1 1632 198 MIYOGA: A RANDOMISED CONTROLLED TRIAL OF A MINDFULNESS MOVEMENT PROGRAMME BASED ON HATHA YOGA PRINCIPLES FOR CHILDREN WITH CEREBRAL PALSY: A STUDY PROTOCOL. INTRODUCTION: CEREBRAL PALSY (CP) IS THE MOST COMMON CHILDHOOD PHYSICAL DISABILITY, WITH LIFE-LONG IMPACTS FOR 1.77 IN 1000 CHILDREN. ALTHOUGH CP IS PRIMARILY A PHYSICAL DISABILITY, CHILDREN WITH CP HAVE AN INCREASED RISK OF EXPERIENCING COGNITIVE DIFFICULTIES, PARTICULARLY ATTENTION AND EXECUTIVE FUNCTION DEFICITS. IMPAIRMENT IN COGNITIVE ABILITIES CAN LEAD TO SUBSEQUENT IMPAIRMENT IN INDEPENDENT FUNCTIONING, EDUCATION, EMPLOYMENT AND INTERPERSONAL RELATIONSHIPS. THIS PAPER REPORTS THE PROTOCOL OF A RANDOMISED CONTROLLED TRIAL OF A NOVEL FAMILY-CENTRED LIFESTYLE INTERVENTION BASED ON MINDFULNESS AND HATHA YOGA PRINCIPLES (MIYOGA). MIYOGA AIMS TO ENHANCE CHILD AND PARENT OUTCOMES FOR CHILDREN WITH CP. METHODS AND ANALYSIS: THE AIM IS TO RECRUIT 36 CHILD-PARENT DYADS (CHILDREN AGED 6-16 YEARS; BILATERAL OR UNILATERAL CP; GROSS MOTOR FUNCTION CLASSIFICATION SYSTEM I-III), WHO WILL BE RANDOMLY ASSIGNED TO TWO GROUPS: MIYOGA ANDWAITLISTT CONTROL. THE MIYOGA PROGRAMME WILL BE FACILITATED IN A GROUP FORMAT FOR 8 WEEKS. ASSESSMENTS WILL BE ADMINISTERED AT BASELINE, PRIOR TO MIYOGA, FOLLOWING COMPLETION OF MIYOGA, AND AT 6-MONTH FOLLOW-UP (RETENTION). THE PRIMARY OUTCOME WILL BE THE CHILD'S SUSTAINED ATTENTIONAL ABILITY AS MEASURED BY THE CONNER'S CONTINUOUS PERFORMANCE TEST II. OTHER OUTCOMES OF INTEREST FOR CHILDREN WITH CP CONSISTS OF ATTENTIONAL CONTROL, PHYSICAL FUNCTIONING, BEHAVIOURAL AND WELL-BEING. FOR PARENTS, THE OUTCOMES OF INTEREST ARE MINDFULNESS, PSYCHOLOGICAL FLEXIBILITY AND WELL-BEING. DATA WILL BE ANALYSED USING GENERAL LINEAR MODELS, SPECIFICALLY ANALYSIS OF COVARIANCE AND ANALYSIS OF VARIANCE. ETHICS AND DISSEMINATION: FULL ETHICAL APPROVAL FOR THIS STUDY HAS BEEN OBTAINED BY THE CHILDREN'S HEALTH QUEENSLAND HOSPITAL AND HEALTH SERVICE RESEARCH ETHICS COMMITTEE (HREC/12/QRCH/120) AND THE UNIVERSITY OF QUEENSLAND (2012000993). IF MIYOGA IS PROVEN EFFECTIVE, ITS DISSEMINATION WOULD ASSIST CHILDREN WITH CP AND COMPLEMENT THEIR ONGOING THERAPY BY IMPROVING THE ABILITY OF THE CHILD TO PAY ATTENTION AT SCHOOL AND IN THERAPY, AND ALLEVIATING ENVIRONMENTALSTRESSORSS FOR BOTH THE CHILD AND HIS/HER PARENTS. TRIAL REGISTRATION NUMBER: ACTRN12613000729729; PRE-RESULTS.HTTP://WWW.ANZCTR.ORG.AU/ACTRN12613000729729.ASPX DATE OF TRIAL REGISTRATION: PROSPECTIVELY REGISTERED ON 2 JULY 2013-PRESENT (ONGOING). FINDINGS TO DATE: RECRUITMENT IS COMPLETE. DATA ARE STILL BEING COLLECTED AT PRESENT. WE AIM TO COMPLETE DATA COLLECTION BY FEBRUARY 2017.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
2 1165  65 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	

