s α). 3) Comparing changes from pre to post to meaningful clinically important difference in the research literature (135). Pseudo R2 statistics for each model were calculated as unconditional model residual variance – trimmed model residual variance / unconditional model residual variance. These statistics indicate the reduction in residual variance between the unconditional and trimmed model and provide an estimate of effect size similar to traditional OLS regression (202). These effects can be interpreted using Cohen’s criteria of >.02 as a small effect >.13 as a moderate effect and >.26 as a large effect (142). All statistical significance levels were set at p = .05 with a two-tailed test. 3.3.5.3 Acute Effects (objectives 1a & 1b). Estimated marginal means models were created to assess overall changes in valence, activation and attention pre-post each yoga class (objective 1a). Multilevel regression analyses were then conducted to assess concurrent associations between valence, activation and attention and the moderating effects of baseline demographics, physical activity, previous yoga experience, beliefs about yoga, affect, mindfulness, and / or psychological functioning (objective 1b). 3.3.5.4 Longitudinal Effects (objectives 2a & 2b). Estimated marginal means models were created to assess overall change in outcome, predictor, and continuous covariates longitudinally, pre-post and at three-and six-month follow-ups (objective 2a). Multilevel regression analyses were conducted to assess concurrent associations between mood disturbance, stress symptoms and HRQL, proposed predictor variables including 78 affect and mindfulness, and covariates including demographics, time since diagnosis, physical activity, previous yoga experience and beliefs about yoga (objective 2b). 3.3.5.5 Yoga Practice Maintenance (objectives 3a & 3b). Associations of predictor and outcome variables with program maintenance (ongoing yoga participation in either the yoga for cancer survivors program, community-based yoga programming or engaging in home practice) was assessed via logistic generalized estimating equations (GEE) (203). In this context, GEE take into consideration the within-subject relationships between predictor and outcome variables. Yoga maintenance was dichotomized as either 0 – no yoga or 1 – ongoing yoga. To determine whether there was a difference between those who practiced yoga and those who did not at each time point, an initial estimated marginal means model with no predictors was run (objective 3a). Logistic GEE were then run to determine associations between yoga practice and predictor variables (objective 3b). Individual covariates for age, time since diagnosis and previous yoga experience were entered individually as main effects, followed by physical activity, affect, mindfulness and health outcomes (data not shown). A final trimmed model was developed by entering all significant predictors and their interactions to test overall prediction of yoga practice maintenance across time (exclusion p >.1). 3.4 Results Results are reported in the following order: demographics: brief overview of descriptive participant demographics; acute effects: estimated marginal means models examining program-averaged pre-post class change in measures of valence, activation and attention (objective 1a); multilevel regression analyses examining predictors of prepost class change in valence, activation, and attention (objective 1b); longitudinal effects: 79 estimated marginal means models examining longitudinal changes in mood disturbance, stress symptoms and HRQL, predictor variables including affect and mindfulness, and covariates (objective 2a), multilevel regression analyses examining predictors of longitudinal change in mood disturbance, stress symptoms and quality of life (objective 2b); yoga practice maintenance: longitudinal GEE logistic estimated marginal means models of yoga practice pre-post seven-week yoga program and at three-and six-month follow-ups (objective 3a), longitudinal GEE logistic regression analyses examining predictors of yoga practice maintenance over time (objective 3b) 3.4.1 Demographics The average participant was approximately 53 years of age. The study sample was 90% female and 62.1% of participants had received a breast cancer diagnosis, stage II-III approximately two years prior to study enrollment. Most participants were married (66.7%), highly educated (54.5% had completed university / college) and affluent (60.6% had a combined household income > $80,000 per annum). Many participants (39.4%) had returned to work fulltime. Participants attended an average five of seven yoga sessions (see Table 3.1). 3.4.2 Acute Class Effects (objectives 1a and 1b) Estimated marginal means models were calculated pre-post each class for selfreported measures of valence, activation and attention based on a combined average of all seven-weeks of the Yoga Thrive program (objective 1a). Participants reported large increases in valence and attention and small increases in activation over the seven-week program (see Table 3.2, Figure 3.3). Multilevel regression analyses were then computed for valence, activation and attention (objective 1b). 80 3.4.2.1 Valence. Increases in valence pre-post yoga session over the seven-week program were significantly associated with the linear passage of time. Those with higher self-reported tiredness and mood disturbance at baseline reported lower valence pre-post class. In addition, those who reported higher dissociative attention reported lower valence, while those who reported higher activation reported higher valence. The Pseudo R2 value suggests inclusion of these variables reduced error in predicting valence pre-post class by 83% (see Table 3.3). 3.4.2.2 Activation. Increased activation was also associated with the acute passage of time pre-post class. However, the significant linear effect of time was eclipsed by the inclusion of valence in the model (p= .499, unconditional growth model not shown). Those with higher valence concurrently reported higher activation pre-post class. Conversely, those with higher scores in tiredness and the ability to be non-judgemental of inner experience at baseline reported lower activation pre-post class. The Pseudo R2 value suggests inclusion of these variables reduced error in predicting activation pre-post class by 34% (see Table 3.3). 3.4.2.3 Attention. An acute decrease in dissociative attention was observed prepost class. Higher reported tension at baseline was associated with increased dissociative attention pre-post yoga class. Higher reported baseline valence, and ability to describe events and act with awareness were associated with decreased dissociative attention prepost yoga class. Interestingly, higher mood disturbance at baseline was also associated with lower dissociative attention pre-post class. The Pseudo R2 value suggests inclusion of these variables reduced error in predicting attention by 68% (see Table 3.3). 81 3.4.3 Longitudinal Program Effects (objectives 2a and 2b) Estimated marginal means models were computed for covariates including age, time since diagnosis, physical activity, and previous yoga experience, predictor variables including affect and mindfulness, and outcome variables including mood disturbance, stress symptoms, and HRQL (objective 2a). 3.4.3.1 Covariates. Participants had already completed Yoga Thrive 1.46 times prior to study enrollment. Most participants reported completing the Yoga Thrive program at eight-weeks, and had completed the program an additional time by the six month follow-up. Small significant increases from baseline in moderate-vigorous PA were observed at the three- and six-month follow-ups. Participants increased their moderate- to vigorous PA from 93 to 121 minutes per week over the course of the study, still less than the recommended 150 minutes / week of vigorous to moderate PA (23), and these increases did not exceed the SEM of the measure. A small significant increase in total physical activity (LSI) was also observed at the six-month follow-up (see Table 3.4, Figure 3.4). 3.4.3.2 Affect. Small increases in energy were observed post-program that became more pronounced at the three- and six-month follow-up. Small decreases in tiredness post-program were not maintained at the 3-month follow-up but again improved at the 6-month follow-up. Small decreases in tension were observed post-program, were not maintained at the three-month follow-up, improved at the six-month follow-up, but did not exceed the SEM. Small increases in self-reported calmness were observed prepost intervention that approached significance but this increase abated over time (see Table 3.4, Figure 3.5). 82 3.4.3.3 Mindfulness. Small significant increases in observational skills were observed only at the six-month follow-up. However they did not exceed the SEM. No changes in participants’ ability to describe were observed throughout the program. Moderate increases in participants’ ability to act with awareness were observed postprogram that were maintained at the three- and six-month follow-ups. Small increases in participants’ ability to be non-judgmental of inner experience were observed postprogram that were maintained at the three- and six-month follow-up. However, the estimated difference at the 3-month follow-up did not exceed the SEM. No significant changes in non-reaction were observed post program but small significant improvements were observed at the three- and six-month follow-ups. However, neither change exceeded the SEM (see Table 3.4, Figure 3.6). 3.4.3.4 Mood Disturbance, Stress Symptoms and Quality of Life. Decreases in mood disturbance were moderate post program. Reductions in mood disturbance were not maintained at the three-month follow-up but improved to post-program values at the sixmonth follow-up. A moderate decrease in stress symptoms was observed from baseline to post program that was maintained at both the three- and six-month follow-ups. A small statistically significant improvement in HRQL was observed post program that did not exceed the SEM. However, HRQL significantly improved at the three-month follow-up and was maintained at the six-month follow-up (see Table 3.4, Figure 3.7). Follow-up multilevel regression analyses were conducted to explore the associations between mood disturbance, symptoms of stress, and HRQL, predictor variables including affect and mindfulness and moderating variables including age, time 83 since diagnosis, physical activity, previous yoga experience and yoga beliefs (objective 2b). 3.4.3.5 Mood Disturbance. Significant linear, quadratic, and cubic effects were observed for time. Those with higher beliefs in yoga at baseline reported lower mood disturbance at all time points. Those who reported higher levels of overall PA, higher energy, higher levels of the ability to act with awareness and be non-reactive to inner experience also reported lower mood disturbance. Those who reported greater tiredness reported greater mood disturbance. The Pseudo R2 value suggests inclusion of these variables reduced error in predicting mood disturbance by 31% (see Table 3.5). 3.4.3.6 Stress Symptoms. There were significant linear and quadratic effects of time, indicating an initial decline in stress symptoms that slowed over time. Higher positive beliefs about yoga at baseline were associated with lower symptoms of stress. Those who reported higher moderate to vigorous PA and a greater ability to act with awareness and be non-judgmental of inner experience concurrently reported lower stress symptom scores. Higher tension was significantly associated with higher stress symptoms. The Pseudo R2 value suggests inclusion of these variables reduced error in predicting stress symptoms by 40% (see Table 3.5). 3.4.3.7 Quality of Life. A significant linear increase in HRQL was observed prepost yoga intervention and at three- and six-month follow-ups. Higher baseline beliefs about yoga were associated with higher HRQL. Those who reported higher overall PA, energy and the ability to be non-judgmental of inner experience reported higher HRQL. Those who reported high levels of tension reported lower levels of HRQL. The Pseudo 84 R2 value suggests inclusion of these predictor variables reduced error in predicting HRQL by 29% (see Table 3.5). 3.4.4 Yoga Practice Maintenance (objectives 3a and 3b) Longitudinal GEE logistic estimated marginal means models were conducted examining yoga practice pre-post yoga program and at three-and six-month follow-ups (objective 3a). Upon initiation of the current study, 48% (32 participants) reported previous yoga practice experience either through the Yoga Thrive program, community classes, home practice or combinations thereof. At the end of the seven-week yoga program, 96% were still practicing yoga in various settings, a significant increase of 48% from baseline. At the three-month follow-up yoga practice had dropped, with 69% of participants were still practicing yoga in various settings, a significant 20% increase from baseline. At the six-month follow-up there was a slight increase in participation rates, with 76% of participants reporting continued yoga practice in various settings, a significant 27% increase from baseline (see Table 3.6, Figure 3.8). Follow-up GEE logistic regression analyses were performed to examine what participant characteristics were related to ongoing yoga practice (objective 3b). In examining associations between yoga practice at each time point and predictor variables, there was an initial positive linear effect for time, reflecting the increased rate of participants reporting yoga practice pre-post program. The quadratic trend reflects a significant decline post-intervention completion in yoga practice at three- and sixmonths. Those who reported more frequent participation in the Yoga Thrive program at each time had an 88% greater chance of continuing their yoga practice for each time they completed the Yoga Thrive program. In addition, those who reported higher energy at 85 each time point were 14% more likely to maintain a yoga practice for each one unit increase in energy, as were those who reported a greater ability to be non-reactive to inner experience. These individuals were 8% more likely to continue yoga practice for each one unit increase in non-reactive ability. Finally, those with higher self-reported HRQL at each time point had a 3% greater chance for each one unit increase in HRQL to continue yoga practice (see Table 3.7). 3.5 Discussion Despite an emerging body of evidence highlighting the benefits of yoga for cancer survivors, little work has been done to bridge these clinical findings with theoretical mechanisms of action. The current research seeks to bridge this gap between determining clinical benefits and describing the mechanisms underlying these improvements in mood disturbance, stress symptoms and HRQL. Using the Circumplex Model of Affect as it has been applied in exercise settings (73) and emerging work examining the mechanisms of mindfulness (94,181,185,204-207) and yoga (38,45,109) a series of multilevel models were developed to examine: 1) acute changes pre-post yoga class in measures of valence, activation and attention in a seven week intervention and potential moderators of change (objectives 1a and 1b); 2) longitudinal changes in mood disturbance, stress symptoms and HRQL, predictor variables including affect and mindfulness, and whether these predictor variables moderated change in psychological outcomes (objectives 2a and 2b); and 3) maintenance of yoga practice and whether maintenance could be predicted by moderating variables (objectives 3a and 3b). 86 3.5.1 Acute Class Effects (objectives 1a and 1b): Based on average scores compiled over seven sessions, acute increases in valence, activation and associative attention were observed. These findings are consistent with studies demonstrating that a single exercise session elicits positive core affect (73) as well as increases in associative attention (89,95) (See Figure 3.3). This high-activation state of pleasant affect has been variously referred to as energy, pleasant activation, positive activation and positive activated effect (72). Findings in the field of aerobic exercise suggest this state is facilitated immediately post-exercise for intensity-duration doses considered low to moderate (72). The 75-minute duration of the Yoga Thrive sessions exceeded this definition of moderate duration (up to 35 minutes). However, it must be kept in mind that yoga is not steady state exercise per se, but rather varies in intensity. Specifically, during active yoga sequences, heart rate and respiration may increase consistent with exercise (114), while during the restful supine sequences and meditation that conclude most yoga classes, activity is consistent with relaxation and reduced physiological arousal (115). Findings suggest focus of attention shifts pre-post yoga class to a primarily associative state, characterised by inward attention on kinesthetic and interoceptive cues (89). This associative attentional state has been described as a rough correlate of states of mindfulness at the acute level (95). A more specific corollary may be what Lutz and colleagues (208) have called “focused attention,” a state characterized by voluntary focus of attention on a chosen object. In the case of yoga, this often consists of awareness of the coordination of breath and movement (97). 87 In examining the multilevel regression analyses of these acute increases in valence, activation and attention, baseline measures of mood disturbance are associated with poorer rating of valence and higher associative attention both pre-post class. This association suggests higher baseline mood disturbance makes one increasingly aware of not feeling good. This association fits within the rubric of the notion of “mood congruency” (81) whereby based on our existing mood we are cognitively-primed to attend to stimuli that reiterate these feelings. Higher tiredness (fatigue) at baseline is associated with decreased valence and activation pre-and post yoga class, while those who report higher tension at baseline report higher dissociative attention pre-post class. Taken together, these findings highlight how underlying mood and affective states can impact acute measures of core affect and attention. Those who reported a greater ability to describe events and act with awareness at baseline reported higher associative attention. The ability to accurately describe feelings and thoughts may be related to more associative attentional states while acting with awareness, which focuses on attending to activities in the present moment, is highly congruent with the construct of associative attention (180). Their association likely reflects this overlapping meaning. Those who reported higher non-judgemental awareness at baseline reported lower activation pre-post yoga session. Non-judging of inner experience is associated with acceptance of present-moment experience (181). This openness to present moment experience has been associated with reduced arousal in experienced meditators (209). 88 3.5.2 Longitudinal Program Effects (objectives 2a and 2b): This research confirms previous work suggesting yoga is clinically efficacious in reducing psychological symptoms and improving HRQL (1,2,33). Moderate clinicallysignificant improvements in both mood disturbance and stress symptoms and small improvements in HRQL were seen post-program completion. Continued significant changes in all three measured health outcomes were observed, despite the fact that 48% of participants at baseline were already yoga practitioners and had arguably derived initial program benefits. However, without a comparison group, it is impossible to determine whether these positive effects were directly caused by the yoga program, or may have been due to the simple passage of time. Affect: While the ADACL as a measure of Circumplex Affect has been used in primarily acute exercise settings (73), findings in the area of regular aerobic training (71) suggest positive improvements in areas of energy (high-activation positive affect) over time, provided the exercise is of lower intensity and duration. Current study results suggest a linear increase in energy over time, consistent with acute increases in valence and activation pre-post each yoga class. Given the burden of fatigue in cancer survivors, these improvements are important and corroborate corollary improvements in fatigue indices in both the cancer exercise (9,19,210), mindfulness (179,211) and yoga literature (1). Reductions in tension were most prominent post-program completion. Interestingly no changes in levels of calmness longitudinally were observed. This is of interest, as yoga is often associated with states of increased calmness versus increased energy (33). Mindfulness: Scores on the FFMQ at baseline were similar to those reported by Baer for a non-meditating community sample (212), with the exception of the ability to 89 act with awareness and non-judgment of internal experience, which were lower in the current sample. This finding was somewhat surprising, given associations made between mindfulness and yoga (96) and the fact 48% of the current sample had an existing yoga practice. In comparison to Branstrom’s study examining mindfulness as a mediator in cancer patients (175,182), in the current study baseline mindfulness scores were comparatively lower at all time points, with the exception of a higher score in nonreaction to inner experience. Baseline mindfulness scores were comparable to those of Garland’s (183) study examining relations between mindfulness, stress and mood in those completing an eight-week MBSR course in cancer settings, with the exception of a lower reported ability to act with awareness and be non-judgmental of inner experience. In the present study, overall mindfulness effect sizes pre-post intervention indicate moderate clinically significant increases in the ability to act with awareness and small increases in the ability to be non-judgmental of inner experience. Similar improvements in these mindfulness facets were reported by Garland (183) and Branstrom (175,182) though these effects were of a larger magnitude and also included improvements in the other facets of mindfulness. While improvements in facets of mindfulness in the current study were associated with mood disturbance, stress and HRQL, these changes were to a lesser degree than mindfulness-based programs in which intensive mindfulness practice is central. Mood Disturbance, Stress Symptoms and Quality of Life: Baseline positive yoga beliefs were consistently associated with lower mood disturbance, stress symptoms and higher HRQL at all time points. Sohl and colleagues (187) suggest these beliefs are intrinsic to both initial program engagement and reported health outcomes. In addition, 90 those who reported higher baseline physical activity reported lower mood disturbance, stress symptoms and higher HRQL at all time points. These findings reflect the large body of research suggesting the effects of exercise on mental health and HRQL in cancer survivors (210,213). Higher energy at all time points was consistently associated with lower mood disturbance and higher quality of life. Higher tension was associated with higher stress symptoms and lower HRQL, while higher tiredness was associated with increased mood disturbance. These findings are consistent other research suggesting dimensional measures of affective states may mediate more categorical mood states (68,214,215). Higher reported ability to act with awareness was associated with decreased stress and mood disturbance. As mentioned previously, this ability to attend to events in the present moment is most strongly correlated with associative attentional strategies and may have been related to participant yoga practice. Higher non-judgment of inner experiences relation to lower stress symptoms and higher HRQL may reflect an accepting attentional strategy in which participants have found alternate ways to respond to stressful situations (94). Higher non-reactivity to inner experience was related to lower mood disturbance and has been implicated as a primary mediator in the improvement of overall psychological wellbeing in a mixed sample of university students and experienced meditators (216). In sum, observed improvements in mood disturbance, stress and HRQL are encouraging given participants had already completed the program 1.5 times on average at baseline and thus while they had potentially already derived some benefit, they were still experiencing program-related improvements. Findings suggest improvements in 91 health outcomes are associated with beliefs about yoga, physical activity, the circumplex model of affect, particularly the dimensions of energy, tension and tiredness, and facets of mindfulness, including the ability to act with awareness, be nonjudgmental of and nonreactive to inner experience. Associations between positive affective states and mindfulness are becoming clearer in the current research literature as state and trait measures of both constructs have been found to be highly related (170). Moreover, this examination of distinctive elements of mindfulness may ultimately provide novel views concerning the role of positive affect in exercise and other behavioral interventions (217). 