1 1181 107 EVALUATION OF THE FEASIBILITY OF A HOME-BASED TELEYOGA INTERVENTION IN PARTICIPANTS WITH BOTH CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND HEART FAILURE. OBJECTIVE: TEST THE FEASIBILITY AND CLINICAL OUTCOMES OF A HOME-BASED VIDEOCONFERENCING YOGA INTERVENTION IN PARTICIPANTS DIAGNOSED WITH BOTH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND HEART FAILURE (HF). BACKGROUND: YOGA HAS POTENTIAL BENEFIT FOR SYMPTOM RELIEF IN PARTICIPANTS WITH COPD AND WITH HF; HOWEVER, FUNCTIONAL IMPAIRMENT AND TRANSPORTATION ISSUES CAN HINDER ACCESS TO TYPICAL YOGA CLASSES. METHODS: A CONTROLLED, NONRANDOMIZED TRIAL WAS CONDUCTED OF AN 8-WEEK TELEYOGA INTERVENTION VERSUS AN EDUCATIONAL CONTROL (INFORMATION LEAFLETS MAILED TO PARTICIPANTS WITH ONE WEEKLY PHONE CALL). ONE-HOUR TELEYOGA CLASSES WERE IMPLEMENTED TWICE WEEKLY VIA MULTIPOINT VIDEOCONFERENCING, WHICH CONNECTED PARTICIPANTS TO LIVE CLASSES VIA AN INTERNET CONNECTION TO THEIR TELEVISIONS. RESULTS: FOURTEEN PARTICIPANTS WITH COPD AND HF TOOK PART IN THE PILOT STUDY (7 IN THE INTERVENTION GROUP AND 8 IN THE CONTROL). INTERVENTION PARTICIPANTS WERE ADHERENT TO CLASSES, ABLE TO SAFELY PARTICIPATE, AND FOUND THE CLASSES ENJOYABLE AFTER THE 8-WEEK PROGRAM. DYSPNEA AFTER EXERCISE IMPROVED IN THE INTERVENTION GROUP. CONCLUSIONS: DESPITE THEIR FRAILTY, PATIENTS DIAGNOSED WITH BOTH COPD AND HF WERE ABLE TO PERFORM YOGA SAFELY IN THE HOME SETTING. TELEYOGA WAS ACCEPTABLE AND ADHERENCE WAS GOOD; HOWEVER, TECHNICAL ISSUES WERE AN IMPORTANT HINDRANCE TO PARTICIPATION. 2017 2 1872 20 RAPID CONVERSION OF A GROUP-BASED YOGA TRIAL FOR DIVERSE OLDER WOMEN TO HOME-BASED TELEHEALTH: LESSONS LEARNED USING ZOOM TO DELIVER MOVEMENT-BASED INTERVENTIONS. THIS BRIEF REPORT DESCRIBES THE RAPID CONVERSION OF A RANDOMIZED TRIAL OF A HATHA-BASED YOGA PROGRAM FOR OLDER WOMEN WITH URINARY INCONTINENCE TO A TELEHEALTH VIDEOCONFERENCE PLATFORM DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PANDEMIC. INTERIM RESULTS DEMONSTRATE THE FEASIBILITY OF RECRUITING AND RETAINING PARTICIPANTS ACROSS A WIDE RANGE OF AGES AND ETHNIC BACKGROUNDS, BUT ALSO POINT TO POTENTIAL OBSTACLES AND SAFETY CONCERNS ARISING FROM TELEHEALTH-BASED INSTRUCTION. THE INVESTIGATORS PRESENT LESSONS LEARNED ABOUT THE BENEFITS AND CHALLENGES OF USING TELEHEALTH PLATFORMS TO DELIVER MOVEMENT-BASED INTERVENTIONS AND CONSIDER STRATEGIES TO PROMOTE ACCESSIBLE AND WELL-TOLERATED TELEHEALTH-BASED YOGA PROGRAMS FOR OLDER AND DIVERSE POPULATIONS. CLINICAL TRIAL REGISTRATION NUMBER: NCT03672461. 