3  258  55 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
4  144  36 A QUALITATIVE APPROACH EXPLORING THE ACCEPTABILITY OF YOGA FOR MINORITIES LIVING WITH ARTHRITIS: 'WHERE ARE THE PEOPLE WHO LOOK LIKE ME?' OBJECTIVES: TO EXAMINE THE ACCEPTABILITY OF YOGA RESEARCH TAILORED TO RECRUIT AND RETAIN A MINORITY POPULATION (BOTH ENGLISH AND SPANISH SPEAKING) WITH ARTHRITIS. YOGA RESEARCH FOR ARTHRITIS OFTEN UNDERREPRESENTS MINORITIES AND ACCEPTABILITY FOR THIS POPULATION HAS NOT PREVIOUSLY BEEN INVESTIGATED. DESIGN: ACCEPTABILITY WAS EVALUATED USING RETENTION, ADHERENCE, JOURNALS, AND SEMI-STRUCTURED EXIT INTERVIEWS FROM TWELVE PARTICIPANTS WITH OSTEOARTHRITIS OR RHEUMATOID ARTHRITIS UNDERGOING AN 8-WEEK YOGA INTERVENTION. JOURNAL QUOTES WERE ANALYZED USING CONTENT ANALYSIS TECHNIQUES. NVIVO SOFTWARE WAS USED TO ORGANIZE TRANSCRIPTS AND ASSEMBLE THEMES. TWO METHODS OF TRIANGULATION (DATA AND INVESTIGATOR) WERE USED TO OVERCOME POTENTIAL BIAS FROM A SINGLE-PERSPECTIVE INTERPRETATION. EXIT INTERVIEW COMMENTS WERE CONTENT ANALYZED USING A CARD SORT METHOD. THE STUDY WAS DESIGNED WITH A CULTURAL INFRASTRUCTURE INCLUDING A MULTICULTURAL RESEARCH TEAM, TRANSLATORS, AND BILINGUAL MATERIALS AND CLASSES, TO FACILITATE TRUST AND ACCEPTABILITY FOR PRIMARILY HISPANIC AND BLACK/AFRICAN-AMERICAN ADULTS. SETTING: WASHINGTON, D.C. METROPOLITAN AREA, USA. RESULTS: ON AVERAGE PARTICIPANTS ATTENDED 10 OF 16 CLASSES, WITH HOME PRACTICE 2-3DAYS A WEEK. ALL WHO COMPLETED WERE STILL PRACTICING YOGA THREE-MONTHS LATER. QUALITATIVE NARRATIVE ANALYSIS IDENTIFIED MAJOR THEMES RELATED TO FACILITATING FACTORS AND BARRIERS FOR YOGA PRACTICE, SELF-EFFICACY, AND SUPPORT. PARTICIPANT COMMENTS INDICATED THAT OFFERING AN ARTHRITIS-BASED YOGA INTERVENTION AND USING A CULTURALLY CONGRUENT RESEARCH DESIGN WAS FOUND TO BE ACCEPTABLE. CONCLUSIONS: AS YOGA RESEARCH GROWS, THERE IS A NEED TO UNDERSTAND AND PROMOTE ACCEPTABILITY FOR TYPICALLY UNDER-REPRESENTED POPULATIONS. THIS STUDY ATTEMPTS TO INFORM THE EXPANSION OF MULTICULTURAL RESEARCH DESIGNED TO RECRUIT AND RETAIN THOSE FROM DIVERSE BACKGROUNDS.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
5 2843  52 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
6 2831  51 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN CAUSES SUBSTANTIAL MORBIDITY AND COST TO SOCIETY WHILE DISPROPORTIONATELY IMPACTING LOW-INCOME AND MINORITY ADULTS. SEVERAL RANDOMIZED CONTROLLED TRIALS SHOW YOGA IS AN EFFECTIVE TREATMENT. HOWEVER, THE COMPARATIVE EFFECTIVENESS OF YOGA AND PHYSICAL THERAPY, A COMMON MAINSTREAM TREATMENT FOR CHRONIC LOW BACK PAIN, IS UNKNOWN. METHODS/DESIGN: THIS IS A RANDOMIZED CONTROLLED TRIAL FOR 320 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN, COMPARING YOGA, PHYSICAL THERAPY, AND EDUCATION. INCLUSION CRITERIA ARE ADULTS 18-64 YEARS OLD