1 614 158 DEVELOPMENT OF A YOGA-BASED CARDIAC REHABILITATION (YOGA-CARE) PROGRAMME FOR SECONDARY PREVENTION OF MYOCARDIAL INFARCTION. CARDIAC REHABILITATION (CR) AFTER MYOCARDIAL INFARCTION IS HIGHLY EFFECTIVE. IT IS UNAVAILABLE IN PUBLIC HOSPITALS IN INDIA DUE TO LIMITED RESOURCES. OUR OBJECTIVE WAS TO DEVELOP A SCALABLE MODEL OF CR FOR INDIA BASED ON YOGA, WHICH COULD ALSO APPEAL TO SOME GROUPS WITH LOW UPTAKE OF CR (E.G., ETHNIC MINORITIES, WOMEN, AND OLDER PEOPLE) GLOBALLY. THE INTERVENTION WAS DEVELOPED USING A STRUCTURED PROCESS. A LITERATURE REVIEW AND CONSULTATIONS WITH YOGA EXPERTS, CR EXPERTS, AND POSTMYOCARDIAL INFARCTION PATIENTS WERE CONDUCTED TO SYSTEMATICALLY IDENTIFY AND SHORTLIST APPROPRIATE YOGA EXERCISES AND POSTURES, BREATHING EXERCISES, MEDITATION AND RELAXATION PRACTICES, AND LIFESTYLE CHANGES, WHICH WERE INCORPORATED INTO A CONVENTIONAL CR FRAMEWORK. THE DRAFT INTERVENTION WAS FURTHER REFINED BASED ON THE FEEDBACK FROM AN INTERNAL STAKEHOLDER GROUP AND AN EXTERNAL PANEL OF INTERNATIONAL EXPERTS, BEFORE BEING PILOTED WITH YOGA INSTRUCTORS AND PATIENTS WITH MYOCARDIAL INFARCTION. A FOUR-PHASE YOGA-BASED CR (YOGA-CARE) PROGRAMME WAS DEVELOPED FOR DELIVERY BY A SINGLE YOGA INSTRUCTOR WITH BASIC TRAINING. THE PROGRAMME CONSISTS OF A TOTAL OF 13 INSTRUCTOR-LED SESSIONS (2 INDIVIDUAL AND 11 GROUP) OVER A 3-MONTH PERIOD. GROUP SESSIONS INCLUDE GUIDED PRACTICE OF YOGA EXERCISES AND POSTURES, BREATHING EXERCISES, AND MEDITATION AND RELAXATION PRACTICES, AND SUPPORT FOR THE LIFESTYLE CHANGE AND COPING THROUGH A MODERATED DISCUSSION. PATIENTS ARE ENCOURAGED TO SELF-PRACTICE DAILY AT HOME AND CONTINUE LONG-TERM WITH THE HELP OF A BOOKLET AND DIGITAL VIDEO DISC (DVD). FAMILY MEMBERS/CARERS ARE ENCOURAGED TO JOIN THROUGHOUT. IN CONCLUSION, A NOVEL YOGA-BASED CR PROGRAMME HAS BEEN DEVELOPED, WHICH PROMISES TO PROVIDE A SCALABLE CR SOLUTION FOR INDIA AND AN ALTERNATIVE CHOICE FOR CR GLOBALLY. IT IS CURRENTLY BEING EVALUATED IN A LARGE MULTICENTRE RANDOMISED CONTROLLED TRIAL ACROSS INDIA. 2019 2 2857 50 YOGA-BASED CARDIAC REHABILITATION AFTER ACUTE MYOCARDIAL INFARCTION: A RANDOMIZED TRIAL. BACKGROUND: GIVEN THE SHORTAGE OF CARDIAC REHABILITATION (CR) PROGRAMS IN INDIA AND POOR UPTAKE WORLDWIDE, THERE IS AN URGENT NEED TO FIND ALTERNATIVE MODELS OF CR THAT ARE INEXPENSIVE AND MAY OFFER CHOICE TO SUBGROUPS WITH POOR UPTAKE (E.G., WOMEN AND ELDERLY). OBJECTIVES: THIS STUDY SOUGHT TO EVALUATE THE EFFECTS OF YOGA-BASED CR (YOGA-CARE) ON MAJOR CARDIOVASCULAR EVENTS AND SELF-RATED HEALTH IN A MULTICENTER RANDOMIZED CONTROLLED TRIAL. METHODS: THE TRIAL WAS CONDUCTED IN 24 MEDICAL CENTERS ACROSS INDIA. THIS STUDY RECRUITED 3,959 PATIENTS WITH ACUTE MYOCARDIAL INFARCTION WITH A MEDIAN AND MINIMUM FOLLOW-UP OF 22 AND 6 MONTHS. PATIENTS WERE INDIVIDUALLY RANDOMIZED TO RECEIVE EITHER A YOGA-CARE PROGRAM (N = 1,970) OR ENHANCED STANDARD CARE INVOLVING EDUCATIONAL ADVICE (N = 1,989). THE CO-PRIMARY OUTCOMES WERE: 1) FIRST OCCURRENCE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) (COMPOSITE OF ALL-CAUSE MORTALITY, MYOCARDIAL INFARCTION, STROKE, OR EMERGENCY CARDIOVASCULAR HOSPITALIZATION); AND 2) SELF-RATED HEALTH ON THE EUROPEAN QUALITY OF LIFE-5 DIMENSIONS-5 LEVEL VISUAL ANALOGUE SCALE AT 12 WEEKS. RESULTS: MACE OCCURRED IN 131 (6.7%) PATIENTS IN THE YOGA-CARE GROUP AND 146 (7.4%) PATIENTS IN THE ENHANCED STANDARD CARE GROUP (HAZARD RATIO WITH YOGA-CARE: 0.90; 95% CONFIDENCE INTERVAL [CI]: 0.71 TO 1.15; P = 0.41). SELF-RATED HEALTH WAS 77 IN YOGA-CARE AND 75.7 IN THE ENHANCED STANDARD CARE GROUP (BASELINE-ADJUSTED MEAN DIFFERENCE IN FAVOR OF YOGA-CARE: 1.5; 95% CI: 0.5 TO 2.5; P = 0.002). THE YOGA-CARE GROUP HAD GREATER RETURN TO PRE-INFARCT ACTIVITIES, BUT THERE WAS NO DIFFERENCE IN TOBACCO CESSATION OR MEDICATION ADHERENCE BETWEEN THE TREATMENT GROUPS (SECONDARY OUTCOMES). CONCLUSIONS: YOGA-CARE IMPROVED SELF-RATED HEALTH AND RETURN TO PRE-INFARCT ACTIVITIES AFTER ACUTE MYOCARDIAL INFARCTION, BUT THE TRIAL LACKED STATISTICAL POWER TO SHOW A DIFFERENCE IN MACE. YOGA-CARE MAY BE AN OPTION WHEN CONVENTIONAL CR IS UNAVAILABLE OR UNACCEPTABLE TO INDIVIDUALS. (A STUDY ON EFFECTIVENESS OF YOGA BASED CARDIAC REHABILITATION PROGRAMME IN INDIA AND UNITED KINGDOM; CTRI/2012/02/002408). 2020 3 1293 34 GROUP-BASED YOGIC WEIGHT LOSS WITH AYURVEDA-INSPIRED COMPONENTS: A PILOT INVESTIGATION OF FEMALE YOGA PRACTITIONERS AND NOVICES. INTRODUCTION: OVERWEIGHT/OBESITY IS A PRESSING INTERNATIONAL HEALTH CONCERN AND CONVENTIONAL TREATMENTS DEMONSTRATE POOR LONG-TERM EFFICACY. PRELIMINARY EVIDENCE SUGGESTS YOGA AND AYURVEDA MAY BE PROMISING APPROACHES, ALTHOUGH RECENT NHIS ESTIMATES INDICATE RARE UTILIZATION OF AYURVEDA IN THE US. GROUP-BASED CURRICULA THAT INTEGRATE YOGA AND AYURVEDA-INSPIRED PRINCIPLES TO ATTENUATE OVERWEIGHT AND OBESITY ACROSS INDIVIDUALS MAY PROVE A FEASIBLE, DISSEMINABLE CLINICAL ADJUNCT TO FACILITATE PSYCHOSOCIAL HEALTH AND WEIGHT LOSS AND/OR MAINTENANCE. AIMS: DETERMINE FEASIBILITY AND PRELIMINARY EFFECTIVENESS OF A TEN-WEEK YOGA - BASED, AYURVEDA-INSPIRED WEIGHT MANAGEMENT CURRICULUM (YWL) PILOTED IN FEMALE YOGA PRACTITIONERS (STUDY 1) THEN REFINED AND TAILORED FOR YOGA NAIVES (STUDY 2), ON SELF-REPORTED PSYCHOSOCIAL PROCESS VARIABLES AND % OF SELF-REPORTED TOTAL BODY WEIGHT LOSS (%TBWL). METHODOLOGY: STUDY 1 ENROLLED 22 YOGA-EXPERIENCED WOMEN (48.2 +/- 14.3 YEARS, BMI 30.8 +/- 4.2 KG/M2) IN A 10-WEEK YOGA-BASED PROGRAM (YWL-YE). STUDY 2 ENROLLED 21 YOGA- NAIVE WOMEN (49.4 +/- 10.7 YEARS, BMI 35.5 +/- 6.8 KG/M2) IN A REVISED 10-WEEK PROGRAM (YWL-YN). SELF-REPORTED WEIGHT AND SELF-RATINGS OF MINDFUL EATING BEHAVIOR, BODY