3.5.3 Yoga Practice Maintenance (objectives 3a & 3b): Participants reported a high level of adherence to the yoga program, with a 96% adherence rate post-program. It should be emphasised that at baseline, 48% had already self-identified as having some form of regular yoga practice, either as a previous Yoga Thrive program participant, enrolled in community classes, engaged in home practice or combinations thereof. This rate dropped from 96% to 69% at the three-month follow-up. However, 76% of participants were engaged in yoga practice at the subsequent six-month follow-up. Previous participation in the Yoga Thrive program was a significant predictor of yoga practice maintenance at all time points. This finding is similar to Speed-Andrews and colleagues’ finding that yoga experience over the past year was significantly related to current yoga adherence (218). Positive experiences and increased wellbeing derived from yoga classes are suggested mechanisms for this increased program adherence (219). Those reporting higher energy at each time point were also more likely to continue yoga practice. This relationship between positive affect and adherence has been widely reported in the literature (71,76,167). It is hypothesised the positive appraisal of 92 physical activity as pleasurable is likely to bolster participant self-efficacy and lead to increased adherence and maintenance (66). Recent ACSM guidelines also suggest positive affect may be an important determinant of exercise adherence (74). Results suggesting those higher in non-reactivity were more likely to adhere to yoga practice are supported in the literature. Research by Ulmer and colleagues (220) suggests those with higher mindfulness scores are less reactive and better able to accurately appraise and respond to stressors that may impact routine activities, including yoga practice. Non-reaction refers specifically to the ability to remain calm in the face of distressing thoughts and emotions. This ability to be non-reactive to inner experience has salutary effects and seems to be a key facet of mindfulness as well as one of the facets most effected by contemplative training (216). Finally higher HRQL has been associated with increasing individual self-efficacy to adhere and maintain exercise programs (66). Taken together these results suggest previous yoga experience coupled with higher energy, a greater reported ability to be non-reactive to inner experience and higher HRQL interact to improve the likelihood participants will maintain yoga practice. If affect and mindfulness are both associated with improved HRQL and mental health outcomes and cited as leading to increased intervention adherence, it behooves clinicians to consider developing approaches that focus more exclusively on the inherent psychological benefits of exercise (73,74). 3.5.4 Limitations: A significant limitation of the current study is the lack of a measure of home practice. Current work (221) suggests the addition of home practice predicts mindfulness, subjective wellbeing, fatigue, sleep and a variety of behavioral outcomes. In addition 93 frequency of yoga home practice was a better predictor of health than either total years of practice or class frequency. Given these findings, the thorough assessment of yoga practice outside of class time is imperative. Additional limitations include the self-report nature of all outcomes. While markers of clinical significance have been introduced for these outcomes, including effect sizes and the SEM, future research would be better served by including more objective anchor-based methodology as well as supportive biomarkers of change (62). In addition, including participants who had already completed the program added complexity to the current analyses. However this complexity is inherent to community-based research. Multilevel analyses allowed for the integration of theory to develop novel research designs able to evaluate program outcomes, contextual factors and interactions thereof within existing clinical treatment programs (63,222). 3.5.5 Conclusion Before yoga can be broadly applied within psychosocial oncology, carefully designed and executed research that convincingly evaluates not only the efficacy of yoga in clinical settings but also posits potential mechanisms of action underlying these interventions is required (51). The current research provides a foundation to more fully explore the applications and benefits of yoga for cancer survivors. These objectives have been examined within the structure of the existing Yoga Thrive program to explore whether these associations are observed in routine, everyday practice. Examining these proposed theoretically-based mechanisms for yoga’s salutary effects enables a broader understanding not only of “if” yoga works, but also “how.” This combined knowledge can then be transferred directly back into the community to further develop innovative 94 yoga programs and best practices with the express aim of improving psychosocial health and HRQL in cancer survivors. 95 Table 3.1 Demographics Baseline (n = 66) Age, years (SD) Cancer Diagnosis – Breast Cancer Stage II III Time Since Diagnosis, months Gender – Female Marital Status – Married / Common-law Education Level – completed university / college Annual Household Income - > $80,000 Employment Status – Fulltime Program attendance, sessions n (%) 52.88 (8.11) 41 (62.1) 22 (33.3) 17 (25.8) 23.93 (21.93) 60 (90.9) 44 (66.7) 36 (54.5) 40 (60.6) 26 (39.4) 5.08 (1.94) 96 Table 3.2 Pre-Post Class Estimated Marginal Means Models Pre Class T1 (n=66) Outcome Variable Measure Post Class T2 (n=66) T2 –T1 SMD Mean (SE) Mean (SE) Mean Difference (SE) p d 1.16 (0.18) 3.07 (0.18) 1.91 (0.15) .000 1.59 3.29 (0.12) 3.69 (0.12) 0.40 (0.14) .006 0.36 5.51 (0.18) 3.96 (0.18) -1.55 (0.21) .000 0.95 Valence -Feeling Scale Activation -Felt Arousal Scale Attention -AssociationDissociation Scale SMD = standard mean difference, SE = standard error, p = significance, d = Cohen’s d Predictor Est. (SE) 1.69 (0.33) Valence Activation (Feeling Scale) (Felt Arousal Scale) Est. (SE) df t p df 107.64 5.10 .000 3.37 (0.09) 56.95 t 35.63 p .000 Attention (Association-Dissociation Scale) Est. (SE) df t p 5.15 (0.15) 55.50 33.85 .000 Intercept Time Linear Time 1.31 (0.17) 81.49 7.50 .000 0.12 (0.18) 93.08 0.68 .499 -0.48 (0.25) 98.83 -1.89 Baseline Outcomes Mood -0.02 (0.004) 55.24 -3.63 .001 -0.02 (0.01) 61.95 -2.27 Disturbance Baseline Affect Tension 0.08 (0.04) 55.78 1.92 Tired -0.08 (0.02) 57.88 -3.43 .001 -0.04 (0.02) 62.10 -1.98 .052 Baseline Mindfulness Describe -0.06 (0.02) 55.54 -2.85 Act w/ -0.04 (0.02) 55.60 -1.85 Awareness Non-judgement -0.04 (0.01) 54.82 -2.73 .009 Concurrent Measures Valence NA NA NA NA 0.13 (0.05) 72.65 2.30 .024 -0.54 (0.08) 86.24 -6.09 Activation 0.29 (0.08) 72.74 3.52 .001 NA NA NA NA Attention -0.32 (0.06) 92.83 -5.46 .000 NA NA NA Pseudo R2 Valence = 0.83 Activation = 0.34 Attention = 0.68 Variables Excluded (p > .1): age, time since diagnosis, previous Yoga Thrive experience, yoga beliefs (BAYS) baseline physical activity (GLTEQ), energy and calmness (ADACL), observe &non-reaction (FFMQ), stress symptoms (SOSI), quality of life (FACTG). Est. = Estimate, SE = standard error, df = degrees of freedom; p = significance. .062 .026 .059 .006 .070 .000 NA Table 3.3 Acute Associations – Pre-Post Class Multilevel Regression Model 97 97 Baseline T1 (N=66) 8-weeks post T2 (n=53) Measures 3-month follow-up T3 (n=48) T2 –T1 SMD 6-month follow-up T4 (n=45) T3 – T1 SMD T4 – T1 SMD Cronbach α SEM Mean (SE) p d Mean (SE) p d Mean (SE) p d 20.20 (2.46) .93 5.25 11.58 (2.61) .000 -0.47 15.01 (2.67) .036 -0.27 11.63 (2.74) .001 -0.44 59.08 (3.10) .91 7.49 47.41 (3.26) .000 -0.63 46.78 (3.31) .000 -0.64 49.11 (3.35) .000 0.51 73.51 (1.98) .93 4.15 76.71 (2.06) .017 0.30 78.97 (2.09) .000 0.50 79.66 (2.12) .000 0.54 0.61 2.45 (0.29) .000 1.00 3.02 (0.30) .000 1.37 3.49 (0.30) .000 1.73 Mean (SE) Outcome Variables Mood Disturbance -POMS Total Stress Symptoms -SOSI Total Quality of Life -FACT G Total Predictor Variables Program Experience (Yoga Thrive) 1.46 .93 - Enrolment (0.29) (ICC) Physical Activity -LSI 21.70 (2.03) .88 5.66 23.39 (2.18) .388 0.11 25.39 (2.22) .066 0.23 27.83 (2.26) .003 0.38 -GLTEQ 92.94 (13.64) .86 41.13 96.50 (14.52) .788 0.03 121.74 (15.27) .042 0.26 120.48 (15.48) .055 0.24 Table 3.4 Longitudinal Estimated Marginal Means Model 98 98 Baseline T1 (N=66) 8-weeks post T2 (n=53) Measures T2 –T1 SMD Mean (SE) Cronbach α SEM .88 1.45 .84 1.74 .79 1.59 .80 1.54 Predictor Variables Affect -Energy -Tired -Tension -Calm Mindfulness 3-month follow-up T3 (n=48) 9.53 (0.52) 11.60 (0.54) 9.35 (0.43) 12.77 (0.43) Mean (SE) 10.88 (0.57) 10.16 (0.59) 7.66 (0.47) 13.77 (0.47) p d .022 0.29 .023 -0.29 .001 -0.43 .054 0.24 T3 – T1 SMD Mean (SE) 11.86 (0.59) 10.62 (0.62) 8.47 (0.49) 13.27 (0.49) p d .000 0.48 .136 -0.19 .084 -0.23 .350 0.12 24.92 25.81 26.08 .85 2.47 .244 0.15 .139 (0.79) (0.85) (0.87) 23.04 23.86 23.20 -Describe .87 2.46 .243 0.16 .821 (0.85) (0.90) (0.92) -Act w/ 18.54 20.40 20.31 .89 1.85 .000 0.46 .001 Awareness (0.69) (0.73) (0.74) 20.35 22.47 21.96 -Non-Judging .91 2.02 .006 0.35 .041 (0.84) (0.90) (0.92) 19.92 20.82 21.61 -Non-Reacting .88 1.76 .082 0.22 .002 (0.63) (0.67) (0.68) T = time, SMD = standard mean difference, SE = Standard error, p = significance, d = Cohen’s d. -Observe 6-month follow-up T4 (n=45) 0.18 0.03 0.42 0.34 0.40 T4 – T1 SMD Mean (SE) 13.11 (0.60) 8.82 (0.63) 7.99 (0.50) 13.23 (0.50) 27.13 (0.90) 24.12 (0.93) 21.23 (0.75) 22.65 (0.94) 21.51 (0.69) p d .000 0.72 .000 -0.52 .009 -0.33 .399 0.10 .007 0.34 .151 0.18 .000 0.62 .005 0.36 .004 0.36 Table 3.4 – continued 99 99 Predictor Intercept Time Linear Time Time2 Time3 Moderators Beliefs about Yoga Physical Activity Leisure Score Index Moderate + Vigorous PA Affect Mood Disturbance (POMS Total) Est. (SE) df 16.98 76.35 (2.10) -5.36 (2.22) 1.59 (0.74) -0.12 (0.06) t 8.09 Stress Symptoms (C-SOSI Total) Est. (SE) p df 54.89 .000 69.19 (2.40) 91.15 -2.41 .018 86.47 2.16 85.68 -1.96 .053 -0.57 (0.22) 52.55 -2.63 .011 -0.17 (0.08) 161.15 -2.17 .032 - - - .033 - Energy -0.67 (0.34) Tension - - - - 0.75 (0.31) 176.96 2.45 .015 Tired 178.62 -1.96 .052 -3.90 (0.97) 0.41 (0.11) Quality of Life (FACTG Total) p Est. (SE) t df 76.95 22.87 .000 60.94 (1.49) t p 51.53 .000 108.75 -4.04 .000 0.27 (0.16) 60.05 1.65 .104 90.10 3.62 .000 - - - - - - - - - - - -0.79 (0.27) 50.62 -2.87 .006 0.42 (0.19) 57.19 2.23 .030 - - - - 0.14 (0.05) 173.61 2.86 .005 .037 - - - - 158.34 2.62 .010 150.36 -4.27 .000 -0.03 (0.01) - 174.50 -2.10 - 1.35 (0.33) 158.74 - - - - 4.07 .000 - - 0.44 (0.17) -0.81 (0.19) - - - - Table 3.5 Longitudinal Multilevel Regression Model 100 100 Predictor Mindfulness Act w/ Awareness Non-judgement Non-Reaction Mood Disturbance (POMS Total) Est. df (SE) -0.58 (0.25) -0.56 (0.26) t p 144.80 -2.33 .021 - - - 140.04 -2.13 .035 Stress Symptoms (C-SOSI Total) Est. df (SE) -0.67 (0.29) -0.76 (0.24) - t p Quality of Life (FACTG Total) Est. df (SE) t p 174.16 -2.29 .023 - - - - 185.89 -3.20 .002 0.56 (0.12) 180.77 4.71 .000 - - - - - - - Pseudo R2 Mood Disturbance = 0.31 Stress Symptoms = 0.40 Quality of Life = 0.29 Variables Excluded (p>.1): age, time since diagnosis, previous Yoga Thrive program experience, calm (ADACL), observe & describe (FFMQ). Est. = estimate, df = degrees of freedom, p = significance. Table 3.5 – continued 101 101 Baseline T1 (N=66) 8-weeks post T2 (n=53) T2 –T1 SMD Measures Adherence 3-month follow-up T3 (n=48) 6-month follow-up T4 (n=45) T3 – T1 SMD T4 – T1 SMD Mean (SE) Mean (SE) Mean Difference (SE) p d Mean (SE) Mean Difference (SE) p d Mean (SE) Mean Difference (SE) 0.48 (0.06) 0.96 (0.03) 0.48 (0.07) .000 0.98 0.69 (0.07) 0.20 (0.08) .008 0.41 0.76 (0.06) 0.27 (0.09) p d .002 0.55 T = time, SMD = standard mean difference, SE = standard error, p = significance, d = Cohen’s d. Table 3.6 Yoga Practice Maintenance Estimated Marginal Means Model 102 102 103 Table 3.7 Predictors of Yoga Practice Maintenance. B Wald Odds Ratio Parameter p 2 (SE) χ (95% CI) 1.50 4.50 (Intercept) 15.77 .000 (0.38) (2.14, 9.45) 0.63 1.87 Time 7.11 .008 (0.23) (1.18. 2.96) -0.09 0.91 Time2 10.83 .001 (0.03) (0.86, 0.96) Previous Participation in Yoga 0.63 1.88 8.42 .004 Thrive (0.22) (1.23, 2.87) 0.13 1.14 Energy 4.94 .026 (0.06) (1.02, 1.27) 0.08 1.08 Non-Reaction to Inner Experience 5.86 .015 (0.03) (1.02, 1.16) 0.03 1.03 Quality of Life 4.23 .040 (0.01) (1.00, 1.06) Excluded variables (p>.1): age, time since diagnosis, yoga beliefs, attendance, physical activity, tension, tired, calm, observe, describe , act with awareness, non-judgment, mood disturbance, stress symptoms. B = estimate, SE = standard error, p = significance. Figure 3.1 Circumplex Model of Affect 104 104 Figure 3.2 Participant Recruitment Flow Diagram 105 105 Figure 3.3 Affect Circumplex 2D Model (valence, activation) 106 106 Figure 3.4 Affect Circumplex 3D Model (valence, activation, affect, attention) 107 107 Figure 3.5 Continuous Moderators: total physical activity (LSI), moderate-vigorous physical activity (GLTEQ) and previous Yoga Thrive experience († p<0.10, * p<0.05, ** p<0.01, *** p<0.001). 108 108 Figure 3.5 Continuous Moderators (continued): total physical activity (LSI), moderate-vigorous physical activity (GLTEQ) and previous Yoga Thrive experience – continued († p<0.10, * p<0.05, ** p<0.01, *** p<0.001). 109 109 Figure 3.6 Longitudinal Changes in Affect (AD ACL) († p<0.10, * p<0.05, ** p<0.01, *** p<0.001). 110 110 Figure 3.6 Longitudinal Changes in Affect (AD ACL) – continued († p<0.10, * p<0.05, ** p<0.01, *** p<0.001). 111 111 Figure 3.7 Longitudinal Changes in Mindfulness (FFMQ) († p<0.10, * p<0.05, ** p<0.01, *** p<0.001). 112 112 Figure 3.7 Longitudinal Changes in Mindfulness (FFMQ) – continued († p<0.10, * p<0.05, ** p<0.01, *** p<0.001). 113 113 Figure 3.7 Longitudinal Changes in Mindfulness (FFMQ) – continued († p<0.10, * p<0.05, ** p<0.01, *** p<0.001). 114 114 Figure 3.8 Longitudinal Changes in Mood Disturbance (POMS), Stress Symptoms (C-SOSI), and Quality of Life (FACT-G) († p<0.10, * p<0.05, ** p<0.01, *** p<0.001). 115 115 Figure 3.8 Longitudinal Changes in Mood Disturbance (POMS), Stress Symptoms (C-SOSI), and Quality of Life (FACT-G) – continued († p<0.10, * p<0.05, ** p<0.01, *** p<0.001). 116 116 Figure 3.9 Yoga Practice Maintenance († p<0.10, * p<0.05, ** p<0.01, *** p<0.001). 117 117 118 CHAPTER 4: MODELLING ASSOCIATIONS BETWEEN AFFECT, ATTENTION AND HEART RATE VARIABILITY IN A SINGLE YOGA SESSION FOR CANCER SURVIVORS: A NEUROPHENOMENOLOGICAL APPROACH 119 4.1 Introduction Contemporary yoga practice consists of lifestyle prescriptions, postures, breath regulation, and meditative techniques modifiable based on desired outcomes as well as participant health status (51). Yoga practices are said to have numerous applications, ranging from liberation or kaivalya, as per the Yoga Sutras (YS IV.34), to ordinary physical and mental training (55). Emerging research suggests yoga shares many of the benefits of exercise in addition to yoga-specific psychophysiological control (38,223). Studies comparing the effects of yoga and exercise indicate that in healthy individuals and those with various health conditions, yoga may be as effective as more contemporary western forms of exercise including walking, jogging, cycling and aerobics at improving a variety of health-related outcome measures (48). Within cancer settings yoga groups compared to waitlist control groups or supportive therapy groups show greater improvements in overall QOL, psychological health, stress-related symptoms, and fatigue indices (1,2,33). The root aim of yoga can be summarised in Patanjali’s definition of Yoga as a path towards, “stilling the fluctuations of the mind (YS I.2).” Importantly, meditative states experienced within yoga practice are correlated to neurophysiological systems that mediate both positive affect and internalised attention (58,59). Based on this definition of yoga, the aims of the current study were threefold: 1) to investigate whether yoga practice elicits change in affect, attention, perceived exertion and cardiac activity including heart rate variability (HRV), a non-invasive metric of cardiac autonomic function, during a single yoga session; 2) to determine the mechanisms by which these changes were elicited. Specifically, whether changes in affect, attention, and perceived exertion were 120 associated with one another and cardiac activity; and 3) whether participants own subjective experience of the yoga session corroborated these quantitative findings. 4.1.1 Affect A current area of clinical research interest is the study of positive affect as an independent, adaptive pathway in the cancer experience (68). Engagement in behaviours associated with state positive affect may cultivate trait-like changes that correspond with enhanced QOL and mental health indices (69). In general, positive affect tends to increase pre- to post-exercise following exercise intensities that are not exhaustive (73). In two recent studies, a single session of yoga was associated with significant improvements in positive affect and reductions in negative affect comparable to changes seen with aerobic exercise (77,78). In addition, a recent pilot RCT reported significant improvement in positive affect, emotional function and cognitive function, and decreased negative affect in the yoga group as compared to supportive therapy controls (80). These findings suggest positive affect is an important health outcome and may be correlated with positive changes in HRQL and mental health indices. 4.1.2 Attention Previous research has shown an individual’s focus of attention during exercise can influence changes in affective responses (89). Associative and dissociative attentional strategies indicate the extent to which exercisers focus their attention on exercise-related feedback. Associative attention is defined as focusing attention on present-moment physical sensations related to exercise, in which exercisers seek to monitor sensory input and adjust their effort accordingly. Dissociative attention is defined as focusing on nonexercise related stimuli that divert attention away from internal sensations and present 121 moment exercise experience, such as listening to music, watching television while exercising, or making plans for post-exercise activities (90). The practice of mindfulness, or the ability to direct attention towards events in the field of consciousness (thoughts, emotions, body sensations) in the present moment without judgement (94), is conceptually similar to associative attentional processing as described via a dimensional model, with the exception that this associative state does not necessarily carry with it the attitude on non-judgement. Mindfulness in exercise settings is believed to enhance accurate observation and acceptance of both one’s internal bodily cues, the content of thoughts and the external environment (95). Higher levels of both trait and state mindfulness have been associated with higher positive affect and lower negative affect via engagement of sustained non-reactive attention upon immediate experience and disengagement of habitual cognitive processing (224). Within exercise settings, mindfulness builds upon associative attention by refining perceptions of perceived exertion on a moment-by-moment basis via increased sensitivity to a host of cognitive and interoceptive cues, and concurrently limits emotional reactivity to these cues via non-reactivity to these experiences (95). It is hypothesised the strong mind-body interaction within contemporary yoga practice adds a unique contemplative dimension to exercise and has been referred to as ‘mindfulness in motion’ (96). The practice of yoga provides an opportunity for sustained attention to the body, breath and mind through a progressive sequence of dynamic movements, restful postures, breathing exercises and periods of meditative awareness. Making these sensations the focus of attention facilitates a strong mindfulness practice. Froeliger and colleagues (98) suggest the object of mindfulness in contemporary yoga 122 practice comes from both physical sensations of the body moving and awareness of breath. 