WITH NON-SPECIFIC LOW BACK PAIN LASTING >/= 12 WEEKS AND A SELF-REPORTED AVERAGE PAIN INTENSITY OF >/= 4 ON A 0-10 SCALE. RECRUITMENT TAKES PLACE AT BOSTON MEDICAL CENTER, AN URBAN ACADEMIC SAFETY-NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS LOCATED IN DIVERSE NEIGHBORHOODS. THE 52-WEEK STUDY HAS AN INITIAL 12-WEEK TREATMENT PHASE WHERE PARTICIPANTS ARE RANDOMIZED IN A 2:2:1 RATIO INTO I) A STANDARDIZED WEEKLY HATHA YOGA CLASS SUPPLEMENTED BY HOME PRACTICE; II) A STANDARDIZED EVIDENCE-BASED EXERCISE THERAPY PROTOCOL ADAPTED FROM THE TREATMENT BASED CLASSIFICATION METHOD, INDIVIDUALLY DELIVERED BY A PHYSICAL THERAPIST AND SUPPLEMENTED BY HOME PRACTICE; AND III) EDUCATION DELIVERED THROUGH A SELF-CARE BOOK. CO-PRIMARY OUTCOME MEASURES ARE 12-WEEK PAIN INTENSITY MEASURED ON AN 11-POINT NUMERICAL RATING SCALE AND BACK-SPECIFIC FUNCTION MEASURED USING THE MODIFIED ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 40-WEEK MAINTENANCE PHASE, YOGA PARTICIPANTS ARE RE-RANDOMIZED IN A 1:1 RATIO TO EITHER STRUCTURED MAINTENANCE YOGA CLASSES OR HOME PRACTICE ONLY. PHYSICAL THERAPY PARTICIPANTS ARE SIMILARLY RE-RANDOMIZED TO EITHER FIVE BOOSTER SESSIONS OR HOME PRACTICE ONLY. EDUCATION PARTICIPANTS CONTINUE TO FOLLOW RECOMMENDATIONS OF EDUCATIONAL MATERIALS. WE WILL ALSO ASSESS COST EFFECTIVENESS FROM THE PERSPECTIVES OF THE INDIVIDUAL, INSURERS, AND SOCIETY USING CLAIMS DATABASES, ELECTRONIC MEDICAL RECORDS, SELF-REPORT COST DATA, AND STUDY RECORDS. QUALITATIVE DATA FROM INTERVIEWS WILL ADD SUBJECTIVE DETAIL TO COMPLEMENT QUANTITATIVE DATA. TRIAL REGISTRATION: THIS TRIAL IS REGISTERED IN CLINICALTRIALS.GOV, WITH THE ID NUMBER: NCT01343927.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
7 2008  60 STUDY PROTOCOL FOR YOGA-BASED LIFESTYLE INTERVENTION FOR HEALTHY AGEING PHENOTYPE IN THE OLDER ADULTS (YHAP): A TWO-ARMED, WAITLIST RANDOMISED CONTROLLED TRIAL WITH MULTIPLE PRIMARY OUTCOMES. INTRODUCTION: THE CONCEPTUALISATION OF HEALTHY AGEING PHENOTYPE (HAP) AND THE AVAILABILITY OF A TENTATIVE PANEL FOR HAP BIOMARKERS RAISE THE NEED TO TEST THE EFFICACY OF POTENTIAL INTERVENTIONS TO PROMOTE HEALTH IN OLDER ADULTS. THIS STUDY PROTOCOL REPORTS THE METHODOLOGY FOR A 24-WEEK PROGRAMME TO EXPLORE THE HOLISTIC INFLUENCE OF THE YOGA-BASED INTERVENTION ON THE (BIO)MARKERS OF HAP. METHODS AND ANALYSIS: THE STUDY IS A TWO-ARMED, RANDOMISED WAITLIST CONTROLLED TRIAL WITH BLINDED OUTCOME ASSESSORS AND MULTIPLE PRIMARY OUTCOMES. WE AIM TO RECRUIT 250 SUBJECTS, AGED 60-80 YEARS FROM THE RESIDENTIAL COMMUNITIES AND OLD AGE CLUBS IN BANGALORE CITY, INDIA, WHO WILL UNDERGO RANDOMISATION INTO INTERVENTION OR CONTROL ARMS (1:1). THE INTERVENTION WILL INCLUDE A YOGA-BASED PROGRAMME TAILORED FOR THE OLDER ADULTS, 1 HOUR PER DAY FOR 6 DAYS A WEEK, SPREAD FOR 24 