2022 3 2360 32 VIDEOCONFERENCED YOGA INTERVENTIONS FOR CANCER PATIENTS AND THEIR CAREGIVERS DURING THE COVID-19 PANDEMIC: A REPORT FROM A CLINICIAN'S PERSPECTIVE. BACKGROUND: THE ACCEPTABILITY OF VIDEOCONFERENCING DELIVERY OF YOGA INTERVENTIONS IN THE ADVANCED CANCER SETTING IS RELATIVELY UNEXPLORED. THE CURRENT REPORT SUMMARIZES THE CHALLENGES AND SOLUTIONS OF THE TRANSITION FROM AN IN-PERSON (IE, FACE-TO-FACE) TO A VIDEOCONFERENCE INTERVENTION DELIVERY APPROACH IN RESPONSE TO THE CORONAVIRUS DISEASE PANDEMIC. METHOD: PARTICIPANTS INCLUDED PATIENT-FAMILY CAREGIVER DYADS WHO WERE ENROLLED IN ONGOING YOGA TRIALS AND 2 CERTIFIED YOGA THERAPISTS WHO DELIVERED THE YOGA SESSIONS. WE SUMMARIZED THEIR EXPERIENCES USING RECORDINGS OF THE YOGA SESSIONS AND INTERVENTIONISTS' PROGRESS NOTES. RESULTS: OUT OF 7 DYADS PARTICIPATING IN THE PARENT TRIAL, 1 DECLINED THE VIDEOCONFERENCED SESSIONS. PARTICIPANTS WERE BETWEEN THE AGES OF 55 AND 76 AND MOSTLY NON-HISPANIC WHITE (83%). PATIENTS WERE MAINLY MALE (83%), ALL HAD STAGE III OR IV CANCER AND WERE UNDERGOING RADIOTHERAPY. CAREGIVERS WERE ALL FEMALE. DESPITE CHALLENGES IN THE AREAS OF TECHNOLOGY, LOCATION, AND SETTING, INSTRUCTION AND PERSONAL CONNECTION, THE OVERALL ACCEPTABILITY WAS HIGH AMONG PATIENTS, CAREGIVERS, AND INSTRUCTORS. THROUGH THIS TRANSITION PROCESS, SOLUTIONS TO THESE CHALLENGES WERE FOUND, WHICH ARE DESCRIBED HERE. CONCLUSION: ALTHOUGH IN-PERSON INTERVENTIONS ARE FAVORED BY BOTH THE STUDY PARTICIPANTS AND THE INTERVENTIONISTS, VIDEOCONFERENCE SESSIONS WERE DEEMED ACCEPTABLE. ALL PARTICIPANTS HAD THE BENEFIT OF A PREVIOUS IN-PERSON EXPERIENCE, WHICH WAS HELPFUL AND PERHAPS NECESSARY FOR OLDER AND ADVANCED CANCER PATIENTS REQUIRING PRACTICE MODIFICATIONS. IN A REMOTE SETTING, THE ASSISTANCE OF CAREGIVERS SEEMS PARTICULARLY BENEFICIAL TO ENSURE PRACTICE SAFETY. CLINICALTRIALS.GOV: NCT03948100; NCT02481349. 2021 4 551 33 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 5 336 70 APPROPRIATENESS AND ACCEPTABILITY OF A TELE-YOGA INTERVENTION FOR PEOPLE WITH HEART FAILURE AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE: QUALITATIVE FINDINGS FROM A CONTROLLED PILOT STUDY. BACKGROUND: HEART FAILURE (HF) AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ARE HIGHLY PREVALENT AND ASSOCIATED WITH A LARGE SYMPTOM BURDEN, THAT IS COMPOUNDED IN A DUAL HF-COPD DIAGNOSIS. YOGA HAS POTENTIAL BENEFIT FOR SYMPTOM RELIEF; HOWEVER FUNCTIONAL IMPAIRMENT HINDERS ACCESS TO USUAL YOGA CLASSES. WE DEVELOPED A TELE-YOGA INTERVENTION AND EVALUATED IT IN A CONTROLLED PILOT TRIAL. THIS PAPER REPORTS ON THE APPROPRIATENESS AND ACCEPTABILITY OF THE INTERVENTION AND THE EVALUATION DESIGN. METHODS: A CONTROLLED, NON-RANDOMISED TRIAL WAS CONDUCTED OF AN 8-WEEK TELE-YOGA INTERVENTION VERSUS AN EDUCATIONAL CONTROL (INFORMATION LEAFLETS MAILED TO PARTICIPANTS WITH ONE PHONE CALL A WEEK). BIWEEKLY ONE-HOUR TELE-YOGA CLASSES WERE IMPLEMENTED VIA MULTIPOINT VIDEOCONFERENCING THAT CONNECTED PARTICIPANTS TO LIVE CLASSES VIA AN INTERNET CONNECTION TO THEIR TELEVISIONS. SEMI-STRUCTURED QUALITATIVE INTERVIEWS WERE CONDUCTED WITH