IMAGE DISTURBANCE, WEIGHT LOSS SELF-EFFICACY, BODY AWARENESS, AND SELF-COMPASSION WERE COLLECTED AT BASELINE, POST-TREATMENT (T2), AND 3-MONTH FOLLOW- UP (T3). RESULTS: YWL CURRICULA WAS FEASIBLE IN BOTH STUDIES. WHILE ATTRITION RATES FOR BOTH STUDIES FAVORABLY COMPARED TO OTHER WEIGHT MANAGEMENT STUDIES, ATTRITION WAS HIGHER FOR YWL-YN (28.6%) THAN YWL-YE (18.2%). IN BOTH STUDIES, SELF-REPORTED PROCESS VARIABLES AND SELF-REPORTED % TBWL CHANGED IN HYPOTHESIZED DIRECTIONS AT T2 AND EVIDENCED GREATER IMPROVEMENT AT T3; EFFECT SIZES ACROSS ALL PROCESS VARIABLES WERE MEDIUM (-0.4) TO LARGE (-1.8). % TBWL REACHED CLINICAL SIGNIFICANCE (>5%) ONLY AT T3 FOR THE YWL-YE GROUP. CONCLUSIONS: THE YWL CURRICULA EMPLOYED HERE APPEAR TO IMPROVE PSYCHOSOCIAL HEALTH AMONG BOTH OVERWEIGHT/OBESE YOGA-EXPERIENCED AND YOGA- NAIVE WOMEN. RESULTS MUST BE INTERPRETED WITH CAUTION DUE TO STUDY DESIGN, SELF-REPORT ASSESSMENTS, AND OTHER LIMITATIONS. NONETHELESS, HYPOTHESES ARE GENERATED FOR FUTURE INVESTIGATION. 2016 4 1997 35 STRATEGIES FOR EVALUATING SELF-EFFICACY AND OBSERVED SUCCESS IN THE PRACTICE OF YOGA POSTURES FOR THERAPEUTIC INDICATIONS: METHODS FROM A YOGA INTERVENTION FOR URINARY INCONTINENCE AMONG MIDDLE-AGED AND OLDER WOMEN. BACKGROUND: MOST CLINICAL INVESTIGATIONS INVOLVING YOGA LACK ADEQUATE DESCRIPTION OF THE SPECIFIC YOGA ELEMENTS, INCLUDING PHYSICAL POSTURES. FEW STUDIES HAVE MEASURED SELF-EFFICACY REGARDING THE PERFORMANCE OF YOGA POSTURES OR ASSESSED OBSERVED SUCCESS IN PERFORMING POSTURES. METHODS: WE DEVELOPED AND PILOTED SEVERAL TOOLS TO EVALUATE SELF-EFFICACY AND OBSERVED SUCCESS IN PRACTICING YOGA IN THE CONTEXT OF A RANDOMIZED FEASIBILITY TRIAL OF AN IYENGAR-BASED YOGA INTERVENTION FOR URINARY INCONTINENCE IN AMBULATORY WOMEN >/=50 YEARS. AT THE END OF THE 12-WEEK YOGA INTERVENTION INVOLVING TWICE WEEKLY GROUP YOGA CLASSES AND ONCE WEEKLY HOME PRACTICE, PARTICIPANTS RATED THEIR SELF-EFFICACY IN PERFORMING EACH OF THE INCLUDED 15 YOGA POSTURES ON A 5-POINT LIKERT SCALE. DURING THE 12TH WEEK, AN EXPERT YOGA CONSULTANT OBSERVED PARTICIPANTS AND RATED THEIR COMPETENCY IN PERFORMING POSTURES ON A 5-POINT SCALE. PARTICIPANTS COMPLETED A QUESTIONNAIRE ABOUT SELF-EFFICACY IN ADHERING TO HOME YOGA PRACTICE. WE EXAMINED THE DISTRIBUTION OF AND CORRELATIONS BETWEEN SCORES ON THE ABOVE MEASURES. RESULTS: AMONG 27 PARTICIPANTS (MEAN AGE 65 YEARS), THE RANGE OF MEANS FOR SELF-EFFICACY RATINGS FOR INDIVIDUAL POSTURES WAS 3.6 TO 4.5. THE RANGE OF MEANS FOR OBSERVED COMPETENCY RATINGS FOR INDIVIDUAL POSTURES WAS 3.3 TO 5.0. MEAN SELF-EFFICACY RATING FOR CONFIDENCE IN ADHERING TO THE ASSIGNED ONCE-WEEKLY HOME YOGA PRACTICE WAS 2.8 (RANGE 1 TO 5). POSTURE SELF-EFFICACY WAS INVERSELY CORRELATED WITH PARTICIPANT AGE (P = 0.01) AND POSITIVELY CORRELATED WITH SELF-REPORTED PHYSICAL FUNCTION (P = 0.03) AND MOBILITY (P = 0.01). NO SIGNIFICANT CORRELATIONS WERE FOUND BETWEEN POSTURE SELF-EFFICACY SCALE SCORES AND EXPERT-OBSERVED YOGA COMPETENCY RATINGS OR PRACTICE ADHERENCE SELF-EFFICACY SCORES. CONCLUSIONS: THESE MEASURES HOLD PROMISE FOR ADVANCING YOGA RESEARCH AND PRACTICE BY DESCRIBING METHODS TO: 1) MEASURE SELF-EFFICACY IN PERFORMING SPECIFIC YOGA POSTURES; 2) USE AN EXPERT OBSERVER TO ASSESS PARTICIPANTS' COMPETENCE IN PERFORMING YOGA POSTURES; AND 3) MEASURE SELF-EFFICACY IN ADHERING TO HOME PRACTICE. THESE PROPOSED MEASURES CAN BE USED TO DESCRIBE SPECIFIC COMPONENTS OF YOGA INTERVENTIONS, TO ASSESS WHETHER STUDY PARTICIPANTS ARE ABLE TO LEARN TO PRACTICE PHYSICAL ASPECTS OF YOGA AND/OR MAINTAIN THIS PRACTICE OVER TIME, AS WELL AS TO INVESTIGATE RELATIONSHIPS BETWEEN SELF-EFFICACY AND COMPETENCY IN PERFORMING YOGA POSTURES TO ACHIEVE SPECIFIC HEALTH OUTCOMES. TRIAL REGISTRATION: CLINICALTRIALS.GOV, NCT02342678, JANUARY 21, 2015. 2020 5 2766 35 YOGA PROTOCOL FOR TREATMENT OF BREAST CANCER-RELATED LYMPHEDEMA. INTRODUCTION: VAQAS AND RYAN (2003) ADVOCATED YOGA AND BREATHING EXERCISES FOR LYMPHEDEMA. NARAHARI ET AL. (2007) DEVELOPED AN INTEGRATIVE MEDICINE PROTOCOL FOR LOWER-LIMB LYMPHEDEMA USING YOGA. STUDIES HAVE HYPOTHESIZED THAT YOGA PLAYS A SIMILAR ROLE AS THAT OF CENTRAL MANUAL LYMPH DRAINAGE OF FOLDI'S TECHNIQUE. THIS STUDY EXPLAINS HOW WE HAVE USED YOGA AND BREATHING AS A SELF-CARE INTERVENTION FOR BREAST CANCER-RELATED LYMPHEDEMA (BCRL). METHODS: THE STUDY OUTCOME WAS TO CREATE A YOGA PROTOCOL FOR BCRL. SELECTION OF YOGA WAS BASED ON THE ACTIONS OF MUSCLES ON JOINTS, ANATOMICAL AREAS ASSOCIATED WITH DIFFERENT GROUPS OF LYMPH NODES, STRETCHING OF SKIN, AND METHOD OF BREATHING IN EACH YOGA. THE PROTOCOL WAS PILOTED IN EIGHT BCRL PATIENTS, OBSERVED ITS DIFFICULTIES BY INTERACTING WITH PATIENTS. A LITERATURE SEARCH WAS CONDUCTED IN PUBMED AND COCHRANE LIBRARY TO IDENTIFY THE YOGA PROTOCOLS FOR BCRL. RESULTS: TWENTY YOGA AND 5 BREATHING EXERCISES WERE ADOPTED. THEY HAVE SLOW, METHODICAL JOINT MOVEMENTS WHICH HELPED PATIENTS TO TOLERATE PAIN. BREATHING WAS LONG AND DIAPHRAGMATIC. FLEXION OF JOINTS WAS COORDINATED WITH EXHALATION AND EXTENSION WITH INHALATION. ALTERNATE YOGA WAS INTRODUCED TO FACILITATE PATIENTS TO PERFORM COMPLEX MOVEMENTS. YOGA'S JOINT MOVEMENTS, INITIAL POSITIONS, AND MODE OF BREATHING WERE COMPARED TO TWO OTHER PROTOCOLS. THE VOLUME REDUCED FROM 2.4 TO 1.2 L IN EIGHT PATIENTS AFTER CONTINUOUS PRACTICE OF YOGA AND COMPRESSION AT HOME FOR 3 MONTHS. THERE WAS IMPROVEMENT IN THE RANGE OF MOVEMENT AND INTENSITY OF PAIN. DISCUSSION: YOGA EXERCISES WERE SELECTED ON THE BASIS OF THEIR ROLE IN CHEST EXPANSION, MAXIMIZING RANGE OF MOVEMENTS: FLEXION OF LARGE MUSCLES, MAXIMUM STRETCH OF SKIN, AND THUS PART-BY-PART LYMPH DRAINAGE FROM