WEEKS. DATA WOULD BE COLLECTED AT THE BASELINE AND POST-INTERVENTION, THE 24TH WEEK. THE MULTIPLE PRIMARY OUTCOMES OF THE STUDY ARE THE (BIO)MARKERS OF HAP: GLYCATED HAEMOGLOBIN, LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C), SYSTOLIC BLOOD PRESSURE, AND FORCED EXPIRATORY VOLUME IN 1 S FOR PHYSIOLOGICAL AND METABOLIC HEALTH; DIGIT SYMBOL SUBSTITUTION TEST, TRAIL MAKING TESTS A AND B FOR COGNITION; HAND GRIP STRENGTH AND GAIT SPEED FOR PHYSICAL CAPABILITY; LONELINESS FOR SOCIAL WELL-BEING AND WHO QUALITY OF LIFE INSTRUMENT-SHORT FORM FOR QUALITY OF LIFE. THE SECONDARY OUTCOMES INCLUDE INFLAMMATORY MARKERS, TUMOUR NECROSIS FACTOR-ALPHA RECEPTOR II, C REACTIVE PROTEIN, INTERLEUKIN 6 AND SERUM KLOTHO LEVELS. ANALYSES WILL BE BY INTENTION-TO-TREAT AND THE HOLISTIC IMPACT OF YOGA ON HAP WILL BE ASSESSED USING GLOBAL STATISTICAL TEST. ETHICS AND DISSEMINATION: THE STUDY IS APPROVED BY THE INSTITUTIONAL ETHICS COMMITTEE OF SWAMI VIVEKANANDA YOGA ANUSANDHANA SAMSTHANA UNIVERSITY, BANGALORE (ID: RES/IEC-SVYASA/143/2019). WRITTEN INFORMED CONSENT WILL BE OBTAINED FROM EACH PARTICIPANT PRIOR TO INCLUSION. RESULTS WILL BE AVAILABLE THROUGH RESEARCH ARTICLES AND CONFERENCES. TRIAL REGISTRATION NUMBER: CTRI/2021/02/031373.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
8 1093  64 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
9 1224  39 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
10 2389  70 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	
                                                                                                                                                                                                                                                                                              
11 2861  60 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
12  199  44 A RESEARCH PROTOCOL FOR A PILOT, RANDOMIZED CONTROLLED TRIAL DESIGNED TO EXAMINE THE FEASIBILITY OF A DYADIC VERSUS INDIVIDUAL YOGA PROGRAM FOR FAMILY CAREGIVERS OF GLIOMA PATIENTS UNDERGOING RADIOTHERAPY. BACKGROUND: ALTHOUGH THE DIAGNOSIS AND TREATMENT OF A PRIMARY BRAIN TUMOR PRESENT UNIQUE CHALLENGES TO PATIENTS AND THEIR FAMILY CAREGIVERS, EVIDENCE-BASED SUPPORTIVE CARE INTERVENTIONS ARE GENERALLY LACKING. THE PRIMARY AIM OF THIS RESEARCH PROTOCOL IS TO DETERMINE THE FEASIBILITY OF IMPLEMENTING A DYADIC YOGA (DY) VERSUS A CAREGIVER YOGA (CY) INTERVENTION OR A WAIT-LIST CONTROL (WLC) GROUP USING A RANDOMIZED CONTROLLED TRIAL DESIGN. METHODS: SEVENTY-FIVE GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR FAMILY CAREGIVERS ARE RANDOMIZED TO THE DY, CY, OR A WLC GROUP. PATIENT-CAREGIVER DYADS IN THE DY GROUP AND CAREGIVERS IN THE CY GROUP RECEIVE 15 SESSIONS (45 MIN EACH) OVER THE COURSE OF PATIENTS' STANDARD RADIOTHERAPY (6 