PARTICIPANTS POST STUDY EXIT TO EXPLORE REASONS FOR AND EXPERIENCES OF PARTICIPATING, INCLUDING VIEWS OF STUDY OUTCOME MEASURES AND PHYSIOLOGICAL TESTS. TRANSCRIBED INTERVIEWS WERE ANALYSED USING THEMATIC CONTENT ANALYSIS. RESULTS: FIFTEEN PEOPLE PARTICIPATED IN THE PILOT STUDY (7 IN THE INTERVENTION GROUP, 8 IN THE CONTROL). OF THESE, 12 PARTICIPANTS WERE INTERVIEWED, 6 IN EACH GROUP, MEAN AGE 71.2 YEARS (SD 10.09); 3 WERE MALE. THEMES ARE REPORTED IN THE FOLLOWING CATEGORIES: ACCEPTABILITY AND APPROPRIATENESS OF THE INTERVENTION, POTENTIAL ACTIVE INGREDIENTS OF THE INTERVENTION, ACCEPTABILITY AND APPROPRIATENESS OF THE CONTROL, PARTICIPATION IN THE RESEARCH, AND ACCEPTABILITY OF THE TESTING PROCEDURES. THE INTERVENTION WAS ACCEPTABLE AND APPROPRIATE: THE INTERVENTION GROUP REPORTED ENJOYING YOGA AND VALUING THE HOME-BASED ASPECT AND PARTICIPANTS DESCRIBED A HIGH SYMPTOM BURDEN AND SOCIAL ISOLATION. HOWEVER, TECHNOLOGICAL PROBLEMS RESULTED IN POOR VIDEO-STREAMING QUALITY FOR SOME PARTICIPANTS. POTENTIAL ACTIVE INGREDIENTS INCLUDED PHYSICAL POSTURES, BREATHING EXERCISES AND GUIDANCE IN RELAXATION AND MEDITATION. THE EDUCATIONAL CONTROL INTERVENTION WAS ACCEPTABLE AND APPROPRIATE, WITH PARTICIPANTS REPORTING LITTLE EFFECT ON THEIR WELL-BEING AND NO IMPACT ON MECHANISMS HYPOTHESISED TO EXPLAIN YOGA'S EFFECTIVENESS. THE QUESTIONNAIRES AND HOME PHYSIOLOGICAL TESTING WERE ACCEPTABLE TO PARTICIPANTS. CONCLUSIONS: TELE-YOGA IS AN ACCEPTABLE AND APPROPRIATE INTERVENTION IN PEOPLE WITH HF AND COPD AND FURTHER RESEARCH IS WARRANTED TO REFINE THE TECHNOLOGY USED IN ITS DELIVERY. FINDINGS PROVIDE GUIDANCE FOR RESEARCHERS WORKING IN TELE-INTERVENTIONS, YOGA, AND SIMILAR POPULATIONS. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT02078739 (4 MARCH 2014). 2015 6 2389 47 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 7 2019 24 SYNCHRONOUS TELEHEALTH YOGA AND COGNITIVE PROCESSING GROUP THERAPIES FOR WOMEN VETERANS WITH POSTTRAUMATIC STRESS DISORDER: A MULTISITE RANDOMIZED CONTROLLED TRIAL ADAPTED FOR COVID-19. BACKGROUND: PROVIDING CARE OVER TELEHEALTH GREW SLOWLY UNTIL THE COVID-19 PANDEMIC. SINCE THE ONSET OF THE COVID-19 PANDEMIC, PROVIDING MENTAL HEALTH CARE WAS READILY ADAPTED TO VIRTUAL MEANS; HOWEVER, CLINICAL TRIAL RESEARCH IS NASCENT IN ADAPTING METHODS AND PROCEDURES TO THE VIRTUAL WORLD. METHODS: WE PRESENT PROTOCOL MODIFICATIONS TO PIVOT A MULTISITE RANDOMIZED CONTROLLED TRIAL STUDY, CONDUCTED AT SOUTHEASTERN AND PACIFIC NORTHWESTERN VETERANS AFFAIRS HEALTH CARE SYSTEMS, FROM BEING CONDUCTED IN-PERSON TO VIRTUALLY, FOLLOWING THE ONSET OF THE COVID-19 PANDEMIC. WE MEASURED OUTCOMES OF POSTTRAUMATIC STRESS DISORDER (PTSD) SYMPTOMS AND PSYCHOPHYSIOLOGICAL MARKERS OF STRESS AMONG FEMALE VETERANS WITH PTSD SECONDARY TO MILITARY SEXUAL TRAUMA. WE COLLECTED QUALITATIVE