1 2861 149 YOGA-BASED EXERCISE TO PREVENT FALLS IN COMMUNITY-DWELLING PEOPLE AGED 60 YEARS AND OVER: STUDY PROTOCOL FOR THE SUCCESSFUL AGEING (SAGE) YOGA RANDOMISED CONTROLLED TRIAL. INTRODUCTION: FALLS SIGNIFICANTLY REDUCE INDEPENDENCE AND QUALITY OF LIFE IN OLDER AGE. BALANCE-SPECIFIC EXERCISE PREVENTS FALLS IN PEOPLE AGED 60+ YEARS. YOGA IS GROWING IN POPULARITY AND CAN PROVIDE A HIGH CHALLENGE TO BALANCE; HOWEVER, THE EFFECT OF YOGA ON FALLS HAS NOT BEEN EVALUATED. THIS TRIAL AIMS TO ESTABLISH THE EFFECT ON FALLS OF A YOGA EXERCISE PROGRAMME COMPARED WITH A YOGA RELAXATION PROGRAMME IN COMMUNITY-DWELLERS AGED 60+ YEARS. METHOD AND ANALYSIS: THIS RANDOMISED CONTROLLED TRIAL WILL INVOLVE 560 COMMUNITY-DWELLING PEOPLE AGED 60+ YEARS. PARTICIPANTS WILL BE RANDOMISED TO EITHER: (1) THE SUCCESSFUL AGEING (SAGE) YOGA EXERCISE PROGRAMME OR (2) A YOGA RELAXATION PROGRAMME. PRIMARY OUTCOME IS RATE OF FALLS IN THE 12 MONTHS POST RANDOMISATION. SECONDARY OUTCOMES INCLUDE MENTAL WELL-BEING, PHYSICAL ACTIVITY, HEALTH-RELATED QUALITY OF LIFE, BALANCE SELF-CONFIDENCE, PHYSICAL FUNCTION, PAIN, GOAL ATTAINMENT AND SLEEP QUALITY AT 12 MONTHS AFTER RANDOMISATION. THE NUMBER OF FALLS PER PERSON-YEAR WILL BE ANALYSED USING NEGATIVE BINOMIAL REGRESSION MODELS TO ESTIMATE BETWEEN-GROUP DIFFERENCE IN FALL RATES. GENERALISED LINEAR MODELS WILL ASSESS THE EFFECT OF GROUP ALLOCATION ON THE CONTINUOUSLY SCORED SECONDARY OUTCOMES, ADJUSTING FOR BASELINE SCORES. AN ECONOMIC ANALYSIS WILL COMPARE THE COST-EFFECTIVENESS AND COST-UTILITY OF THE TWO YOGA PROGRAMMES. ETHICS AND DISSEMINATION: PROTOCOL WAS APPROVED BY THE HUMAN RESEARCH ETHICS COMMITTEE AT THE UNIVERSITY OF SYDNEY, AUSTRALIA (APPROVAL 2019/604). TRIAL RESULTS WILL BE DISSEMINATED VIA PEER-REVIEWED ARTICLES, CONFERENCE PRESENTATIONS, LAY SUMMARIES. TRIAL REGISTRATION NUMBER: THE PROTOCOL FOR THIS TRIAL IS REGISTERED WITH THE AUSTRALIAN NEW ZEALAND CLINICAL TRIALS REGISTRY (ACTRN12619001183178). 2020 2 1093 63 EFFECTS OF YOGA ON WELL-BEING AND HEALTHY AGEING: STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL (FITFORAGE). INTRODUCTION: DUE TO AGEING POPULATIONS WORLDWIDE, THE BURDEN OF DISABILITY IS INCREASING. IT IS THEREFORE IMPORTANT TO DEVELOP INTERVENTIONS THAT IMPROVE HEALTHY AGEING, REDUCE DISABILITY ONSET AND ENHANCE LIFE QUALITY. PHYSICAL ACTIVITY CAN PROMOTE HEALTHY AGEING AND HELP MAINTAIN INDEPENDENCE, YET MANY OLDER ADULTS ARE INACTIVE. YOGA IS A FORM OF PHYSICAL ACTIVITY THAT AIMS TO IMPROVE HEALTH AND MAY BE PARTICULARLY SUITABLE FOR OLDER ADULTS. RESEARCH INDICATES POSITIVE EFFECTS OF YOGA ON SEVERAL HEALTH-RELATED OUTCOMES; HOWEVER, EMPIRICAL STUDIES EXAMINING THE BENEFITS OF YOGA ON WELL-BEING AMONG THE ELDERLY REMAIN SCARCE. THIS STUDY PROTOCOL REPORTS THE METHODOLOGY FOR A 12-WEEK YOGA PROGRAMME AIMED TO IMPROVE HEALTH AND WELL-BEING AMONG PHYSICALLY INACTIVE OLDER ADULTS. METHODS AND ANALYSIS: THREE GROUP PARALLEL, SINGLE-BLIND RANDOMISED CONTROLLED TRIAL. TWO COMPARISON GROUPS ARE INCLUDED: AEROBIC EXERCISE AND A NON-ACTIVE WAIT-LIST CONTROL. IN TOTAL, 180 PARTICIPANTS AGED 65-85 YEARS WILL BE RECRUITED. ASSESSMENTS WILL BE PERFORMED AT BASELINE AND POSTINTERVENTION (12-WEEK FOLLOW-UP). THE PRIMARY OUTCOME IS SUBJECTIVE WELL-BEING. SECONDARY OUTCOMES INCLUDE PHYSICAL ACTIVITY/SEDENTARY BEHAVIOUR, MOBILITY/FALL RISK, COGNITION, DEPRESSION, ANXIETY, MOOD, STRESS, PAIN, SLEEP QUALITY, SOCIAL SUPPORT AND CARDIOMETABOLIC RISK FACTORS. DATA WILL BE ANALYSED USING INTENTION-TO-TREAT ANALYSES, WITH MIXED LINEAR MODELLING. ETHICS AND DISSEMINATION: THIS STUDY IS APPROVED BY THE ETHICAL REVIEW BOARD IN STOCKHOLM (2017/1862-31/2). ALL PARTICIPANTS MUST VOLUNTARILY AGREE TO PARTICIPATE AND ARE FREE TO WITHDRAW FROM THE STUDY AT ANY POINT. WRITTEN INFORMED CONSENT WILL BE OBTAINED FROM EACH PARTICIPANT PRIOR TO INCLUSION. RESULTS WILL BE AVAILABLE THROUGH RESEARCH ARTICLES AND CONFERENCES. A SUMMARY OF KEY RESULTS WILL BE PUBLICLY AVAILABLE THROUGH NEWSPAPER ARTICLES. TRIAL REGISTRATION NUMBER: DRKS00015093, U1111-1217-4248. 2019 3 2843 55 YOGA, COGNITIVE-BEHAVIOURAL THERAPY VERSUS EDUCATION TO IMPROVE QUALITY OF LIFE AND REDUCE HEALTHCARE COSTS IN PEOPLE WITH ENDOMETRIOSIS: A RANDOMISED CONTROLLED TRIAL. INTRODUCTION: ENDOMETRIOSIS IS A DEBILITATING CHRONIC INFLAMMATORY CONDITION HIGHLY BURDENSOME TO THE HEALTHCARE SYSTEM. THE PRESENT TRIAL WILL ESTABLISH THE EFFICACY OF (1) YOGA AND (2) COGNITIVE-BEHAVIOURAL THERAPY (CBT), ABOVE (3) EDUCATION, ON QUALITY OF LIFE, BIOPSYCHOSOCIAL OUTCOMES AND COST-EFFECTIVENESS. METHODS AND ANALYSIS: THIS STUDY IS A PARALLEL RANDOMISED CONTROLLED TRIAL. PARTICIPANTS WILL BE RANDOMLY ALLOCATED TO YOGA, CBT OR EDUCATION. PARTICIPANTS WILL BE ENGLISH-SPEAKING ADULTS, HAVE A DIAGNOSIS OF ENDOMETRIOSIS BY A QUALIFIED PHYSICIAN, WITH PAIN FOR AT LEAST 6 MONTHS, AND ACCESS TO INTERNET. PARTICIPANTS WILL ATTEND 8 WEEKLY GROUP CBT SESSIONS OF 120 MIN; OR 8 WEEKLY GROUP YOGA SESSIONS OF 60 MIN; OR RECEIVE WEEKLY EDUCATIONAL HANDOUTS ON ENDOMETRIOSIS. THE PRIMARY OUTCOME MEASURE IS QUALITY OF LIFE. THE ANALYSIS WILL INCLUDE MIXED-EFFECTS ANALYSIS OF VARIANCE AND LINEAR MODELS, COST-UTILITY ANALYSIS FROM A SOCIETAL AND HEALTH SYSTEM PERSPECTIVE AND QUALITATIVE THEMATIC ANALYSIS. ETHICS AND DISSEMINATION: ENROLMENT IN THE STUDY IS VOLUNTARY AND PARTICIPANTS CAN WITHDRAW AT ANY TIME. PARTICIPANTS WILL BE GIVEN THE OPTION TO DISCUSS THE STUDY WITH THEIR NEXT OF KIN/TREATING PHYSICIAN. FINDINGS WILL BE DISSEMINATED VIA PUBLICATIONS, CONFERENCES AND BRIEFS TO PROFESSIONAL ORGANISATIONS. THE UNIVERSITY'S MEDIA TEAM WILL ALSO BE USED TO FURTHER DISSEMINATE VIA LAY PERSON ARTICLES AND MEDIA RELEASES. TRIAL REGISTRATION NUMBER: ACTRN12620000756921P; PRE-RESULTS. 