4.1.3 Heart Rate Variability A commonly reported neurophysiological mechanism potentially mediating relations between yoga practice, improved attention regulation and positive affect lies in the Autonomic Nervous System (ANS). The ANS is the most prominent physiological factor in determining heart functions and is comprised of both parasympathetic and sympathetic input, and the amount of input the body is receiving from each can be examined through the study of heart rate variability (HRV), the modulation of the heart rate about its mean value (101). HRV offers a non-invasive quantitative method of investigating autonomic effects on the heart. HRV is also increasingly being used as an index of affect regulation (104106). HRV represents the sequences of complex beat-to-beat variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity as recorded via an electrocardiogram (ECG), known as the R-R interval. HRV measurements are classified under three broad domains: time domains, spectral analyses and non-linear methods. Time-domain measures plot HRV as the normal R-R ratio (N-N) over time (225). Commonly reported time domain measures include SDNN, the standard deviation of all N-N intervals thought to reflect overall HRV, and RMSSD, the root mean square of successive N-N interval differences, thought to reflect vagal activity. Spectral analyses of HRV distinguish among sources of HRV by plotting the frequency at which the length of the N-N interval changes (225), as these rhythms occur at different frequencies (101). Low frequency HRV (LF) occurs at a range of 0.04-0.15 Hz and reflects mixed 123 sympathetic and parasympathetic modulation of HRV and is often used as an index of cardiac sympathetic nervous system activity (226). High frequency HRV (HF) occurs at a range of 0.15-0.4 Hz and is widely used indicator of cardiac parasympathetic nervous system activity (vagal tone) (227). The ratio of low-frequency to high-frequency HRV (LF/HF) is a purported measure of sympathovagal balance (101). Non-linear methods are purported to better measure biological mechanisms such as heart rate. Entropy measures (approximate entropy, sample entropy) represent the total complexity of the time domain. The larger the entropy value the more complex and healthier the system is (107). In general, higher SDNN, RMSSD, HF HRV and sample entropy are indicative of positive health outcomes, while higher LF HRV and LF/HF ratio are associated with negative health outcomes (107). In cancer settings, impaired autonomic nervous system function, as evidenced by lower HRV, has been implicated in an increased risk of depression in metastatic breast cancer patients (228), poorer prognosis in colorectal cancer (229), cancer-related fatigue in a breast cancer sample (230), increased nausea post-chemotherapy (231), increased cancer cachexia (wasting) (232) and shortened survival time in cancer patients with advanced cancer (233-235). Conversely, exercise has been associated with higher HRV in cancer survivors and improved autonomic function and quality of life and has been implicated in longer survival times (236). Yoga programs are reported to result in increased parasympathetic nervous system (PNS) activity and significantly increases cardiac vagal modulation (108). Streeter and colleagues (2012) hypothesise yoga practice corrects PNS under-activity via stimulation of the vagus nerves to ameliorate stress-related illness symptoms (109). The 124 conscious regulation of breathing practiced in yoga may influence autonomic function by regulating the balance of sympathetic and parasympathetic activation, the latter increasing as the breath deepens and slows (110,111). Yoga practice also appears to result in increased vagal modulation (113) and control over autonomic responses such as heart rate (112). During active poses, heart rate and respiration may increase consistent with exercise (114). However, during and following the restful supine and seated meditative postures that conclude most yoga classes, parasympathetic activity, as measured via HRV frequency domains, consistent with relaxation and a reduction in physiological arousal is apparent (115). In a cross-sectional study examining resting HRV in yoga and non yoga practitioners, LF HRV appeared higher in non-yoga practitioners while HF HRV was higher in those who practice yoga versus those who did not (237). 4.1.4 Neuro-Affective Theories and Approaches The current research uses several supportive theories from the psychological sciences to further frame these phenomena. These theories include: 1) the Circumplex Model of Affect, 2) the Dual-Mode Theory of Affective Responses to Exercise, 3) the Effort-related Attention Model, 4) the Neurovisceral Integration Model, all utilised within the confines of an overarching 4) Neurophenomenological approach. 4.1.4.1 Circumplex Model of Affect. Given the proposed importance of positive affect and yoga’s influence on affect, the Circumplex Model of Affect (81) offers an important parsimonious explanatory approach. According to this model, affect is best understood as an underlying state comprised of two orthogonal dimensions: feeling good or bad (valence), and energized or enervated (activation-arousal). These two dimensions of valence and activation-arousal, termed core affect, underlie all affective states. Upon 125 this affective basis are layered various cognitive processes that interpret and refine emotions and moods and influence reflexes, perception, cognition, and behaviour (82). Specific affective states are considered combinations of these two dimensions. The four quadrants within this model can be described as: high activation pleasure (energy), low activation pleasure (calmness), high activation displeasure (tension), and low activation displeasure (tiredness) (see Figure 4.1). 4.1.4.2 Dual Mode Theory. The Circumplex approach can be further contextualised to exercise research settings utilising Dual Mode Theory (168), which suggests exercise experiences are regulated by affect via the continuous interplay of two mechanisms; 1) cognitive processes, and 2) interoceptive cues. The relative importance of these two factors in the regulation of core affect is hypothesized to shift systematically as a function of exercise intensity, with cognitive factors being dominant at low and moderate intensities and interoceptive cues becoming more prominent at higher intensities (85). To date, Dual Mode Theory has been used primarily in affective responses at various exercise intensities (73) but has not been utilised in the exploration of lower-intensity activity such as yoga. 4.1.4.3 Effort-Related Attention Model. The Effort-Related Attention Model suggests these attention strategies during exercise vary based on intensity (91). During low or moderate intensity workloads attention is voluntary and can switch between dissociative and associative attentional strategies, as external stimuli do not compete with internal stimuli, while at higher exercise intensities increased physiological cues demand attention. As a result attention narrows, shifts internally and becomes associative (92). 126 4.1.4.4 Neurovisceral Integration Model. The Neurovisceral Integration Model (116) links these dimensions of valence, activation and attention via cardiac autonomic function and specifically PNS function, as measured by heart rate and HRV. There is abundant evidence that regular exercise training induces greater parasympathetic modulation of cardiac function as measured via HRV in physically fit individuals (238). Daily exercise also improves positive affect by shifting the autonomic balance to parasympathetic predominance as measured via spectral HRV (119). Conversely, evidence suggests sedentary lifestyles result in negative mood symptoms, especially feelings of fatigue and depressive symptoms, which are related to decreases in parasympathetic function as measured via LF/HF ratio (118). 4.1.4.5 Neurophenomenology. The present research is concerned with the phenomenological lived experience of contemporary yoga practice. The phenomena are, in part, explored via the lens of neurophenomenology, a convergent mixed methods research approach that combines qualitative subjective first-person narratives, quantitative self-reports and physiological data to develop a layered approach to conscious experience (123,239,240). The strategy of neurophenomenology is to provide mutually informative insights between first-person and neurophysiological accounts as a means of generating new data in the exploration of consciousness (121). In addition, the importance of contemplative mental training for research on consciousness is central to neurophenomenology (123). This novel research approach has been used previously in examining contemplative practices, particularly with advanced meditation practitioners (208), using both EEG and fMRI methodologies in neuroscientific research. However, 127 this same approach has never been used in a contemporary yoga setting using HRV as a psychophysiological correlate of affect and attention responses. 4.2 Objectives The present study explores participants’ experience of a single yoga session in an effort to understand how yoga practice influences participants’ immediate experience both during and immediately post-yoga practice. Based on the Circumplex Model of Affect (81), the Dual-Mode Theory of Affective Responses to Exercise (85), the EffortRelated Attention Model (91), the Neurovisceral Integration Model (106,116,117), and Neurophenomenology (123,239,240), this lab-based protocol examines the relations between valence, activation, attention, perceived exertion and cardiac activity both during and before and after a single yoga session in cancer survivors. Objective 1a: To examine changes in valence, activation, attention and perceived exertion during a single yoga session as well as associated measures of cardiac activity, including heart rate and HRV. Objective 1b: To examine whether changes in valence, activation, attention and perceived exertion were related to one another and/or changes in cardiac activity. Objective 1c: To examine whether changes in valence, activation, attention, perceived exertion and cardiac activity were related to subjective first-person descriptions of the yoga session. Objective 2a: To examine whether significant changes in dimensions of affect, including measures or energy, tension, tiredness and calmness, occurred pre-post yoga class. Objective 2b: To examine whether changes in dimensions of affect were related to one another and/or to concurrent changes in valence, activation, attention, perceived exertion, and cardiac activity. Objective 2c: To examine whether 128 changes in affect or cardiac activity were related to subjective first-person descriptions of the yoga session. 4.3 Methods 4.3.1 Subject Recruitment Ethical approval was obtained from the Conjoint Health Research Ethics Board of the University of Calgary/Alberta Health Services (Ethics ID # 23313). Purposeful sampling was used with the goal of identifying information-rich participants in order to study each participant in-depth during a single yoga session. The sample was thus drawn from participants who had previously completed the 7-week Yoga Thrive intervention for cancer survivors (149,186). For the quantitative component of this study, a preliminary power calculation using GPower 3.1 (241) using an a priori clinically meaningful effect size of 0.50 (139) on the Feeling Scale (188) as the primary outcome with an α of .05 and power of .80, indicated a minimum of 16 participants were required. 4.3.2 Procedures Upon arrival in the lab, participants completed a questionnaire package assessing baseline demographics, weekly physical activity, previous yoga experience, yoga beliefs, and general affect. Participants then completed an individually-taught, single standardized 80-minute yoga session. In order to assess objective 1a, using a research protocol similar to Ekkekakis and colleagues (242-244), psychological measures including valence, activation, attention and perceived exertion were completed eight times during the yoga session. The assessments were completed in 10-minute intervals at the end of each of the following sequences: 1) supine resting baseline, 2) supine yoga, 3) seated yoga, 4) kneeling yoga, 5) standing yoga, 6) second supine yoga, 7) supine 129 meditation, and 8) supine resting post yoga session. In order to assess objective 2a, a measure of general affect was completed at the end of all supine resting sequences: 1) supine resting baseline, 2) supine meditation, and 3) supine resting post yoga session. Participants had prior training in filling out all self-reported measures, having participated in a yoga intervention study previously that used these measures. Cardiac activity was assessed throughout the lab study via a wireless chest-band heart rate monitor (RS800CX, Polar Electro, Kempele, Finland) to obtain continuous ambulatory measures of heart rate and HRV as indicants of psychophysiological function (104,106,245). Measures included heart rate (bpm) and HRV (time domains: SDNN, RMSSD; frequency domains: HF HRV nu; non-linear: Sample Entropy) (101). Because HRV is regulated differently throughout the day, experiments were conducted during the morning to ensure similar cardiac activity for all participants (246). In addition, participants were asked not to exercise or consume caffeine or alcoholic beverages 12 hours prior to the experiment and to refrain from eating and drinking 3 hours prior to the experiment, as these agents have been shown to influence HRV (101,247). All measures were subsequently divided into 5-minute epochs derived from the midpoint of each yoga sequence for data analysis. Both resting and ambulatory measures of heart rate and HRV are included in the study. While the validity of non-resting measures of HRV has been called into question (248), given the low-intensity (peak 52% of age-predicted maximum heart rate) of the yoga session and previous research in yoga settings using HRV as an ambulatory measure (115), this data was examined throughout. Following completion of all self-report scales, each participant completed a single 10-minute interview after the post-yoga supine resting condition (objective 1c and 2c). 130 The aim of the interview was to provide a structure that tapped into specific areas of participants’ subjective experience of the yoga session (249). Participants were asked to describe their experience of each component of the session via a series of open-ended questions (243). All self-report scale and questionnaire data was then reviewed with participants as well as heart rate range at the beginning and end of each sequence (HRV data required additional processing and analysis and could not be reviewed at this time). Participants were invited to reflect and comment on all available data. This interview approach permitted discussion and allowed for data to enter the interview not directly elicited, allowing patients to provide information they believed was important and relevant to them (250). At the end of each interview, the main points were summarized by the researcher for the individual for the purpose of member-checking and credibility (153). All interviews were audio taped with consent. 4.3.3 Instruments – Baseline Demographics: Demographic information included age, education, marital status and current employment status. Medical history included cancer diagnosis, date of diagnosis and type(s) of cancer treatment. Participant height and weight was also measured to calculate Body Mass Index (BMI) (mass (kg) / height (m)2). Godin Leisure Time Exercise Questionnaire . The GLTEQ (193) has been used to assess previous physical activity levels. The LSI contains three questions that assess frequency of mild, moderate, and strenuous physical activity performed for at least 15 minutes duration in a typical week within the past month. A weekly total of minutes of moderate-vigorous physical activity can also be computed from this scale (baseline Cronbach’s α: LSI = .88; moderate + vigorous physical activity = .86). 131 Beliefs about Yoga Scale. The BAYS (187) is an 11-item self-report measure developed to examine common positive and negative beliefs about yoga in order to help yoga instructors understand participant expectations related to yoga (baseline Cronbach’s α = .78). 4.3.4 Instruments – In-Task Measures (objective 1a): Feeling Scale. The FS (188) is an 11-point, single-item, bipolar measure of affective valence (pleasure-displeasure). The scale ranges from -5 to +5. Anchors are provided at zero (‘Neutral’) and at all odd integers, ranging from ‘Very Good’ (+5) to ‘Very Bad’ (-5). Instructions were to “estimate how good or bad you feel right now.” The FS is commonly used for the assessment of affective responses during exercise (189) (ICC = 0.90). Felt Arousal Scale. The FAS (190) is a 6-point, single-item measure of perceived activation. The scale ranges from 1 to 6, with anchors at 1 (‘Low Arousal’) and 6 (‘High Arousal’) (ICC = 0.89). Instructions were to “estimate how aroused you feel right now (low arousal = calm or fatigued, high arousal = anxious or energized). Association / Dissociation Scale. The A/D S (191) is a single-item 10 point bipolar scale designed to measure to what extent attention is primarily associative or dissociative. The scale ranges from 1 to 10, with anchors at 1 (very associative) and 10 (very dissociative) (192) (ICC = 0.74). Instructions were to “estimate your present state of attention right now (associative = focused in present moment, dissociative = unfocused in past or future). Rating of Perceived Exertion. The RPE (251) is a single item measure used to assess perceptions of effort. The RPE is a 15-point scale ranging from 6 (Extremely 132 Light) to 20 (Extremely Hard) (ICC = 0.83). Instructions were to “rate your perception of exertion (i.e., how strenuous the exercise felt to you / how tired you feel as a result).” Heart Rate Variability. Given the high multicollinearity (r >.7) between various time and spectral estimates of HRV (101), a stepwise multivariable approach (252) was used to choose appropriate indices of HRV. Measures included in the HRV analysis were HF HRV nu, SDNN, RMSSD, and Sample Entropy. Both SDNN and Sample Entropy are thought to represent total complexity of the heart rate signal including both sympathetic and parasympathetic components, while both RMSSD and HF HRV nu are thought to reflect parasympathetic activation of the cardiac autonomic nervous system (107). 4.3.5 Instruments – Pre, Post-Supine Meditation & Post-Yoga Supine Resting (objective 2a) Activation Deactivation Adjective Check List. The AD ACL (194) is a 20-item measure of the four quadrants of circumplex affective space. Energy is theorized to map the high activation pleasure quadrant of the circumplex, Tension maps the high-activation displeasure quadrant, Tiredness maps the low-activation displeasure quadrant, and Calmness maps the low-activation pleasure quadrant (83) (baseline α: energy = .88; tired = .84; tension = .79; calm = .80). 4.3.6 Data Analysis All data analyses were conducted using IBM SPSS version 19. Demographics and medical history were described using frequency and descriptive statistics to characterize study participants. This investigation used a repeated measures design in which participants served as their own control. Before beginning primary analyses, all continuous variables were checked for normality (skewness, kurtosis) and corrected 133 where necessary. Statistical analyses were conducted on the entire sample (n = 18). HRV indices were analysed via five-minute epochs derived from the mid-point of each yoga sequence (115). 4.3.6.1 Multilevel Modelling. In the initial analyses, multilevel models (linear mixed models) were used to create estimated marginal means models to sequentially examine change between: 1) baseline measures and all sequences of the yoga intervention (objective 1a), and 2) between baseline measures, the end of the yoga session and the end of the post yoga session supine-resting condition (objective 2a). The purpose of these two separate analyses is to allow comparisons between the conclusions that were drawn from pre-to-post assessments as opposed to in-task assessments (242). Multilevel models are appropriate for analyzing data with dependent observations (such as within-subject repeated measures) due to the hierarchical structure of the data. That is, each time measurement of a given variable (level 1) was nested within each participant (level 2) (198). Correlations among observations from the same individual were modeled using an unstructured covariance matrix across all time points. Objective 1b: In the exploratory analyses, multilevel regression analyses were conducted to assess concurrent associations between valence, activation, attention, and perceived exertion with indices of cardiac function. Age, BMI, time since diagnosis, physical activity, previous yoga experience, and baseline affect were modelled as timeinvariant covariates. Time was measured continuously and included linear and quadratic terms (200). All models were tested step by step (202,253). First, an initial unconditional model was developed for each outcome variable (data not shown) followed by an unconditional growth model that included only time variables (data not shown). Predictor 134 variables were then added individually to the unconditional growth model and tested for main and interaction effects with each time term (data not shown). Significant predictors and their time interactions, if significant, were then tested together as part of their respective overall scale (data not shown). A final trimmed model was developed by entering all significant predictors and their interactions to test overall associations across time (exclusion p >.1). This method of model development has proven robust with smaller sample sizes and ensures these models do not tax the “carrying-capacity” of the dataset (201). If interaction terms were not significant it could be assumed relations between predictor and outcome variables were constant throughout the study. In each model the time variable was centered at initial status; therefore the intercept of the regression model can be interpreted as participant reports of the outcome variable at baseline. To enhance interpretability of the model intercept parameters, all predictor variables were grandmean centered. Follow-up multilevel regression analyses were not computed for cardiac activity indices but instead were used as continuous predictors in models predicting, valence, activation, attention and perceived exertion. Objective 2b: These same steps were followed to examine resting measures on the ADACL at three time points 1) post-resting baseline, 2) post-supine meditation condition, 3) post-yoga session supine resting condition. Associations between the ADACL and all other time invariant and time-varying predictors were then examined via additional multilevel regression analyses. 