DATA ABOUT PROVIDER AND PARTICIPANT EXPERIENCES WITH TELEHEALTH. RESULTS: ACROSS SITES, 200 PARTICIPANTS WERE CONSENTED (48 VIRTUALLY), 132 WERE RANDOMIZED (28 TO VIRTUAL GROUPS), AND 117 COMPLETED DATA COLLECTION AND TREATMENT (69 COMPLETED ALL OR SOME DATA COLLECTION OR TREATMENT VIRTUALLY). CONCLUSIONS: THE PIVOTS MADE FOR THIS STUDY WERE IN RESPONSE TO THE COVID-19 PANDEMIC AND OFFER INNOVATIVE PROCEDURES LEVERAGING TECHNOLOGY AND CONTRIBUTING TO THE BROADER LANDSCAPE OF CONDUCTING RESEARCH VIRTUALLY. CLINICAL TRIALS NUMBER: NCT02640690. 2022 8 2763 31 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 9 144 32 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 10 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 11 2831 25 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 12 2035 20 TELE-YOGA FOR CHRONIC PAIN: CURRENT STATUS AND FUTURE DIRECTIONS. PAIN IS A PERVASIVE, DEBILITATING DISORDER THAT IS RESISTANT TO LONG-TERM PHARMACOLOGICAL INTERVENTIONS. ALTHOUGH PSYCHOLOGICAL THERAPIES SUCH AS COGNITIVE BEHAVIOR THERAPY DEMONSTRATE MODERATE EFFICACY, MANY INDIVIDUALS CONTINUE TO HAVE ONGOING DIFFICULTIES FOLLOWING TREATMENT. THERE IS A CURRENT TREND TO ESTABLISH COMPLEMENTARY AND INTEGRATIVE HEALTH INTERVENTIONS FOR CHRONIC PAIN, FOR WHICH YOGA HAS BEEN FOUND TO HAVE EXCITING POTENTIAL. NEVERTHELESS, AN IMPORTANT CONSIDERATION WITHIN THE FIELD IS ACCESSIBILITY TO ADEQUATE CARE. TELEHEALTH CAN BE USED TO PROVIDE REAL-TIME INTERACTIVE VIDEO CONFERENCING LEADING TO INCREASED ACCESS TO HEALTH CARE FOR INDIVIDUALS LOCATED REMOTELY OR WHO OTHERWISE HAVE DIFFICULTY ACCESSING SERVICES, PERHAPS THROUGH ISSUES OF MOBILITY OR PROXIMITY OF ADEQUATE SERVICES. THIS ARTICLE ASSESSES THE CURRENT STATUS AND FEASIBILITY OF IMPLEMENTING TELE-YOGA FOR CHRONIC PAIN. METHODOLOGICAL LIMITATIONS AND RECOMMENDATIONS FOR FUTURE RESEARCH ARE DISCUSSED. 2018 13 258 35 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 14 199 32 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 15 217 28 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 16 1903 31 RESULTS FROM A CLINICAL YOGA PROGRAM FOR VETERANS: YOGA VIA TELEHEALTH PROVIDES COMPARABLE SATISFACTION AND HEALTH IMPROVEMENTS TO IN-PERSON YOGA. BACKGROUND: YOGA IS INCREASINGLY POPULAR, THOUGH LITTLE DATA REGARDING ITS IMPLEMENTATION IN HEALTHCARE SETTINGS IS AVAILABLE. SIMILARLY, TELEHEALTH IS BEING UTILIZED MORE FREQUENTLY TO INCREASE ACCESS TO HEALTHCARE; HOWEVER WE KNOW OF NO RESEARCH ON THE ACCEPTABILITY OR EFFECTIVENESS OF YOGA DELIVERED THROUGH TELEHEALTH. THEREFORE, WE EVALUATED THE FEASIBILITY, ACCEPTABILITY, AND PATIENT-REPORTED EFFECTIVENESS OF A CLINICAL YOGA PROGRAM AT A VETERANS AFFAIRS MEDICAL CENTER AND ASSESSED WHETHER THESE OUTCOMES DIFFERED BETWEEN THOSE PARTICIPATING IN-PERSON AND THOSE PARTICIPATING VIA