2021 4 888 67 EFFECT OF YOGA VERSUS LIGHT EXERCISE TO IMPROVE WELL-BEING AND PROMOTE HEALTHY AGING AMONG OLDER ADULTS IN CENTRAL INDIA: A STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: AGING IS A NATURAL PROCESS ASSOCIATED WITH MANY FUNCTIONAL AND STRUCTURAL CHANGES. THESE CHANGES MAY INCLUDE IMPAIRED SELF-REGULATION, CHANGES IN TISSUES AND ORGANS. AGING ALSO AFFECTS MOOD, PHYSICAL STATUS AND SOCIAL ACTIVITY. THERE ARE ADVERSE CHANGES IN COGNITIVE BEHAVIOR, PERCEIVED SENSATION AND THINKING PROCESSES. REGULAR PHYSICAL ACTIVITY CAN ALLEVIATE MANY HEALTH PROBLEMS; YET, MANY OLDER ADULTS ARE INACTIVE. YOGA IS ONE OF THE SCIENTIFIC AND POPULAR LIFESTYLE PRACTICE CONSIDERED AS THE INTEGRATION OF MIND, BODY AND SOUL. RESULTS OF PREVIOUS STUDIES REPORTED POSITIVE EFFECTS OF YOGA ON MULTIPLE HEALTH OUTCOMES IN ELDERLY. HOWEVER, THERE IS SCARCITY OF SCIENTIFIC INFORMATION WHERE YOGA'S EFFECT IS EXAMINED ON OVER WELL-BEING AND ON MULTIPLE HEALTH OUTCOMES SIMULTANEOUSLY IN ELDERLY. THIS PROTOCOL DESCRIBES METHODS FOR A 12-WEEK YOGA-BASED INTERVENTION EXPLORING THE EFFECTS OF YOGA ON WELL-BEING IN PHYSICALLY INACTIVE ELDERLY LIVING IN COMMUNITY. METHODS AND ANALYSIS: THIS TWO GROUP PARALLEL SINGLE BLIND RANDOMIZED CONTROLLED TRIAL THAT WILL BE CONDUCTED AT A DESIGNATED FACILITY OF R.D. GARDI MEDICAL COLLEGE, UJJAIN, MADHYA PRADESH, CENTRAL INDIA. A 12-WEEK 60-MIN YOGA INTERVENTION THREE TIMES WEEKLY IS DESIGNED. COMPARISON GROUP PARTICIPANTS WILL UNDERGO A 60-MIN PROGRAM COMPRISING LIGHT EXERCISE FOCUSING ON CONVENTIONAL STRETCHING TO IMPROVE MOBILITY. AFTER SCREENING, 144 PARTICIPANTS AGED 60-80 YEARS WILL BE RECRUITED. THE PRIMARY OUTCOME IS SUBJECTIVE WELL-BEING. SECONDARY OUTCOMES INCLUDE MOBILITY, FALL RISK, COGNITION, ANXIETY AND DEPRESSION, MOOD AND STRESS, SLEEP QUALITY, PAIN, PHYSICAL ACTIVITY/SEDENTARY BEHAVIOR AND CARDIO-METABOLIC RISK FACTORS. ASSESSMENTS WILL BE CONDUCTED AT BASELINE (0 WEEK), AFTER THE INTERVENTION (12+1 WEEK) AND AT FOLLOW-UP (36+1 WEEK). INTENTION-TO-TREAT ANALYSES WITH MIXED LINEAR MODELING WILL BE APPLIED. DISCUSSION: THROUGH THIS TRIAL, WE AIM TO DETERMINE WHETHER ELDERLY PEOPLE IN THE INTERVENTION GROUP PRACTICING YOGA SHOW MORE FAVORABLE PRIMARY (WELL-BEING) AND SECONDARY OUTCOMES THAN THOSE IN THE LIGHT EXERCISE FOCUSING ON CONVENTIONAL STRETCHING GROUP. WE ASSUME THAT YOGA MAY BE PRACTICED TO MAINTAIN HEALTH, REDUCE PARTICULAR SYMPTOMS COMMONLY ASSOCIATED WITH SKELETAL PAIN, ASSIST IN PAIN RELIEF AND ENHANCE WELL-BEING. WE ANTICIPATE THAT PRACTICING YOGA WILL IMPROVE WELL-BEING AND MENTAL HEALTH AND MAY LEAD TO SIGNIFICANT IMPROVEMENT IN DEPRESSION, PAIN AND SLEEP QUALITY.ETHICS AND DISSEMINATION: THIS STUDY IS APPROVED BY THE INSTITUTIONAL ETHICS COMMITTEE OF R.D. GARDI MEDICAL COLLEGE, UJJAIN, IEC REF NO. 09/2018. ALL PARTICIPANTS WOULD BE PROVIDED WITH WRITTEN AND VERBAL INFORMATION ABOUT THE PURPOSE OF THE PROJECT AND WOULD BE FREE TO WITHDRAW FROM THE STUDY AT ANY TIME. REFUSAL TO PARTICIPATE IN THE STUDY WOULD NOT HAVE ANY NEGATIVE CONSEQUENCES. CONFIDENTIALITY OF THE INFORMATION OF EACH PARTICIPANT WOULD BE ENSURED. KNOWLEDGE OBTAINED WOULD BE DISSEMINATED TO STAKEHOLDERS THROUGH WORKSHOPS, MEETINGS AND RELEVANT SCIENTIFIC CONFERENCES. TRIAL REGISTRATION: THE TRIAL IS PROSPECTIVELY REGISTERED WITH THE INDIAN COUNCIL OF MEDICAL RESEARCH TRIAL REGISTRY CTRI/2018/07/015051. 2019 5 2598 53 YOGA FOR OLDER ADULTS WITH MULTIMORBIDITY (THE GENTLE YEARS YOGA TRIAL): STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL. BACKGROUND: MULTIMORBIDITY IS COMMON IN OLDER ADULTS AND ASSOCIATED WITH HIGH LEVELS OF ILLNESS BURDEN AND HEALTHCARE EXPENDITURE. THE EVIDENCE BASE FOR HOW TO MANAGE OLDER ADULTS WITH MULTIMORBIDITY IS WEAK. YOGA MIGHT BE A USEFUL INTERVENTION BECAUSE IT HAS THE POTENTIAL TO IMPROVE HEALTH-RELATED QUALITY OF LIFE, PHYSICAL FUNCTIONING, AND SEVERAL MEDICAL CONDITIONS. THE BRITISH WHEEL OF YOGA'S GENTLE YEARS YOGA(C) (GYY) PROGRAMME WAS DEVELOPED SPECIFICALLY FOR OLDER ADULTS, INCLUDING THOSE WITH CHRONIC MEDICAL CONDITIONS. DATA FROM A PILOT TRIAL SUGGESTED FEASIBILITY OF USING GYY IN THIS POPULATION, BUT ITS EFFECTIVENESS AND COST-EFFECTIVENESS REMAIN UNCERTAIN. METHODS: THIS IS A MULTI-SITE, INDIVIDUALLY RANDOMISED, SUPERIORITY TRIAL WITH AN EMBEDDED PROCESS EVALUATION AND AN ECONOMIC ANALYSIS OF COST-EFFECTIVENESS. THE TRIAL WILL COMPARE AN EXPERIMENTAL STRATEGY OF OFFERING A 12-WEEK GYY PROGRAMME AGAINST A CONTROL STRATEGY OF NO OFFER IN COMMUNITY-DWELLING ADULTS AGED 65 OR OVER WHO HAVE MULTIMORBIDITY, DEFINED AS HAVING TWO OR MORE CHRONIC CONDITIONS FROM A PREDEFINED LIST. THE PRIMARY OUTCOME IS HEALTH-RELATED QUALITY OF LIFE MEASURED USING THE EQ-5D-5L, THE PRIMARY ENDPOINT BEING THE OVERALL DIFFERENCE OVER 12 MONTHS. BOTH GROUPS WILL CONTINUE TO BE ABLE TO ACCESS THEIR USUAL CARE FROM PRIMARY, SECONDARY, COMMUNITY, AND SOCIAL SERVICES. PARTICIPANTS, CARE PROVIDERS, AND YOGA TEACHERS WILL NOT BE BLINDED TO THE ALLOCATED INTERVENTION. OUTCOME MEASURES ARE PRIMARILY SELF-REPORTED. THE ANALYSIS WILL FOLLOW INTENTION-TO-TREAT PRINCIPLES. DISCUSSION: THIS PRAGMATIC RANDOMISED CONTROLLED TRIAL WILL DEMONSTRATE IF THE GYY PROGRAMME IS AN EFFECTIVE, COST-EFFECTIVE, AND VIABLE ADDITION TO THE MANAGEMENT OF OLDER ADULTS WITH MULTIMORBIDITY. TRIAL REGISTRATION: ISRCTN ISRCTN13567538 . REGISTERED ON 18 MARCH 2019. 