1 2843 130 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 2 2861 55 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 3 536 45 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 4 1093 50 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 5 2117 36 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 6 1161 37 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 7 2194 46 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 8 175 39 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 9 2598 39 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 10 1617 43 MINDFUL YOGA FOR WOMEN WITH METASTATIC BREAST CANCER: DESIGN OF A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: WOMEN WITH METASTATIC BREAST CANCER (MBC) HAVE AVERAGE LIFE EXPECTANCIES OF ABOUT 2 YEARS, AND REPORT HIGH LEVELS OF DISEASE-RELATED SYMPTOMS INCLUDING PAIN, FATIGUE, SLEEP DISTURBANCE, PSYCHOLOGICAL DISTRESS, AND FUNCTIONAL IMPAIRMENT. THERE IS GROWING RECOGNITION OF THE LIMITATIONS OF MEDICAL APPROACHES TO MANAGING SUCH SYMPTOMS. YOGA IS A MIND-BODY DISCIPLINE THAT HAS DEMONSTRATED A POSITIVE IMPACT ON PSYCHOLOGICAL AND FUNCTIONAL HEALTH IN EARLY STAGE BREAST CANCER PATIENTS AND SURVIVORS, BUT HAS NOT BEEN RIGOROUSLY STUDIED IN ADVANCED CANCER SAMPLES. METHODS: THIS RANDOMIZED CONTROLLED TRIAL EXAMINES THE FEASIBILITY AND INITIAL EFFICACY OF A MINDFUL YOGA PROGRAM, COMPARED WITH A SOCIAL SUPPORT CONDITION THAT CONTROLS FOR ATTENTION, ON MEASURES OF DISEASE-RELATED SYMPTOMS SUCH AS PAIN AND FATIGUE. THE STUDY WILL BE COMPLETED BY DECEMBER 2017. SIXTY-FIVE WOMEN WITH MBC AGE >/= 18 ARE BEING IDENTIFIED AND RANDOMIZED WITH A 2:1 ALLOCATION TO MINDFUL YOGA OR A SUPPORT GROUP CONTROL INTERVENTION. THE 120-MIN INTERVENTION SESSIONS TAKE PLACE WEEKLY FOR 8 WEEKS. THE STUDY IS CONDUCTED AT AN URBAN TERTIARY CARE ACADEMIC MEDICAL CENTER LOCATED IN DURHAM, NORTH CAROLINA. THE PRIMARY FEASIBILITY OUTCOME IS ATTENDANCE AT INTERVENTION SESSIONS. EFFICACY OUTCOMES INCLUDE PAIN, FATIGUE, SLEEP QUALITY, PSYCHOLOGICAL DISTRESS, MINDFULNESS AND FUNCTIONAL CAPACITY AT POST-INTERVENTION, 3-MONTH FOLLOW-UP, AND 6-MONTH FOLLOW-UP. DISCUSSION: IN THIS ARTICLE, WE PRESENT THE CHALLENGES OF DESIGNING A RANDOMIZED CONTROLLED TRIAL WITH LONG-TERM FOLLOW-UP AMONG WOMEN WITH MBC. THESE CHALLENGES INCLUDE ENSURING ADEQUATE RECRUITMENT INCLUDING OF MINORITIES, LIMITING AND CONTROLLING FOR SELECTION BIAS, TAILORING OF THE YOGA INTERVENTION TO ADDRESS SPECIAL NEEDS, AND MAXIMIZING ADHERENCE AND RETENTION. THIS PROJECT WILL PROVIDE IMPORTANT INFORMATION REGARDING YOGA AS AN INTERVENTION FOR WOMEN WITH ADVANCED CANCER, INCLUDING PRELIMINARY DATA ON THE PSYCHOLOGICAL AND FUNCTIONAL EFFECTS OF YOGA FOR MBC PATIENTS. THIS INVESTIGATION WILL ALSO ESTABLISH RIGOROUS METHODS FOR FUTURE RESEARCH INTO YOGA AS AN INTERVENTION FOR THIS POPULATION. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFER: NCT01927081 , REGISTERED AUGUST 16, 2013. 2017 11 1165 48 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 12 2824 51 YOGA VERSUS EDUCATION FOR VETERANS WITH CHRONIC LOW BACK PAIN: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN IS THE MOST FREQUENT PAIN CONDITION IN VETERANS AND CAUSES SUBSTANTIAL SUFFERING, DECREASED FUNCTIONAL CAPACITY, AND LOWER QUALITY OF LIFE. SYMPTOMS OF POST-TRAUMATIC STRESS, DEPRESSION, AND MILD TRAUMATIC BRAIN INJURY ARE HIGHLY PREVALENT IN VETERANS WITH BACK PAIN. YOGA FOR LOW BACK PAIN HAS BEEN DEMONSTRATED TO BE EFFECTIVE FOR CIVILIANS IN RANDOMIZED CONTROLLED TRIALS. HOWEVER, IT IS UNKNOWN IF RESULTS FROM PREVIOUSLY PUBLISHED TRIALS GENERALIZE TO MILITARY POPULATIONS. METHODS/DESIGN: THIS STUDY IS A PARALLEL RANDOMIZED CONTROLLED TRIAL COMPARING YOGA TO EDUCATION FOR 120 VETERANS WITH CHRONIC LOW BACK PAIN. PARTICIPANTS ARE VETERANS >/=18 YEARS OLD WITH LOW BACK PAIN PRESENT ON AT LEAST HALF THE DAYS IN THE PAST SIX MONTHS AND A SELF-REPORTED AVERAGE PAIN INTENSITY IN THE PREVIOUS WEEK OF >/=4 ON A 0-10 SCALE. THE 24-WEEK STUDY HAS AN INITIAL 12-WEEK INTERVENTION PERIOD, WHERE PARTICIPANTS ARE RANDOMIZED EQUALLY INTO (1) A STANDARDIZED WEEKLY GROUP YOGA CLASS WITH HOME PRACTICE OR (2) EDUCATION DELIVERED WITH A SELF-CARE BOOK. PRIMARY OUTCOME MEASURES ARE CHANGE AT 12 WEEKS IN LOW BACK PAIN INTENSITY MEASURED BY THE DEFENSE AND VETERANS PAIN RATING SCALE (0-10) AND BACK-RELATED FUNCTION USING THE 23-POINT ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 12-WEEK FOLLOW-UP PERIOD, YOGA PARTICIPANTS ARE ENCOURAGED TO CONTINUE HOME YOGA PRACTICE AND EDUCATION PARTICIPANTS CONTINUE FOLLOWING RECOMMENDATIONS FROM THE BOOK. QUALITATIVE INTERVIEWS WITH VETERANS IN THE YOGA GROUP AND THEIR PARTNERS EXPLORE THE IMPACT OF CHRONIC LOW BACK PAIN AND YOGA ON FAMILY RELATIONSHIPS. WE ALSO ASSESS COST-EFFECTIVENESS FROM THREE PERSPECTIVES: THE VETERAN, THE VETERANS HEALTH ADMINISTRATION, AND SOCIETY USING ELECTRONIC MEDICAL RECORDS, SELF-REPORTED COST DATA, AND STUDY RECORDS. DISCUSSION: THIS STUDY WILL HELP DETERMINE IF YOGA CAN BECOME AN EFFECTIVE TREATMENT FOR VETERANS WITH CHRONIC LOW BACK PAIN AND PSYCHOLOGICAL COMORBIDITIES. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT02224183. 2016 13 888 51 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 14 132 38 A PRAGMATIC MULTICENTERED RANDOMIZED CONTROLLED TRIAL OF YOGA FOR CHRONIC LOW BACK PAIN: ECONOMIC EVALUATION. STUDY DESIGN: MULTICENTERED RANDOMIZED CONTROLLED TRIAL WITH QUALITY OF LIFE AND RESOURCE USE DATA COLLECTED. OBJECTIVE: THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE COST-EFFECTIVENESS OF YOGA INTERVENTION PLUS USUAL CARE COMPARED WITH USUAL CARE ALONE FOR CHRONIC OR RECURRENT LOW BACK PAIN. SUMMARY OF BACKGROUND DATA: YOGA HAS BEEN SHOWN AS AN EFFECTIVE INTERVENTION FOR TREATING CHRONIC OR RECURRENT LOW BACK PAIN. HOWEVER, THERE IS LITTLE EVIDENCE ON ITS COST-EFFECTIVENESS. THE DATA ARE EXTRACTED FROM A PRAGMATIC, MULTICENTERED, RANDOMIZED CONTROLLED TRIAL THAT HAS BEEN CONDUCTED TO EVALUATE THE EFFECTIVENESS AND COST-EFFECTIVENESS OF A 12-WEEK PROGRESSIVE PROGRAM OF YOGA PLUS USUAL CARE IN PATIENTS WITH CHRONIC OR RECURRENT LOW BACK PAIN. METHODS: WITH THIS TRIAL DATA, A COST-EFFECTIVENESS ANALYSIS DURING THE TIME PERIOD OF 12 MONTHS FROM BOTH PERSPECTIVES OF THE UK NATIONAL HEALTH SERVICE AND THE SOCIETAL IS PRESENTED. MAIN OUTCOME MEASURE IS AN INCREMENTAL COST PER QUALITY-ADJUSTED LIFE-YEAR (QALY). RESULTS: FROM THE PERSPECTIVE OF THE U.K. NATIONAL HEALTH SERVICE, YOGA INTERVENTION YIELDS AN INCREMENTAL COST-EFFECTIVENESS RATIO OF POUND13,606 PER QALY. GIVEN A WILLINGNESS TO PAY FOR AN ADDITIONAL QALY OF POUND20,000, THE PROBABILITY OF YOGA INTERVENTION BEING COST-EFFECTIVE IS 72%. FROM THE PERSPECTIVE OF THE SOCIETY, YOGA INTERVENTION IS A DOMINANT TREATMENT COMPARED WITH USUAL CARE ALONE. THIS RESULT IS SURROUNDED BY FEWER UNCERTAINTIES-THE PROBABILITY OF YOGA BEING COST-EFFECTIVE REACHES 95% AT A WILLINGNESS TO PAY FOR AN ADDITIONAL QALY OF POUND20,000. SENSITIVE ANALYSES SUGGEST THE SAME RESULTS THAT YOGA INTERVENTION IS LIKELY TO BE COST-EFFECTIVE IN BOTH PERSPECTIVES. CONCLUSION: ON THE BASIS OF THIS TRIAL, 12 WEEKLY GROUP CLASSES OF SPECIALIZED YOGA ARE LIKELY TO BE A COST-EFFECTIVE INTERVENTION FOR TREATING PATIENTS WITH CHRONIC OR RECURRENT LOW BACK PAIN. 2012 15 1953 44 SECONDARY OUTCOMES FROM A RANDOMIZED CONTROLLED TRIAL OF YOGA FOR VETERANS WITH CHRONIC LOW-BACK PAIN. CHRONIC LOW-BACK PAIN (CLBP) IS A PREVALENT CONDITION, AND