CENTER AND PERIPHERY. THIS PROTOCOL ADDRESSED FUNCTIONAL, VOLUME, AND MOVEMENT ISSUES OF BCRL AND WAS FOUND TO BE SUPERIOR TO OTHER BCRL YOGA PROTOCOLS. HOWEVER, THIS PROTOCOL NEEDS TO BE TESTED IN CENTERS ROUTINELY MANAGING BCRL. 2016 6 900 52 EFFECTIVENESS AND COST-EFFECTIVENESS OF A YOGA-BASED CARDIAC REHABILITATION (YOGA-CARE) PROGRAM FOLLOWING ACUTE MYOCARDIAL INFARCTION: STUDY RATIONALE AND DESIGN OF A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CARDIAC REHABILITATION (CR) IS A STANDARD TREATMENT FOR SECONDARY PREVENTION OF ACUTE MYOCARDIAL INFARCTION (AMI) IN HIGH INCOME COUNTRIES (HICS), BUT IT IS INACCESSIBLE TO MOST PATIENTS IN INDIA DUE TO HIGH COSTS AND SKILLS REQUIRED FOR MULTIDISCIPLINARY CR TEAMS. WE DEVELOPED A LOW-COST AND SCALABLE CR PROGRAM BASED ON CULTURALLY-ACCEPTABLE PRACTICE OF YOGA (YOGA-CARE). IN THIS PAPER, WE REPORT THE RATIONALE AND DESIGN FOR EVALUATION OF ITS EFFECTIVENESS AND COST-EFFECTIVENESS. METHODS: THIS IS A MULTI-CENTER, SINGLE-BLIND, TWO-ARM PARALLEL-GROUP RANDOMIZED CONTROLLED TRIAL ACROSS 22 CARDIAC CARE HOSPITALS IN INDIA. FOUR THOUSAND PATIENTS AGED 18-80YEARS WITH AMI WILL BE RECRUITED AND RANDOMIZED 1:1 TO RECEIVE YOGA-CARE PROGRAM (13 SESSIONS SUPERVISED BY AN INSTRUCTOR AND ENCOURAGEMENT TO SELF-PRACTICE DAILY) OR ENHANCED STANDARD CARE (3 SESSIONS OF HEALTH EDUCATION) DELIVERED OVER A PERIOD OF THREE MONTHS. PARTICIPANTS WILL BE FOLLOWED 3-MONTHLY TILL THE END OF THE TRIAL. THE CO-PRIMARY OUTCOMES ARE A) TIME TO OCCURRENCE OF FIRST CARDIOVASCULAR EVENT (COMPOSITE OF ALL-CAUSE MORTALITY, NON-FATAL MYOCARDIAL INFARCTION, NON-FATAL STROKE AND EMERGENCY CARDIOVASCULAR HOSPITALIZATION), AND B) QUALITY OF LIFE (EURO-QOL-5L) AT 12WEEKS. SECONDARY OUTCOMES INCLUDE NEED FOR REVASCULARIZATION PROCEDURES, RETURN TO PRE-INFARCT ACTIVITIES, TOBACCO CESSATION, MEDICATION ADHERENCE, AND COST-EFFECTIVENESS OF THE INTERVENTION. CONCLUSION: THIS TRIAL WILL ALONE CONTRIBUTE >20% PARTICIPANTS TO EXISTING META-ANALYSES OF RANDOMIZED TRIALS OF CR WORLDWIDE. IF YOGA-CARE IS FOUND TO BE EFFECTIVE, IT HAS THE POTENTIAL TO SAVE MILLIONS OF LIVES AND TRANSFORM CARE OF AMI PATIENTS IN INDIA AND OTHER LOW AND MIDDLE INCOME COUNTRY SETTINGS. 2019 7 613 55 DEVELOPMENT OF A YOGA PROGRAM FOR TYPE-2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE IN INDIA. INTRODUCTION: MANY INDIANS ARE AT HIGH-RISK OF TYPE-2 DIABETES MELLITUS (T2DM). YOGA IS AN ANCIENT INDIAN MIND-BODY DISCIPLINE, THAT HAS BEEN ASSOCIATED WITH IMPROVED GLUCOSE LEVELS AND CAN HELP TO PREVENT T2DM. THE STUDY AIMED TO SYSTEMATICALLY DEVELOP A YOGA PROGRAM FOR T2DM PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE IN INDIA USING A COMPLEX INTERVENTION DEVELOPMENT APPROACH. MATERIALS AND METHODS: AS PART OF THE INTERVENTION, WE DEVELOPED A BOOKLET AND A HIGH-DEFINITION VIDEO FOR PARTICIPANTS AND A MANUAL FOR YOGA-DP INSTRUCTORS. A SYSTEMATIC ITERATIVE PROCESS WAS FOLLOWED TO DEVELOP THE INTERVENTION AND INCLUDED FIVE STEPS: (I) A SYSTEMATIC REVIEW OF THE LITERATURE TO GENERATE A LIST OF YOGIC PRACTICES THAT IMPROVES BLOOD GLUCOSE LEVELS AMONG ADULTS AT HIGH-RISK OF OR WITH T2DM, (II) VALIDATION OF IDENTIFIED YOGIC PRACTICES BY YOGA EXPERTS, (III) DEVELOPMENT OF THE INTERVENTION, (IV) CONSULTATION WITH YOGA, EXERCISE, PHYSICAL ACTIVITY, DIET, BEHAVIOR CHANGE, AND/OR DIABETES EXPERTS ABOUT THE INTERVENTION, AND (V) PRETEST THE INTERVENTION AMONG YOGA PRACTITIONERS AND LAY PEOPLE (THOSE AT RISK OF T2DM AND HAD NOT PRACTICED YOGA BEFORE) IN INDIA. RESULTS: YOGA-DP IS A STRUCTURED LIFESTYLE EDUCATION AND EXERCISE PROGRAM, PROVIDED OVER A PERIOD OF 24 WEEKS. THE EXERCISE PART IS BASED ON YOGA AND INCLUDES SHITHILIKARANA VYAYAMA (LOOSENING EXERCISES), SURYA NAMASKAR (SUN SALUTATION EXERCISES), ASANA (YOGIC POSES), PRANAYAMA (BREATHING PRACTICES), AND DHYANA (MEDITATION) AND RELAXATION PRACTICES. ONCE PARTICIPANTS COMPLETE THE PROGRAM, THEY ARE STRONGLY ENCOURAGED TO MAINTAIN A HEALTHY LIFESTYLE IN THE LONG-TERM. CONCLUSIONS: WE SYSTEMATICALLY DEVELOPED A NOVEL YOGA PROGRAM FOR T2DM PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE IN INDIA. A MULTI-CENTER FEASIBILITY RANDOMIZED CONTROLLED TRIAL IS IN PROGRESS IN INDIA. 2020 8 2763 33 YOGA PROGRAM FOR TYPE 2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE: QUALITATIVE STUDY TO EXPLORE REASONS FOR NON-PARTICIPATION IN A FEASIBILITY RANDOMIZED CONTROLLED TRIAL IN INDIA. BACKGROUND: YOGA-BASED INTERVENTIONS CAN BE EFFECTIVE IN PREVENTING TYPE 2 DIABETES MELLITUS (T2DM). WE DEVELOPED A YOGA PROGRAM FOR T2DM PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE AND CONDUCTED A FEASIBILITY RANDOMIZED CONTROLLED TRIAL (RCT) IN INDIA. THE OBJECTIVE OF THIS STUDY WAS TO IDENTIFY AND EXPLORE WHY POTENTIAL PARTICIPANTS DECLINED TO PARTICIPATE IN THE FEASIBILITY RCT. METHODS: AN EXPLORATORY QUALITATIVE STUDY, USING SEMI-STRUCTURED INTERVIEWS, WAS CONDUCTED AT A YOGA CENTER IN NEW DELHI, INDIA. FOURTEEN PEOPLE (10 WOMEN AND FOUR MEN) WHO DECLINED TO PARTICIPATE IN THE FEASIBILITY RCT WERE INTERVIEWED, AND 13 OF THEM COMPLETED THE NON-PARTICIPANT QUESTIONNAIRE, WHICH CAPTURED THEIR SOCIO-DEMOGRAPHICS, DIETS, PHYSICAL ACTIVITIES, AND REASONS FOR DECLINING. RESULTS: THREE TYPES OF BARRIERS WERE IDENTIFIED AND EXPLORED WHICH PREVENTED PARTICIPATION IN THE FEASIBILITY RCT: (1) PERSONAL BARRIERS, SUCH AS LACK OF TIME, PERCEIVED SUFFICIENCY OF KNOWLEDGE, PREFERENCES ABOUT SELF-MANAGEMENT OF HEALTH, AND TRUST IN OTHER TRADITIONAL AND ALTERNATIVE THERAPIES; (2) CONTEXTUAL BARRIERS, SUCH AS SOCIAL INFLUENCES AND LACK OF AWARENESS ABOUT PREVENTIVE CARE; AND (3) STUDY-RELATED BARRIERS, SUCH AS LACK OF STUDY INFORMATION, POOR ACCESSIBILITY TO THE YOGA SITE, AND LACK OF TRUST IN THE STUDY METHODS AND INTERVENTION. CONCLUSIONS: WE IDENTIFIED AND EXPLORED PERSONAL, CONTEXTUAL, AND STUDY-RELATED BARRIERS TO PARTICIPATION IN A FEASIBILITY RCT IN INDIA. THE FINDINGS WILL HELP TO ADDRESS RECRUITMENT CHALLENGES IN FUTURE YOGA AND OTHER RCTS. CLINICAL TRIAL REGISTRATION:WWW.CLINICALTRIALS.GOV, IDENTIFIER: CTRI/2019/05/018893. 