2021 6 2194 51 THE EFFECTS OF YOGA VERSUS STRETCHING AND RESISTANCE TRAINING EXERCISES ON PSYCHOLOGICAL DISTRESS FOR PEOPLE WITH MILD-TO-MODERATE PARKINSON'S DISEASE: STUDY PRXOTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: PSYCHOLOGICAL DISTRESS IS PREVALENT AMONG PEOPLE WITH PARKINSON'S DISEASE (PD) AND AGGRAVATES THEIR MOTOR SYMPTOMS, THEREBY LEADING TO INCREASED DISABILITY, HIGH HEALTHCARE COSTS, AND POOR HEALTH-RELATED QUALITY OF LIFE (HRQOL). THE UNDER-RECOGNITION AND ADVERSE EFFECTS OF THE PHARMACOLOGICAL MANAGEMENT OF ANXIETY AND DEPRESSION AMONG THE PD POPULATION ARE CONSIDERABLE. THUS, ADOPTING A COMPLEMENTARY AND ALTERNATIVE MANAGEMENT (CAM) APPROACH TO ADDRESS THIS PROBLEM IS IMPORTANT. YOGA, ONE OF THE MOST COMMON "MIND-BODY" CAM THERAPIES, CAN IMPROVE THE PSYCHOLOGICAL WELLBEING OF PEOPLE WITH CHRONIC ILLNESSES. HOWEVER, LIMITED RESEARCH ON THE EFFECTS OF YOGA IN PEOPLE WITH PD HAS BEEN CONDUCTED. THIS STUDY WILL DETERMINE THE EFFECTS OF YOGA ON THE PSYCHOLOGICAL WELLBEING OF PEOPLE WITH MILD-TO-MODERATE PD AND WILL COMPARE THESE EFFECTS WITH THOSE OF STRETCHING AND RESISTANCE TRAINING EXERCISES. METHODS: A COMMUNITY-BASED, SINGLE-BLIND, RANDOMIZED TRIAL WILL BE CONDUCTED. A TOTAL OF 126 SUBJECTS WILL BE RECRUITED AND RANDOMLY DIVIDED INTO YOGA (N = 63) OR STRETCHING AND RESISTANCE EXERCISE (N = 63) GROUPS. FOR 8 WEEKS, THE YOGA GROUP WILL RECEIVE A WEEKLY 90-MIN SESSION OF YOGA, AND THE CONTROL GROUP WILL RECEIVE A WEEKLY 60-MIN SESSION OF STRETCHING AND RESISTANCE EXERCISES. THE PRIMARY OUTCOME WILL BE THE LEVEL OF PSYCHOLOGICAL DISTRESS MEASURED USING THE HOSPITAL ANXIETY AND DEPRESSION SCALE. THE SECONDARY OUTCOMES WILL INCLUDE THE SEVERITY OF MOTOR SYMPTOMS MEASURED BY THE MOVEMENT DISORDERS SOCIETY - UNIFIED PARKINSON'S DISEASE SCALE - PART III MOTOR EXAMINATION; MOBILITY, BALANCE, AND FALL RISK MEASURED BY THE TIMED UP AND GO TEST; SPIRITUAL WELLBEING MEASURED BY THE HOLISTIC WELLBEING SCALE; AND HRQOL MEASURED BY THE PARKINSON'S DISEASE QUESTIONNAIRE-8. ASSESSMENT WILL BE CONDUCTED AT BASELINE, 8TH, AND 20TH WEEKS OF FOLLOW-UPS. DISCUSSION: THIS STUDY WILL BE THE FIRST RANDOMIZED TRIAL TO COMPARE THE EFFECT OF YOGA VERSUS STRETCHING AND RESISTANCE TRAINING EXERCISES IN A PD POPULATION. RESULTS WILL CONTRIBUTE TO THE VALUE OF YOGA AS A THERAPEUTIC OPTION FOR MANAGING PSYCHOLOGICAL DISTRESS IN PD PATIENTS. MULTIPLE OUTCOMES INCLUDING PSYCHOLOGICAL, PHYSIOLOGICAL, AND SPIRITUAL AND HRQOL WILL ALSO BE MEASURED TO ELUCIDATE THE POTENTIAL MECHANISMS OF YOGA. THE EFFECT OF YOGA ON PEOPLE WITH CHRONIC ILLNESSES WILL FURTHER BE ELUCIDATED. THIS INFORMATION SHOULD CONTRIBUTE TO FUTURE RESEARCH, PRACTICE, AND POLICY RELATED TO PD MANAGEMENT. TRIAL REGISTRATION: WHO PRIMARY REGISTRY - CHINESE CLINICAL TRIALS REGISTRY (CHICTR): CUHK_CCRB00522 REGISTERED ON 8 OCTOBER 2016; DATE OF APPROVAL 19 AUGUST 2016. 2017 7 1161 44 EVALUATING A GROUP-BASED YOGA OF STRESS RESILIENCE PROGRAMME: A PRAGMATIC BEFORE-AFTER INTERVENTIONAL STUDY PROTOCOL. INTRODUCTION: RATES OF MENTAL HEALTH ILLNESSES AND BURNOUT ARE INCREASING INTERNATIONALLY. THERAPEUTIC YOGA IS INCREASINGLY USED TO IMPROVE AND MAINTAIN PHYSICAL, MENTAL AND EMOTIONAL WELL-BEING AND GENERAL HEALTH. THIS PROTOCOL DESCRIBES A STUDY TO EVALUATE THE EFFECTIVENESS OF AN EXISTING PRIMARY CARE GROUP-BASED THERAPEUTIC YOGA PROGRAMME, THE YOGA OF STRESS RESILIENCE PROGRAMME, WHICH COMBINES YOGA AND PSYCHOTHERAPEUTIC TECHNIQUES, IN IMPROVING MENTAL HEALTH AND DECREASING BURNOUT. IMPLEMENTATION FACTORS WILL ALSO BE EVALUATED FOR POTENTIAL SCALE-UP. METHODS AND ANALYSIS: A PRAGMATIC BEFORE-AFTER INTERVENTIONAL TRIAL DESIGN WILL BE USED TO STUDY CHANGES IN OCCUPATIONAL PARTICIPATION AND MENTAL HEALTH OUTCOMES, INCLUDING ANXIETY, DEPRESSION, BURNOUT, FUNCTIONAL IMPAIRMENT, INSOMNIA, PERCEIVED STRESS, LONELINESS, SELF-COMPASSION AND READINESS FOR CHANGE IN ADULTS EXPERIENCING ANXIETY AND BURNOUT. REPEATED MEASURES ANALYSIS OF VARIANCE WILL BE USED TO DETERMINE CHANGES IN OUTCOME MEASURES OVER TIME. REGRESSION AND MULTIVARIATE ANALYSES WILL BE CONDUCTED TO EXAMINE RELATIONSHIPS BETWEEN PARTICIPANT CHARACTERISTICS AND OUTCOMES AND AMONG VARIOUS OUTCOMES. THE REACH, EFFECTIVENESS, ADOPTION, IMPLEMENTATION, AND MAINTENANCE FRAMEWORK WILL BE USED TO GUIDE THE ANALYSES. ETHICS AND DISSEMINATION: APPROVAL FROM THE HAMILTON INTEGRATED RESEARCH ETHICS BOARD HAS BEEN WAIVED: PROJECT NUMBER 7082 (FULL REVIEW WAIVED). INFORMED CONSENT WILL BE OBTAINED PRIOR TO ENROLLING ANY PARTICIPANT INTO THE STUDY. ALL DATA WILL BE KEPT CONFIDENTIAL. PEER-REVIEWED PUBLICATIONS AND PRESENTATIONS WILL TARGET RESEARCHERS AND HEALTH PROFESSIONALS. TRIAL REGISTRATION NUMBER: THE CLINICALTRIALS.GOV REGISTRY (NCT03973216). 