WEEKS). PATIENTS AND CAREGIVERS IN ALL GROUPS COMPLETE BASELINE ASSESSMENTS OF SYMPTOMS, QUALITY OF LIFE (QOL), AND HEALTH UTILIZATION OUTCOMES PRIOR TO RANDOMIZATION. FOLLOW-UP ASSESSMENTS ARE PERFORMED 6 WEEKS AND THEN AGAIN 3 MONTHS LATER. THE PRIMARY OUTCOME IS FEASIBILITY (I.E., >/= 50% OF ELIGIBLE DYADS CONSENT, >/= 70% OF ENROLLED DYADS COMPLETE ALL ASSESSMENTS, AND >/= 50% OF ALL PRACTICE SESSIONS ARE ATTENDED). WE WILL ALSO PERFORM PRIMARILY DESCRIPTIVE ANALYSES OF THE SELF-REPORTED OUTCOMES (E.G., FATIGUE, OVERALL QOL) AND EXPLORE POTENTIAL INTERVENTION MODERATORS (E.G., PERFORMANCE STATUS) TO INFORM A LARGER FUTURE TRIAL. CONCLUSION: THIS TRIAL WILL PROVIDE IMPORTANT INFORMATION REGARDING THE FEASIBILITY OF A DYADIC VERSUS A CAREGIVER YOGA INTERVENTION REGARDING SYMPTOM, QOL, AND HEALTH UTILIZATION OUTCOMES IN GLIOMA PATIENTS AND THEIR CAREGIVERS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT02481349.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
13 2638  43 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
14  122  47 A PILOT STUDY OF YOGA AS SELF-CARE FOR ARTHRITIS IN MINORITY COMMUNITIES. BACKGROUND: WHILE ARTHRITIS IS THE MOST COMMON CAUSE OF DISABILITY, NON-HISPANIC BLACKS AND HISPANICS EXPERIENCE WORSE ARTHRITIS IMPACT DESPITE HAVING THE SAME OR LOWER PREVALENCE OF ARTHRITIS COMPARED TO NON-HISPANIC WHITES. PEOPLE WITH ARTHRITIS WHO EXERCISE REGULARLY HAVE LESS PAIN, MORE ENERGY, AND IMPROVED SLEEP, YET ARTHRITIS IS ONE OF THE MOST COMMON REASONS FOR LIMITING PHYSICAL ACTIVITY. MIND-BODY INTERVENTIONS, SUCH AS YOGA, THAT TEACH STRESS MANAGEMENT ALONG WITH PHYSICAL ACTIVITY MAY BE WELL SUITED FOR INVESTIGATION IN BOTH OSTEOARTHRITIS AND RHEUMATOID ARTHRITIS. YOGA USERS ARE PREDOMINANTLY WHITE, FEMALE, AND COLLEGE EDUCATED. THERE ARE FEW STUDIES THAT EXAMINE YOGA IN MINORITY POPULATIONS; NONE ADDRESS ARTHRITIS. THIS PAPER PRESENTS A STUDY PROTOCOL EXAMINING THE FEASIBILITY AND ACCEPTABILITY OF PROVIDING YOGA TO AN URBAN, MINORITY POPULATION WITH ARTHRITIS. METHODS/DESIGN: IN THIS ONGOING PILOT STUDY, A CONVENIENCE SAMPLE OF 20 MINORITY ADULTS DIAGNOSED WITH EITHER OSTEOARTHRITIS OR RHEUMATOID ARTHRITIS UNDERGO AN 8-WEEK PROGRAM OF YOGA CLASSES. IT IS BELIEVED THAT BY ATTENDING YOGA CLASSES DESIGNED FOR PATIENTS WITH ARTHRITIS, WITH RACIALLY CONCORDANT INSTRUCTORS; ACCEPTABILITY OF YOGA AS AN ADJUNCT TO STANDARD ARTHRITIS TREATMENT AND SELF-CARE WILL BE ENHANCED. SELF-CARE IS DEFINED AS ADOPTING BEHAVIORS THAT IMPROVE PHYSICAL AND MENTAL WELL-BEING. THIS CONCEPT IS QUANTIFIED THROUGH COLLECTING PATIENT-REPORTED OUTCOME MEASURES RELATED TO SPIRITUAL GROWTH, HEALTH RESPONSIBILITY, INTERPERSONAL RELATIONS, AND STRESS MANAGEMENT. ADDITIONAL MEASURES COLLECTED DURING THIS STUDY INCLUDE: PHYSICAL FUNCTION, ANXIETY/DEPRESSION, FATIGUE, SLEEP