2021 9 2389 49 YOGA AND AEROBIC DANCE FOR PAIN MANAGEMENT IN JUVENILE IDIOPATHIC ARTHRITIS: PROTOCOL FOR A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: JUVENILE IDIOPATHIC ARTHRITIS (JIA) IS ONE OF THE MOST COMMON TYPES OF ARTHRITIS AMONG CHILDREN. ACCORDING TO JIA GUIDELINES FOR PHYSICAL ACTIVITY (PA), STRUCTURED PA INTERVENTIONS LED TO IMPROVED HEALTH OUTCOMES. HOWEVER, MANY PA PROGRAMS, SUCH AS YOGA AND AEROBIC DANCE, HAVE NOT BEEN STUDIED IN THIS POPULATION DESPITE BEING POPULAR AMONG YOUTH. WEB-BASED PA PROGRAMS COULD PROVIDE PATIENTS WITH ACCESSIBLE AND AFFORDABLE INTERVENTIONS. OBJECTIVE: THE PRIMARY AIMS OF THE PROPOSED PILOT RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO EXAMINE (1) THE FEASIBILITY OF CONDUCTING A FULL-SCALE RCT TO EVALUATE THE EFFECTIVENESS OF TWO POPULAR TYPES OF PA: A YOGA TRAINING PROGRAM AND AN AEROBIC DANCE TRAINING PROGRAM, IN FEMALE ADOLESCENTS (AGED 13-18 YEARS) WITH JIA COMPARED WITH AN ELECTRONIC PAMPHLET CONTROL GROUP; AND (2) THE ACCEPTABILITY OF THESE INTERVENTIONS. METHODS: A THREE-ARM PROSPECTIVE RANDOMIZED OPEN-LABEL STUDY WITH A PARALLEL GROUP DESIGN WILL BE USED. A TOTAL OF 25 FEMALE ADOLESCENTS WITH JIA WHO HAVE PAIN WILL BE RANDOMIZED IN A RATIO OF 2:2:1 TO ONE OF THE 3 GROUPS: (1) ONLINE YOGA TRAINING PROGRAM (GROUP A: N=10); (2) ONLINE AEROBIC DANCE TRAINING PROGRAM (GROUP B: N=10); AND (3) ELECTRONIC PAMPHLET CONTROL GROUP (GROUP C: N=5). PARTICIPANTS IN GROUPS A AND B WILL COMPLETE 3 INDIVIDUAL 1-HOUR SESSIONS PER WEEK USING ONLINE EXERCISE VIDEOS, AS WELL AS A 1-HOUR VIRTUAL GROUP SESSION PER WEEK USING A VIDEOCONFERENCING PLATFORM FOR 12 WEEKS. PARTICIPANTS FROM ALL GROUPS WILL HAVE ACCESS TO AN ELECTRONIC EDUCATIONAL PAMPHLET ON PA FOR ARTHRITIS DEVELOPED BY THE ARTHRITIS SOCIETY. ALL PARTICIPANTS WILL ALSO TAKE PART IN WEEKLY ONLINE CONSULTATIONS WITH A RESEARCH COORDINATOR AND DISCUSSIONS ON FACEBOOK WITH PARTICIPANTS FROM THEIR OWN GROUP. FEASIBILITY (IE, RECRUITMENT RATE, SELF-REPORTED ADHERENCE TO THE INTERVENTIONS, DROPOUT RATES, AND PERCENTAGE OF MISSING DATA), ACCEPTABILITY, AND USABILITY OF FACEBOOK AND THE VIDEOCONFERENCING PLATFORM WILL BE ASSESSED AT THE END OF THE PROGRAM. PAIN INTENSITY, PARTICIPATION IN GENERAL PA, MORNING STIFFNESS, FUNCTIONAL STATUS, FATIGUE, SELF-EFFICACY, PATIENT GLOBAL ASSESSMENT, DISEASE ACTIVITY, AND ADVERSE EVENTS WILL BE ASSESSED USING SELF-ADMINISTERED ELECTRONIC SURVEYS AT BASELINE AND THEN WEEKLY UNTIL THE END OF THE 12-WEEK PROGRAM. RESULTS: THIS PILOT RCT HAS BEEN FUNDED BY THE ARTHRITIS HEALTH PROFESSIONS ASSOCIATION. THIS PROTOCOL WAS APPROVED BY THE CHILDREN'S HOSPITAL OF EASTERN ONTARIO RESEARCH ETHICS BOARD (#17/08X). AS OF MAY 11, 2020, RECRUITMENT AND DATA COLLECTION HAVE NOT STARTED. CONCLUSIONS: TO OUR KNOWLEDGE, THIS IS THE FIRST STUDY TO EVALUATE THE EFFECTIVENESS OF YOGA AND AEROBIC DANCE AS PAIN MANAGEMENT INTERVENTIONS FOR FEMALE ADOLESCENTS WITH JIA. THE USE OF ONLINE PROGRAMS TO DISSEMINATE THESE 2 PA INTERVENTIONS MAY FACILITATE ACCESS TO ALTERNATIVE METHODS OF PAIN MANAGEMENT. THIS STUDY CAN LEAD TO A FULL-SCALE RCT. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/12823. 2020 10 258 30 ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME (RLS): STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: RESTLESS LEGS SYNDROME (RLS) IS A COMMON AND BURDENSOME SLEEP DISORDER ASSOCIATED WITH PROFOUND IMPAIRMENT OF HEALTH, WELL-BEING, AND QUALITY OF LIFE. UNFORTUNATELY, THE MEDICATIONS USED FOR RLS MANAGEMENT CARRY RISK OF SERIOUS SIDE EFFECTS, INCLUDING AUGMENTATION OF SYMPTOMS. YOGA, AN ANCIENT MIND-BODY DISCIPLINE DESIGNED TO PROMOTE PHYSICAL, EMOTIONAL, AND MENTAL WELL-BEING, MAY OFFER A VIABLE, LOW-RISK NEW TREATMENT. THE PRIMARY OBJECTIVES OF THIS PILOT, PARALLEL-ARM, RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO ASSESS THE ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RLS. METHODS: FORTY-FOUR ADULTS WITH CONFIRMED MODERATE TO SEVERE RLS WILL BE RECRUITED AND RANDOMIZED TO A 12-WEEK YOGA (N = 22) OR STANDARDIZED EDUCATIONAL FILM PROGRAM (N = 22). YOGA GROUP PARTICIPANTS WILL ATTEND TWO 75-MIN IYENGAR YOGA CLASSES PER WEEK FOR THE FIRST 4 WEEKS, THEN ONE 75-MIN CLASS PER WEEK FOR THE REMAINING 8 WEEKS, AND WILL COMPLETE A 30-MIN HOMEWORK ROUTINE ON NON-CLASS DAYS. EDUCATIONAL FILM GROUP PARTICIPANTS WILL ATTEND ONE 75-MIN CLASS PER WEEK FOR 12 WEEKS AND COMPLETE A DAILY RLS TREATMENT LOG; CLASSES WILL INCLUDE INFORMATION ON: RLS MANAGEMENT, INCLUDING SLEEP HYGIENE PRACTICES; OTHER SLEEP DISORDERS; AND COMPLEMENTARY THERAPIES LIKELY TO BE OF INTEREST TO THOSE PARTICIPATING IN A YOGA AND SLEEP EDUCATION STUDY. YOGA AND TREATMENT LOGS WILL BE COLLECTED WEEKLY. FEASIBILITY OUTCOMES WILL INCLUDE RECRUITMENT, ENROLLMENT, AND RANDOMIZATION RATES, RETENTION, ADHERENCE, AND PROGRAM SATISFACTION. PROGRAM EVALUATION AND YOGA-DOSING QUESTIONNAIRES WILL BE COLLECTED AT WEEK 12; DATA ON EXPLORATORY OUTCOMES (E.G., RLS SYMPTOM SEVERITY (IRLS), SLEEP QUALITY (PSQI), MOOD (POMS, PSS), AND HEALTH-RELATED QUALITY OF LIFE (SF-36)) WILL BE GATHERED AT BASELINE AND WEEK 12. DISCUSSION: THIS STUDY WILL LAY THE ESSENTIAL GROUNDWORK FOR A PLANNED LARGER RCT TO DETERMINE THE EFFICACY OF A YOGA PROGRAM FOR REDUCING SYMPTOMS AND ASSOCIATED BURDEN OF RLS. IF THE FINDINGS OF THE CURRENT TRIAL AND THE SUBSEQUENT LARGER RCTS ARE POSITIVE, THIS STUDY WILL ALSO HELP SUPPORT A NEW APPROACH TO CLINICAL TREATMENT OF THIS CHALLENGING DISORDER, HELP FOSTER IMPROVED UNDERSTANDING OF RLS ETIOLOGY, AND ULTIMATELY CONTRIBUTE TO REDUCING THE INDIVIDUAL, SOCIETAL, AND ECONOMIC BURDEN ASSOCIATED WITH THIS CONDITION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, ID: NCT03570515 . RETROSPECTIVELY REGISTERED ON 1 FEBRUARY 2017. 