4.3.6.2 Clinical Significance. Clinical significance, or meaningful clinically important difference, a marker of program effectiveness, was assessed using multiple 135 criteria including: 1) an effect size using Cohen’s interpretation of >.20 as a small effect >.50 as a moderate effect and >.80 as a large effect (142), 2) a standard mean difference between baseline and follow-up time points ≥ 1 standard error of the measure (SEM), and by comparing changes from pre to post to meaningful clinically important difference in the research literature (135). Effect sizes were calculated using Cohen’s d for each outcome variable, representing change from baseline to the end of each yoga sequence and the post-yoga session resting condition (T1-Tx / T1 SE * √N). SEM was calculated as baseline (SE * √n) * (√1 – ICC) (254). Pseudo R2 statistics were calculated as unconditional model residual variance – trimmed model residual variance / unconditional model residual variance. These statistics indicate the reduction in residual variance between the unconditional and trimmed model and provide an estimate of effect size similar to traditional OLS regression (202) and can be interpreted using Cohen’s criteria of >.02 as a small effect >.13 as a moderate effect and >.26 as a large effect (142). All statistical significance levels were set at p = .05 with a two-tailed test. 4.3.6.3 Qualitative Analysis (objectives 1c and 2c). All interviews were conducted by a single researcher (MM), and coded independently by a research assistant (AW) and the interviewer (MM). Interviews were transcribed verbatim and analysed using the NVivo 9 computer program. Using a process of inductive thematic analysis (249), raw data quotes were identified, labelled and organized into key themes. Common themes were then combined into higher-order categories. Themes and categories were compared and contrasted to assure consistency of coding and that all data was accounted for by the core categories. Direct quotes were provided from participants to ensure the 136 transferability of categorical assertions made by the researchers and so that readers can experience for themselves participant perspectives (153,243,255). 4.3.6.4 Mixed Methods. Finally, a convergent mixed methods neurophenomenological approach was used to analyse and integrate self-report questionnaire / scale, physiological and qualitative datasets. This multilayered analysis and interpretation provided mutual insights between phenomenological first-person accounts and physiological data. In coding with triangulation in mind, the emphasis was placed on seeking corroboration between quantitative and qualitative data (256). Specifically, after initial quantitative analysis and independent coding of the qualitative data, the latter was used to further guide analysis and interpretation of the quantitative data. This led in several cases to re-examining and remodelling data from the multilevel regression analyses. Theoretically, integrating quantitative and qualitative methods and applying an iterative analytic process (257) permits more accurate quantitative descriptors of phenomena and a more parsimonious understanding of measured constructs (258). 4.4 Results: Results were examined in the following order: demographics: a brief overview of participant demographics. In-task effects: estimated marginal means models examined change in valence, activation, attention, perceived exertion and cardiac activity during the single yoga session (objective 1a); exploratory multilevel regression analyses examined the associations between valence, activation, attention, perceived exertion and cardiac activity (objective 1b); qualitative descriptions of both the yoga class and participantproposed explanatory mechanisms for the effects of yoga (objective 1c). Pre-post yoga 137 session effects: estimated marginal means models examined changes in energy, tension, tiredness and calmness before and after the single yoga session (objective 2a); exploratory multilevel regression analyses examined the relationships between these affective states, valence, activation, attention, perceived exertion and cardiac activity (objective 2b); qualitative descriptions of the four affective states as experienced before and after the single yoga session (objective 2c). 4.4.1 Demographics Forty participants from a concurrent yoga intervention study were eligible to participate in this research. Of those 40 participants, 18 chose to participate in the singlesession yoga study. The mean participant age was 54.0 years. All participants were female and 61.1% of participants had received a breast cancer diagnosis, stage II-III, approximately 36.0 months prior to study enrollment. Participants were commonly married (55.6%), highly educated (61.1%), affluent (44%) and many participants had returned to work fulltime (61.1%). Participants had completed the Yoga Thrive program a mean of 4.9 times previously. The average participant BMI was 24.8, considered to be in the high normal to overweight range. Participants reported an average of 144.9 minutes of moderate-vigorous physical activity per week, just short of CSEP / ACSM recommended levels of 150 minutes per week (23). In addition, participants reported high positive beliefs concerning the outcomes of engaging in yoga practice (see Table 4.1). 4.4.2 Valence, activation, attention, perceived exertion and cardiac activity during yoga session (objectives 1a and 1b): 4.4.2.1 Valence. A marginally significant increase (p = .100) in valence began during the kneeling sequence, exceeding 1 SEM from baseline criteria. This increase in 138 valence became more pronounced during the standing sequence, second supine sequence and supine meditation conditions and was maintained post yoga intervention [F(7,119) = 19.37, p < .001] (see Table 4.2, Figure 4.3). To examine what may have elicited these changes, exploratory multilevel regression analyses were computed. Time was a significant predictor of a linear increase in valence over the course of the intervention. In addition, those with higher overall physical activity and energy at baseline reported higher valence during all subsequent yoga sequences. Increased associative attention and lower RPE were also related to higher reported valence consistently over time. Finally, a marginally significant effect for SDNN was observed, suggesting the possibility those with higher recorded HRV reported higher affective valence throughout the yoga session. The Pseudo R2 value suggests inclusion of these predictor variables reduced error in predicting valence during the yoga session by 60% (see Table 4.4). 4.4.2.2 Activation. A marginal statistically significant increase in activation was observed that exceeded the 1 SEM during the seated yoga condition and was maintained during the kneeling yoga condition. Activation peaked in the standing yoga condition and a moderate effect was maintained in the second supine yoga condition, before returning to baseline values for both the supine meditation and post-yoga supine resting conditions [F(7, 119) = 2.12, p = .045] (see Table 4.2, Figure 4.3). In further exploring what may have predicted change in activation, a quadratic growth pattern was evident, indicating an initial linear increase in activation followed by a significant decline. Those with a higher BMI at baseline reported lower activation throughout the yoga session. In addition, those with higher dissociative attention also consistently reported higher activation. Finally, a marginally significant effect for SDNN was observed, suggesting the possibility those 139 with lower recorded HRV consistently reported higher activation throughout the yoga session. The Pseudo R2 value suggests inclusion of these predictor variables reduced error in predicting activation during the yoga session by 42% (see Table 4.4). 4.4.2.3 Attention. Attention began to significantly shift during the kneeling yoga sequence and became progressively more associative, culminating during the supine meditation condition. This state of associative attention was maintained during the postyoga supine resting period [F(7,119) = 9.02, p < .001] (see Table 4.2, Figure 4.3). In further examining what predicted changes in attention, a marginally significant effect for linear time was found when time was remodelled as a linear continuous variable. In addition, higher reported affective valence was associated with increased associative attention at all time points, while increased activation was associated with increased dissociative attention. A complex interaction was observed between sample entropy and time in relation to attention. Follow-up simple slopes analyses (259) illustrate those with low HRV had the lowest dissociative attention scores at baseline but experienced nonsignificant reductions in dissociative attention over time, while those with average HRV experience significant decreases in dissociative attention over time. Those with high HRV had the highest dissociative attention scores at baseline but experienced the greatest decrease in dissociative attention (see Figure 4.2). The Pseudo R2 value suggests inclusion of these predictor variables reduced error in predicting attention during the yoga session by 57% (see Table 4.4). 4.4.2.4 Rating of Perceived Exertion. RPE significantly increased from baseline to the standing yoga sequence, then dropping in the second supine yoga condition before returning to baseline values in the supine meditation and post yoga session supine resting 140 conditions [F(7,119) = 21.30, p <.001] (see Table 4.2, Figure 4.3). In multilevel regression analyses time exhibited a quadratic growth curve: an initial linear increase was observed followed by a significant decrease in growth. Higher reported physical activity and energy at baseline consistently predicted increased RPE. Those who reported lower valence also reported increased RPE and those that reported higher activation also reported higher RPE. Finally, higher heart rate was associated with higher RPE. The Pseudo R2 value suggests inclusion of these predictor variables reduced error in predicting perceived exertion during the yoga session by 60% (see Table 4.4). 4.4.2.5 Cardiac Activity. Estimated marginal means models suggest heart rate was responsive to each yoga sequence [F(7,119) = 74.84, p< .001], with significant increases in heart rate from baseline in the seated, kneeling, and standing conditions, followed by a significant decrease during the supine meditation that was maintained during the postyoga session supine resting condition. HF HRV nu exhibited a consistent pattern of vagal withdrawal [F(7,119) = 9.02, p < .001], showing a consistent decline up until the standing condition, followed by an increase during the second supine yoga condition and then a return to baseline values during supine meditation and the post- yoga session supine resting condition. SDNN exhibited initial increases during the first supine and seated conditions before returning to baseline values during the kneeling, standing and second supine conditions. An additional increase in SDNN was observed during supine meditation before a return to baseline values during the post yoga supine resting condition [F(7,119) = 4.16, p < .001]. RMSSD remained stable from baseline throughout the first supine, seated and kneeling conditions. Significant vagal withdrawal was observed during the standing yoga sequence that returned to baseline values during the 141 second supine sequence, followed by a subsequent increase in vagal activity during supine meditation prior to RMSSD returning to baseline values during post-yoga supine resting condition [F(7,119) = 4.02, p = .001]. Finally, sample entropy showed a pattern of lessening complexity beginning in the initial supine sequence, culminating in the kneeling sequence. Sample entropy remained reduced in both the standing and second supine conditions before returning to approximate baseline values in the supine meditation and post-yoga resting conditions [F(7,119) = 17.27, p < .001] (see Table 4.3, Figure 4.4). 4.4.3 In-Task Yoga Session Qualitative Findings (objective 1c): Several themes emerged in analysing the qualitative interview data that supported findings from quantitative data analyses. Themes were grouped into two overarching categories: 1) description of yoga session; and 2) explanatory mechanisms including, a) attention and b) breath awareness. 4.4.3.1 Description of Events . This category consisted of participant descriptions of the yoga sequence. Baseline: The majority of participants drew comparisons between the baseline resting condition and all subsequent sequences. Many participants characterised baseline as a time where dissociative attention was predominant, activation was alternately characterised as either low or high, and valence was low. In examining the high degree of dissociative attention reported at baseline, many participants suggested they lacked focus at the beginning: “I found my head was doing all sorts of busy brain stuff.” and, “I was feeling agitated – my thoughts were all over the place.” Contrary to the quantitative 142 findings and the majority of participant comments, others found the resting baseline very relaxing: “I felt good and relaxed – looking forward to what we were going to do.” Supine I, Seated, Kneeling, and Standing Yoga Sequences: The first supine sequence was characterised by many participants as a preparatory phase of rest and relaxation. Contrary to the quantitative findings, several participants reported noticing an immediate shift in attention during the first supine yoga sequence: “The first sequence got my mind focused. Focusing on breathing really clears your mind.” Other participants reported, in concordance with the quantitative findings, that shifts in valence, activation and attention occurred later in the yoga session: “It takes a bit for me to get there. Then suddenly I am there in the moment. It was about the 2nd (seated) or 3rd (kneeling) sequence when I felt I’d really gotten there.” Participants remarked that increased exertion (RPE) and physical sensation as the yoga sequences became physically more active facilitated attention: “The lunge part (kneeling sequence) is where I actually felt I was doing more physical yoga for the first time in the series. I like doing physical yoga so that was a good feeling for me.” and, “I was feeling a bit more focused because my body was doing something, so the mind was not able to go grocery shopping.” The standing sequence was described as more physically demanding than the previous yoga sequences, which is corroborated by the quantitative data. “This was just more physically demanding, more muscles working” and, “I definitely felt like that was the most energetic of the sequences.” Another participant commented the standing sequence elicited, “More wakefulness and more energy.... it felt like it was all coming together better.” Several participants suggested during the active poses that heart rate was a good indicator of their level of exertion: 143 “Your heart tells you what you are doing.” These supine, seated, kneeling and standing yoga sequences reflect changes in valence and associative attention, including awareness of heart rate, activation and rating of perceived exertion. Supine Yoga Sequence II and Supine Meditation: In the second supine sequence, quantitative analyses showed that self-reported activation and perceived exertion remained high, valence increased somewhat and attention was similar to the standing sequence. Despite participants continuing to report high activation and RPE, their subjective descriptions characterised the second supine sequence as more relaxing: “I can feel that deep rest and let go. I can feel my hips and how things are relaxing the whole way down.” During the supine meditation sequence valence and associative attention peaked and there were moderate increases in RMSSD and SDNN and moderate decreases in heart rate. One participant described this sequence as follows: “I was really in the yoga moment... I was really experiencing my breath and the sensation through my whole body.” Breath awareness was a strong point of associative attention in the supine meditation sequence: “Breath awareness allows you to realise your breath goes through your body... It was great to realise how much your breath affects every part of you.” Despite generally positive self-reports of increased valence and associative attention and accompanying shifts in decreased heart rate and increased SDNN and RMSSD, not all participants had a pleasant experience in the supine meditation sequence. One participant reported, “Not so good. I completely zoned out.” When asked why this was the case the participant replied: “I think it’s just because I am very dissociative normally, it’s my default. I have a hard time focusing and am very easily distracted.” For others, the supine meditation was associated with sleep states: “It was nice and relaxing. 144 I probably could have fallen asleep. Nothing was really going through my mind.” Several participants indicated the concluding supine meditation left them feeling more wakeful. “When I came in I was drowsy and sleepy. Savasana (supine meditation) is just like having a power nap... at the end of it I was feeling much more energized.” Concurrent increases in energy and calmness and reductions in tension during the supine meditation sequence seem to corroborate these descriptions. Post Yoga Session Supine Resting: Several participants commented on the return of dissociative attentional patterns immediately following the supine meditation. These descriptions reflect shifts in attention as well as decreases in SDNN and RMSSD: “My mind started to wake up and think again because you don’t have anything to focus on.” and, “I still felt very relaxed, but there is a difference between just lying around and savasana (supine meditation).” Others characterised this time as a continuation of the previous supine meditation condition: “I was still pretty relaxed from the carry-over from savasana (supine meditation).” Differences highlight these experiences are not uniform and give weight to multilevel regression models that help to tease apart associations between self-reported outcomes and other moderating variables. Comparisons between Pre and Post Yoga Session: When participants were asked to reflect on what they felt changed from the initial supine resting condition until the final post yoga supine resting condition, the following insights were offered in relation to focus of attention: “When I came in my mind was jumping everywhere. At the end I was very focused... whereas at the start there was just no focus.” Participants reported these shifts regardless of baseline valence: “At the end you just feel better than when you started, no matter where you started. Even if you start feeling really poor, you feel better 145 even if it’s not great at the end.” and, “I feel much better than when I came in even though I felt good when I came in. I thought I was relaxed, but I am a bit more relaxed now.” At the end of the session participants still reported higher valence and associative attention. Physiologically post yoga session participants had lower resting heart rate than baseline, while measures of HRV had returned to baseline values. 4.4.3.2 Explanatory Mechanisms. Many participants offered their own explanations for mechanisms that may have played a role in their experience of the single yoga session. Two common reported mechanisms were 1) attention, and 2) breathing. Attention: Participant references to shifts in attention were common. Several participants described yoga as a different state of relaxed consciousness: “It focuses you and totally gets rid of all the noise: the stuff going on in your brain.” and, “I am very focused. I am right here, right now.” As participants continued their practice, they noticed a shift in attention concomitant with positive valence: “I was very focused on what we were doing and really enjoy how it feels... I didn’t find the busy brain was taking over.” Despite a linear decrease in dissociative attention over the course of the intervention, many participants reported this state was not uniform: “I was really relaxed but also had some monkey brain moments… I would pay attention for a few breaths and then my mind would go off… Before you know it I am busy running errands.” Taken together, these participant statements suggest a strong emphasis is placed on the role of attention in the experience of a single yoga session. Supporting the quantitative data, focus of attention was implicated in changes in both valence and activation in the multilevel regression analyses, with those indicating greater associative attention concurrently reporting greater valence and lower activation. 