RATES ARE HIGHER AMONG MILITARY VETERANS. CLBP IS A PERSISTENT CONDITION, AND TREATMENT OPTIONS HAVE EITHER MODEST EFFECTS OR A SIGNIFICANT RISK OF SIDE-EFFECTS, WHICH HAS LED TO RECENT EFFORTS TO EXPLORE MIND-BODY INTERVENTION OPTIONS AND REDUCE OPIOID MEDICATION USE. PRIOR STUDIES OF YOGA FOR CLBP IN COMMUNITY SAMPLES, AND THE MAIN RESULTS OF A RECENT TRIAL WITH MILITARY VETERANS, INDICATE THAT YOGA CAN REDUCE BACK-RELATED DISABILITY AND PAIN INTENSITY. SECONDARY OUTCOMES FROM THE TRIAL OF YOGA WITH MILITARY VETERANS ARE PRESENTED HERE. IN THE STUDY, 150 MILITARY VETERANS (VETERANS ADMINISTRATION PATIENTS) WITH CLBP WERE RANDOMIZED TO EITHER YOGA OR A DELAYED-TREATMENT GROUP RECEIVING USUAL CARE BETWEEN 2013 AND 2015. ASSESSMENTS OCCURRED AT BASELINE, 6 WEEKS, 12 WEEKS, AND 6 MONTHS. INTENT-TO-TREAT ANALYSES WERE CONDUCTED. YOGA CLASSES LASTING 60 MINUTES EACH WERE OFFERED TWICE WEEKLY FOR 12 WEEKS. YOGA SESSIONS CONSISTED OF PHYSICAL POSTURES, MOVEMENT, FOCUSED ATTENTION, AND BREATHING TECHNIQUES. HOME PRACTICE GUIDED BY A MANUAL WAS STRONGLY RECOMMENDED. THE PRIMARY OUTCOME MEASURE WAS ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES AFTER 12 WEEKS. SECONDARY OUTCOMES INCLUDED PAIN INTENSITY, PAIN INTERFERENCE, DEPRESSION, FATIGUE, QUALITY OF LIFE, SELF-EFFICACY, AND MEDICATION USAGE. YOGA PARTICIPANTS IMPROVED MORE THAN DELAYED-TREATMENT PARTICIPANTS ON PAIN INTERFERENCE, FATIGUE, QUALITY OF LIFE, AND SELF-EFFICACY AT 12 WEEKS AND/OR 6 MONTHS. YOGA PARTICIPANTS HAD GREATER IMPROVEMENTS ACROSS A NUMBER OF IMPORTANT SECONDARY HEALTH OUTCOMES COMPARED TO CONTROLS. BENEFITS EMERGED DESPITE SOME VETERANS FACING CHALLENGES WITH ATTENDING YOGA SESSIONS IN PERSON. THE FINDINGS SUPPORT WIDER IMPLEMENTATION OF YOGA PROGRAMS FOR VETERANS, WITH ATTENTION TO INCREASING ACCESSIBILITY OF YOGA PROGRAMS IN THIS POPULATION. 2020 16 2628 30 YOGA FOR THE MANAGEMENT OF PAIN AND SLEEP IN RHEUMATOID ARTHRITIS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: THE AIM OF THE PRESENT STUDY WAS TO DETERMINE THE FEASIBILITY OF A RELAXATION-BASED YOGA INTERVENTION FOR RHEUMATOID ARTHRITIS, DESIGNED AND REPORTED IN ACCORDANCE WITH DELPHI RECOMMENDATIONS FOR YOGA INTERVENTIONS FOR MUSCULOSKELETAL CONDITIONS. METHODS: PARTICIPANTS WERE RECRUITED FROM A HOSPITAL DATABASE, AND RANDOMIZED TO EITHER EIGHT WEEKLY 75-MIN YOGA CLASSES OR A USUAL CARE CONTROL. FEASIBILITY WAS DETERMINED BY RECRUITMENT RATES, RETENTION, PROTOCOL ADHERENCE, PARTICIPANT SATISFACTION