2020 8 2117 43 THE EFFECT OF YOGA ON WOMEN WITH SECONDARY ARM LYMPHOEDEMA FROM BREAST CANCER TREATMENT. BACKGROUND: WOMEN WHO DEVELOP SECONDARY ARM LYMPHOEDEMA SUBSEQUENT TO TREATMENT ASSOCIATED WITH BREAST CANCER REQUIRE LIFE-LONG MANAGEMENT FOR A RANGE OF SYMPTOMS INCLUDING ARM SWELLING, HEAVINESS, TIGHTNESS IN THE ARM AND SOMETIMES THE CHEST, UPPER BODY IMPAIRMENT AND CHANGES TO A RANGE OF PARAMETERS RELATING TO QUALITY OF LIFE. WHILE EXERCISE UNDER CONTROLLED CONDITIONS HAS HAD POSITIVE OUTCOMES, THE IMPACT OF YOGA HAS NOT BEEN INVESTIGATED. THE AIM OF THIS STUDY IS TO DETERMINE THE EFFECTIVENESS OF YOGA IN THE PHYSICAL AND PSYCHO-SOCIAL DOMAINS, IN THE HOPE THAT WOMEN CAN BE OFFERED ANOTHER SAFE, HOLISTIC MODALITY TO HELP CONTROL MANY, IF NOT ALL, OF THE EFFECTS OF SECONDARY ARM LYMPHOEDEMA. METHODS AND DESIGN: A RANDOMISED CONTROLLED PILOT TRIAL WILL BE CONDUCTED IN HOBART AND LAUNCESTON WITH A TOTAL OF 40 WOMEN RECEIVING EITHER YOGA INTERVENTION OR CURRENT BEST PRACTICE CARE. INTERVENTION WILL CONSIST OF EIGHT WEEKS OF A WEEKLY TEACHER-LED YOGA CLASS WITH A HOME-BASED DAILY YOGA PRACTICE DELIVERED BY DVD. PRIMARY OUTCOME MEASURES WILL BE THE EFFECTS OF YOGA ON LYMPHOEDEMA AND ITS ASSOCIATED SYMPTOMS AND QUALITY OF LIFE. SECONDARY OUTCOME MEASURES WILL BE RANGE OF MOTION OF THE ARM AND THORACIC SPINE, SHOULDER STRENGTH, AND WEEKLY AND DAILY PHYSICAL ACTIVITY. PRIMARY AND SECONDARY OUTCOMES WILL BE MEASURED AT BASELINE, WEEKS FOUR, EIGHT AND A FOUR WEEK FOLLOW UP AT WEEK TWELVE. RANGE OF MOTION OF THE SPINE, IN A SELF-NOMINATED GROUP, WILL BE MEASURED AT BASELINE, WEEKS EIGHT AND TWELVE. A FURTHER OUTCOME WILL BE THE WOMEN'S PERCEPTIONS OF THE YOGA COLLECTED BY INTERVIEW AT WEEK EIGHT. DISCUSSION: THE RESULTS OF THIS TRIAL WILL PROVIDE INFORMATION ON THE SAFETY AND EFFECTIVENESS OF YOGA FOR WOMEN WITH SECONDARY ARM LYMPHOEDEMA FROM BREAST CANCER TREATMENT. IT WILL ALSO INFORM METHODOLOGY FOR FUTURE, LARGER TRIALS. TRIAL REGISTRATION: ACTRN12611000202965. 2012 9 1242 44 FEASIBILITY OF A YOGA INTERVENTION TO DECREASE PAIN IN OLDER WOMEN: A RANDOMIZED CONTROLLED PILOT STUDY. BACKGROUND: A SIGNIFICANT PROPORTION OF OLDER WOMEN SUFFER FROM CHRONIC PAIN, WHICH CAN DECREASE QUALITY OF LIFE. THE OBJECTIVE OF THIS PILOT RANDOMIZED STUDY WAS TO EVALUATE THE FEASIBILITY OF A FLOW-RESTORATIVE YOGA INTERVENTION DESIGNED TO DECREASE PAIN AND RELATED OUTCOMES AMONG WOMEN AGED 60 OR OLDER. METHODS: FLOW-RESTORATIVE YOGA CLASSES WERE HELD TWICE WEEKLY FOR 1 HOUR AND LED BY A CERTIFIED YOGA INSTRUCTOR. PARTICIPANTS RANDOMIZED TO THE INTERVENTION GROUP ATTENDED THE YOGA CLASSES FOR 12 WEEKS AND RECEIVED SUPPLEMENTAL MATERIALS FOR AT-HOME PRACTICE. THOSE RANDOMIZED TO THE CONTROL GROUP WERE ASKED TO MAINTAIN THEIR NORMAL DAILY ROUTINE. FEASIBILITY WAS EVALUATED USING RECRUITMENT AND RETENTION RATES, CLASS AND HOME PRACTICE ADHERENCE RATES, AND PARTICIPANT SATISFACTION SURVEYS. OUTCOME MEASURES (SELF-REPORTED PAIN, INFLAMMATORY MARKERS, FUNCTIONAL FITNESS, QUALITY OF LIFE, RESILIENCE, AND SELF-REPORTED PHYSICAL ACTIVITY) WERE ASSESSED AT BASELINE AND POST-INTERVENTION. PAIRED T-TESTS OR WILCOXON SIGNED-RANK TESTS WERE USED TO EXAMINE CHANGES IN OUTCOME MEASURES WITHIN TREATMENT GROUPS. RESULTS: THIRTY-EIGHT PARTICIPANTS WERE RECRUITED AND RANDOMIZED. PARTICIPANTS WERE PRIMARILY WHITE, COLLEGE-EDUCATED, AND HIGHER FUNCTIONING, DESPITE EXPERIENCING VARIOUS FORMS OF CHRONIC PAIN. ATTENDANCE AND RETENTION RATES WERE HIGH (91 AND 97%, RESPECTIVELY) AND THE MAJORITY OF PARTICIPANTS WERE SATISFIED WITH THE YOGA PROGRAM (89%) AND WOULD RECOMMEND IT TO OTHERS (87%). INTERVENTION PARTICIPANTS ALSO EXPERIENCED REDUCTIONS IN PAIN INTERFERENCE AND IMPROVEMENTS IN ENERGY AND SOCIAL FUNCTIONING. CONCLUSIONS: THIS PILOT STUDY PROVIDES ESSENTIAL DATA TO INFORM A FULL SCALE RANDOMIZED TRIAL OF FLOW-RESTORATIVE YOGA FOR OLDER WOMEN WITH CHRONIC PAIN. FUTURE STUDIES SHOULD EMPHASIZE STRATEGIES TO RECRUIT A MORE DIVERSE STUDY POPULATION, PARTICULARLY OLDER WOMEN AT HIGHER RISK OF DISABILITY AND FUNCTIONAL DECLINE. TRIAL REGISTRATION: CLINICALTRIALS.GOV , NCT03790098 . REGISTERED 31 DECEMBER 2018 - RETROSPECTIVELY REGISTERED. 2020 10 175 45 A RANDOMIZED CONTROLLED TRIAL EXAMINING IYENGAR YOGA FOR YOUNG ADULTS WITH RHEUMATOID ARTHRITIS: A STUDY PROTOCOL. BACKGROUND: RHEUMATOID ARTHRITIS IS A CHRONIC, DISABLING DISEASE THAT CAN COMPROMISE MOBILITY, DAILY FUNCTIONING, AND HEALTH-RELATED QUALITY OF LIFE, ESPECIALLY IN OLDER ADOLESCENTS AND YOUNG ADULTS. IN THIS PROJECT, WE WILL COMPARE A STANDARDIZED IYENGAR YOGA PROGRAM FOR YOUNG PEOPLE WITH RHEUMATOID ARTHRITIS TO A STANDARD CARE WAIT-LIST CONTROL CONDITION. METHODS/DESIGN: SEVENTY RHEUMATOID ARTHRITIS PATIENTS AGED 16-35 YEARS WILL BE RANDOMIZED INTO EITHER THE 6-WEEK IYENGAR YOGA PROGRAM (12 - 1.5 HOUR SESSIONS TWICE WEEKLY) OR THE 6-WEEK WAIT-LIST CONTROL CONDITION. A 20% ATTRITION RATE IS ANTICIPATED. THE WAIT-LIST GROUP WILL RECEIVE THE YOGA PROGRAM FOLLOWING COMPLETION OF THE FIRST ARM OF THE STUDY. WE WILL COLLECT DATA QUANTITATIVELY, USING QUESTIONNAIRES AND MARKERS OF DISEASE ACTIVITY, AND QUALITATIVELY USING SEMI-STRUCTURED INTERVIEWS. ASSESSMENTS INCLUDE STANDARDIZED MEASURES OF GENERAL AND ARTHRITIS-SPECIFIC FUNCTION, PAIN, MOOD, AND HEALTH-RELATED QUALITY OF LIFE, AS WELL AS QUALITATIVE INTERVIEWS, BLOOD PRESSURE/RESTING HEART RATE MEASUREMENTS, A MEDICAL EXAM AND THE ASSESSMENT OF PRO-INFLAMMATORY CYTOKINES. DATA WILL BE COLLECTED THREE TIMES: BEFORE TREATMENT, POST-TREATMENT, AND TWO MONTHS FOLLOWING THE TREATMENT. DISCUSSION: RESULTS FROM THIS STUDY WILL PROVIDE CRITICAL DATA ON NON-PHARMACOLOGIC METHODS FOR ENHANCING FUNCTION IN RHEUMATOID ARTHRITIS PATIENTS. IN PARTICULAR, RESULTS WILL SHED LIGHT ON THE FEASIBILITY AND POTENTIAL EFFICACY OF A NOVEL INTERVENTION FOR RHEUMATOID ARTHRITIS SYMPTOMS, PAVING THE WAY FOR A LARGER CLINICAL TRIAL. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT01096823. 