2019 11 1224 31 FEASIBILITY AND ASSESSMENT OF OUTCOME MEASURES FOR YOGA AS SELF-CARE FOR MINORITIES WITH ARTHRITIS: A PILOT STUDY. BACKGROUND: WHILE THERE IS A GROWING INTEREST IN THE THERAPEUTIC BENEFITS OF YOGA, MINORITY POPULATIONS WITH ARTHRITIS TEND TO BE UNDER-REPRESENTED IN THE RESEARCH. ADDITIONALLY, THERE IS AN ABSENCE OF GUIDANCE IN THE LITERATURE REGARDING THE USE OF MULTICULTURAL TEAMS AND SOCIOCULTURAL HEALTH BELIEFS, WHEN DESIGNING YOGA STUDIES FOR A RACIALLY DIVERSE POPULATION WITH ARTHRITIS. THIS PILOT STUDY EXAMINED THE FEASIBILITY OF OFFERING YOGA AS A SELF-CARE MODALITY TO AN URBAN, BILINGUAL, MINORITY POPULATION WITH OSTEOARTHRITIS (OA) OR RHEUMATOID ARTHRITIS (RA), IN THE WASHINGTON, DC AREA. METHODS: THE PRIMARY OBJECTIVE OF THE STUDY WAS TO ASSESS THE FEASIBILITY OF OFFERING AN 8-WEEK, BILINGUAL YOGA INTERVENTION ADAPTED FOR ARTHRITIS TO A CONVENIENCE SAMPLE OF PRIMARILY HISPANIC AND BLACK/AFRICAN-AMERICAN ADULTS. A RACIALLY DIVERSE INTERDISCIPLINARY RESEARCH TEAM WAS ASSEMBLED TO DESIGN A STUDY TO FACILITATE RECRUITMENT AND RETENTION. THE SECOND OBJECTIVE IDENTIFIED OUTCOME MEASURES TO OPERATIONALIZE POTENTIAL FACILITATORS AND BARRIERS TO SELF-CARE AND SELF-EFFICACY. THE THIRD OBJECTIVE DETERMINED THE FEASIBILITY OF USING COMPUTER-ASSISTED SELF-INTERVIEW (CASI) FOR DATA COLLECTION. RESULTS: ENROLLED PARTICIPANTS (N = 30) WERE MOSTLY FEMALE (93%), SPANISH SPEAKING (69%), AND DIAGNOSED WITH RA (88.5%). FEASIBILITY WAS EVALUATED USING PRACTICALITY, ACCEPTABILITY, ADAPTATION, AND EXPANSION OF AN ARTHRITIS-ADAPTED YOGA INTERVENTION, MODIFIED FOR THIS POPULATION. RECRUITMENT (51%) AND PARTICIPATION (60%) RATES WERE SIMILAR TO PREVIOUS RESEARCH AND CLINICAL EXPERIENCE WITH THE STUDY POPULATION. OF THOSE ENROLLED, 18 STARTED THE INTERVENTION. FOR ADHERENCE, 12 OUT OF 18 (67%) PARTICIPANTS COMPLETED THE INTERVENTION. ALL (100%), WHO COMPLETED THE INTERVENTION, CONTINUED TO PRACTICE YOGA 3 MONTHS AFTER COMPLETING THE STUDY. USING NONPARAMETRIC TESTS, SELECTED OUTCOME MEASURES SHOWED A MEASURABLE CHANGE POST-INTERVENTION SUGGESTING APPROPRIATE USE IN FUTURE STUDIES. AN IN-PERSON COMPUTERIZED QUESTIONNAIRE WAS DETERMINED TO BE A FEASIBLE METHOD OF DATA COLLECTION. CONCLUSIONS: FINDINGS FROM THIS PILOT STUDY CONFIRM THE FEASIBILITY OF OFFERING YOGA TO THIS RACIALLY/ETHNICALLY DIVERSE POPULATION WITH ARTHRITIS. THIS ARTICLE PROVIDES RECRUITMENT/RETENTION RATES, OUTCOME MEASURES WITH ERROR RATES, AND DATA COLLECTION RECOMMENDATIONS FOR A PREVIOUSLY UNDER-REPRESENTED POPULATION. SUGGESTIONS INCLUDE ALLOCATING RESOURCES FOR TRANSLATION AND USING A MULTICULTURAL DESIGN TO FACILITATE RECRUITMENT AND RETENTION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, NCT01617421. 2018 12 74 35 A GROUP-BASED YOGA THERAPY INTERVENTION FOR URINARY INCONTINENCE IN WOMEN: A PILOT RANDOMIZED TRIAL. OBJECTIVE: THE AIM OF THIS STUDY IS TO EXAMINE THE FEASIBILITY, EFFICACY, AND SAFETY OF A GROUP-BASED YOGA THERAPY INTERVENTION FOR MIDDLE-AGED AND OLDER WOMEN WITH URINARY INCONTINENCE. METHODS: WE CONDUCTED A PILOT RANDOMIZED TRIAL OF AMBULATORY WOMEN AGED 40 YEARS AND OLDER WITH STRESS, URGENCY, OR MIXED-TYPE INCONTINENCE. WOMEN WERE RANDOMIZED TO A 6-WEEK YOGA THERAPY PROGRAM (N = 10) CONSISTING OF TWICE WEEKLY GROUP CLASSES AND ONCE WEEKLY HOME PRACTICE OR A WAIT-LIST CONTROL GROUP (N = 9). ALL PARTICIPANTS ALSO RECEIVED WRITTEN PAMPHLETS ABOUT STANDARD BEHAVIORAL SELF-MANAGEMENT STRATEGIES FOR INCONTINENCE. CHANGES IN INCONTINENCE WERE ASSESSED WITH 7-DAY VOIDING DIARIES. RESULTS: THE MEAN (SD) AGE WAS 61.4 (8.2) YEARS, AND THE MEAN BASELINE FREQUENCY OF INCONTINENCE WAS 2.5 (1.3) EPISODES/D. AFTER 6 WEEKS, THE TOTAL INCONTINENCE FREQUENCY DECREASED BY 70% (1.8 [0.9] FEWER EPISODES/D) IN THE YOGA THERAPY VERSUS 13% (0.3 [1.7] FEWER EPISODES/D) IN THE CONTROL GROUP (P = 0.049). PARTICIPANTS IN THE YOGA THERAPY GROUP ALSO REPORTED AN AVERAGE OF 71% DECREASE IN STRESS INCONTINENCE FREQUENCY (0.7 [0.8] FEWER EPISODES/D) COMPARED WITH A 25% INCREASE IN CONTROLS (0.2 [1.1] MORE EPISODES/D) (P = 0.039). NO SIGNIFICANT DIFFERENCES IN REDUCTION IN URGENCY INCONTINENCE WERE DETECTED BETWEEN THE YOGA THERAPY VERSUS CONTROL GROUPS (1.0 [1.0] VERSUS 0.5 [0.5] FEWER EPISODES/D; P = 0.20). ALL WOMEN STARTING THE YOGA THERAPY PROGRAM COMPLETED AT LEAST 90% OF THE GROUP CLASSES AND PRACTICE SESSIONS. TWO PARTICIPANTS IN EACH GROUP REPORTED ADVERSE EVENTS UNRELATED TO THE INTERVENTION. CONCLUSIONS: FINDINGS PROVIDE PRELIMINARY EVIDENCE TO SUPPORT THE FEASIBILITY, EFFICACY, AND SAFETY OF A GROUP-BASED YOGA THERAPY INTERVENTION TO IMPROVE URINARY INCONTINENCE IN WOMEN. 