TELEHEALTH. METHODS: VETERANS WHO ATTENDED A YOGA CLASS AT THE VA PALO ALTO HEALTH CARE SYSTEM WERE INVITED TO COMPLETE AN ANONYMOUS PROGRAM EVALUATION SURVEY. RESULTS: 64 VETERANS COMPLETED THE SURVEY. PARTICIPANTS REPORTED HIGH SATISFACTION WITH THE CLASSES AND THE INSTRUCTORS. MORE THAN 80% OF PARTICIPANTS WHO ENDORSED A PROBLEM WITH PAIN, ENERGY LEVEL, DEPRESSION, OR ANXIETY REPORTED IMPROVEMENT IN THESE SYMPTOMS. THOSE WHO PARTICIPATED VIA TELEHEALTH DID NOT DIFFER FROM THOSE WHO PARTICIPATED IN-PERSON IN ANY MEASURE OF SATISFACTION, OVERALL IMPROVEMENT (P = .40), OR IMPROVEMENT IN ANY OF 16 SPECIFIC HEALTH PROBLEMS. CONCLUSIONS: DELIVERING YOGA TO A WIDE RANGE OF PATIENTS WITHIN A HEALTHCARE SETTING APPEARS TO BE FEASIBLE AND ACCEPTABLE, BOTH WHEN DELIVERED IN-PERSON AND VIA TELEHEALTH. PATIENTS IN THIS CLINICAL YOGA PROGRAM REPORTED HIGH LEVELS OF SATISFACTION AND IMPROVEMENT IN MULTIPLE PROBLEM AREAS. THIS PRELIMINARY EVIDENCE FOR THE EFFECTIVENESS OF A CLINICAL YOGA PROGRAM COMPLEMENTS PRIOR EVIDENCE FOR THE EFFICACY OF YOGA AND SUPPORTS THE USE OF YOGA IN HEALTHCARE SETTINGS. 2017 17 41 34 A BRIEF YOGA INTERVENTION IMPLEMENTED DURING CHEMOTHERAPY: A RANDOMIZED CONTROLLED PILOT STUDY. OBJECTIVES: FATIGUE AND OTHER TREATMENT-RELATED SYMPTOMS (E.G., SLEEP DISTURBANCE) ARE CRITICAL TARGETS FOR IMPROVING QUALITY OF LIFE IN PATIENTS UNDERGOING CHEMOTHERAPY. YOGA MAY REDUCE THE BURDEN OF SUCH SYMPTOMS. THIS STUDY INVESTIGATED THE FEASIBILITY OF CONDUCTING A RANDOMIZED CONTROLLED STUDY OF A BRIEF YOGA INTERVENTION DURING CHEMOTHERAPY FOR COLORECTAL CANCER. DESIGN: WE RANDOMIZED ADULTS WITH COLORECTAL CANCER TO A BRIEF YOGA SKILLS TRAINING (YST) OR AN ATTENTION CONTROL (AC; EMPATHIC ATTENTION AND RECORDED EDUCATION). SETTING: THE INTERVENTIONS AND ASSESSMENTS WERE IMPLEMENTED INDIVIDUALLY IN THE CLINIC WHILE PATIENTS WERE IN THE CHAIR RECEIVING CHEMOTHERAPY. INTERVENTIONS: BOTH INTERVENTIONS CONSISTED OF THREE SESSIONS AND RECOMMENDED HOME PRACTICE. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS FEASIBILITY (ACCRUAL, RETENTION, ADHERENCE, DATA COLLECTION). SELF-REPORTED OUTCOMES (I.E., FATIGUE, SLEEP DISTURBANCE, QUALITY OF LIFE) AND INFLAMMATORY BIOMARKERS WERE ALSO DESCRIBED TO INFORM FUTURE STUDIES. RESULTS: OF 52 PATIENTS INITIALLY IDENTIFIED, 28 WERE APPROACHED, AND 15 ENROLLED (AGE MEAN = 57.5 YEARS; 80% WHITE; 60% MALE). REASONS FOR DECLINING PARTICIPATION WERE: NOT INTERESTED (N = 6), DID NOT PERCEIVE A NEED (N = 2), AND OTHER (N = 5). TWO PARTICIPANTS WERE LOST TO FOLLOW-UP IN EACH GROUP DUE TO TREATMENT CHANGES. THUS, 75% OF PARTICIPANTS WERE RETAINED IN THE YST AND 71% IN THE AC ARM. PARTICIPANTS RETAINED IN THE STUDY ADHERED TO 97% OF THE IN-PERSON INTERVENTION SESSIONS AND COMPLETED ALL QUESTIONNAIRES. CONCLUSIONS: THIS STUDY DEMONSTRATED THE FEASIBILITY OF CONDUCTING A LARGER RANDOMIZED CONTROLLED TRIAL TO ASSESS YST AMONG PATIENTS RECEIVING CHEMOTHERAPY FOR COLORECTAL CANCER. DATA COLLECTED AND CHALLENGES ENCOUNTERED WILL INFORM FUTURE RESEARCH. 