AND ADVERSE EVENTS. SECONDARY PHYSICAL AND PSYCHOSOCIAL OUTCOMES WERE ASSESSED USING SELF-REPORTED QUESTIONNAIRES AT BASELINE (WEEK 0), WEEK 9 (PRIMARY TIME POINT) AND WEEK 12 (FOLLOW-UP). RESULTS: OVER A 3-MONTH PERIOD, 26 PARTICIPANTS WITH MILD PAIN, MILD TO MODERATE FUNCTIONAL DISABILITY AND MODERATE DISEASE ACTIVITY WERE RECRUITED INTO THE STUDY (25% RECRUITMENT RATE). RETENTION RATES WERE 100% FOR YOGA PARTICIPANTS AND 92% FOR USUAL CARE PARTICIPANTS AT BOTH WEEKS 9 AND 12. PROTOCOL ADHERENCE AND PARTICIPANT SATISFACTION WERE HIGH. YOGA PARTICIPANTS ATTENDED A MEDIAN OF SEVEN CLASSES; ADDITIONALLY, SEVEN OF THE YOGA PARTICIPANTS (54%) REPORTED CONTINUING YOGA AT HOME DURING THE FOLLOW-UP PERIOD. NO SERIOUS ADVERSE EVENTS WERE RELATED TO THE STUDY. SECONDARY OUTCOMES SHOWED NO GROUP EFFECTS OF YOGA COMPARED WITH USUAL CARE. CONCLUSIONS: A RELAXATION-BASED YOGA PROGRAMME WAS FOUND TO BE FEASIBLE AND SAFE FOR PARTICIPANTS WITH RHEUMATOID ARTHRITIS-RELATED PAIN AND FUNCTIONAL DISABILITY. ADVERSE EVENTS WERE MINOR, AND NOT UNEXPECTED FROM AN INTERVENTION INCLUDING PHYSICAL COMPONENTS. THIS PILOT PROVIDES A FRAMEWORK FOR LARGER INTERVENTION STUDIES, AND SUPPORTS FURTHER EXPLORATION OF YOGA AS A COMPLEX INTERVENTION TO ASSIST WITH THE MANAGEMENT OF RHEUMATOID ARTHRITIS. 2018 17 2609 36 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 18 2577 37 YOGA FOR GENERALIZED ANXIETY DISORDER: DESIGN OF A RANDOMIZED CONTROLLED CLINICAL TRIAL. GENERALIZED ANXIETY DISORDER (GAD) IS A COMMON DISORDER ASSOCIATED WITH SIGNIFICANT DISTRESS AND INTERFERENCE. ALTHOUGH COGNITIVE BEHAVIORAL THERAPY (CBT) HAS BEEN SHOWN TO BE THE MOST EFFECTIVE FORM OF PSYCHOTHERAPY, FEW PATIENTS RECEIVE OR HAVE ACCESS TO THIS INTERVENTION. YOGA THERAPY OFFERS ANOTHER PROMISING, YET UNDER-RESEARCHED, INTERVENTION THAT IS GAINING INCREASING POPULARITY IN THE GENERAL PUBLIC, AS AN ANXIETY REDUCTION INTERVENTION. THE PURPOSE OF THIS INNOVATIVE CLINICAL TRIAL PROTOCOL IS TO INVESTIGATE THE EFFICACY OF A KUNDALINI YOGA INTERVENTION, RELATIVE TO CBT AND A CONTROL CONDITION. KUNDALINI YOGA AND CBT ARE COMPARED WITH EACH OTHER IN A NONINFERIORITY TEST AND BOTH TREATMENTS ARE COMPARED TO STRESS EDUCATION TRAINING, AN ATTENTION CONTROL INTERVENTION, IN SUPERIORITY TESTS. THE SAMPLE WILL CONSIST OF 230 INDIVIDUALS WITH A PRIMARY DSM-5 DIAGNOSIS OF GAD. THIS RANDOMIZED CONTROLLED TRIAL WILL COMPARE YOGA (N=95) TO BOTH CBT FOR GAD (N=95) AND STRESS EDUCATION (N=40), A COMMONLY USED CONTROL