146 Breathing: Many participants referenced the breathing aspect of yoga practice and suggested a functional link between the breath and associative attention: “The more you have to focus on your breathing, the more it clears all the other stuff out of your mind... You are so focused on breathing, quieting, being calm… (Yoga) really quiets your mind.” Attention to breathing and the physical postures was reported to help keep participants focused and present: “When I finally start concentrating on my breath I realise I am right here, right now, in this moment.” and, “When you are just concentrating on the breathing and on doing the poses, everything else just disappears... It is so nice to just be in the moment.” Several participants shared changes in valence, activation and attention prepost yoga were linked to breath regulation: “It was much easier for me to bring my breathing back down. I got more relaxed and more feeling, so better focus.” While the present research study did not measure breathing specifically, examining the changes in cardiac activity associated with valence, activation, attention and perceived exertion in the regression analyses suggest this connection, given these autonomic changes can be associated with breath awareness (260). 4.4.4 Pre-Post Yoga Session Affect Regulation (objectives 2a & 2b) 4.4.4.1 Energy. Energy increased from baseline values to the end of the yoga session and was maintained during the post yoga supine resting condition [F(2,34) = 6.91, p = .003] (see Table 4.5, Figure 4.5). When follow-up multilevel regression models were built, the effect of valence eclipsed the previously significant linear effect of time (p=.998; unconditional growth model not shown), due to a high degree of multicolinearity between the two variables (r >.7). Those who reported higher valence consistently reported higher energy levels. Higher energy was also related to decreased 147 tiredness. Those with higher energy also exhibited higher HF HRV nu and SDNN and lower RMSSD. The Pseudo R2 value suggests inclusion of these predictor variables reduced error in predicting energy pre-post yoga session by 86% (see Table 4.6). 4.4.4.2 Tension. Tension decreased from baseline values to the end of the yoga session and was maintained during the post yoga supine resting condition [F(2,34) = 3.67, p = .036] (see Table 4.5, Figure 4.5). In examining predictors of change in tension, those with lower resting HF HRV nu reported higher levels of tension. The Pseudo R2 value suggests inclusion of these predictor variables reduced error in predicting tension pre-post yoga session by 72% (see Table 4.6). 4.4.4.3 Tiredness. A marginally significant decline in Tiredness was observed prepost intervention that did not exceed the SEM. However this difference became significant during the post yoga supine resting condition [F(2,34) = 3.35, p = .047] (Table 4.5, Figure 4.5). In examining predictors of change, increased time since diagnosis predicted increased tiredness. Increased activation and increased heart rate were also associated with decreased tiredness. The Pseudo R2 value suggests inclusion of these predictor variables reduced error in predicting tiredness pre-post yoga session by 63% (see Table 4.6). 4.4.4.4 Calmness. Calmness increased from baseline to the end of the yoga program. An additional increase in calmness was observed during the post yoga supine resting condition [F(2,34) = 9.34, p = .001] (see Table 4.5, Figure 4.5). Increased tension was associated with decreased calmness while higher resting heart rate was associated with increased calmness. The Pseudo R2 value suggests inclusion of these predictor 148 variables reduced error in predicting calmness pre-post yoga session by 49% (see Table 4.6). 4.4.5 Pre-Post Yoga Session Qualitative Findings (objective 2c) In examining participants’ interview data, categories emerged reflecting the four quadrants of the circumplex model: energy, tension, tiredness and calmness. 4.4.5.1 Energy. In agreement with regression analyses indicating a relationship between increased energy, valence and decreased tiredness, participants generally reported feeling they had more energy at the end of the yoga session: “I felt really relaxed and actually felt more energized than when I came in. I was ready to go off and conquer the world.” and, “I feel way more energized. I feel like I had a great nap (laughs)... If I practice yoga I have more energy, not less.” These findings suggest increased feelings of energy are related to in–task feelings of rest and relaxation. 4.4.5.2 Tension. Generally participants reported feelings of tension when they first arrived: “At the beginning I was probably more tense and not for anything other than I hadn’t done the yoga yet.” Post yoga session, they reported tension to have decreased: “It makes me relax more so I don’t feel as tense, which is good because you should be relaxing more if you are doing these things (yoga).” States of tension were associated with a pre-yogic state while engaging in the yoga session was associated with reduced tension and heightened relaxation. 4.4.5.3 Tiredness. Many people reported decreased tiredness at the end of the yoga session: “I was tired at the start. My mind was just thinking a bunch of different things: totally unfocused.” Participants also spoke about tiredness in relationship to energy levels: “I was very tired coming in. I feel a lot more energetic now and rested.” 149 and, “You have that battery charge... You are rested but not tired.” The multilevel regression analyses suggest participants reported higher arousal levels and had higher recorded heart rate in relation to lower tiredness. While participants suggest a relationship between tiredness and dissociative attention, this relationship was not borne out in the multilevel regression analyses. 4.4.5.4 Calmness. Discussion of feelings of calmness was a prevalent theme. “I am calm. I am ready to go now. I feel in a unit. I feel good. I’d like to give you some professional (sounding) words but I can’t...” In describing pre-post yoga session increases in calmness, one participant related this increased calmness to decreases in tension and this connection was also evident in the regression analyses: “I think over the course of the practice, the calmness level really increased... You can almost feel yourself exhaling, letting the tension go.” Many participants noted that although they were calmer, they felt more energy. “I’m calmer, but more energized, as opposed to being tired and lethargic.” However, the connection between calmness and energy was not evident in the regression analyses. Several participants also described calm in conjunction with focus of attention: “It really focuses you and calms you. It stops your mind from going crazy all over the place.” and, “Maybe it’s just the experience of yoga that makes me feel calmer. As I feel calmer I tend to be, I guess, in the present. It’s when I’m not calm that I’m in the future.” Despite these subjective first-person descriptions, attention was not associated with calmness in the multilevel regression analyses. 4.5 Discussion This is the first study which has integrated the Circumplex Model of Affect, DualMode Theory, Effort-Related Attention Model, Neurovisceral Integration Model, 150 Neurophenomenology and accompanying methodologies (patient reported outcomes, physiological indices, and first-person phenomenological reports) in the exploration of the subjective experience of a single yoga session in a group of cancer survivors. 4.5.1 In Task Effects (objectives 1a and 1b): In reviewing results in relation to the circumplex model of affect, the majority of change in the single yoga session occurred in the low-activation pleasure quadrant, touching into the high-activation pleasure quadrant in yoga sequences of higher intensity. Specifically, participants report increasingly improved valence throughout the yoga session while reported activation and perceived exertion rose and fell largely with the intensity of each yoga sequence (see Figure 4.6). The addition of a dimensional measure of associative attention leads to a 3-dimensional spherical model of eight quadrants. The majority of change in the single yoga session occurs in the low-activation / pleasure / associative attention quadrant, touching into the high-activation / pleasure / associative attention quadrant in more strenuous yoga sequences (see Figure 4.7). Specifically, both valence and attention improve over the course of the yoga session and activation rises and falls with the difficulty of the yoga sequence. 4.5.1.1 Valence. The linear trend in valence is in concordance with previous research utilising Dual-Mode Theory examining steady state exercise above or below the lactate or ventilatory threshold (73), which suggests pleasant changes in valence in most individuals at sub-threshold intensities. Given participants in the current experiment worked at a maximum of 52% of their age-predicted maximal heart rate (208 - 0.7 * age) (261) during the standing yoga sequence, the overall yoga session can be considered lowintensity exercise and changes in valence would be indicative of these sub-threshold 151 states. The correspondence between SDNN and valence corroborates emerging research utilising the Neurovisceral Integration Model linking HRV and affective responses (104,262,263). 4.5.1.2 Activation. Activation was related to an overall quadratic time effect, evidence of the measure’s responsiveness to differing yoga sequences based on intensity. A negative relationship between body mass and activation was also observed, with those with higher BMIs reporting lower activation during each yoga sequence. These findings are contrary to work by Ekkekakis and colleagues (264), whose findings did not indicate a negative relationship between BMI and activation but rather BMI and valence. Those who reported higher activation reported higher dissociative attention and reduced total HRV. Participant-reported activation also reflected these sub-threshold intensities, with only moderate activation expressed by participants throughout more active sequences (i.e., standing yoga). Participant ratings of perceived exertion also reflect these changes, with a maximum reported score of approximately 11 of 20 in the standing yoga sequence, indicative of a “light” and “somewhat hard” exertion. The association between HRV and the activation dimension of the circumplex model of affect is consistent with previous research (265). 4.5.1.3 Attention. Attention shifted linearly from a dissociative to associative state. This shift in associative attention does not seem to be as intensity-based as other forms of exercise (89). In the case of concurrently monitored HRV (sample entropy), those with higher recorded sample entropy reported greater increases in associative attention than those with lower recorded sample entropy, for whom there were no significant changes in focus of attention. These findings suggest potential HRV 152 modulation of attention (266,267). We concur with a recent review by Salmon and colleague’s (95) that associative attentional states may be somewhat analogous to mindful awareness and, in the case of yoga, may heighten kinesthetic awareness of yoga practice. However, this highly-valenced, pleasant associative attentional state may be more closely aligned with what Lutz and colleagues have termed “focused attention” meditation states (208). 4.5.2 Pre-Post Yoga Session (objectives 2a and 2b): Pre-post affective states captured during supine resting conditions (baseline resting, supine meditation, post yoga sessions resting) by the ADACL suggest significant improvements in energy and calmness, and corresponding reductions in tension and tiredness. These findings are consistent with increases in energy and decreases in tiredness and tension seen pre-post other acute exercise sessions, regardless of exercise intensity (86). However, we also see increases in calmness not apparent in other research (242), perhaps indicating a unique feature of yoga practice. Moreover, participants corroborated that changes in affect pre-post class were related to yoga practice. This participant confirmation adds credibility to the research (257). 4.5.3 Integration (all objectives) Building on experimental frameworks previously developed by Telles and colleagues (113,115,260) and Ekkekakis and colleagues (73), this research suggests measures of affective valence and associative attention increase linearly throughout a single yoga session, while measure of activation and perceived exertion are contingent on the intensity of each yoga sequence. Specifically, participants denote higher activation 153 and exertion in more vigorous sequences and lower activation-exertion in more gentle sequences. Recorded cardiac indices suggest a similar pattern, with participants reaching subbaseline resting heart rates in the final supine meditation and post-yoga resting sequences. The relationship of HRV to these conditions is more complex, with time domains showing a pattern of vagal withdrawal and lowered HRV in the active yoga sequences but increased HRV in the supine meditation sequence. These findings are consistent with previous research (115) examining HRV in a single yoga session. These increases in vagal activity may also be in part due to the inherent benefits of supine posture in post-exercise parasympathetic reactivation (268). However, frequency and non-linear measures show a consistent pattern of vagal withdrawal relative to the intensity of the respective yoga sequence. Participants’ first-person phenomenological accounts largely corroborate these growth models and provide interesting insight into the multilevel regression analyses as to differences in the experience of the yoga session. While participants’ collective subjective descriptions say little about the physiological measures per se, their descriptive emphasis on the attentional aspect of yoga and awareness of breath specifically is illuminating given the relationship between HRV, respiration and attention (112,260,269). Given these associations between all three levels of evidence, additional research devoted to respiratory influences on core affect, attention and autonomic function are of great interest. The current research was designed to model neurophenomenological processes and outcomes, resulting in a detailed exploration of the lived experience of yoga in the 154 context of valence, activation, attention, perceived exertion, cardiac activity and phenomenological first-person narratives. The experience of yoga had not been studied using an integrated theoretical and methodological approach to date. The intention was to bridge the “explanatory gap” (121) between the phenomenal character of experience with the quantitative measurement of that experience and to further contextualise this research via subjective description. From this theoretical and methodological integration a more coherent picture of the experience of yoga emerged. 4.5.4 Limitations Many participants remarked that compared to their usual yoga classes and routines the single session was lighter intensity. This discrepancy between the acute single yoga session and participants regular yoga practice must be kept in mind. In addition, given the primacy participants placed on awareness of breathing in the yoga session, consideration of the use of an ambulatory measure of breaths per minute is warranted. While several exercise studies support the validity of using ambulatory heart rate monitors to assess HRV (270,271) there has been some controversy in their use with women over age 60 (272,273). Given the age and health status of participants in the current study these limitations must be kept in mind. Another area of concern is the use of multilevel modelling on such a small sample size. While the study was powered on detecting a 0.50 difference on the feeling scale it was not powered for the multilevel regression analyses. While research suggests samples of 50 or more are preferable, numbers of as small as 50 observations may be sufficient and will show little bias in the regression coefficients (274). 155 4.5.5 Conclusion Identifying potential mechanisms that explain how yoga leads to clinically significant outcomes is an important next step as yoga programs are increasingly used in oncology settings. Recent recommendations from the UK Medical Research Council (63) suggest time spent delineating the mechanisms behind complex interventions, both theoretically and practically, helps to strengthen the causal chain of evidence and further refine both interventions and research design. Taking the opportunity to explore participants’ lived experience of yoga provides useful information that strongly suggests future directions for research. The richness of this data provides a source from which questions and theories can emerge concerning the self-perceived experiences of those who practice yoga and have had a cancer experience. 156 Table 4.1 Demographics Baseline (n = 18) Age, years (SD) n (%) 53.97 (8.49) Gender – Female Time since diagnosis, months (SD) Times previously completed Yoga Thrive 18 (100) 35.95 (19.00) 4.94 (3.00) Cancer Diagnosis – Breast Cancer Stage II III Marital Status – Married / Common-law Education Level – completed university / college Annual Household Income – > $80,000 Employment Status – Fulltime 11 (61.1) Body Mass Index (BMI) LSI GLTEQ, minutes per week 24.80 (4.49) 31.17 (17.40) 144.89 (112.51) Beliefs about Yoga Scale (BAYS) 54.59 (8.65) 6 (33.3) 5 (27.8) 10 (55.6) 11 (61.1) 8 (44) 11 (61.1) Valence Activation Attention Exertion (Feeling Scale; (Felt Arousal Scale; (Assoc. – Dissoc. Scale; (Borg RPE Scale; ICC = 0.90, SEM = 0.36) ICC = 0.89, SEM = 0.45) ICC = 0.74, SEM = 1.10) ICC = 0.83, SEM = 0.82) Mean Mean Mean Mean P d p d p d p d (SE) (SE) (SE) (SE) 2.06 2.78 5.06 6.33 Pre- Resting (0.27) (0.32) (0.51) (0.47) 2.28 2.83 4.56 7.89 Supine 1 .409 0.20 .864 0.04 .147 -0.23 .005 0.79 (0.27) (0.32) (0.51) (0.47) 2.22 3.28 4.50 9.28 Seated .536 0.15 .124 0.37 .107 -0.26 .000 1.49 (0.27) (0.32) (0.51) (0.47) 2.50 3.22 4.06 10.44 Kneeling .100 0.39 .171 0.32 .004 -0.46 .000 2.08 (0.27) (0.32) (0.51) (0.47) 2.78 3.56 3.83 10.78 Standing .008 0.64 .018 0.57 .001 -0.56 .000 2.25 (0.27) (0.32) (0.51) (0.47) 3.50 3.61 3.78 9.28 Supine 2 .000 1.28 .011 0.61 .000 -0.59 .000 1.49 (0.27) (0.32) (0.51) (0.47) Supine 4.11 2.83 2.72 7.11 .000 1.83 .864 0.04 .000 -1.08 .151 0.39 Meditation (0.27) (0.32) (0.51) (0.47) 4.06 2.94 3.44 6.39 Post-Resting .000 1.78 .607 0.12 .000 -0.75 .918 0.03 (0.27) (0.32) (0.51) (0.47) ICC = Intraclass correlation coefficient, SEM = Standard Error of Measurement; Cohen’s = Tx – T1 / (T1SE*(√N)) Table 4.2 Estimated Marginal Means Models – Valence, Activation, Attention and Rate of Perceived Exertion. 157 157 Heart Rate (ICC = 0.97, SEM = 1.68) Pre- Resting Supine 1 Seated Kneeling Standing Supine 2 Supine Meditation Post-Resting Mean (SE) 67.94 (2.29) 69.48 (2,29) 75.07 (2.29) 81.52 (2,29) 88.19 (2,29) 70.04 (2.29) 62.08 (2.29) 62.53 (2.29) HF HRVnu (ICC = 0.83, SEM = 7.48) p D - - .302 0.16 .000 0.73 .000 1.40 .000 2.09 .159 0.22 .000 -0.60 .000 -0.56 Mean (SE) 41.41 (4.28) 22.90 (4.28) 18.77 (4.28) 21.72 (4.28) 22.51 (4.28) 27.84 (4,28) 35.59 (4,28) 41.76 (4.28) SDNN (ICC = 0.91, SEM = 7.91) p d - - .000 -1.02 .000 -1.25 .000 -1.09 .000 -1.04 .002 -0.75 .185 -0.32 .935 0.02 Mean (SE) 35.96 (6.21) 46.56 (6.21) 44.56 (6.21) 40.18 (6.21) 29.88 (6.21) 41.28 (6.21) 49.03 (6.21) 38.84 (6.21) Sample Entropy (ICC = 0.82, SEM = 0.14) RMSSD (ICC = 0.90, SEM = 8.82) p d - - .014 0.40 .045 0.33 .321 0.16 .155 -0.23 .212 0.20 .003 0.50 .497 0.11 Mean (SE) 35.87 (6.57) 38.08 (6.57) 34.59 (6.57) 32.34 (6.57) 22.34 (6.57) 35.57 (6.57) 47.26 (6.57) 40.15 (6.57) p d - - .658 0.08 .798 -0.05 .481 -0.13 .008 -0.49 .952 -0.01 .024 0.41 .393 0.15 Mean (SE) 1.43 (0.08) 1.20 (0.08) 1.04 (0.08) 0.66 (0.08) 0.88 (0.08) 1.13 (0.08) 1.36 (0.08) 1.30 (0.08) p d - - .010 -0.68 .000 -1.15 .000 -2.29 .000 -1.62 .001 -0.89 .429 -0.21 .127 -0.40 ICC = Intraclass correlation coefficient, SEM = Standard Error of Measurement; SE = Standard Error; P = significance, d = Cohen’s d - Tx – T1 / (T1SE*(√N)); HF HRV nu = High Frequency Heart Rate Variability (normalized units); SDNN = standard deviation of all normal-normal r-r intervals; RMSSD = square root of the mean of squares of successive r-r interval differences. Table 4.3 Estimated Marginal Means Models – Heart Rate, HF HRVnu, SDNN, RMSSD, Sample Entropy. 158 158 Predictor Intercept Linear Time Time2 Valence (Feeling Scale) B (SE) 1.95 (0.21) Activation (Felt Arousal Scale) df T p 15.96 9.36 .000 0.28 (0.04) 21.74 7.97 .000 - - - - Body Mass Index B (SE) 2.42 (0.24) Attention (Association-Dissociation Scale) B df t p (SE) df t p 25.70 10.21 .000 4.49 (0.50) 19.15 8.96 .000 .000 -0.14 (0.07) 28.70 -1.97 .059 .000 - - - - 0.48 108.07 4.09 (0.12) -0.06 106.36 -3.98 (0.01) Perceived Exertion (Borg RPE Scale) B (SE) 6.05 (0.49) 1.96 (0.25) -0.26 (0.04) df t p 28.39 12.29 .000 133.99 7.71 .000 124.45 -7.13 .000 -0.08 (0.04) 15.90 -2.06 .056 - - - - - - - - Physical Activity (LSI) 0.03 (0.01) 17.02 2.76 .013 - - - - - - - - 0.05 (0.01) 13.32 3.35 .005 Baseline Energy 0.11 (0.04) 17.46 3.12 .006 - - - - - - - - 0.16 (0.05) 12.48 3.02 .010 Valence - - - - - - - - -0.27 118.33 -2.89 (0.09) .005 -0.56 (0.16) 122.72 -3.60 .000 Activation - - - - - - - - 0.29 128.90 (0.09) 3.36 .001 0.32 (0.11) 42.78 2.84 .007 Attention -0.13 (0.05) 65.38 -2.55 .013 0.22 (0.06) 77.46 3.65 .000 - - - - - - - - RPE -0.12 120.02 -4.48 (0.03) .000 - - - - - - - - - - - - Table 4.4 Multilevel Regression Analyses – Valence, Activation, Attention and Rate of Perceived Exertion 159 159 Valence (Feeling Scale) Predictor Heart Rate SDNN Attention (Association-Dissociation Scale) Activation (Felt Arousal Scale) Perceived Exertion (Borg RPE Scale) B (SE) df T p B (SE) df t p B (SE) df t p B (SE) df t p - - - - - - - - - - - - 0.04 (0.02) 73.55 2.27 .026 1.76 .082 .065 - - - - - - - - 0.008 124.11 (0.004) -0.008 103.28 -1.86 (0.004) Sample Entropy - - - - - - - - 1.05 122.49 (0.45) 2.30 .022 - - - - Sample Entropy *Time - - - - - - - - -0.30 118.96 -2.75 (0.11) .007 - - - - Pseudo R2 Valence = 0.60 Activation = 0.42 Attention =0.57 Perceived Exertion = 0.60 Excluded (p > .1): age, time since diagnosis, previous yoga thrive experience, yoga beliefs (BAYS), baseline tension, tiredness calmness (ADACL), HF HRV nu, RMSSD. B = estimate; SE = standard error; df = degrees of freedom; p = significance. Table 4.4 – continued 160 160 Predictor Energy (ICC = 0.77, SEM = 1.98) Tension Tired (ICC = 0.50, SEM = 1.28) (ICC = 0.83, SEM = 1.59) Calm (ICC = 0.55, SEM = 1.43) Mean (SE) P d Mean (SE) p d Mean (SE) p d Mean (SE) p d Pre- Resting 10.17 (0.97) - - 6.78 (0.43) - - 10.39 (0.91) - - 17.00 (0.50) - - Savasana 13.39 (0.97) .002 0.78 5.44 (0.43) .020 -0.73 9.00 (0.91) .089 -0.36 18.50 (0.50) .004 0.71 Post-Resting 13.00 (0.97) .005 0.69 5.56 (0.43) .032 -0.67 8.39 (0.91) .016 -0.52 19.00 (0.50) .000 0.94 ICC = intraclass correlation coefficient; SEM = Standard Error of Measurement; SE = Standard Error; p = significance; d = Cohen’s d - Tx-T1 / (T1*(√N)). Table 4.5 Estimated Marginal Means Model – AD ACL. 161 161 Predictor Intercept Linear Time Time Since Diagnosis Tension Energy B (SE) Df 12.18 25.99 (0.92) 0.0003 38.51 (0.18) T p 13.29 .000 0.002 .998 Valence 6.78 (0.65) -0.20 (0.09) df t p 16.97 10.44 .000 17.02 -2.15 .046 Tired B (SE) df t 10.87 16.40 13.08 (0.83) -0.37 21.76 -2.79 (0.13) 0.14 15.66 2.68 (0.05) - - - - - - - - - - - - - - - - - - .000 - - - - - .045 - - - - - -0.61 403.72 -5.54 (0.11) 0.92 44.49 2.06 (0.45) Tired Tension B (SE) p .000 .011 Calm B (SE) 16.86 (0.56) 0.30 (0.08) df t p 18.08 29.90 .000 24.73 3.97 .001 .017 - - - - - - -0.28 (0.14) 31.40 -2.03 .051 - - - - - - - - - - - - - - .015 - - - - .035 0.10 (0.04) 29.02 2.614 .014 -0.70 37.24 -2.56 (0.27) -0.14 29.01 -2.21 (0.06) Activation - - - - - - - - Heart Rate - - - - - - - - 2.56 .017 -0.02 (.009) 35.62 -1.90 .066 - - - - - - - - 2.34 .026 - - - - - - - - - - - - -2.60 .014 - - - - - - - - - - - - HF HRV SDNN RMSSD Pseudo R 2 0.06 25.25 (0.02) 0.15 29.78 (0.07) -0.14 33.43 (0.06) Energy = 0.86 Tension = 0.72 Tired = 0.63 Calm = 0.49 Excluded (p > .1): age, previous yoga thrive experience, baseline physical activity (GLTEQ), yoga beliefs (BAYS). BMI, energy and calm (ADACL); attention (ADS); perceived exertion (RPE); sample entropy. B = estimate; SE = Standard Error; df = degrees of freedom, p = significance. Table 4.6 Multilevel Regression Analyses – AD ACL. 162 162 Figure 4.1 Circumplex Model of Affect. 