2014 13 2636 41 YOGA FOR TREATING URINARY INCONTINENCE IN WOMEN. BACKGROUND: URINARY INCONTINENCE IN WOMEN IS ASSOCIATED WITH POOR QUALITY OF LIFE AND DIFFICULTIES IN SOCIAL, PSYCHOLOGICAL AND SEXUAL FUNCTIONING. THE CONDITION MAY AFFECT UP TO 15% OF MIDDLE-AGED OR OLDER WOMEN IN THE GENERAL POPULATION. CONSERVATIVE TREATMENTS SUCH AS LIFESTYLE INTERVENTIONS, BLADDER TRAINING AND PELVIC FLOOR MUSCLE TRAINING (USED EITHER ALONE OR IN COMBINATION WITH OTHER INTERVENTIONS) ARE THE INITIAL APPROACHES TO THE MANAGEMENT OF URINARY INCONTINENCE. MANY WOMEN ARE INTERESTED IN ADDITIONAL TREATMENTS SUCH AS YOGA, A SYSTEM OF PHILOSOPHY, LIFESTYLE AND PHYSICAL PRACTICE THAT ORIGINATED IN ANCIENT INDIA. OBJECTIVES: TO ASSESS THE EFFECTS OF YOGA FOR TREATING URINARY INCONTINENCE IN WOMEN. SEARCH METHODS: WE SEARCHED THE COCHRANE INCONTINENCE AND COCHRANE COMPLEMENTARY MEDICINE SPECIALISED REGISTERS. WE SEARCHED THE WORLD HEALTH ORGANIZATION INTERNATIONAL CLINICAL TRIALS REGISTRY PLATFORM (WHO ICTRP) AND CLINICALTRIALS.GOV TO IDENTIFY ANY ONGOING OR UNPUBLISHED STUDIES. WE HANDSEARCHED PROCEEDINGS OF THE INTERNATIONAL CONGRESS ON COMPLEMENTARY MEDICINE RESEARCH AND THE EUROPEAN CONGRESS FOR INTEGRATIVE MEDICINE. WE SEARCHED THE NHS ECONOMIC EVALUATION DATABASE FOR ECONOMIC STUDIES, AND SUPPLEMENTED THIS SEARCH WITH SEARCHES FOR ECONOMICS STUDIES IN MEDLINE AND EMBASE FROM 2015 ONWARDS. DATABASE SEARCHES ARE UP-TO-DATE AS OF 21 JUNE 2018. SELECTION CRITERIA: RANDOMISED CONTROLLED TRIALS IN WOMEN DIAGNOSED WITH URINARY INCONTINENCE IN WHICH ONE GROUP WAS ALLOCATED TO TREATMENT WITH YOGA. DATA COLLECTION AND ANALYSIS: TWO REVIEW AUTHORS INDEPENDENTLY SCREENED TITLES AND ABSTRACTS OF ALL RETRIEVED ARTICLES, SELECTED STUDIES FOR INCLUSION, EXTRACTED DATA, ASSESSED RISK OF BIAS AND EVALUATED THE CERTAINTY OF THE EVIDENCE FOR EACH REPORTED OUTCOME. ANY DISAGREEMENTS WERE RESOLVED BY CONSENSUS. WE PLANNED TO COMBINE CLINICALLY COMPARABLE STUDIES IN REVIEW MANAGER 5 USING RANDOM-EFFECTS META-ANALYSIS AND TO CARRY OUT SENSITIVITY AND SUBGROUP ANALYSES. WE PLANNED TO CREATE A TABLE LISTING ECONOMIC STUDIES ON YOGA FOR INCONTINENCE BUT NOT CARRY OUT ANY ANALYSES ON THESE STUDIES. MAIN RESULTS: WE INCLUDED TWO STUDIES (INVOLVING A TOTAL OF 49 WOMEN). EACH STUDY COMPARED YOGA TO A DIFFERENT COMPARATOR, THEREFORE WE WERE UNABLE TO COMBINE THE DATA IN A META-ANALYSIS. A THIRD STUDY THAT HAS BEEN COMPLETED BUT NOT YET FULLY REPORTED IS AWAITING ASSESSMENT.ONE INCLUDED STUDY WAS A SIX-WEEK STUDY COMPARING YOGA TO A WAITING LIST IN 19 WOMEN WITH EITHER URGENCY URINARY INCONTINENCE OR STRESS URINARY INCONTINENCE. WE JUDGED THE CERTAINTY OF THE EVIDENCE FOR ALL REPORTED OUTCOMES AS VERY LOW DUE TO PERFORMANCE BIAS, DETECTION BIAS, AND IMPRECISION. THE NUMBER OF WOMEN REPORTING CURE WAS NOT REPORTED. WE ARE UNCERTAIN WHETHER YOGA RESULTS IN SATISFACTION WITH CURE OR IMPROVEMENT OF INCONTINENCE (RISK RATIO (RR) 6.33, 95% CONFIDENCE INTERVAL (CI) 1.44 TO 27.88; AN INCREASE OF 592 FROM 111 PER 1000, 95% CI 160 TO 1000). WE ARE UNCERTAIN WHETHER THERE IS A DIFFERENCE BETWEEN YOGA AND WAITING LIST IN CONDITION-SPECIFIC QUALITY OF LIFE AS MEASURED ON THE INCONTINENCE IMPACT QUESTIONNAIRE SHORT FORM (MEAN DIFFERENCE (MD) 1.74, 95% CI -33.02 TO 36.50); THE NUMBER OF MICTURITIONS (MD -0.77, 95% CI -2.13 TO 0.59); THE NUMBER OF INCONTINENCE EPISODES (MD -1.57, 95% CI -2.83 TO -0.31); OR THE BOTHERSOMENESS OF INCONTINENCE AS MEASURED ON THE UROGENITAL DISTRESS INVENTORY 6 (MD -0.90, 95% CI -1.46 TO -0.34). THERE WAS NO EVIDENCE OF A DIFFERENCE IN THE NUMBER OF WOMEN WHO EXPERIENCED AT LEAST ONE ADVERSE EVENT (RISK DIFFERENCE 0%, 95% CI -38% TO 38%; NO DIFFERENCE FROM 222 PER 1000, 95% CI 380 FEWER TO 380 MORE).THE SECOND INCLUDED STUDY WAS AN EIGHT-WEEK STUDY IN 30 WOMEN WITH URGENCY URINARY INCONTINENCE THAT COMPARED MINDFULNESS-BASED STRESS REDUCTION (MBSR) TO AN ACTIVE CONTROL INTERVENTION OF YOGA CLASSES. THE STUDY WAS UNBLINDED, AND THERE WAS HIGH ATTRITION FROM BOTH STUDY ARMS FOR ALL OUTCOME ASSESSMENTS. WE JUDGED THE CERTAINTY OF THE EVIDENCE FOR ALL REPORTED OUTCOMES AS VERY LOW DUE TO PERFORMANCE BIAS, ATTRITION BIAS, IMPRECISION AND INDIRECTNESS. THE NUMBER OF WOMEN REPORTING CURE WAS NOT REPORTED. WE ARE UNCERTAIN WHETHER WOMEN IN THE YOGA GROUP WERE LESS LIKELY TO REPORT IMPROVEMENT IN INCONTINENCE AT EIGHT WEEKS COMPARED TO WOMEN IN THE MBSR GROUP (RR 0.09, 95% CI 0.01 TO 1.43; A DECREASE OF 419 FROM 461 PER 1000, 95% CI 5 TO 660). WE ARE UNCERTAIN ABOUT THE EFFECT OF MBSR COMPARED TO YOGA ON REPORTS OF CURE OR IMPROVEMENT IN INCONTINENCE, IMPROVEMENT IN CONDITION-SPECIFIC QUALITY OF LIFE MEASURED ON THE OVERACTIVE BLADDER HEALTH-RELATED QUALITY OF LIFE SCALE, REDUCTION IN INCONTINENCE EPISODES OR REDUCTION IN BOTHERSOMENESS OF INCONTINENCE AS MEASURED ON THE OVERACTIVE BLADDER SYMPTOM AND QUALITY OF LIFE-SHORT FORM AT EIGHT WEEKS. THE STUDY DID NOT REPORT ON ADVERSE EFFECTS. AUTHORS' CONCLUSIONS: WE IDENTIFIED FEW TRIALS ON YOGA FOR INCONTINENCE, AND THE EXISTING TRIALS WERE SMALL AND AT HIGH RISK OF BIAS. IN ADDITION, WE DID NOT FIND ANY STUDIES OF ECONOMIC OUTCOMES RELATED TO YOGA FOR URINARY INCONTINENCE. DUE TO THE LACK OF EVIDENCE TO ANSWER THE REVIEW QUESTION, WE ARE UNCERTAIN WHETHER YOGA IS USEFUL FOR WOMEN WITH URINARY INCONTINENCE. ADDITIONAL, WELL-CONDUCTED TRIALS WITH LARGER SAMPLE SIZES ARE NEEDED. 