CONDITION. ALL THREE TREATMENTS WILL BE ADMINISTERED BY TWO INSTRUCTORS IN A GROUP FORMAT OVER 12 WEEKLY SESSIONS WITH FOUR TO SIX PATIENTS PER GROUP. GROUPS WILL BE RANDOMIZED USING PERMUTED BLOCK RANDOMIZATION, WHICH WILL BE STRATIFIED BY SITE. TREATMENT OUTCOME WILL BE EVALUATED BI-WEEKLY AND AT 6MONTH FOLLOW-UP. FURTHERMORE, POTENTIAL MEDIATORS OF TREATMENT OUTCOME WILL BE INVESTIGATED. GIVEN THE INDIVIDUAL AND ECONOMIC BURDEN ASSOCIATED WITH GAD, IDENTIFYING ACCESSIBLE ALTERNATIVE BEHAVIORAL TREATMENTS WILL HAVE SUBSTANTIVE PUBLIC HEALTH IMPLICATIONS. 2015 19 2638 40 YOGA FOR VETERANS WITH CHRONIC LOW BACK PAIN: DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL. CHRONIC LOW BACK PAIN (CLBP) AFFLICTS MILLIONS OF PEOPLE WORLDWIDE, WITH PARTICULARLY HIGH PREVALENCE IN MILITARY VETERANS. MANY TREATMENT OPTIONS EXIST FOR CLBP, BUT MOST HAVE LIMITED EFFECTIVENESS AND SOME HAVE SIGNIFICANT SIDE EFFECTS. IN GENERAL POPULATIONS WITH CLBP, YOGA HAS BEEN SHOWN TO IMPROVE HEALTH OUTCOMES WITH FEW SIDE EFFECTS. HOWEVER, YOGA HAS NOT BEEN ADEQUATELY STUDIED IN MILITARY VETERAN POPULATIONS. IN THE CURRENT PAPER WE WILL DESCRIBE THE DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL AIMED AT EXAMINING WHETHER YOGA CAN EFFECTIVELY REDUCE DISABILITY AND PAIN IN US MILITARY VETERANS WITH CLBP. A TOTAL OF 144 US MILITARY VETERANS WITH CLBP WILL BE RANDOMIZED TO EITHER YOGA OR A DELAYED TREATMENT COMPARISON GROUP. THE YOGA INTERVENTION WILL CONSIST OF 2X WEEKLY YOGA CLASSES FOR 12WEEKS, COMPLEMENTED BY REGULAR HOME PRACTICE GUIDED BY A MANUAL. THE DELAYED TREATMENT GROUP WILL RECEIVE THE SAME INTERVENTION AFTER SIX MONTHS. THE PRIMARY OUTCOME IS THE CHANGE IN BACK PAIN-RELATED DISABILITY MEASURED WITH THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE AT BASELINE AND 12-WEEKS. SECONDARY OUTCOMES INCLUDE PAIN INTENSITY, PAIN INTERFERENCE, DEPRESSION, ANXIETY, FATIGUE/ENERGY, QUALITY OF LIFE, SELF-EFFICACY, SLEEP QUALITY, AND MEDICATION USAGE. ADDITIONAL PROCESS AND/OR MEDIATIONAL FACTORS WILL BE MEASURED TO EXAMINE DOSE RESPONSE AND EFFECT MECHANISMS. ASSESSMENTS WILL BE CONDUCTED AT BASELINE, 6-WEEKS, 12-WEEKS, AND 6-MONTHS. ALL RANDOMIZED PARTICIPANTS WILL BE INCLUDED IN INTENTION-TO-TREAT ANALYSES. STUDY RESULTS WILL PROVIDE MUCH NEEDED EVIDENCE ON THE FEASIBILITY AND EFFECTIVENESS OF YOGA AS A THERAPEUTIC MODALITY FOR THE TREATMENT OF CLBP IN US MILITARY VETERANS. 2016 20 1243 33 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