163 163 164 Figure 4.2 Simple slopes of the regression for dissociative attention on condition at low, mean, and high levels of sample entropy. Note: low, medium, and high values of sample entropy are defined as plus and minus 1 sd above the mean (-0.40, 0, 0.40). Slopes of the simple regression for high and mean sample entropy significantly differ from zero, but the simple slope at low sample entropy does not. 164 Figure 4.3 Estimated Marginal Means Models for Valence, Activation, Attention and Perceived Exertion. 165 165 Figure 4.3 Estimated Marginal Means Models for Valence, Activation, Attention and Perceived Exertion – continued. 166 166 Figure 4.4 Estimated Marginal Means Models for Heart Rate, HF HRV nu, SDNN, RMSSD & Sample Entropy. 167 167 Figure 4.4 Estimated Marginal Means Models for Heart Rate, HF HRV nu, SDNN, RMSSD & Sample Entropy – continued. 168 168 Figure 4.4 Estimated Marginal Means Models for Heart Rate, HF HRV nu, SDNN, RMSSD & Sample Entropy – continued. 169 169 Figure 4.5 Estimated Marginal Means Models for Activation-Deactivation Adjective Checklist. 170 170 Figure 4.5 Estimated Marginal Means Models for Activation-Deactivation Adjective Checklist – continued. 171 171 Figure 4.6 Affective responses (Mean FS and FAS) to a single yoga session plotted on a two-dimensional circumplex model. Labels indicate time points for affective responses: Baseline, Supine 1, Seated, Kneeling, Standing, Supine 2, Supine Meditation, Post. 172 172 Figure 4.7 Affective responses (Mean FS, FAS and the addition of ADTS) to a single yoga session plotted on a three-dimensional circumplex model (Valence, Activation & Attention). Labels indicate time points for affective responses: Baseline, Supine 1, Seated, Kneeling, Standing, Supine 2, Supine Meditation, Post. 173 173 174 CHAPTER 5: GENERAL DISCUSSION 175 5.1 The Present Studies The impetus for the present studies was to explore yoga’s ability to, “still the fluctuations of the mind” in contemporary cancer settings. In these efforts, at least two streams of research were combined: 1) the use and benefits of yoga practice in cancer settings (51); and 2) how meditative states experienced within yoga practice are correlated to psychophysiological systems that regulate positive affect and internalised attention (58,59). The purpose was both to examine “if” and “to what extent” benefits occur from practicing yoga for cancer survivors and explore by what mechanisms these benefits accrue. Research evidence suggests: 1) yoga practice is associated with improved HRQL and psychological functioning; 2) a key definition of what yoga “is” or “does” entails “stilling the fluctuations of the mind;” and 3) psychophysiological states elicited during yoga practice are said to be associated with both positive affect and states of internalised attention. Based on these statements, three studies were constructed that: 1) systematically reviewed the current literature on yoga in cancer settings; 2) examined longitudinal changes in HRQL and psychological outcomes, and their relations to affect and attention-mindfulness in a community based yoga for cancer survivors program; and 3) examined the acute effects of a single yoga session on measures of core affect and attention and concurrent associations with cardiac activity. 5.1.1 Integration of Theoretical Models, Constructs and Approaches To aid in this examination of relations between yoga practice, affect, attention and health outcomes, several existing theoretical models, constructs and approaches were made use of, including: the Circumplex Model of Affect, Dual Mode Theory, the Effort- 176 Related Attention Model, the Neurovisceral Integration Model and a mixed methods research approach, Neurophenomenology. The Circumplex Model provided the overarching affective framework for both Chapters 3 and 4. The Dual Mode Theory assisted in the investigation and explanation of acute changes in affect pre-post yoga class in Chapter 3 and changes in affect during a single yoga session in Chapter 4. The Effort-Related Attention Model described the use of associative and dissociative attention at varying intensities in both Chapters 3 and 4. The construct of mindfulness facilitated the exploration of several different “skills of attention” in Chapter 3. The Neurovisceral Integration Model provided a theoretical rationale for including the use of HRV as a neurophysiological correlate of autonomic activity, affect and attention regulation in Chapter 4. Neurophenomenology allowed the entire scope of these affective, attentional and neurophysiological processes to be subsumed under one large model and was used in Chapter 4 to provide an overarching mixed methods approach to the examination of the quantitative and qualitative data. 5.2 Study Findings Having developed both a theoretical background and study objectives, research began in Summer, 2010 on the systematic review which was completed in Fall, 2011 and accepted for publication in Spring, 2012 by Evidence-Based Complementary and Alternative Medicine. Recruitment for the longitudinal study began in the Fall, 2010 and was completed in Summer, 2011. All data from the final six-month follow-up for the longitudinal study was available by Winter, 2011. Recruitment for the lab study began in Fall, 2011 and was completed in Spring, 2012. A summary of all three study findings follows. 177 5.2.1 Study 1(Clinical Significance Review, Chapter 2) Objective 1a: Yoga programs were offered primarily to breast cancer patients. Classes were 60-90 minutes in length, met from one to five times a week and lasted from 6-26 weeks. Objective 1b: There were clinically significant effects of yoga practice on HRQL, psychological indices and, to a lesser extent, fatigue and sleep indices (1). 5.2.2 Study 2 (Longitudinal Study, Chapter 3) Objective 1a: Yoga practice was associated with increased valence, activation and attention pre-post yoga class in the seven-week program. Objective 1b: These improvements were related to baseline measures of affect and mindfulness. Objective 2a: Significant decreases in mood disturbance and stress symptoms were observed post- yoga program that were maintained at the three- and six month follow-ups, while HRQL improved linearly across all time points. Energy improved linearly across all time points, while tension and tiredness decreased post intervention, regressed towards baseline values at the three-month follow-up and returned to post-program completion values at the six-month follow-up. Mindfulness based skills in observation increased significantly from baseline only at the six-month follow-up, while act with awareness and nonjudgement of inner experience both showed small-moderate increases post yoga program that were maintained at the three- and six- month follow-ups. Small improvements in non-reaction were seen at the three and six-month follow-ups. Objective 2b: Longitudinal improvements in mood disturbance, stress symptoms and HRQL were related to concomitant changes in affect and mindfulness. Objective 3a: 48% of the participants had an existing yoga practice at baseline and 96% reported continued practice upon completion of the seven-week program. 69% and 76% were still practicing yoga at the 178 three-and six-month follow-ups respectively. Objective 3b: Yoga practice maintenance was related to previous yoga experience, energy and non-reaction to inner experience. 5.2.3 Study 3 (Lab Study, Chapter 4) Objective 1a: Participation in a single yoga session was related to a linear increase in valence and attention during class, while shifts in activation, perceived exertion and cardiac activity were related to each yoga sequence. Objective 1b: Changes in valence, activation, attention and perceived exertion were related to cardiac activity. Objective 1c: First-person interviews largely confirmed quantitative findings. Participants suggested increased associative attention and awareness of breath were potential mechanisms for the effects of yoga during the single session. Objective 2a: Pre-post class significant increases in energy and calmness were observed and reductions in tension and tiredness. Objective 2b: Changes were related to one another and concomitant changes in valence, activation, and cardiac activity. Objective 2c: First-person interviews confirmed quantitative findings and participants attributed improvements in affect pre-post the single yoga session specifically to yoga practice. 5.3 Theoretical Integration 5.3.1 Acute Effects The present research highlights associations between yoga practice as a means of “stilling the fluctuations of the mind,” affect and attention regulation, HRQL and mental health outcomes. In both the longitudinal and lab studies, significant increases in valence, activation and associative attention were observed pre-post class. Within the lab session, increases in valence and associative attention were related to one another and moderated by activation, perceived exertion and cardiac activity. The relationship between valence 179 and activation is corroborated by Ekkekakis and colleagues (73), whose research suggests exercise below lactate threshold is generally reported as pleasant both during the actual exercise session and upon completion. This lower-intensity level may have also led to a continued primacy of positive cognitive attentional cues versus negatively-valenced interoceptive cues seen at higher exercise intensities, as evidenced in the Effort-Based Attention Model (91). Research concerning the peak-end rule (275) suggests affect experienced at both the highest intensity of exercise and conclusion of exercise predicts exercise adherence. Given yoga is experienced at its affective and attentional peak in supine meditation, it is not surprising findings indicate yoga is experienced positively both throughout and at the end of the yoga session. Peak positive affect pre-post class may in part explain the high rate of yoga practice maintenance, with 96% of participants reporting continued yoga practice upon program completion and 69% and 76% of participants reporting ongoing participation at three- and six-month follow-ups, though these relations were not assessed directly. This is in contrast to commonly reported exercise maintenance rates in cancer settings which average approximately 50% (26). This facilitation of positive affect in cancer survivors may well lead to a high expectancy of program success for cancer survivors and correspondingly increased exercise adherence (76). 5.3.2 Longitudinal Measures of Affect The use of the Activation-Deactivation Checklist to measure changes in affect longitudinally is uncommon. We ascribed to Russell’s (2003) thesis that when affective dimensions are examined longitudinally, they are no longer tied to a specific context as in acute exercise settings, where the temporal proximity to an exercise session is evident. 180 Rather, these measures become more reflective of general mood, or what Russell (2003) has termed prolonged, objectless core affect (81). Higher energy at each time period was related to reduced mood disturbance and improved HRQL. Conversely, higher tension was related to increased stress symptoms and reduced HRQL, while tiredness was related to increased mood disturbance. It could be argued including both the Profile of Mood States and Activation-Deactivation Checklist created measurement redundancies, as both measure moods. However, each measure is categorically different, as the POMS serves as a categorical indicator of mood disturbance using discrete largely pathological categories (with the exception of vigour), while the ADACL uses a dimensional model to describe a range of negatively and positively valenced, high and low activation states. Given yoga conceptually contains a range of affective states, including both low-activation pleasure (calm) and high-activation pleasure (energy) and that individuals, particularly cancer survivors for whom fatigue can figure so prominently, may also experience both lowactivation displeasure (tired) and high activation displeasure (tension), it behooves researchers to utilize measures that capture the full range of affective experiences. Furthermore, dimensional measures of affective states may mediate more categorical mood states (68,214,215). 5.3.3 The Role of Attention in Affective Experience While the role of valence and activation has been thoroughly studied in the literature, the role of attention in these experiences is less clear (89,95,276). Yoga facilitated a highly associative state related to positive affect in both the longitudinal and lab studies. This associative attentional strategy has been correlated with measures of mindfulness (96) as well as focused attention states (58,208). 181 These acute focused attention states are purported to develop three skills of regulative attention (208): 1) the ability to monitor distractions without destabilizing the intended focus; 2) the ability to disengage from distractions without further involvement; and 3) the ability to redirect focus promptly on a chosen object. It is suggested these three skills are related to significant decreases in emotional reactivity (208). Longitudinal findings suggest participants reported a greater ability to act with awareness, a mindfulness facet closely related to one’s ability to concentrate and a corollary of associative and focused attention. Participants also reported increased nonjudging of inner experience, the taking of an impartial stance to thoughts and feelings, and non-reaction to inner experience, the ability to let thoughts and emotions come and go. Research suggests act with awareness, non judgment and non-reaction are most tied to decreased psychological distress (180). The ability to act with awareness was associated with lower mood disturbance and stress symptoms at all times, while nonjudging of inner experience was related to reduced stress symptoms and improved HRQL. Non-reaction was related to reduced mood disturbance. These findings are similar to Garland (183), in which both the ability to act with awareness and be nonjudgmental of inner experience was correlated with reduced stress and mood disturbance. While non-reaction to inner experience was not related to any health outcomes in the Garland study, research with experienced meditators and non-meditators suggests the ability to be non-reactive to inner experience is highly related to meditation experience and is most likely to mediate psychological health outcomes (216). The lack of change in both the observe and describe facets in the longitudinal study may have been due to 182 participant unfamiliarity with the specific mindfulness constructs described in these subscales (212). 5.3.4 Autonomic Concomitants of Affect and Attention Both the neurovisceral integration model and neurophenomenological approach were of primary theoretical interest in the lab study. These models highlight the dynamic interactions between physiological, cognitive and behavioral systems in the regulation of affect and attention (104,106,240). Overall, heart rate and HRV indices indicate a period of vagal withdrawal up to the standing poses, reflecting the intensity of the yoga session. These values begin to return to resting values during the supine sequence. During the supine meditation increased HRV in the time domains and decreased heart rate are evident. These findings seem to corroborate research that suggests yoga’s active poses create physiological stress similar to exercise (114) while the resting poses heighten autonomic activity, however briefly (115). Valence and activation were moderated by high and low SDNN respectively, a correlate of total heart rate complexity. Attention was related to sample entropy, such that higher sample entropy predicted a significant increase in associative attention while lower sample entropy resulted in no significant change in attention throughout the intervention. As expected, perceived exertion was linked to participant heart rate (277). However, in contrast to findings reported using Tenenbaum’s Effort-Related Attention model (91,93), attention was not related to perceived exertion but rather core affect, specifically higher valence and lower activation. This suggests the regulation of attention may not be intensity-dependent in the case of yoga. Higher energy was related to higher HF HRV and SDNN and lower RMSSD, while tension was related to lower HRV. Lower tiredness was related to higher resting heart 183 rate, and calmness was related to higher resting heart rate. In the case of both calmness and tiredness, associations with higher resting heart rate may be related to higher states of awareness, and concomitant increases in heart rate that affect low-activation pleasant and unpleasant affective states (58). This increased heart rate may be an example of the socalled “meditation paradox” (278) in which a given meditative technique may elicit a higher mean heart rate in states that are objectively relaxing. However, in examining mean heart rates in the estimated marginal means models, heart rate during supine meditation and post yoga session are significantly lower than baseline. Nor was attention associated with calmness or tension. Overall, findings support the neurovisceral integration models main thesis that both attention and affect are linked via underlying autonomic function (106). Specifically, associations between valence, activation, attention and perceived exertion and HRV were all in the expected directions during the yoga sequence, as were both energy and tension during baseline, supine meditation and post-resting states. 5.3.5 Integration of the Neurophenomenological Approach Utilising the neurophenomenological approach allowed us to further compare data at all levels, including patient-reported measures of valence, activation, attention and perceived exertion during the yoga sequences, continuously monitored heart rate and HRV data, pre-post yoga session measures of affect, and participant’s subjective experiences of these conditions. These detailed descriptions informed both the analysis and its interpretation, highlighting that participants themselves viewed changes in attention both during class and pre-post class as a primary mechanisms of engagement in yoga practice and in deriving affective benefits. Participants further suggested awareness 184 of breath was a primary technique to achieve these aims. These subjective reports highlighted elements of the data that were not observable by strict quantitative analysis alone and provided much needed context for the quantitative research findings (122). Taken together, findings suggest yoga practice facilitates an increasingly associative, positively-valenced affective state both during and after a single yoga session. Longitudinally, measures of affect and mindfulness were related to changes in mood disturbance, stress symptoms and HRQL and maintenance of yoga practice. Findings from the lab-based study suggest both valence and attention have autonomic correlates within yoga practice and preliminary neurophenomenological findings suggest these changes may be related to increased associative attention, particularly to sensations of the breath and body during yoga practice. 5.4 The Role of Yoga in Exercise Settings 5.4.1 Yoga as Cardiovascular Exercise Given the regulation of valence, activation and attention in cancer survivors both acutely during yoga practice and over time with practice, an additional inquiry might be what is the role of yoga in exercise settings in general and within the scope of cancer treatment specifically? A common comment in the literature is that the intensity of most yoga practices is not sufficient enough to elicit the cardiovascular benefits of regular exercise training (279). Research by Hagins and colleagues (280) suggests in a typical yoga session, healthy participants’ heart rate averaged only 49.4% of maximum heart rate, peaking at 54.8% of maximum heart during a sun salutation sequence. These findings are similar to the current lab study, in which participants reached 52% of their maximum heart rate 185 during the standing sequence and this intensity was maintained for approximately 10 minutes of a 75 minute yoga practice. The authors conclude yoga is a low-intensity form of exercise that does not meet the recommendations for maintaining or improving health or cardiovascular fitness (280). However, several studies have found yoga does lead to reductions in age-related deterioration in cardiovascular function. Specifically, yoga practitioners with five or more years of experience report reduced heart rate, systolic and diastolic blood pressure in comparison to age-matched controls (281). These findings were further corroborated in an intervention study in which reductions in heart rate, systolic and diastolic blood pressure were seen over a period of six months in which participants engaged in an hour of daily yoga training (282). Yoga was also linked to improved exercise tolerance after 45 minutes of daily yoga training for two months (283) and improved pulmonary function after a minimum of ten weeks of training (284). A clinical review further suggests yoga can be beneficial in both primary and secondary prevention of cardiovascular disease (285). Mechanisms for yoga specific improvement in cardiovascular health are related primarily to increased breathing efficiency and improved cardiac autonomic function (111,286). Future research directions in this area include appropriately matched comparative RCTs in which both exercise and yoga are tested concurrently. Given the laboratory findings, both a cross-sectional study and longitudinal RCT could be designed in which HRV is measured daily in matched yoga practitioners and exercisers to examine the cardiovascular benefits in both populations. 