2019 14 593 36 DEVELOPMENT AND EVALUATION OF A YOGA INTERVENTION PROGRAM FOR PARKINSON'S DISEASE. PRELIMINARY RESEARCH INDICATES THAT YOGA COULD BE A VALUABLE TOOL FOR PEOPLE SUFFERING FROM PARKINSON'S DISEASE (PD). HOWEVER, LITTLE HAS BEEN PUBLISHED ABOUT THE PROCESS BY WHICH THE YOGA INTERVENTIONS WERE DESIGNED AND EVALUATED. THIS STUDY ELABORATES ON THE PROCESS OF DEVELOPING AND TESTING A BI-WEEKLY, 12-WEEK YOGA PROGRAM TO DETERMINE ITS SAFETY AND FEASIBILITY FOR PEOPLE WITH PD. THE LEAD YOGA TEACHER USED INPUT FROM A FOCUSED LITERATURE REVIEW TO DESIGN AN INITIAL DRAFT OF THE INTERVENTION PROGRAM. THIS DRAFT WAS REVIEWED BY A GROUP OF YOGA EXPERTS ( N = 6) TO DEVELOP THE FINAL INTERVENTION PROGRAM. THIS 12-WEEK INTERVENTION WAS IMPLEMENTED IN 19 PARTICIPANTS WITH PD (MEAN AGE 63 +/- 8, RANGE 49-75) VIA TWICE-WEEKLY YOGA CLASSES. THROUGH THIS COMPREHENSIVE DEVELOPMENT PROCESS, A SERIES OF 24 INDIVIDUAL 1-HOUR YOGA SEQUENCES WAS CREATED. THESE SEQUENCES INCLUDED YOGA POSTURES (ASANA), BREATHING TECHNIQUES (PRANAYAMA), AND MINDFULNESS MEDITATION PRINCIPLES SPECIFICALLY CHOSEN TO ADDRESS CONCERNS UNIQUE TO THE PD POPULATION. THE FEASIBILITY OF THE PROGRAM WAS SUPPORTED WITH EXCELLENT ATTENDANCE: 90% OF PARTICIPANTS ATTENDED > 75% OF THE CLASSES, WITH FOUR PARTICIPANTS ATTENDING 100%. NO ADVERSE EVENTS WERE REPORTED. THIS DEVELOPMENT PROCESS PRODUCED A SAFE AND ENJOYABLE YOGA PROGRAM SPECIFIC FOR THE NEEDS OF PEOPLE WITH PD. HOWEVER, THIS METHODOLOGY COULD SERVE AS A TEMPLATE FOR FUTURE STUDIES ON HOW TO DEVELOP SAFE AND EFFECTIVE YOGA INTERVENTIONS FOR OTHER POPULATIONS. 2018 15 518 27 COMPARING ONCE- VERSUS TWICE-WEEKLY YOGA CLASSES FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY LOW INCOME MINORITIES: A RANDOMIZED DOSING TRIAL. BACKGROUND. PREVIOUS STUDIES HAVE DEMONSTRATED THAT ONCE-WEEKLY YOGA CLASSES ARE EFFECTIVE FOR CHRONIC LOW BACK PAIN (CLBP) IN WHITE ADULTS WITH HIGH SOCIOECONOMIC STATUS. THE COMPARATIVE EFFECTIVENESS OF TWICE-WEEKLY CLASSES AND GENERALIZABILITY TO RACIALLY DIVERSE LOW INCOME POPULATIONS ARE UNKNOWN. METHODS. WE CONDUCTED A 12-WEEK RANDOMIZED, PARALLEL-GROUP, DOSING TRIAL FOR 95 ADULTS RECRUITED FROM AN URBAN SAFETY-NET HOSPITAL AND FIVE COMMUNITY HEALTH CENTERS COMPARING ONCE-WEEKLY (N = 49) VERSUS TWICE-WEEKLY (N = 46) STANDARDIZED YOGA CLASSES SUPPLEMENTED BY HOME PRACTICE. PRIMARY OUTCOMES WERE CHANGE FROM BASELINE TO 12 WEEKS IN PAIN (11-POINT SCALE) AND BACK-RELATED FUNCTION (23-POINT MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE). RESULTS. 82% OF PARTICIPANTS WERE NONWHITE; 77% HAD ANNUAL HOUSEHOLD INCOMES <$40,000. THE SAMPLE'S BASELINE MEAN PAIN INTENSITY [6.9 (SD 1.6)] AND FUNCTION [13.7 (SD 5.0)] REFLECTED MODERATE TO SEVERE BACK PAIN AND IMPAIRMENT. PAIN AND BACK-RELATED FUNCTION IMPROVED WITHIN BOTH GROUPS (P < 0.001). HOWEVER, THERE WERE NO DIFFERENCES BETWEEN ONCE-WEEKLY AND TWICE-WEEKLY GROUPS FOR PAIN REDUCTION [-2.1 (95% CI -2.9, -1.3) VERSUS -2.4 (95% CI -3.1, -1.8), P = 0.62] OR BACK-RELATED FUNCTION [-5.1 (95% CI -7.0, -3.2) VERSUS -4.9 (95% CI -6.5, -3.3), P = 0.83]. CONCLUSIONS. TWELVE WEEKS OF ONCE-WEEKLY OR TWICE-WEEKLY YOGA CLASSES WERE SIMILARLY EFFECTIVE FOR PREDOMINANTLY LOW INCOME MINORITY ADULTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN. THIS TRIAL IS REGISTERED WITH CLINICALTRIALS.GOV NCT01761617. 2013 16 1495 41 INTERVENTION PROTOCOL FOR INVESTIGATING YOGA IMPLEMENTED DURING CHEMOTHERAPY. OBJECTIVE: FATIGUE AND OTHER TREATMENT-RELATED SYMPTOMS ARE CRITICAL THERAPEUTIC TARGETS FOR IMPROVING QUALITY OF LIFE IN PATIENTS WITH COLORECTAL CANCER DURING CHEMOTHERAPY. YOGA IS A PROMISING INTERVENTION FOR IMPROVING THESE THERAPEUTIC TARGETS AND HAS BEEN PRIMARILY INVESTIGATED IN THE GROUP-CLASS FORMAT, WHICH IS LESS FEASIBLE FOR CANCER PATIENTS WITH HIGH SYMPTOM BURDEN TO ATTEND. THUS, WE DEVELOPED A PROTOCOL FOR IMPLEMENTING YOGA INDIVIDUALLY IN THE CLINIC AMONG PATIENTS RECEIVING CHEMOTHERAPY. METHODS: WE FOLLOWED RECOMMENDED DOMAINS FOR DEVELOPING A YOGA PROTOCOL TO BE USED IN AN EFFICACY TRIAL. THESE RECOMMENDATIONS INCLUDE CONSIDERATION TO THE STYLE, DELIVERY, COMPONENTS OF THE INTERVENTION, DOSE, SPECIFIC CLASS SEQUENCES, FACILITATION OF HOME PRACTICE, MEASUREMENT OF INTERVENTION FIDELITY, SELECTION OF INSTRUCTORS, AND DEALING WITH MODIFICATIONS. THE INTERVENTION PROTOCOL WAS DEVELOPED BY AN INTERDISCIPLINARY TEAM. PROTOCOL: YOGA SKILLS TRAINING (YST) CONSISTS OF FOUR 30-MINUTE IN-PERSON SESSIONS AND WAS IMPLEMENTED WHILE IN THE CHAIR DURING CHEMOTHERAPY INFUSIONS FOR COLORECTAL CANCER WITH RECOMMENDED DAILY HOME PRACTICE FOR EIGHT WEEKS. THERAPEUTIC GOALS OF THE YST ARE TO REDUCE FATIGUE, CIRCADIAN DISRUPTION, AND PSYCHOLOGICAL DISTRESS. ELEMENTS OF THE YST ARE AWARENESS MEDITATION, GENTLE SEATED MOVEMENT, BREATHING PRACTICE, AND RELAXATION MEDITATION. ATTENTION, COMFORT, AND EASE ARE ALSO HIGHLIGHTED. CONCLUSION: THIS DESCRIPTION OF A PROTOCOL FOR INTEGRATING YOGA WITH CONVENTIONAL CANCER TREATMENT WILL INFORM FUTURE STUDY DESIGNS AND CLINICAL PRACTICE. THE DESIGN OF THE YST IS NOVEL BECAUSE IT IMPLEMENTS YOGA-MOST COMMONLY STUDIED WHEN TAUGHT TO GROUPS OUTSIDE OF THE CLINICAL SETTING- INDIVIDUALLY DURING CLINICAL CARE. 2016 17 105 30 A PILOT FEASIBILITY STUDY OF WHOLE-SYSTEMS AYURVEDIC MEDICINE AND YOGA THERAPY FOR WEIGHT LOSS. OBJECTIVE: TO DEVELOP AND TEST THE FEASIBILITY OF A WHOLE-SYSTEMS LIFESTYLE INTERVENTION FOR OBESITY TREATMENT BASED ON THE PRACTICES OF AYURVEDIC MEDICINE/ YOGA THERAPY. DESIGN: A PRE-POST WEIGHT LOSS INTERVENTION PILOT STUDY USING CONVENTIONAL AND AYURVEDIC DIAGNOSIS INCLUSION CRITERIA, TAILORED TREATMENT WITHIN A STANDARDIZED TREATMENT ALGORITHM, AND STANDARDIZED DATA COLLECTION INSTRUMENTS FOR COLLECTING AYURVEDIC OUTCOMES. PARTICIPANTS: A CONVENIENCE SAMPLE OF OVERWEIGHT/OBESE ADULT COMMUNITY MEMBERS FROM TUCSON, ARIZONA INTERESTED IN A "HOLISTIC WEIGHT LOSS PROGRAM" AND MEETING PREDETERMINED INCLUSION/EXCLUSION CRITERIA. INTERVENTION: A COMPREHENSIVE DIET, ACTIVITY, AND LIFESTYLE MODIFICATION PROGRAM BASED ON PRINCIPLES OF AYURVEDIC MEDICINE/YOGA THERAPY WITH SIGNIFICANT SELF-MONITORING OF LIFESTYLE BEHAVIORS. THE 3-MONTH PROGRAM WAS DESIGNED TO CHANGE EATING AND ACTIVITY PATTERNS AND TO IMPROVE SELF-EFFICACY, QUALITY OF LIFE, WELL-BEING, VITALITY, AND SELF-AWARENESS AROUND FOOD CHOICES, STRESS