2011 11 2243 43 THE INFLUENCE OF TAI CHI AND YOGA ON BALANCE AND FALLS IN A RESIDENTIAL CARE SETTING: A RANDOMISED CONTROLLED TRIAL. ABSTRACT FALLS AMONGST OLDER PEOPLE IS A GLOBAL PUBLIC HEALTH CONCERN. WHILST FALLING IS NOT A TYPICAL FEATURE OF AGEING, OLDER PEOPLE ARE MORE LIKELY TO FALL. FALL INJURIES AMONGST OLDER PEOPLE ARE A LEADING CAUSE OF DEATH AND DISABILITY. MANY OLDER PEOPLE DO NOT DO REGULAR EXERCISE SO THAT THEY LOSE MUSCLE TONE, STRENGTH, AND FLEXIBILITY WHICH AFFECT BALANCE AND PREDISPOSE THEM TO FALLS. THE MANAGEMENT OF FALLS IN RESIDENTIAL CARE SETTINGS IS A MAJOR CONCERN WITH STRATEGIES FOR PREVENTION AND MONITORING A FOCUS IN THIS SETTING. YOGA AND TAI CHI HAVE SHOWN POTENTIAL TO IMPROVE BALANCE AND PREVENT FALLS IN OLDER ADULTS. THEY ALSO HAVE POTENTIAL TO IMPROVE PAIN AND QUALITY OF LIFE. THE AIM OF THIS STUDY WAS TO DETERMINE THE FEASIBILITY OF CONDUCTING A 3-ARM RCT WITH FRAIL OLDER PEOPLE IN A RESIDENTIAL CARE SETTING TO TEST THE HYPOTHESIS THAT A 14 WEEK MODIFIED TAI CHI OR YOGA PROGRAM IS MORE EFFECTIVE THAN USUAL CARE ACTIVITY IN IMPROVING BALANCE FUNCTION, QUALITY OF LIFE, PAIN EXPERIENCE AND IN REDUCING NUMBER OF FALLS. THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN THE THREE GROUPS IN THE OCCURRENCE OF FALLS. YOGA DEMONSTRATED A SLIGHT DECREASE IN FALL INCIDENCE; QUALITY OF LIFE IMPROVED FOR THE TAI CHI GROUP. ONLY THE YOGA GROUP EXPERIENCED A REDUCTION IN AVERAGE PAIN SCORES THOUGH NOT STATISTICALLY SIGNIFICANT. THE FINDINGS OF THE STUDY SUGGEST IT IS POSSIBLE TO SAFELY IMPLEMENT MODIFIED YOGA AND TAI CHI IN A RESIDENTIAL CARE SETTING AND EVALUATE THIS USING RCT DESIGN. THEY SHOW POSITIVE CHANGES TO BALANCE, PAIN AND QUALITY OF LIFE AND A HIGH LEVEL OF INTEREST THROUGH ATTENDANCE AMONGST THE OLDER PARTICIPANTS. THE RESULTS SUPPORT OFFERING TAI CHI AND YOGA TO OLDER PEOPLE WHO ARE FRAIL AND DEPENDENT WITH PHYSICAL AND COGNITIVE LIMITATIONS. 2014 12 69 46 A FEASIBILITY RANDOMISED CONTROLLED TRIAL OF NOVEL ACTIVITY MANAGEMENT IN SEVERE ASTHMA-TAILORED EXERCISE (NAMASTE): YOGA AND MINDFULNESS. BACKGROUND: PHYSICAL INACTIVITY IS COMMON IN SEVERE ASTHMA AND ASSOCIATED WITH POOR HEALTH OUTCOMES. NEW APPROACHES ARE NEEDED TO ADDRESS PHYSICAL INACTIVITY IN THIS GROUP. OBJECTIVE: TO EXAMINE WHETHER YOGA AND MINDFULNESS IMPROVES HEALTH-RELATED QUALITY OF LIFE (HRQOL) COMPARED WITH A MINIMAL ACTIVE CONTROL GROUP AND COLLECT FEASIBILITY DATA TO INFORM FUTURE STUDIES. METHODS: OVER 12-WEEKS, ADULTS WITH SEVERE ASTHMA WERE RECRUITED. PARTICIPANTS WERE RANDOMISED 2:1 TO PARALLEL YOGA OR CONTROL GROUPS. ALL PARTICIPANTS RECEIVED AN ACTIVITY TRACKER. THE YOGA GROUP RECEIVED TAILORED GROUP CLASSES TWICE A WEEK FOR 16-WEEKS WITH A QUALIFIED YOGA INSTRUCTOR. THE CONTROL GROUP SET ACTIVITY GOALS WITH A RESEARCH OFFICER AND RECEIVED EIGHT PROGRESS CALLS. OUTCOMES WERE ASSESSED AT 16-WEEKS. PRIMARY OUTCOME WAS ST GEORGE'S RESPIRATORY QUESTIONNAIRE (SGRQ). SECONDARY OUTCOMES INCLUDED ASTHMA CONTROL, PHYSICAL ACTIVITY, BREATHLESSNESS, AND INFLAMMATION. FACE-TO-FACE QUALITATIVE INTERVIEWS WERE CONDUCTED TO DETERMINE ACCEPTABILITY. RESULTS: THERE WERE 15 PARTICIPANTS RANDOMISED TO YOGA (MEAN 67 YEARS; 60% FEMALE) AND 9 TO CONTROL (68 YEARS; 56% FEMALE). PLANNED COMPARISONS INDICATED THE YOGA GROUP HAD GREATER SGRQ IMPROVEMENT THAN THE CONTROL GROUP. THERE WAS LITTLE CHANGE IN SECONDARY OUTCOMES. MODERATE-VIGOROUS ACTIVITY INCREASED SUBSTANTIALLY IN THE CONTROL GROUP. PARTICIPANTS FOUND THE INTERVENTION ACCEPTABLE; KEY BARRIERS AND FACILITATORS WERE SOCIAL CONNECTION, THE SETTING, ADDRESSING BREATHING AND ASTHMA SYMPTOMS, CHANGING THEIR MINDSET, AND THE INTERSECTION OF DIFFERENT ELEMENTS. CONCLUSION: A YOGA AND MINDFULNESS INTERVENTION WAS FEASIBLE, ACCEPTABLE TO PATIENTS AND IMPROVED HRQOL. THE FINDINGS WILL INFORM DESIGN OF MUCH NEEDED FUTURE RESEARCH INTO PHYSICAL ACTIVITY INTERVENTIONS FOR SEVERE ASTHMA. WORLD HEALTH ORGANIZATION INTERNATIONAL CLINICAL TRIALS REGISTRY PLATFORM THE STUDY WAS REGISTERED UNDER THE AUSTRALIAN NEW ZEALAND CLINICAL TRIALS REGISTRY (ANZCTR) ON THE 26TH OF NOVEMBER 2018, TRIAL ID ACTRN12618001914257. 2021 13 536 42 COMPARISON OF YOGA VERSUS STRETCHING FOR CHRONIC LOW BACK PAIN: PROTOCOL FOR THE YOGA EXERCISE SELF-CARE (YES) TRIAL. BACKGROUND: BACK PAIN, ONE OF THE MOST PREVALENT CONDITIONS AFFLICTING AMERICAN ADULTS, IS THE LEADING REASON FOR USING COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) THERAPIES. YOGA IS AN INCREASINGLY POPULAR "MIND-BODY" CAM THERAPY OFTEN USED FOR RELIEVING BACK PAIN AND SEVERAL SMALL STUDIES HAVE FOUND YOGA EFFECTIVE FOR THIS CONDITION. THIS STUDY WILL ASSESS WHETHER YOGA IS EFFECTIVE FOR TREATING CHRONIC LOW BACK PAIN COMPARED WITH SELF CARE AND EXERCISE AND WILL EXPLORE THE MECHANISMS RESPONSIBLE FOR ANY OBSERVED BENEFITS. METHODS/DESIGN: A TOTAL OF 210 PARTICIPANTS WITH LOW BACK PAIN LASTING AT LEAST 3 MONTHS WILL BE RECRUITED FROM PRIMARY CARE CLINICS OF A LARGE HEALTHCARE SYSTEM BASED IN SEATTLE. THEY WILL BE RANDOMIZED IN A 2:2:1 RATIO TO RECEIVE 12 WEEKLY YOGA CLASSES, 12 WEEKLY CONVENTIONAL THERAPEUTIC EXERCISE CLASSES OF COMPARABLE PHYSICAL EXERTION, OR A SELF-CARE BOOK. INTERVIEWERS MASKED TO PARTICIPANTS' TREATMENT GROUP WILL ASSESS OUTCOMES AT BASELINE AND 6, 12 AND 26 WEEKS AFTER RANDOMIZATION. PRIMARY OUTCOMES WILL BE BACK-RELATED DYSFUNCTION AND SYMPTOM BOTHERSOMENESS. IN ADDITION, DATA WILL BE COLLECTED ON PHYSICAL MEASUREMENTS (E.G., FLEXION) AT BASELINE AND 12 WEEKS AND SALIVA SAMPLES WILL BE OBTAINED AT BASELINE, 6 AND 12 WEEKS. INFORMATION WILL BE COLLECTED ON SPECIFIC PHYSICAL, PSYCHOLOGICAL, AND PHYSIOLOGICAL FACTORS TO ALLOW EXPLORATION OF POSSIBLE MECHANISMS OF ACTION THROUGH WHICH YOGA COULD RELIEVE BACK PAIN AND DYSFUNCTION. THE EFFECTIVENESS OF YOGA WILL BE ASSESSED USING ANALYSIS OF COVARIANCE (USING GENERAL ESTIMATING EQUATIONS - GEE) WITHIN AN INTENTION-TO-TREAT CONTEXT. IF YOGA IS FOUND EFFECTIVE, FURTHER ANALYSES WILL EXPLORE WHETHER YOGA'S BENEFITS ARE ATTRIBUTABLE TO PHYSICAL, PSYCHOLOGICAL AND/OR PHYSIOLOGICAL FACTORS. CONCLUSIONS: THIS STUDY WILL PROVIDE THE CLEAREST EVIDENCE TO DATE ABOUT THE VALUE OF YOGA AS A THERAPEUTIC OPTION FOR TREATING CHRONIC BACK PAIN, AND IF THE RESULTS ARE POSITIVE, WILL HELP FOCUS FUTURE, MORE IN-DEPTH, RESEARCH ON THE MOST PROMISING POTENTIAL MECHANISMS OF ACTION IDENTIFIED BY THIS STUDY. 