DISTURBANCE, SOCIAL ROLES, AND PAIN; AS WELL AS BASELINE DEMOGRAPHIC AND CLINICAL DATA. FIELD NOTES, QUANTITATIVE AND QUALITATIVE DATA REGARDING FEASIBILITY AND ACCEPTABILITY ARE ALSO COLLECTED. ACCEPTABILITY IS DETERMINED BY RESPONSE/RETENTION RATES, POSITIVE QUALITATIVE DATA, AND CONTINUING YOGA PRACTICE AFTER THREE MONTHS. DISCUSSION: THERE ARE A NUMBER OF CHALLENGES IN RECRUITING AND RETAINING PARTICIPANTS FROM A COMMUNITY CLINIC SERVING MINORITY POPULATIONS. ADOPTING BEHAVIORS THAT IMPROVE WELL-BEING AND QUALITY OF LIFE INCLUDE THOSE THAT INTEGRATE MENTAL HEALTH (MIND) AND PHYSICAL HEALTH (BODY). FEW STUDIES HAVE EXAMINED OFFERING INTEGRATIVE MODALITIES TO THIS POPULATION. THIS PILOT WAS UNDERTAKEN TO QUANTIFY MEASURES OF FEASIBILITY AND ACCEPTABILITY THAT WILL BE USEFUL WHEN EVALUATING FUTURE PLANS FOR EXPANDING THE STUDY OF YOGA IN URBAN, MINORITY POPULATIONS WITH ARTHRITIS. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT01617421.	2013	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
15 2824  55 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
16 2596  48 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
17  518  35 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
18 2441  46 YOGA AND SCHIZOPHRENIA-A COMPREHENSIVE ASSESSMENT OF NEUROPLASTICITY: PROTOCOL FOR A SINGLE BLIND RANDOMIZED CONTROLLED STUDY OF YOGA IN SCHIZOPHRENIA. INTRODUCTION: SCHIZOPHRENIA IS ONE OF THE MOST SEVERE MENTAL DISORDERS WITH A PREVALENCE OF ABOUT 1% AND A LEADING CAUSE OF DISABILITY AMONG YOUNG ADULTS. PHARMACOTHERAPY IS THE MAINSTAY IN THE MANAGEMENT OF SCHIZOPHRENIA. HOWEVER, EVEN WITH THE BEST OF MEDICATION, SEVERAL PROBLEMS LIKE REFRACTORINESS, NEGATIVE SYMPTOMS, FREQUENT RELAPSES, AND COGNITIVE IMPAIRMENTS PERSIST. METHODS: THIS IS A RANDOMIZED-CONTROLLED CLINICAL STUDY INCLUDING PATIENTS FROM AN URBAN TERTIARY HOSPITAL AND A SEMI-URBAN COMMUNITY CENTER, WITH A BETWEEN-GROUP, REPEATED-MEASURES, LONGITUDINAL DESIGN. THIS STUDY WILL RECRUIT 160 PATIENTS WITH DSM 5 DIAGNOSIS OF SCHIZOPHRENIA WHO ARE ON STABLE MEDICATION FOR A MINIMUM OF 6 WEEKS; THEY WILL BE RANDOMLY ASSIGNED INTO 2 ARMS VIZ., YOGA THERAPY (YT), AND TREATMENT-AS-USUAL (TAU) WITH 80 PATIENTS IN EACH ARM. PARTICIPANTS WILL UNDERGO CLINICAL, LABORATORY, AND RADIOLOGICAL ASSESSMENTS AT BASELINE AND AT INTERVALS OF 1 MONTH, 3 MONTHS, AND 6 MONTHS FROM THE BASELINE. IT IS HYPOTHESIZED THAT YOGA WILL IMPROVE PSYCHOPATHOLOGY AND EMOTION PROCESSING, INCREASE SERUM BRAIN DERIVED NEUROTROPHIC FACTOR (BDNF) AND PLASMA OXYTOCIN LEVELS AND EFFECT CHANGES IN CEREBRAL ACTIVATION IN AREAS OF THE BRAIN ASSOCIATED WITH SCHIZOPHRENIA. DISCUSSION: THIS STUDY AIMS TO MEASURE THE EFFICACY OF A YOGA-BASED INTERVENTION AS AN ADJUNCT IN PATIENTS WITH SCHIZOPHRENIA AS WELL AS THE MECHANISMS OF THESE EFFECTS. TRIAL REGISTRATION: REGISTERED RETROSPECTIVELY WITH CLINICAL TRIAL REGISTRY - INDIA (CTRI) WITH REGISTRATION NUMBER CTRI/2017/08/009219.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