MANAGEMENT, AND BARRIERS TO WEIGHT LOSS. PRIMARY OUTCOME MEASURES: CHANGES IN BODY WEIGHT, BODY MASS INDEX; BODY FAT PERCENTAGE, FAT/LEAN MASS, WAIST/HIP CIRCUMFERENCE AND RATIO, AND BLOOD PRESSURE. SECONDARY OUTCOME MEASURES: DIET AND EXERCISE SELF-EFFICACY SCALES; PERCEIVED STRESS SCALE; VISUAL ANALOG SCALES (VAS) OF ENERGY, APPETITE, STRESS, QUALITY OF LIFE, WELL-BEING, AND PROGRAM SATISFACTION AT ALL TIME POINTS. RESULTS: TWENTY-TWO ADULTS ATTENDED AN IN-PERSON AYURVEDIC SCREENING; 17 INITIATED THE INTERVENTION, AND 12 COMPLETED THE 3-MONTH INTERVENTION. TWELVE COMPLETED FOLLOW-UP AT 6 MONTHS AND 11 COMPLETED FOLLOW-UP AT 9 MONTHS. MEAN WEIGHT LOSS AT 3 MONTHS WAS 3.54 KG (SD 4.76); 6 MONTHS: 4.63 KG, (SD 6.23) AND 9 MONTHS: 5.9 KG (SD 8.52). SELF-REPORT OF PROGRAM SATISFACTION WAS MORE THAN 90% AT ALL TIME POINTS. CONCLUSIONS: AN AYURVEDA-/YOGA-BASED LIFESTYLE MODIFICATION PROGRAM IS AN ACCEPTABLE AND FEASIBLE APPROACH TO WEIGHT MANAGEMENT. DATA COLLECTION, INCLUDING SELF-MONITORING AND CONVENTIONAL AND AYURVEDIC OUTCOMES, DID NOT UNDULY BURDEN PARTICIPANTS, WITH ATTRITION SIMILAR TO THAT OF OTHER WEIGHT LOSS STUDIES. 2014 18 2596 39 YOGA FOR MILITARY VETERANS WITH CHRONIC LOW BACK PAIN: A RANDOMIZED CLINICAL TRIAL. INTRODUCTION: CHRONIC LOW BACK PAIN (CLBP) IS PREVALENT, ESPECIALLY AMONG MILITARY VETERANS. MANY CLBP TREATMENT OPTIONS HAVE LIMITED BENEFITS AND ARE ACCOMPANIED BY SIDE EFFECTS. MAJOR EFFORTS TO REDUCE OPIOID USE AND EMBRACE NONPHARMACOLOGICAL PAIN TREATMENTS HAVE RESULTED. RESEARCH WITH COMMUNITY CLBP PATIENTS INDICATES THAT YOGA CAN IMPROVE HEALTH OUTCOMES AND HAS FEW SIDE EFFECTS. THE BENEFITS OF YOGA AMONG MILITARY VETERANS WERE EXAMINED. DESIGN: PARTICIPANTS WERE RANDOMIZED TO EITHER YOGA OR DELAYED YOGA TREATMENT IN 2013-2015. OUTCOMES WERE ASSESSED AT BASELINE, 6 WEEKS, 12 WEEKS, AND 6 MONTHS. INTENTION-TO-TREAT ANALYSES OCCURRED IN 2016. SETTING/PARTICIPANTS: ONE HUNDRED AND FIFTY MILITARY VETERANS WITH CLBP WERE RECRUITED FROM A MAJOR VETERANS AFFAIRS MEDICAL CENTER IN CALIFORNIA. INTERVENTION: YOGA CLASSES (WITH HOME PRACTICE) WERE LED BY A CERTIFIED INSTRUCTOR TWICE WEEKLY FOR 12 WEEKS, AND CONSISTED PRIMARILY OF PHYSICAL POSTURES, MOVEMENT, AND BREATHING TECHNIQUES. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES AFTER 12 WEEKS. PAIN INTENSITY WAS IDENTIFIED AS AN IMPORTANT SECONDARY OUTCOME. RESULTS: PARTICIPANT CHARACTERISTICS WERE MEAN AGE 53 YEARS, 26% WERE FEMALE, 35% WERE UNEMPLOYED OR DISABLED, AND MEAN BACK PAIN DURATION WAS 15 YEARS. IMPROVEMENTS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES DID NOT DIFFER BETWEEN THE TWO GROUPS AT 12 WEEKS, BUT YOGA PARTICIPANTS HAD GREATER REDUCTIONS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES THAN DELAYED TREATMENT PARTICIPANTS AT 6 MONTHS -2.48 (95% CI= -4.08, -0.87). YOGA PARTICIPANTS IMPROVED MORE ON PAIN INTENSITY AT 12 WEEKS AND AT 6 MONTHS. OPIOID MEDICATION USE DECLINED AMONG ALL PARTICIPANTS, BUT GROUP DIFFERENCES WERE NOT FOUND. CONCLUSIONS: YOGA IMPROVED HEALTH OUTCOMES AMONG VETERANS DESPITE EVIDENCE THEY HAD FEWER RESOURCES, WORSE HEALTH, AND MORE CHALLENGES ATTENDING YOGA SESSIONS THAN COMMUNITY SAMPLES STUDIED PREVIOUSLY. THE MAGNITUDE OF PAIN INTENSITY DECLINE WAS SMALL, BUT OCCURRED IN THE CONTEXT OF REDUCED OPIOID USE. THE FINDINGS SUPPORT WIDER IMPLEMENTATION OF YOGA PROGRAMS FOR VETERANS. TRIAL REGISTRATION: THIS STUDY IS REGISTERED AT WWW.CLINICALTRIALS.GOV NCT02524158. 2017 19 551 29 CONVENIENT AND LIVE MOVEMENT (CALM) FOR WOMEN UNDERGOING BREAST CANCER TREATMENT: CHALLENGES AND RECOMMENDATIONS FOR INTERNET-BASED YOGA RESEARCH. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF INTERNET-BASED, CANCER-ADAPTED YOGA FOR WOMEN RECEIVING BREAST CANCER TREATMENT. DESIGN: WOMEN UNDERGOING RADIATION OR CHEMOTHERAPY FOR BREAST CANCER WERE RECRUITED FOR 12, 75-MIN, BIWEEKLY, CANCER-ADAPTED YOGA CLASSES DELIVERED VIA INTERNET-BASED, MULTIPOINT VIDEOCONFERENCING. DATA WERE COLLECTED ON FEASIBILITY AND ACCEPTABILITY, INCLUDING QUALITATIVE FEEDBACK FROM PARTICIPANTS AND THE YOGA INSTRUCTOR. RESULTS: AMONG 42 WOMEN APPROACHED, 13 DECLINED ELIGIBILITY SCREENING, AND 23 WERE INELIGIBLE. ALL 6 WOMEN WHO WERE ELIGIBLE PROVIDED CONSENT, BUT 2 WITHDREW PRIOR TO BEGINNING YOGA CLASSES. THE REMAINING 4 PARTICIPANTS ATTENDED 1-11 OF 12 ONLINE YOGA CLASSES. IN POST-INTERVENTION INTERVIEWS, PARTICIPANTS AND THE INSTRUCTOR AGREED THAT INTERNET-BASED YOGA CLASSES HOLD GREAT POTENTIAL FOR INCREASING ACCESS AND IMPROVING PSYCHOLOGICAL OUTCOMES IN ADULTS WITH CANCER. QUALITATIVE FEEDBACK FROM PARTICIPANTS REVEALED SUGGESTIONS FOR FUTURE TRIALS OF INTERNET-BASED, CANCER-ADAPTED YOGA CLASSES, INCLUDING: CONTINUED USE OF GROUP FORMAT; OFFERING MORE VARIED CLASS TIMES TO ACCOMMODATE PATIENTS' DEMANDING SCHEDULES AND FLUCTUATING SYMPTOMS; ENROLLING PATIENTS AFTER THEY HAVE ACCLIMATED TO OR COMPLETED CANCER TREATMENT; STREAMLINING THE TECHNOLOGY INTERFACE; AND CAREFUL ATTENTION TO PARTICIPANT BURDEN WHEN DESIGNING SURVEYS/FORMS. THE INSTRUCTOR RECOMMENDED CLOSED SESSION COURSES, AS OPPOSED TO ROLLING ENROLLMENT; TEACHING THE SAME MODIFIED POSES FOR ALL PARTICIPANTS, RATHER THAN INDIVIDUAL TAILORING; AND USING A LARGE SCREEN TO ALLOW CLOSER MONITORING OF STUDENTS' CLASS EXPERIENCE. CONCLUSIONS: INTERNET DELIVERY MAY INCREASE PATIENTS' ACCESS TO CANCER-ADAPTED YOGA CLASSES, BUT CANCER-RELATED AND TECHNOLOGICAL BARRIERS REMAIN. THIS STUDY INFORMS HOW TO OPTIMALLY DESIGN YOGA CLASSES, TECHNOLOGY, AND RESEARCH PROCEDURES TO MAXIMIZE FEASIBILITY AND ACCEPTABILITY IN FUTURE TRIALS. 2018 20 2843 26 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