186 5.4.2 Yoga as Relaxation Perhaps one of the strongest psychophysiological arguments for what yoga “does” is the elicitation of the relaxation response. The relaxation response is a set of integrated physiological changes elicited when a subject assumes a relaxed position and engages in repetitive mental or physical action, while passively ignoring distracting thoughts (287). This relaxed state has been associated with decreases in oxygen consumption, respiratory rate, and blood pressure, and an increased sense of well-being (288) and has been used in the treatment of immunological, cardiovascular, neurodegenerative diseases and psychiatric disorders (289). A review by Khalsa (223) characterises yoga as a coordinated psychophysiological relaxation response that leads to reductions in both cognitive and somatic arousal and modifies the activity of the autonomic nervous system. In yoga practice, a primary mechanism by which these benefits of relaxation occur are attention to the breath and specific breathing practices. The regular practice of breathing exercises increases parasympathetic tone, decreases sympathetic activity, improves cardiovascular and respiratory functions, decreases the effects of stress on the body, and improves physical and mental health (110,290). When combined with meditative practice, effects of slow deep breathing are significantly greater as compared to other relaxation techniques (286). 5.4.3 Yoga as Yoga But is yoga more than just a set of relaxation and breathing exercises? Telles suggests yoga elicits meditative states in which deep relaxation and increased focus of attention co-exist (260). This state is putatively different than relaxation or sleep states, in that one is still alert, mental activity is actively reduced as attention increases, and 187 positive affect increases (58). Traditional meditation texts in the yoga tradition suggest meditative states (as opposed to meditative techniques) in yoga are characterized by a progression from concentration or focused attention (dharana) to contemplation (dhyana), a meditative state characterised by passive attention akin to mindfulness, and finally absorption (samadhi), a state of mental containment in which the mind does not waver (59,208). These meditative states, and the associated practices designed to elicit them, can be better viewed as a family of complex affective and attentional regulatory training regimes developed for various ends, including cultivation of well-being and emotional balance (208). Yoga may outwardly share commonalities with both exercise and relaxation, but may also offer unique meditative benefits that “still the fluctuations of the mind.” 5.5 Concluding Thoughts Current findings suggest yoga does indeed, “still the fluctuations of the mind.” In a single session, yoga practice up-regulates both positive valence and associative attention linearly while activation, exertion, and autonomic function vary based on the intensity of any given yoga sequence. Over time, this leads to an increased energy, decreased tension and tiredness and an improved ability to act with awareness and be both non-judgemental of and non reactive-to inner experience. These affective and attentional mechanisms are related to reduced mood disturbance and stress symptoms and improved HRQL. Ultimately, previous yoga experience, higher energy and a greater ability to let thoughts come and go leads to increased maintenance of yoga practice, arguably further engendering the benefits of these practices (see Figure 5.1). 188 Within this model, yoga is a unique form of exercise that creates a confluence of positive affect and associative attention that effectively stills the fluctuations of the mind via heightened attention to the breath and body. Given the high rate of distress in cancer patients and related lower HRQL, and despite the benefits conventional aerobic exercise may offer in these areas, the addition of yoga to conventional cancer treatment is warranted. Yoga may serve as a complement to common forms of aerobic and resistance exercise that emphasises yoga’s affective and attentional benefits, soothing both mind and body. Given the identified complexity of the cancer experience, the unique challenges faced in each diagnosis, and the tools that yoga offers, highly prescriptive interventions may be developed to aid cancer survivors in their personal quest to still the fluctuations of the mind. While specific cancer treatment must remain a top priority, the health of the overall psychophysiological system must not be overlooked in meeting these aims (61). A reasoned approach that addresses both issues is sure to encourage adherence to treatment and maintenance of health behaviours antagonistic to cancer recurrence but supportive of cancer survivor health. This research is very timely given the large number of practitioners of yoga world-wide, the many touted benefits of yoga and the contemporary discipline’s connection to contemplative teachings that lend themselves to this type of examination. 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(290) Busch V, Magerl W, Kern U, Haas J, Hajak G, Eichhammer P. The effect of deep and slow breathing on pain perception, autonomic activity, and mood processing--an experimental study. Pain Med 2012 Feb;13(2):215-228. 231 APPENDICES 232 Title: Exploring the relationship between yoga practice, affect and attention regulation, health outcomes and program adherence in cancer survivors. Investigators: Dr. S Nicole Culos-Reed (Principal Investigator) Michael Mackenzie (Co-Investigator) Sponsor: None This consent form, a copy of which has been given to you, is only part of the process of informed consent. It should give you the basic idea of what the research is about and what your participation will involve. If you would like more detail about something mentioned here, or information not included here, you should feel free to ask. Please take the time to read this carefully and to understand any accompanying information. Background Yoga appears to be a promising complementary exercise choice for cancer survivors. Within cancer settings, positive effects have been seen on indices of mood, stress-related symptoms, overall quality of life and sleep, as well as functional and physiological measures. Despite preliminary findings, little attention has been paid to the mechanisms by which benefits are attained. Examining these mechanisms for intervention effects will enable us to understand not only if yoga works, but also how. The proposed study addresses this research gap and provides a foundation to more fully explore the applications and benefits of yoga for cancer survivors and support persons. What is the purpose of the study? The purpose of this study is to investigate the psychological benefits of a therapeutic yoga program for cancer survivors and support persons. Specifically we are interested in psychological benefits to mood, stress, and quality of life. What would I have to do? Participants in the Yoga Thrive program will be asked to complete pre and post questionnaires in the week prior to and immediately following the yoga program, and complete the questionnaire portion at three and six-months following the program (i.e., to be completed online or mailed to you with a pre-paid envelope for return). The questionnaire assesses current physical activity beliefs and behaviour, mood, stress and quality of life. Completion of the questionnaires pre and post intervention and at the three and six month follow-ups should take an hour each time for a total of four hours. In addition, participants will be asked to provide feedback on their yoga experience via focus groups. These one hours focus group sessions will be scheduled following completion of the last yoga class and at the three and six month follow-ups for a total of three hours. 233 What are the risks? There are no known physical or psychological risks associated with completing the questionnaires, but you may discontinue at any time if you choose to do so. Will I benefit if I take part? If you agree to participate in this study, there may or may not be a direct benefit to you. Your quality of life may be improved during the study, but there is no guarantee this research will help you. The information we get from this study may help us to provide better and more accessible activity options for cancer survivors and support persons in the future. Do I have to participate? Participation in this study is completely voluntary and you may withdraw at any time without jeopardizing your health care. Please inform the research coordinator or the principal investigator if you choose to withdraw from the study. What else does my participation involve? This study involves no further participation beyond the six-month follow-up mailed questionnaire. Will I be paid for participating, or do I have to pay for anything? There are no costs associated with participating in this research study (questionnaire and focus groups). The Yoga Thrive program all participants will be recruited from is an ongoing community-based program offering fee-based yoga classes for cancer survivors and support persons. Will my records be kept private? The information obtained in this study will be stored on a secure (password protected) computer, and the written assessments will be stored in a secure and locked file cabinet. The information will be kept in Dr. Culos-Reed’s office in the Kinesiology Complex. All records will be coded with non-descriptive ID numbers and kept in the strictest confidence by the principal investigator and individual results will not be disclosed to anyone other than the participant or the University of Calgary Conjoint Health Research Ethics Board. If I suffer a research-related injury, will I be compensated? In the event that you suffer injury as a result of participating in this research, no compensation will be provided to you by the University of Calgary, or the Researchers. You still have your legal rights. Nothing said in this consent form alters your right to seek damages. Consent Your signature on this form indicates that you have understood to your satisfaction the information regarding participation in the research project and agree to participate as a subject. In no way does this waive your legal rights nor release the investigators, or involved institutions from their legal and professional 234 responsibilities. If you have further questions concerning matters related to this research, please contact: Dr. Nicole Culos-Reed, Principal Investigator (403) 220-7540 or Michael Mackenzie, Co-investigator and Research Coordinator (403) 210-8482 If you have any questions concerning your rights as a possible participant in this research, please contact the Director, The Office of Medical Bioethics, University of Calgary, at (403) 220-7990. (name of participant) (date) (signature of participant) (name of investigator) (date) (signature of investigator) (name of witness) (date) (signature of witness) A copy of this consent form has been given to you to keep for your records and reference. The University of Calgary Conjoint Health Research Ethics Board has approved this research study (Ethics ID 23313). 235 Title: Exploring the relationships between a single-session yoga practice and self-regulation in cancer survivors. Investigators: Dr. S Nicole Culos-Reed (Principal Investigator) Michael Mackenzie (Co-Investigator) Sponsor: None This consent form, a copy of which has been given to you, is only part of the process of informed consent. It should give you the basic idea of what the research is about and what your participation will involve. If you would like more detail about something mentioned here, or information not included here, you should feel free to ask. Please take the time to read this carefully and to understand any accompanying information. Background Yoga appears to be a promising complementary exercise choice for cancer survivors. Within cancer settings, positive effects have been seen on indices of mood, stress-related symptoms, overall quality of life and sleep, as well as functional and physiological measures. Despite preliminary findings, little attention has been paid to the mechanisms by which benefits are attained. Examining these mechanisms for intervention effects will enable us to understand not only if yoga works, but also how. The proposed study addresses this research gap and provides a foundation to more fully explore the applications and benefits of yoga for both cancer survivors and support persons. What is the purpose of the study? The purpose of the present study is to examine the psychological effects of a single session of yoga both during and after a yoga practice. What would I have to do? Your participation in this study will involve attending one 75 minute yoga session. The session will be offered at either the University of Calgary, the Holy Cross Hospital Gym or at WellSpring Calgary. The session will include postures, deep relaxation, breathing practices and meditation. The session will be led by a certified yoga instructor with cancer-specific training. You will complete brief psychological measures at the beginning, during, and end of the of the yoga session. Physiological measures (Heart Rate and Heart Rate Variability) will be assessed throughout the class via a wireless ambulatory chest-band heart rate monitor. The yoga session will be conducted during the morning to ensure physiological similar states for all participants. In addition, you will be asked not to exercise or consume caffeine or alcoholic beverages 12 hours prior to the experiment and to refrain from eating and drinking 3 hours prior to the experiment. The entire session, including the yoga practice will take 2.5 hours. 236 What are the risks? The practice of yoga as outlined in this consent form is gentle, should not cause you pain or injury and is therefore considered to be of minimal risk. Nonetheless, there are risks associated with involvement in any physical activity program. Some people have also noticed some initial discomfort associated with the chest-band heart rate monitor. There are no other known physical or psychological risks associated with involvement in the program, but you may discontinue any activity at any time if you choose to do so. Will I benefit if I take part? If you agree to participate in this study, there may or may not be a direct benefit to you. Your quality of life may be improved during the study, but there is no guarantee this research will help you. The information we get from this study may help us to provide better and more accessible activity options for cancer survivors and support persons in the future. Do I have to participate? Participation in this study is completely voluntary and you may withdraw at any time without jeopardizing your health care. Please inform the research coordinator or the principal investigator if you choose to withdraw from the study. What else does my participation involve? This study involves no further active participation beyond the single yoga session, usage of a wireless heart rate monitor and associated questionnaires previously described. Will I be paid for participating, or do I have to pay for anything? There will be no costs to you for participating in this study. Will my records be kept private? The information obtained in this study will be stored on a secure (password protected) computer, and the written assessments will be stored in a secure and locked file cabinet. The information will be kept in Dr. Culos-Reed’s office in the Kinesiology Complex. All records will be coded with non-descriptive ID numbers and kept in the strictest confidence by the principal investigator and individual results will not be disclosed to anyone other than the participant or the University of Calgary Conjoint Health Research Ethics Board. If I suffer a research-related injury, will I be compensated? In the event that you suffer injury as a result of participating in this research, no compensation will be provided to you by the University of Calgary, or the Researchers. You still have your legal rights. Nothing said in this consent form alters your right to seek damages. Signatures Your signature on this form indicates that you have understood to your satisfaction the information regarding participation in the research project and agree to participate as a subject. In no way does this waive your legal rights nor 237 release the investigators, or involved institutions from their legal and professional responsibilities. If you have further questions concerning matters related to this research, please contact: Dr. Nicole Culos-Reed, Principal Investigator (403) 220-7540 or Michael Mackenzie, Co-investigator and Research Coordinator (403) 210-8482 If you have any questions concerning your rights as a possible participant in this research, please contact the Director, The Office of Medical Bioethics, University of Calgary, at (403) 220-7990. Participant’s Name Signature and Date Investigator/Delegate’s Name Signature and Date Witness’ Name Signature and Date The University of Calgary Conjoint Health Research Ethics Board has approved this research study (Ethics ID 23313). A signed copy of this consent form has been given to you to keep for your records and reference. 238 DEMOGRAPHICS (Please answer in relation to your CURRENT status.): Please check only one option. If you do not wish to answer a question, please skip and go to the next question. All information provided will be kept anonymous and confidential. 1. Marital status: Married/ common law: Divorced/ separated: Widowed: Never Married: 2. Education Level (please check highest level attained): Some high school: Completed high school: Some university/ College: Completed University/ College: Some OR completed Grad school: 3. Annual Family Income: <20,000: 20,000-39,999: 40,000-59,999: 60,000-79,999: >80,000: 4. Employment Status: Full-time: Homemaker: Retired: Part-time: Unemployed: Disability/ sick leave: 5. Gender: Male: Female: 6. Age: ___________ 239 MEDICAL INFORMATION Cancer Diagnosis (type and stage): _________________________________________________ Date of Diagnosis (approximate): __________________________________________________ Month / Year Type of Treatment: Radiation therapy Chemotherapy Surgery Other (please specify):___________________________________________________________ If applicable, approximate date you finished active treatment (i.e., radiation, chemo): _____________________________________________________________________________ Month / Year 240 PREVIOUS YOGA EXPERIENCE Have you previously participated in yoga (i.e., class, DVD, tape, or book)? Never: I tried it once or twice: I used to participate regularly: If yes, how often? __________________________________ I currently participate regularly: If yes, how often? ________________________________ If you have any previous yoga experience, what was the format? Instructed class or private lesson(s): DVD or video: CD or cassette tape: Book: Other (please specify):___________________________________________________________ YOGA THRIVE SUPPORT PERSON Do you have a support person who will be attending Yoga Thrive with you? Yes: No: 241 Beliefs about Yoga Likely Neither Unlikely Very Unlikely If I practiced yoga… Extremely Unlikely INSTRUCTIONS: For each of these statements, please indicate the extent to which you believe the statement is true by circling the appropriate number. 1. I would become more flexible. 1 2 3 4 5 6 7 2. There would only be “new age” people in a class. 1 2 3 4 5 6 7 3. It would help me focus. 1 2 3 4 5 6 7 4. It would help me gain self-awareness. 1 2 3 4 5 6 7 5. I would be embarrassed in a class. 1 2 3 4 5 6 7 6. I would have to be more flexible to take a class. 1 2 3 4 5 6 7 7. It would improve my overall health. 1 2 3 4 5 6 7 8. There would only be women in a class. 1 2 3 4 5 6 7 9. I wouldn’t be good at it. 1 2 3 4 5 6 7 10. The instructor would make me uncomfortable 1 2 3 4 5 6 7 11. I would sleep better. 1 2 3 4 5 6 7 242 Feeling Scale Estimate how good or bad you feel right now. -5 -4 Very Bad -3 -2 Bad -1 0 +1 +2 Fairly Neutral Fairly Bad Good +3 +4 Good +5 Very Good Felt Arousal Scale Estimate how aroused you feel right now (low arousal = calm or fatigued, high arousal = anxious or energized). 1 2 3 4 5 6 Low Arousal High Arousal Associative & Dissociative Thoughts Estimate ratio of associative to dissociative thoughts right now (associative = focused in present moment, dissociative = unfocused in past or future). 1 Very Associative 2 3 4 5 6 7 8 9 10 Very Dissociative 243 Godin Leisure Time Exercise Questionnaire We would like you to recall your average weekly exercise over the past month. How many times per week on average did you do the following kinds of exercise over the past month? When answering these questions please remember to: Consider your average weekly exercise over the past month Only count exercise sessions that lasted 15 minutes or longer in duration Only count exercise that was done during free time (i.e., do not included occupation or housework) Note the main difference between the three categories is the intensity of the exercise Write the average frequency on the first line and the average duration on the second line A. STRENUOUS EXERCISE (Heart beats rapidly, sweating) (e.g., running, jogging, hockey, soccer, squash, cross country skiing, judo, roller skating, vigorous swimming, vigorous long distance bicycling, vigorous aerobic dance classes, heavy weight training) In an average week I was involved in strenuous exercise __________ times/week for an average duration of __________ minutes/each session. B. MODERATE EXERCISE (Not exhausting, light perspiration) (e.g., fast walking, baseball, tennis, easy bicycling, volleyball, badminton, easy swimming, alpine skiing, popular and folk dancing) In an average week I was involved in moderate exercise __________ times/week for an average duration of __________ minutes/each session. C. MILD EXERCISE (Minimal effort, no perspiration) (e.g., easy walking, yoga, archery, fishing, bowling, lawn bowling, shuffleboard, horseshoes, golf, snowmobiling) In an average week I was involved in mild exercise __________ times/week for an average duration of __________ minutes/each session. 