19 2763  35 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
20  217  49 A STUDY PROTOCOL OF A THREE-GROUP RANDOMIZED FEASIBILITY TRIAL OF AN ONLINE YOGA INTERVENTION FOR MOTHERS AFTER STILLBIRTH (THE MINDFUL HEALTH STUDY). BACKGROUND: IN THE USA, STILLBIRTH (IN UTERO FETAL DEATH >/=20 WEEKS GESTATION) IS A MAJOR PUBLIC HEALTH ISSUE. WOMEN WHO EXPERIENCE STILLBIRTH, COMPARED TO WOMEN WITH LIVE BIRTH, HAVE A NEARLY SEVENFOLD INCREASED RISK OF A POSITIVE SCREEN FOR POST-TRAUMATIC STRESS DISORDER (PTSD) AND A FOURFOLD INCREASED RISK OF DEPRESSIVE SYMPTOMS. BECAUSE THE MAJORITY OF WOMEN WHO HAVE EXPERIENCED THE DEATH OF THEIR BABY BECOME PREGNANT WITHIN 12-18 MONTHS AND THE LACK OF INTERVENTION STUDIES CONDUCTED WITHIN THIS POPULATION, NOVEL APPROACHES TARGETING PHYSICAL AND MENTAL HEALTH, SPECIFIC TO THE NEEDS OF THIS POPULATION, ARE CRITICAL. EVIDENCE SUGGESTS THAT YOGA IS EFFICACIOUS, SAFE, ACCEPTABLE, AND COST-EFFECTIVE FOR IMPROVING MENTAL HEALTH IN A VARIETY OF POPULATIONS, INCLUDING PREGNANT AND POSTPARTUM WOMEN. TO DATE, THERE ARE NO KNOWN STUDIES EXAMINING ONLINE-STREAMING YOGA AS A STRATEGY TO HELP MOTHERS COPE WITH PTSD SYMPTOMS AFTER STILLBIRTH. METHODS: THE PRESENT STUDY IS A TWO-PHASE RANDOMIZED CONTROLLED TRIAL. PHASE 1 WILL INVOLVE (1) AN ITERATIVE DESIGN PROCESS TO DEVELOP THE ONLINE YOGA PRESCRIPTION FOR PHASE 2 AND (2) QUALITATIVE INTERVIEWS TO IDENTIFY CULTURAL BARRIERS TO RECRUITMENT IN NON-CAUCASIAN WOMEN (I.E., PREDOMINATELY HISPANIC AND/OR AFRICAN AMERICAN) WHO HAVE EXPERIENCED STILLBIRTH (N = 5). PHASE 2 IS A THREE-GROUP RANDOMIZED FEASIBILITY TRIAL WITH ASSESSMENTS AT BASELINE, AND AT 12 AND 20 WEEKS POST-INTERVENTION. NINETY WOMEN WHO HAVE EXPERIENCED A STILLBIRTH WITHIN 6 WEEKS TO 24 MONTHS WILL BE RANDOMIZED INTO ONE OF THE FOLLOWING THREE ARMS FOR 12 WEEKS: (1) INTERVENTION LOW DOSE (LD) = 60 MIN/WEEK ONLINE-STREAMING YOGA (N = 30), (2) INTERVENTION MODERATE DOSE (MD) = 150 MIN/WEEK ONLINE-STREAMING YOGA (N = 30), OR (3) STRETCH AND TONE CONTROL (STC) GROUP = 60 MIN/WEEK OF STRETCHING/TONING EXERCISES (N = 30). DISCUSSION: THIS STUDY WILL EXPLORE THE FEASIBILITY AND ACCEPTABILITY OF A 12-WEEK, HOME-BASED, ONLINE-STREAMED YOGA INTERVENTION, WITH VARYING DOSES AMONG MOTHERS AFTER A STILLBIRTH. IF FEASIBLE, THE FINDINGS FROM THIS STUDY WILL INFORM A FULL-SCALE TRIAL TO DETERMINE THE EFFECTIVENESS OF HOME-BASED ONLINE-STREAMED YOGA TO IMPROVE PTSD. LONG-TERM, HEALTH CARE PROVIDERS COULD USE ONLINE YOGA AS A NON-PHARMACEUTICAL, INEXPENSIVE RESOURCE FOR STILLBIRTH AFTERCARE. TRIAL REGISTRATION: NCT02925481.	2018