2010 14 1106 41 EFFECTS OF YOGA, AEROBIC, AND STRETCHING AND TONING EXERCISES ON COGNITION IN ADULT CANCER SURVIVORS: PROTOCOL OF THE STAY FIT PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CANCER SURVIVORS EXPERIENCE COMPROMISED QUALITY OF LIFE DUE TO IMPAIRED COGNITIVE FUNCTION AS A RESULT OF CANCER DIAGNOSIS AND TREATMENT. ALTHOUGH EXERCISE HAS PROVEN TO BE EFFECTIVE IN IMPROVING COGNITIVE FUNCTION ACROSS THE LIFESPAN, INTERVENTIONS COMPREHENSIVELY TESTING THE EFFECTIVENESS FOR CANCER SURVIVORS ARE LIMITED. THE STAY FIT TRIAL IS A THREE-ARMED PILOT RANDOMIZED CONTROLLED TRIAL DESIGNED TO COMPARE THE EFFECTS OF A 12-WEEK YOGA, AEROBIC WALKING, AND STRETCH AND TONE INTERVENTION ON COGNITIVE FUNCTION AMONG ADULT CANCER SURVIVORS. METHODS: THIS PILOT STUDY AIMS TO RECRUIT 75 ADULT CANCER SURVIVORS WHO WILL COMPLETE ASSESSMENTS OF COGNITIVE FUNCTION, CARDIOVASCULAR FITNESS, PHYSICAL ACTIVITY, AND PSYCHOSOCIAL MEASURES AT BASELINE AND AFTER THE 12-WEEK INTERVENTION. THE AIMS OF STAY FIT ARE (1) TO ASSESS THE EFFICACY OF YOGA TO IMPROVE COGNITIVE FUNCTION AMONG CANCER SURVIVORS, COMPARED TO AEROBIC EXERCISE AND AN ACTIVE CONTROL GROUP; (2) TO EXAMINE CHANGES IN CARDIOVASCULAR FITNESS AS A RESULT OF THE INTERVENTIONS; AND (3) TO ASSESS CHANGES IN QUALITY OF LIFE AMONG OUR POPULATION AS A RESULT OF THE EXERCISE INTERVENTIONS. DISCUSSION: THE STAY FIT TRIAL WILL TEST THE EFFECTIVENESS OF YOGA, AEROBIC EXERCISE, AND STRETCHING AND TONING EXERCISES IN IMPROVING COGNITIVE FUNCTION AND FITNESS AMONG ADULT CANCER SURVIVORS. THE RESULTS OF THIS PILOT STUDY WILL ENABLE US TO UNDERSTAND THE MOST EFFECTIVE PHYSICAL ACTIVITY MODALITY TO IMPROVE COGNITIVE FUNCTION IN THIS POPULATION AND POTENTIALLY COMBAT CANCER-RELATED COGNITIVE IMPAIRMENT. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT03650322 . REGISTERED ON 28 AUGUST 2018. 2020 15 2811 42 YOGA TO PREVENT MOBILITY LIMITATIONS IN OLDER ADULTS: FEASIBILITY OF A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: THE LOSS OF MOBILITY DURING AGING IMPACTS INDEPENDENCE AND LEADS TO FURTHER DISABILITY, MORBIDITY, AND REDUCED LIFE EXPECTANCY. OUR OBJECTIVE WAS TO EXAMINE THE FEASIBILITY AND SAFETY OF CONDUCTING A RANDOMIZED CONTROLLED TRIAL OF YOGA FOR OLDER ADULTS AT RISK FOR MOBILITY LIMITATIONS. METHODS: SEDENTARY OLDER ADULTS (N = 46; AGE 60-89) WERE RECRUITED AND RANDOMIZED TO EITHER YOGA OR A HEALTH EDUCATION COMPARISON GROUP. YOGA SESSIONS (60-MIN) OCCURRED 2X WEEKLY, AND 90-MIN HEALTH EDUCATION SESSIONS OCCURRED WEEKLY, FOR 10 WEEKS. THE PRIMARY OUTCOMES WERE RECRUITMENT RATE, INTERVENTION ATTENDANCE, AND RETENTION AT ASSESSMENTS. ADVERSE EVENT RATES AND PARTICIPANT SATISFACTION WERE ALSO MEASURED. PHYSICAL PERFORMANCE MEASURES OF GAIT, BALANCE, AND STRENGTH AND SELF-REPORT OUTCOME MEASURES WERE ADMINISTERED AT BASELINE AND 10-WEEKS. RESULTS: RECRUITMENT LASTED 6 MONTHS. RETENTION OF PARTICIPANTS AT THE 10-WEEK FOLLOW-UP WAS HIGH (89% - PERFORMANCE MEASURES; 98% - SELF-REPORT QUESTIONNAIRES). ATTENDANCE WAS GOOD WITH 82% OF YOGA AND 74% OF HEALTH EDUCATION PARTICIPANTS ATTENDING AT LEAST 50% OF THE SESSIONS. NO SERIOUS ADVERSE EVENTS WERE REPORTED. PATIENT SATISFACTION WITH THE INTERVENTIONS WAS HIGH. THE MEAN EFFECT SIZE FOR THE PHYSICAL PERFORMANCE MEASURES WAS 0.35 WITH SOME OVER 0.50. THE MEAN EFFECT SIZE FOR SELF-REPORT OUTCOME MEASURES WAS 0.36. CONCLUSIONS: RESULTS INDICATE THAT IT IS FEASIBLE TO CONDUCT A LARGER RCT OF YOGA FOR SEDENTARY OLDER ADULTS AT RISK FOR MOBILITY PROBLEMS. THE YOGA AND COMPARISON INTERVENTIONS WERE SAFE, WELL ACCEPTED, AND WELL ATTENDED. EFFECT SIZES SUGGEST YOGA MAY HAVE IMPORTANT BENEFITS FOR THIS POPULATION AND SHOULD BE STUDIED FURTHER. TRIAL REGISTRATION: CLINICALTRIALS # NCT03544879 ; RETROSPECTIVELY REGISTERED 4 JUNE, 2018. 2018 16 1854 52 RANDOMISED CONTROLLED TRIAL OF A 12 WEEK YOGA INTERVENTION ON NEGATIVE AFFECTIVE STATES, CARDIOVASCULAR AND COGNITIVE FUNCTION IN POST-CARDIAC REHABILITATION PATIENTS. BACKGROUND: NEGATIVE AFFECTIVE STATES SUCH AS ANXIETY, DEPRESSION AND STRESS ARE SIGNIFICANT RISK FACTORS FOR CARDIOVASCULAR DISEASE, PARTICULARLY IN CARDIAC AND POST-CARDIAC REHABILITATION POPULATIONS.YOGA IS A BALANCED PRACTICE OF PHYSICAL EXERCISE, BREATHING CONTROL AND MEDITATION THAT CAN REDUCE PSYCHOSOCIAL SYMPTOMS AS WELL AS IMPROVE CARDIOVASCULAR AND COGNITIVE FUNCTION. IT HAS THE POTENTIAL TO POSITIVELY AFFECT MULTIPLE DISEASE PATHWAYS AND MAY PROVE TO BE A PRACTICAL ADJUNCT TO CARDIAC REHABILITATION IN FURTHER REDUCING CARDIAC RISK FACTORS AS WELL AS IMPROVING SELF-EFFICACY AND POST-CARDIAC REHABILITATION ADHERENCE TO HEALTHY LIFESTYLE BEHAVIOURS. METHOD AND DESIGN: THIS IS A PARALLEL ARM, MULTI-CENTRE, RANDOMISED CONTROLLED TRIAL THAT WILL ASSESS THE OUTCOMES OF POST- PHASE 2 CARDIAC REHABILITATION PATIENTS ASSIGNED TO A YOGA INTERVENTION IN COMPARISON TO A NO-TREATMENT WAIT-LIST CONTROL GROUP. PARTICIPANTS RANDOMISED TO THE YOGA GROUP WILL ENGAGE IN A 12 WEEK YOGA PROGRAM COMPRISING OF TWO GROUP BASED SESSIONS AND ONE SELF-ADMINISTERED HOME SESSION EACH WEEK. GROUP BASED SESSIONS WILL BE LED BY AN EXPERIENCED YOGA INSTRUCTOR. THIS WILL INVOLVE TEACHING BEGINNER STUDENTS A HATHA