244 The Activation-Deactivation Adjective Check List (AD ACL) Short Form Each of the words on the back describes feelings or mood. Please use the rating scale next to each word to describe your feelings at this moment. Work rapidly, but please mark all the words. Your first reaction is best. This should take only a minute or two. Active Placid Sleepy Jittery Energetic Intense Calm Tired Vigorous At-rest Drowsy Fearful Lively Still Wide-awake Clutched-up Quiet Full-of-pep Tense Wakeful Definitely feel Feel slightly Cannot decide Definitely do not feel 245 Five Facet Mindfulness Questionnaire Please rate each of the following statements using the scale provided. Write the number in the blank that best describes your own opinion of what is generally true for you. 1 never or very rarely true 2 rarely true 3 sometimes true often true 4 5 very often or always true _____ 1. When I’m walking, I deliberately notice the sensations of my body moving. _____ 2. I’m good at finding words to describe my feelings. _____ 3. I criticize myself for having irrational or inappropriate emotions. _____ 4. I perceive my feelings and emotions without having to react to them. _____ 5. When I do things, my mind wanders off and I’m easily distracted. _____ 6. When I take a shower or bath, I stay alert to the sensations of water on my body. _____ 7. I can easily put my beliefs, opinions, and expectations into words. _____ 8. I don’t pay attention to what I’m doing because I’m daydreaming, worrying, or otherwise distracted. _____ 9. I watch my feelings without getting lost in them. _____ 10. I tell myself I shouldn’t be feeling the way I’m feeling. _____ 11. I notice how foods and drinks affect my thoughts, bodily sensations, and emotions. _____ 12. It’s hard for me to find the words to describe what I’m thinking. _____ 13. I am easily distracted. _____ 14. I believe some of my thoughts are abnormal or bad and I shouldn’t think that way. _____ 15. I pay attention to sensations, such as the wind in my hair or sun on my face. _____ 16. I have trouble thinking of the right words to express how I feel about things _____ 17. I make judgments about whether my thoughts are good or bad. _____ 18. I find it difficult to stay focused on what’s happening in the present. _____ 19. When I have distressing thoughts or images, I “step back” and am aware of the thought or image without getting taken over by it. 246 1 never or very rarely true 2 rarely true 3 sometimes true 4 often true 5 very often or always true _____ 20. I pay attention to sounds, such as clocks ticking, birds chirping, or cars passing. _____ 21. In difficult situations, I can pause without immediately reacting. _____ 22. When I have a sensation in my body, it’s difficult for me to describe it because I can’t find the right words. _____ 23. It seems I am “running on automatic” without much awareness of what I’m doing. _____24. When I have distressing thoughts or images, I feel calm soon after. _____ 25. I tell myself that I shouldn’t be thinking the way I’m thinking. _____ 26. I notice the smells and aromas of things. _____ 27. Even when I’m feeling terribly upset, I can find a way to put it into words. _____ 28. I rush through activities without being really attentive to them. _____ 29. When I have distressing thoughts or images I am able just to notice them without reacting. _____ 30. I think some of my emotions are bad or inappropriate and I shouldn’t feel them. _____ 31. I notice visual elements in art or nature, such as colors, shapes, textures, or patterns of light and shadow. _____ 32. My natural tendency is to put my experiences into words. _____ 33. When I have distressing thoughts or images, I just notice them and let them go. _____ 34. I do jobs or tasks automatically without being aware of what I’m doing. _____ 35. When I have distressing thoughts or images, I judge myself as good or bad, depending what the thought/image is about. _____ 36. I pay attention to how my emotions affect my thoughts and behavior. _____ 37. I can usually describe how I feel at the moment in considerable detail. _____ 38. I find myself doing things without paying attention. _____ 39. I disapprove of myself when I have irrational ideas. 247 POMS-SF Below is a list of words that describe feelings people have. Please read each one carefully. Then circle ONE answer to the right, which describes HOW YOU HAVE BEEN FEELING OVER THE PAST WEEK INCLUDING TODAY. Not at all A Little Moderately Quite a bit Extremely 1. Tense 0 1 2 3 4 2. Angry 0 1 2 3 4 3. Worn out 0 1 2 3 4 4. Unhappy 0 1 2 3 4 5. Lively 0 1 2 3 4 6. Confused 0 1 2 3 4 7. Peeved 0 1 2 3 4 8. Sad 0 1 2 3 4 9. Active 0 1 2 3 4 10. On edge 0 1 2 3 4 11. Grouchy 0 1 2 3 4 12. Blue 0 1 2 3 4 13. Energetic 0 1 2 3 4 14. Hopeless 0 1 2 3 4 15. Uneasy 0 1 2 3 4 16. Restless 0 1 2 3 4 17. Unable to concentrate 0 1 2 3 4 248 Not at all A Little Moderately Quite a bit Extremely 18. Fatigued 0 1 2 3 4 19. Annoyed 0 1 2 3 4 20. Discouraged 0 1 2 3 4 21. Resentful 0 1 2 3 4 22. Nervous 0 1 2 3 4 23. Miserable 0 1 2 3 4 24. Cheerful 0 1 2 3 4 25. Bitter 0 1 2 3 4 26. Exhausted 0 1 2 3 4 27. Anxious 0 1 2 3 4 28. Helpless 0 1 2 3 4 29. Weary 0 1 2 3 4 30. Bewildered 0 1 2 3 4 31. Furious 0 1 2 3 4 32. Full of pep 0 1 2 3 4 33. Worthless 0 1 2 3 4 34. Forgetful 0 1 2 3 4 35. Vigorous 0 1 2 3 4 36. Uncertain about things 0 1 2 3 4 37. Bushed 0 1 2 3 4 249 FACT-G Quality of Life Questionnaire Below is a list of statements that other cancer survivors have said are important. By circling one (1) number per line, please indicate how true each statement has been for you DURING THE PAST 7 DAYS. PHYSICAL WELL-BEING Not at all A little bit I have a lack of energy…………………………………. 0 1 2 3 4 I have nausea…………………………………………… 0 1 2 3 4 Because of my physical condition, I have trouble meeting the needs of my family………………………... 0 1 2 3 4 I have pain……………………………………………… 0 1 2 3 4 I am bothered by side effects of treatment……………... 0 1 2 3 4 I feel ill…………………………………………………. 0 1 2 3 4 I am forced to spend time in bed……………………….. 0 1 2 3 4 Not at all A little bit I feel close to my friends……………………………….. 0 1 2 3 4 I get emotional support from my family……………….. 0 1 2 3 4 I get support from my friends…………………………... 0 1 2 3 4 My family has accepted my illness…………………….. 0 1 2 3 4 I am satisfied with family communication about my illness…………………………………………………… 0 1 2 3 4 I feel close to my partner (or the person who is my main support)…………………………………………………. 0 1 2 3 4 0 1 2 3 4 SOCIAL/FAMILY WELL-BEING Some- Quite Very what a bit much Some- Quite Very what a bit much Regardless of your current level of sexual activity, please answer the following question. If you prefer not to answer it, please check this box (□) and go to the next section. I am satisfied with my sex life…………………………. 250 By circling one (1) number per line, please indicate how true each statement has been for you during the past 7 days. EMOTIONAL WELL-BEING Not at all A little bit Somewhat Quite a bit Very much I feel sad………………………………………………... 0 1 2 3 4 I am satisfied with how I am coping with my illness…... 0 1 2 3 4 I am losing hope in the fight against my illness………... 0 1 2 3 4 I feel nervous…………………………………………… 0 1 2 3 4 I worry about dying…………………………………….. 0 1 2 3 4 I worry that my condition will get worse………………. 0 1 2 3 4 FUNCTIONAL WELL-BEING Not at all A little bit Somewhat Quite a bit Very much I am able to work (include work at home)……………... 0 1 2 3 4 My work (include work at home) is fulfilling………….. 0 1 2 3 4 I am able to enjoy life…………………………………... 0 1 2 3 4 I have accepted my illness……………………………… 0 1 2 3 4 I am sleeping well……………………………………… 0 1 2 3 4 I am enjoying the things I usually do for fun…………... 0 1 2 3 4 I am content with the quality of my life right now……... 0 1 2 3 4 251 Calgary Symptoms of Stress Inventory (SOSI – C) This questionnaire is designed to measure the different ways people respond to stressful situations. The questionnaire contains sets of questions dealing with various physical, psychological and behavioral responses. We are particularly interested in the frequency with which you may have experienced these stress related symptoms during the past week. Never Infrequently Sometimes Often Very Frequently 0 1 2 3 4 Stress is often accompanied by a variety of emotions. During the last week, have you felt: 1. Like life is entirely hopeless 0 1 2 3 4 2. Unhappy and depressed 0 1 2 3 4 3. Alone and sad 0 1 2 3 4 4. That worrying gets you down 0 1 2 3 4 5. Like crying easily 0 1 2 3 4 6. That you wished you were dead 0 1 2 3 4 7. Frightening thoughts keep coming back 0 1 2 3 4 8. You suffer from severe nervous exhaustion 0 1 2 3 4 9. You become made or anger easily 0 1 2 3 4 10. When you feel angry, you act angrily toward most everything 0 1 2 3 4 11. You are easily annoyed and irritated 0 1 2 3 4 12. That little things get on your nerves 0 1 2 3 4 13. Angry thoughts about an irritating event keep bothering you 0 1 2 3 4 14. You let little annoyances build up until you just explode 0 1 2 3 4 Does it seem: 252 Never Infrequently Sometimes Often Very Frequently 0 1 2 3 4 15. Your anger is so great that you want to strike something 0 1 2 3 4 Muscle tension is a common way of experiencing stress. Have you noticed excessive tension, stiffness, soreness or cramping in the muscles in your: 16. Shoulders 0 1 2 3 4 16. Neck 0 1 2 3 4 18. Back 0 1 2 3 4 19. Jaw 0 1 2 3 4 20. Forehead 0 1 2 3 4 21. Eyes 0 1 2 3 4 22. Hands or arms 0 1 2 3 4 23. Tension headaches 0 1 2 3 4 24. Thumping of your heart 0 1 2 3 4 25. Rapid or racing heart beats 0 1 2 3 4 26. Rapid breathing 0 1 2 3 4 27. Irregular heart beats 0 1 2 3 4 28. Difficult breathing 0 1 2 3 4 29. Pains in your heart of chest 0 1 2 3 4 0 1 2 3 4 Does it seem: Do you experience: 30. Difficulty in staying asleep at night 253 Never Infrequently Sometimes Often Very Frequently 0 1 2 3 4 31. Hot or cold spells 0 1 2 3 4 32. Having to get up in the night to urinate 0 1 2 3 4 33. Sweating excessively even in cold weather 0 1 2 3 4 34. Having to urinate frequently 0 1 2 3 4 35. Early morning awakening 0 1 2 3 4 36. Flushing of your face 0 1 2 3 4 37. Difficulty in falling asleep 0 1 2 3 4 38. Breaking out in cold sweats 0 1 2 3 4 39. Feeling faint 0 1 2 3 4 40. Feeling weak and faint 0 1 2 3 4 41. Spells of severe dizziness 0 1 2 3 4 42. Nausea 0 1 2 3 4 43. Blurring of your vision 0 1 2 3 4 44. Severe pains in your stomach 0 1 2 3 4 45. You must do things very slowly to do them without mistakes 0 1 2 3 4 46. You get directions and orders wrong 0 1 2 3 4 47. Your thinking gets completely mixed-up when you have to do things quickly 0 1 2 3 4 Have you experienced: Does it seem: 254 Never Infrequently Sometimes Often Very Frequently 0 1 2 3 4 48. You have difficulty in concentrating 0 1 2 3 4 49. You become suddenly frightened for no good reason 0 1 2 3 4 50. You become so afraid you can't move 0 1 2 3 4 51. Colds 0 1 2 3 4 52. Hoarseness 0 1 2 3 4 53. Colds with complications (e.g. Bronchitis) 0 1 2 3 4 54. Nasal stuffiness 0 1 2 3 4 55. Having to clear your throat often 0 1 2 3 4 56. Sinus headaches 0 1 2 3 4 Have you experienced: 255 Borg Rate of Perceived Exertion Rate your perception of exertion (i.e. how strenuous the exercise felt to you / how tired you feel as a result). 6 No Exertion at All 7 8 Extremely Light 9 10 Very Light 11 12 Light 13 14 Somewhat Hard 15 16 Hard (Heavy) 17 18 Very Hard 19 Extremely Hard 20 Maximal Exertion 256 Dissertation Proposal Qualitative Research Questions YOGA INTERVENTION FOCUS GROUPS o o o o o o o o o o o o o o Tell me about your experience in the yoga intervention. Why did you decide to participate in the yoga intervention? What did you expect when you started to practice yoga? What was it like for you when you started out? What has changed for you practicing yoga from the beginning of the intervention until now? What motivated you to continue the program? What do you think you have learned from this program? What did you like best / least about this intervention? What do you think are some of the benefits / deficits to practicing yoga? What effects, if any, have you noticed since joining the yoga programme? What role does yoga play in your cancer recovery? When people don't practice yoga as often as they'd like, why not? What suggestions do you have for us to improve the program? What additional information would you like to add today? THREE & SIX MONTH FOLLOW-UP FOCUS GROUPS o o o o o o o o Tell me about your yoga practice since completion of the intervention. What has changed for you practicing yoga from completion of the intervention until now? What effects, if any, have you noticed since completing the yoga programme? What has motivated you to continue practicing yoga? What do you think are some of the benefits / deficits to practicing yoga? What role does yoga play in your cancer recovery? When people don't practice yoga as often as they'd like, why not? What additional information would you like to add today? LAB-BASED YOGA SESSION INDIVIDUAL INTERVIEWS o o o o Tell me about your experience in the yoga session. Can you describe how you felt while you were practicing yoga? What helped you decide you felt that way? What additional information would you like to add today? 257 ATTENDANCE LOG Class Location Class Day & Time Session Dates (date to date, year) Instructor: [Name] NAME Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Attendance log – missing codes W = work; V = vacation; S = sick; M = medical (i.e. cancer-related or injury); U (unknown); other (please note reason why, if known) *If a participant misses more than 2 classes for unknown reasons or informs you they are dropping out, please follow-up to track reasons for ending the program or adverse events as a result of the yoga. 258 YOGA for CANCER RESEARCH STUDY (3 & 6 Month Follow-Up) We would like to know what type of activities you may or may not be participating in since completion of the yoga program. Please answer the following questions: Have you continued your yoga practice (at least once per week) over the past three months? Yes No If yes, on average how often are practicing yoga (sessions per week, including any classes and/or home practice)? Please select one: Once a week Twice a week Five times a week Three times a week Four times a week Six times a week Seven times a week Are you currently engaging in other activities in place of or in addition to yoga? Yes No If yes, please list the activity(s) you are currently doing on a weekly basis: ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ 259 Yoga for Cancer Survivors 7-Week Protocol 260 Week 1: Introduction to the basics 1. Legs up the Wall 2. Legs up the Wall: Hip Cross 3. Legs up the Wall: Pullovers(thumb tips touching) – up and down, and overhead 4. Sitting: Shoulders Rolls 5. Sitting:Breath Stretches 6. Tadasana: (feet 3 points) Rebound energy 7. Tree Pose (and prep) 8. Warrior 1/Crescent (cowboy surrender) 9. Pyramid 10. Floor: Knee to Belly 11. Floor: Supine Twist 12. Floor: Knee circles 13. Floor: Feet to floor 14. Savasana 261 Week 2: Building on the foundation, connecting to body and breath 1. Legs up the Wall 2. Legs up the Wall: Hip Cross (nostrils breathing into hip) 3. Legs up the Wall: Pullovers 4. Sitting: Shoulder Rolls 5. Sitting: Twist (nose in line with navel) 6. Hands and Knees 7. Hands and Knees:Cat and Dog 8. Tadasana 9. Tree Pose – 3 foot placements 10. Shiva twist 11. Warrior sequence: warrior 2, reverse warrior 12. Tadasana 13. Tadasana:Arm movements (flow) 14. Tadasana: Stand aware 15. Floor: Little bridge 16. Floor: Knees to belly 17. Floor:Twist on side – arm movements (like ASS, but not) 18. Savasana 262 Week 3: Building Strength, stability and flexibility 1. Legs up Wall 2. Legs up Wall: Hip Cross 3. Hands and Knees: Cat and Dog both directions 4. Floor: Child’s pose 5. Floor: Child’s pose plus 11 and 1 6. Lunge: arms on thigh/overhead 7. Tadasana: Standing side bend 8. Tree 9. Warrior 1 (cowboy surrender) 10. Pyramid 11. Warrior 3 12. Floor: TrA – silver platter, clock, no gripping 13. Floor: Marching one foot at at time; both feet 14. Floor: Little bridge 15. Floor: Supine twist 16. Floor: Hamstring release with strap – leg across body 17. Savasana – inhale pause inhale exhale pause exhale 263 Week 4: Opening Heart and Chest 1. Legs up Wall 2. Legs up Wall: Hip cross 3. On Floor, Knees Bent Feet on Floor: Connecting to PF, petals – 4. On Floor: Knee drops (soft jaw) 5. Sitting: Arms overhead with strap – circles overhead 6. Sitting: Arms behind back with strap 7. Sitting: Arms shoulder-ish height chest release – add fingers and wrists 8. Sitting: Eagle arms 9. Kneeling: Gateway 10. Tadasana: Arms shoulder-ish height – chest release – dural stretch 11. Tadasana: Eagle Arms 12. Tadasana: Shoulder Rolls 13. Triangle Pose 14. Tree Pose 15. Floor: Laying on Rolled Mat – Vertical 16. Floor: Laying on Rolled Mat – Vertical – Add Pullovers 17. Floor: Laying on Rolled Mat – Horizontal 18. Floor: Laying Twist - Lead with Torso, Arms Follow 19. Floor: Hamstring Traction 20. Savasana 264 Week 5 – Introducing meditation following savasana 1. Floor: Laying over yoga mat - breathe easy 2. Floor: Knee Drops (no mat) 3. Lunge: hands on thigh Reverse Lunge Lunge Sequence forward and back 4. Tadasana: samastiti, feel feet equally, collar bones broad, easy breath 5. Tadasana: Side Bend - body allows for it, right arm alongside ear - you are stability, strength and balancee 6. Tadasana: Arms behind – chest release - neck at ease - finger tips move behind - feeling energy of heart moving through arms going out and coming back. 7. Tadasana:Arm flow - bringing sky toward your heart - follow movement with breath 8. Tadasana:Arm flow 2 - arms to sky, palms touch – to heart. - come back together - palms to sky, and then all the way down to hips 9.Tree pose into Warrior1 /Crescent, Pyramid and Warrior 3 - arms to cowboy surrender - arms to sky 10. Tadasana 11. Tadasana: Shoulder rolls 12. Tadasana: Eagle Arms 13. Floor: Plank Pose - Fingers interlaced –forearms on floor – connect with pelvic floor. - Press heels back. Lowering hips – watch how much 14. Floor: Cobra - Initially, don’t use arms or hands strength. Peel off. - Then, engage torso with legs connect with energy in legs. Feet moving backward. - Tone in legs. Pinky toe touching floor. Peel up. Then add arms. 15. Floor: Little Bridge 16. Floor: Knee to belly (one leg extended along the floor) into Supine Twists. - Pinching in hip flexor tone in right leg. Head of thigh bone in hip socket. Opposite heel to shoulder. Sense all the other parts of you. 17.Savasana 18. Meditation 265 Week 6 – Bringing it all together (part 1) 1. Legs up the Wall – so hum – 5 minutes 2. Legs up the Wall - Press heels up to the ceiling-release and press 3. Sitting 4. Sitting: Massage along inner side of shin. 5. Sitting: Downward energy into and through pelvis. Feel rebound 6. Sitting: Tick Tocks Side to Side with breath 7. Sitting: Tick Tocks Forward and Backward with breath 8. Sitting: Sequential Twist with hands on shoulders 9. Sitting: Shoulder Rolls 10. Sitting: Breath Stretches 11. Tadasana: Bottom of feet - inner and outer lines,energy flow – up inner lines and down outer lines 12. Tadasana: Chest and Arm Release using the wall 13. continue to feel the lines half a step forward openness in chest step back, then step out, and raise hand up the wall repeat repeat 3 or 4 times Tadasana: Dancer’s Pose Modified with wall 14. Tadasana: Half Dog, Table Top (keep in mind energy lines) 15. Tadasana Standing Hip Release 16. Tadasana: Chair Pose 17. Tadasana: Table Top with Feet Wide (aka Standing Wide Legged FB) 18. Floor: Supine Twist (outer hip to outer ankle) 19. Floor: Hamstring Release - Be aware of the pelvis as bottom leg moves away - Move leg across body, Move leg 6 inches away from midline – energy lines 20. Savasana: Breath – Softening front of torso and body softening. 266 Week 7 – Bringing it all together (part 2) 1. A) Legs up the Wall or B) Laying on Rolled Yoga Mat Vertically along spine 2. In the position as above: Pullovers – 2 positions 3. Hands and Knees: Cat and Dog - Leading with tail - Leading with head 4. Lunge: arms can go overhead. 5. Lunge: Reverse Lunge 6. Kneeling: Gateway Pose 7. Tadasana: Feel energetic roots 8. Sequence: Tree Pose, Warrior 1/Crescent Pose, Warrior 3, Warrior 1, Tadasana. 9. Tadasana: Shiva Twist 10. Tadasana: Muscular and Dural Stretch of the arms and chest 11. Tadasana: Eagle Arms 12. Tadasana: Dancer’s Pose 13. Tadasana: Table Top 14. Floor: Twist – ASS 15. Floor: Suping Twist 16. Floor: Knees to Belly – Circles 17. Floor: Marching 18. Floor: Knee Drops 19. Floor: Little Bridge 20. Floor: Hamstring Traction 21. Savasana 22. Sitting Quietly 267 Michael Mackenzie Study 3 Yoga Protocol Legs up the Wall 15. Static Legs up the Wall 16. Legs up the Wall: Hip Cross 17. Legs up the Wall: Pullovers (thumb tips touching) Seated 18. Sitting: Shoulders Rolls 19. Sitting: Breath Stretches 20. Sitting: Twist (nose in line with navel) Kneeling 21. Hands and Knees: Cat and Dog - Leading with tail - Leading with head 22. Chakravakasana 23. Lunge 24. Child’s pose Standing 25. Tadasana: - (feet 3 points) Rebound energy - samastiti, feel feet equally, collar bones broad, easy breath 26. Tadasana: Arm flow - bringing sky toward your heart - follow movement with breath 27. Tree Pose (and prep) 28. Warrior 1/Crescent (cowboy surrender) 29. Forward bend Supine 30. Floor: Breath awareness (hands on chest/belly) 31. Floor: Little bridge 32. Floor: Knee to Belly 33. Floor: Supine Twist 34. Floor: Knee circles Resting 35. Savasana - Breath @ nostrils - Body scan - Whole body breathing - Softening breath/body