YOGA SEQUENCE THAT INCORPORATES ASANA (POSES AND POSTURES), PRANAYAMA (BREATHING CONTROL) AND MEDITATION. THE PRIMARY OUTCOMES OF THIS STUDY ARE NEGATIVE AFFECTIVE STATES OF ANXIETY, DEPRESSION AND STRESS ASSESSED USING THE DEPRESSION ANXIETY STRESS SCALE. SECONDARY OUTCOMES INCLUDE MEASURES OF QUALITY OF LIFE, AND CARDIOVASCULAR AND COGNITIVE FUNCTION. THE CARDIOVASCULAR OUTCOMES WILL INCLUDE BLOOD PRESSURE, HEART RATE, HEART RATE VARIABILITY, PULSE WAVE VELOCITY, CAROTID INTIMA MEDIA THICKNESS MEASUREMENTS, LIPID/GLUCOSE PROFILES AND C-REACTIVE PROTEIN ASSAYS. ASSESSMENTS WILL BE CONDUCTED PRIOR TO (WEEK 0), MID-WAY THROUGH (WEEK 6) AND FOLLOWING THE INTERVENTION PERIOD (WEEK 12) AS WELL AS AT A FOUR WEEK FOLLOW-UP (WEEK 16). DISCUSSION: THIS STUDY WILL DETERMINE THE EFFECT OF YOGA PRACTICE ON NEGATIVE AFFECTIVE STATES, CARDIOVASCULAR AND COGNITIVE FUNCTION IN POST-PHASE 2 CARDIAC REHABILITATION PATIENTS. THE FINDINGS MAY PROVIDE EVIDENCE TO INCORPORATE YOGA INTO STANDARDISED CARDIAC REHABILITATION PROGRAMS AS A PRACTICAL ADJUNCT TO IMPROVE THE MANAGEMENT OF PSYCHOSOCIAL SYMPTOMS ASSOCIATED WITH CARDIOVASCULAR EVENTS IN ADDITION TO IMPROVING PATIENTS' COGNITIVE AND CARDIOVASCULAR FUNCTIONS. TRIAL REGISTRATION: ACTRN12612000358842. 2014 17 1243 37 FEASIBILITY OF A YOGA, AEROBIC AND STRETCHING-TONING EXERCISE PROGRAM FOR ADULT CANCER SURVIVORS: THE STAYFIT TRIAL. BACKGROUND: THE USE OF YOGA AS A MIND-BODY PRACTICE HAS BECOME INCREASINGLY POPULAR AMONG CLINICAL POPULATIONS AND OLDER ADULTS WHO USE THIS PRACTICE TO MANAGE AGE AND CHRONIC DISEASE-RELATED SYMPTOMS. ALTHOUGH YOGA CONTINUES TO GAIN POPULARITY AMONG PRACTITIONERS AND RESEARCHERS, PILOT STUDIES THAT EXAMINE ITS FEASIBILITY AND ACCEPTABILITY, ESPECIALLY AMONG CANCER SURVIVORS, ARE LIMITED. FEASIBILITY STUDIES PLAY A CRITICAL ROLE IN DETERMINING WHETHER THE TARGET POPULATION IS LIKELY TO ENGAGE WITH LARGER SCALE EFFICACY AND EFFECTIVENESS TRIALS. IN THIS PAPER WE PRESENT FEASIBILITY AND ACCEPTABILITY DATA FROM A 12-WEEK RANDOMIZED CONTROLLED TRIAL (RCT) CONDUCTED WITH ADULT CANCER SURVIVORS. METHODS: PARTICIPANTS N = 78 (MEAN AGE: 55 YEARS) WERE RANDOMIZED TO ONE OF THREE GROUPS: A HATHA YOGA, AEROBIC EXERCISE, OR STRETCHING-TONING CONTROL GROUP WITH GROUP EXERCISE CLASSES HELD FOR 150 MIN/WEEK FOR 12 WEEKS. HEREIN WE REPORT FEASIBILITY AND ACCEPTABILITY, INCLUDING ENROLLMENT RATES, ATTENDANCE, ATTRITION AND ADVERSE EVENTS, AND PARTICIPANT FEEDBACK AND SATISFACTION DATA. RESULTS: OF THE 233 ADULTS SCREENED, 109 WERE ELIGIBLE AND 78 RANDOMIZED TO ONE OF THE THREE INTERVENTION ARMS. SESSION ATTENDANCE WAS HIGH FOR ALL GROUPS (75.5-89.5%) AND 17 PARTICIPANTS DROPPED OUT DURING THE 12-WEEK INTERVENTION. PROGRAM SATISFACTION WAS HIGH (4.8 OR HIGHER OUT OF 5) AND NO ADVERSE EVENTS WERE REPORTED. ONE COHORT (N = 15) OF THE INTERVENTION TRANSITIONED TO REMOTE INTERVENTION DELIVERY DUE TO THE COVID-19 PANDEMIC. FEASIBILITY DATA FROM THESE PARTICIPANTS SUGGESTED THAT SYNCHRONIZED GROUP EXERCISE CLASSES VIA ZOOM WITH A LIVE INSTRUCTOR WERE ACCEPTABLE AND ENJOYABLE. PARTICIPANT FEEDBACK REGARDING MOST AND LEAST HELPFUL ASPECTS OF THE PROGRAM AS WELL AS SUGGESTIONS FOR FUTURE YOGA INTERVENTIONS ARE SUMMARIZED. CONCLUSIONS: OVERALL, THE YOGA INTERVENTION WAS HIGHLY FEASIBLE AND ACCEPTABLE. THE FEASIBILITY PARAMETERS FROM THIS TRIAL CAN AID RESEARCHERS IN ESTIMATING RECRUITMENT RATES FOR DESIRED SAMPLE SIZES TO SUCCESSFULLY RANDOMIZE AND RETAIN CANCER SURVIVORS IN SHORT- AND LONG-TERM YOGA-BASED EFFICACY AND EFFECTIVENESS TRIALS. THE FINDINGS ALSO PROVIDE EVIDENCE TO CLINICIANS WHO CAN RECOMMEND UP TO 150 MIN OF A COMBINATION OF EXERCISES-AEROBIC, YOGA, OR STRETCHING-TONING TO THEIR CANCER PATIENTS IN ORDER TO IMPROVE HEALTH AND WELLBEING DURING CANCER SURVIVORSHIP. 2021 18 1165 62 EVALUATING THE FEASIBILITY AND IMPACT OF A YOGA INTERVENTION ON COGNITION, PHYSICAL FUNCTION, PHYSICAL ACTIVITY, AND AFFECTIVE OUTCOMES IN PEOPLE LIVING WITH HIV: PROTOCOL FOR A RANDOMIZED PILOT TRIAL. BACKGROUND: DESPITE LOWER MORTALITY RATES DUE TO COMBINATION ANTIRETROVIRAL THERAPY, PEOPLE LIVING WITH HIV (PLWH) ARE GRAPPLING WITH INCREASINGLY COMPLEX HEALTH ISSUES, INCLUDING COGNITIVE IMPAIRMENTS IN AREAS SUCH AS MEMORY, ATTENTION, PROCESSING SPEED, AND MOTOR FUNCTION. YOGA HAS BEEN SHOWN TO BE AN EFFECTIVE FORM OF EXERCISE AND MINDFULNESS-BASED STRESS REDUCTION FOR MANY CLINICAL POPULATIONS. HOWEVER, NO RANDOMIZED TRIALS HAVE EVALUATED THE IMPACT OF YOGA ON COGNITIVE AND PHYSICAL FUNCTION AMONG PLWH. OBJECTIVE: THE AIM OF THIS PILOT RANDOMIZED TRIAL WAS TO DETERMINE THE FEASIBILITY OF A YOGA INTERVENTION TO LAY THE GROUNDWORK FOR A FULL-SCALE, MULTISITE, COMMUNITY-BASED TRIAL FOR PLWH. SPECIFIC OBJECTIVES ARE TO (1) ASSESS THE FEASIBILITY OF STUDY PROTOCOL AND PROCEDURES, (2) COMPARE COGNITION IN THE YOGA GROUP WITH THE USUAL CARE CONTROL GROUP AFTER 12 WEEKS OF THE INTERVENTION IN PLWH, AND (3) COMPARE THE EFFECTS OF THE 12-WEEK YOGA INTERVENTION VERSUS CONTROL ON BALANCE, WALKING SPEED, PHYSICAL ACTIVITY, MENTAL HEALTH, MEDICATION ADHERENCE, AND QUALITY OF LIFE AMONG PLWH. METHODS: WE PROPOSE A PILOT RANDOMIZED TRIAL WITH 2 PARALLEL GROUPS (YOGA VERSUS CONTROL). WE WILL RECRUIT 25 PLWH (>35 YEARS) FROM COMMUNITY AND HEALTH ORGANIZATIONS IN HALIFAX, CANADA. AFTER BASELINE ASSESSMENT WITH BLINDED ASSESSORS, PARTICIPANTS WILL BE RANDOMLY ASSIGNED TO THE YOGA OR CONTROL GROUP, USING A RANDOM COMPUTER GENERATOR. PARTICIPANTS IN THE YOGA GROUP WILL ENGAGE IN SUPERVISED 60-MIN GROUP-BASED YOGA SESSIONS 3 TIMES A WEEK FOR 12 WEEKS AT A YOGA STUDIO. PARTICIPANTS IN THE CONTROL GROUP WILL MAINTAIN THEIR CURRENT PHYSICAL ACTIVITY LEVELS THROUGHOUT THE STUDY. RESULTS: AS PER THE CONSOLIDATED STANDARDS OF REPORTING TRIALS EXTENSION FOR PILOT STUDIES, MEANS OF ALL OUTCOMES, MEAN CHANGE, AND 95% CIS WILL BE CALCULATED FOR EACH GROUP SEPARATELY. TWO-TAILED INDEPENDENT T TESTS AND FISHER EXACT TESTS WILL BE USED TO COMPARE GROUPS AT BASELINE. WE WILL ANALYZE QUANTITATIVE POSTINTERVENTION QUESTIONNAIRE RESPONSES USING CHI-SQUARE TESTS, AND OPEN-ENDED RESPONSES WILL BE ANALYZED THEMATICALLY. INTENTION-TO-TREAT AND PER-PROTOCOL ANALYSES WILL BE USED TO ANALYZE SECONDARY VARIABLES. CHANGES IN OUTCOME VARIABLES WILL BE EXAMINED BETWEEN GROUPS AND WITHIN GROUPS. EFFECT SIZES WILL BE REPORTED FOR EACH OUTCOME. A PRIORI ADHERENCE AND SATISFACTION CRITERIA WILL BE MET IF PARTICIPANTS ATTEND >70% OF THE YOGA SESSIONS AND IF >70% OF THE PARTICIPANTS ARE SATISFIED WITH THE INTERVENTION AS DETERMINED BY A POSTPARTICIPATION QUESTIONNAIRE. STUDY ENROLLMENT BEGAN IN JANUARY 2018, WITH RESULTS EXPECTED FOR OCTOBER 2019. CONCLUSIONS: THIS PILOT RANDOMIZED TRIAL WILL BE THE FIRST TO INVESTIGATE THE FEASIBILITY AND EFFECT OF A YOGA INTERVENTION ON COGNITIVE AND PHYSICAL OUTCOMES AMONG PLWH. THIS WORK WILL INFORM THE FEASIBILITY OF FURTHER INVESTIGATIONS IN TERMS OF CAPACITY BUILDING, PARTICIPANT RECRUITMENT AND RETENTION, AND ASSESSMENT AND INTERVENTION PROTOCOLS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT03071562; HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT03071562 (ARCHIVED BY WEBCITE AT HTTP://WWW.WEBCITATION.ORG/785SFHWKW). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13818. 2019 19 1591 56 MEDITATION AND YOGA FOR IRRITABLE BOWEL SYNDROME: STUDY PROTOCOL FOR A RANDOMISED CLINICAL TRIAL (MY-IBS STUDY). INTRODUCTION: WHEN DELIVERED IN PERSON, YOGA HAS BEEN SHOWN TO BE EFFECTIVE IN MANAGING IRRITABLE BOWEL SYNDROME (IBS) SYMPTOMS. RESEARCH IS NEEDED TO TEST THE FEASIBILITY AND EFFECTIVENESS OF YOGA AS A THERAPEUTIC OPTION WHEN DELIVERED VIRTUALLY. THE PRIMARY AIM OF THE MIND AND YOGA FOR IBS RANDOMISED CONTROLLED TRIAL IS TO DETERMINE THE EFFECTS OF AN 8-WEEK VIRTUAL MEDITATION AND YOGA INTERVENTION ON IBS SYMPTOM SEVERITY COMPARED WITH AN ADVICE-ONLY ACTIVE CONTROL GROUP. METHODS AND ANALYSIS: ADULTS DIAGNOSED WITH IBS WILL BE RANDOMISED TO RECEIVE EITHER A UPA YOGA INTERVENTION OR AN ADVICE-ONLY CONTROL GROUP. THE INTERVENTION WILL CONSIST OF WEEKLY ONLINE CLASSES FOR 8 WEEKS DELIVERED BY A FACILITATOR USING MICROSOFT OFFICE TEAMS AND DAILY HOME PRACTICE. FEASIBILITY WILL BE EVALUATED BY EXAMINING RECRUITMENT AND ATTRITION RATES, ADHERENCE, PARTICIPANT SATISFACTION WITH THE PROGRAMME AND SAFETY. THE PRIMARY OUTCOME IS IBS SYMPTOM SEVERITY, AND KEY SECONDARY OUTCOMES INCLUDE (BUT NOT LIMITED TO) QUALITY OF LIFE, ANXIETY AND DEPRESSION SYMPTOMS, COVID-19-RELATED STRESS AND ANXIETY, AND FATIGUE. OUTCOMES WILL BE ASSESSED AT BASELINE, 4 WEEKS AND 8 WEEKS. AN EMBEDDED DESIGN EXPERIMENTAL MODEL SUBSTUDY WILL BE CONDUCTED POST INTERVENTION USING QUALITATIVE RESEARCH METHODS TO IDENTIFY PARTICIPANTS' EXPERIENCES IN THE YOGA PROGRAMME. ETHICS AND DISSEMINATION: THIS STUDY HAS BEEN APPROVED BY THE CONJOINT HEALTH RESEARCH ETHICS BOARD (REB ID 20-0084). FINDINGS WILL BE DISSEMINATED THROUGH PEER-REVIEWED PUBLICATION, CONFERENCE PRESENTATION AND SOCIAL MEDIA. TRIAL REGISTRATION NUMBER: NCT04302623. 2022 20 2609 47 YOGA FOR QUALITY OF LIFE IN INDIVIDUALS WITH CHRONIC DISEASE: A SYSTEMATIC REVIEW. BACKGROUND: CHRONIC DISEASES, INCLUDING HEART DISEASE, STROKE, CANCER, AND CHRONIC PULMONARY DISEASE ARE THE LEADING CAUSES OF DEATH AND DISABILITY WORLDWIDE. COMPOUNDING SYMPTOMS AND LOSS OF FUNCTION, PEOPLE LIVING WITH CHRONIC DISEASE OFTEN EXPERIENCE REDUCED QUALITY OF LIFE (QOL). VARIOUS PHYSICAL AND MENTAL PRACTICES HAVE BEEN SHOWN TO RELIEVE STRESS AND IMPROVE QOL. YOGA IS A PHYSICAL AND MENTAL PRACTICE THAT MAY BE A VIABLE APPROACH FOR IMPROVING QOL IN PEOPLE WITH CHRONIC DISEASE. OBJECTIVE: THE OBJECTIVE OF THIS STUDY WAS TO EXAMINE AND SUMMARIZE THE EVIDENCE FOR THE EFFECTIVENESS OF YOGA ON QOL IN PATIENTS WITH CHRONIC DISEASE. DESIGN: THE STUDY DESIGN WAS A A SYSTEMATIC REVIEW WITH QUALITATIVE SYNTHESIS. METHODS: WE INCLUDED RANDOMIZED CONTROLLED TRIALS THAT EVALUATED THE EFFECT OF YOGA ON QOL OR HEALTH-RELATED QOL (HRQOL) FOR INDIVIDUALS WITH CHRONIC DISEASE. WE INCLUDED ONLY STUDIES THAT USED AT LEAST 1 PREVIOUSLY VALIDATED MEASURE OF QOL OR HRQOL AND SPECIFIED A MINIMUM DURATION OF FOLLOW-UP OF AT LEAST 1 WK. INTERVENTIONS: WE INCLUDED BOTH MOVEMENT-BASED AND BREATH-BASED YOGA PRACTICES. STUDIES THAT INCLUDED YOGA AS PART OF A LARGER INTERVENTION PROGRAM (EG, MINDFULNESS-BASED STRESS REDUCTION TRAINING) OR STUDIES THAT DID NOT PROVIDE FINDINGS SPECIFIC TO YOGA WERE EXCLUDED. PRIMARY OUTCOME MEASURES: THE PRIMARY OUTCOME ANALYZED WAS IMPROVEMENT IN QOL AS MEASURED BY A VALIDATED QOL OR HRQOL SCALE. RESULTS: AMONG THE 1488 STUDIES THAT WERE IDENTIFIED ON INITIAL SEARCH, 7 ARTICLES MET ALL INCLUSION CRITERIA. FIVE STUDIES REPORTED A STATISTICALLY SIGNIFICANT ADVANTAGE OVER USUAL CARE ALONE FOR IMPROVEMENT OF QOL IN PATIENTS WITH CHRONIC DISEASE, BUT THE CLINICAL SIGNIFICANCE OF THE DIFFERENCES WAS CLEAR IN ONLY 1 TRIAL. WE FOUND CONSIDERABLE HETEROGENEITY AMONG THE INCLUDED STUDIES AND STUDY QUALITY WAS GENERALLY LOW. CONCLUSIONS: MORE HIGH-QUALITY RESEARCH IS NEEDED TO DETERMINE THE VALUE OF YOGA AS AN ADJUNCTIVE APPROACH TO IMPROVING QOL IN PATIENTS WITH CHRONIC DISEASE. 2019