2016 18 2036 41 TELE-YOGA IN LONG TERM ILLNESS-PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL INCLUDING A PROCESS EVALUATION AND RESULTS FROM A PILOT STUDY. BACKGROUND: FOR PEOPLE WITH LONG-TERM ILLNESS, DEBILITATED BY SEVERE SYMPTOMS, IT CAN BE DIFFICULT TO ATTEND REGULAR YOGA CLASSES. WE HAVE THEREFORE DEVELOPED A TELE-HEALTH FORMAT OF YOGA THAT CAN BE DELIVERED IN THE HOME. THE TELE-YOGA WAS CO-DESIGNED WITH MEMBERS OF A PATIENT-ORGANISATION, YOGA-INSTRUCTOR, AND IT-TECHNICIAN. IT INCLUDES LIVE-STREAMED GROUP-YOGA SESSIONS TWICE A WEEK AND AN APP WITH INSTRUCTIONS ON HOW TO SELF-PERFORM YOGA. AIM: TO DESCRIBE A STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL (RCT) INCLUDING A PROCESS EVALUATION AND REPORT ON A PILOT STUDY EVALUATING METHOD- AND INTERVENTION-RELATED COMPONENTS INCLUDING FEASIBILITY, SAFETY, AND EFFICACY. METHODS: TEN PARTICIPANTS WITH HEART FAILURE AGED BETWEEN 41-76 YEARS WERE RANDOMISED TO TELE-YOGA (N = 5) OR TO THE CONTROL GROUP (N = 5). IN THE PILOT STUDY RECRUITMENT, ENROLMENT, RANDOMISATION, AND DATA COLLECTION OF ALL OUTCOMES INCLUDING PRIMARY, SECONDARY AND PROCESS EVALUATION MEASURES WERE TESTED ACCORDING TO THE STUDY PROTOCOL. FIDELITY, ADHERENCE AND ACCEPTABILITY TO THE TELE-YOGA GROUP TRAINING AND APP USE WAS DETERMINED. SAFETY WAS ASSESSED BY ADVERSE EVENTS. RESULTS: THE PILOT REVEALED THAT THE METHODOLOGICAL ASPECT OF THE PROTOCOL WORKED SUFFICIENTLY IN ALL ASPECTS EXCEPT FOR MISSING DATA IN THE PHYSICAL TEST OF TWO PARTICIPANTS AND ONE PARTICIPANT IN THE CONTROL-GROUP THAT DROPPED OUT OF THE STUDY AT THREE MONTHS FOLLOW-UP. THE TELE-YOGA TRAINING DID NOT LEAD TO ANY ADVERSE EVENTS OR INJURIES, ADHERENCE OF TELE-YOGA WAS SUFFICIENT ACCORDING TO PRESET LIMITS. THE TELE-YOGA INTERVENTION ALSO SHOWED SOME FAVOURABLE TRENDS OF IMPROVEMENTS IN THE COMPOSITE-END POINT COMPARED TO THE ACTIVE CONTROL GROUP. HOWEVER, SINCE DATA ONLY WAS PRESENTED DESCRIPTIVELY DUE TO THE SMALL SAMPLE SIZE, THE IMPACT OF THESE TRENDS SHOULD BE INTERPRETED CAREFULLY. CONCLUSION: OUR PILOT STUDY SHOWED PROMISING RESULTS IN FEASIBILITY, SAFETY, AND ACCEPTABILITY OF THE TELE-YOGA INTERVENTION. SOME CHANGES IN THE PROTOCOL HAVE BEEN MADE TO DECREASE THE RISK OF MISSING DATA IN THE MEASURES OF PHYSICAL FUNCTION AND IN THE FULL-SCALE RCT NOW ONGOING THE RESULTS OF THE SAMPLE SIZE CALCULATION FOR 300 PARTICIPANTS HAVE INCLUDED THE ESTIMATED LEVEL OF DROP OUTS AND MISSING DATA. 2021 19 1495 26 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 20 1251 29 FEASIBILITY TRIAL OF YOGA PROGRAMME FOR TYPE 2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE IN INDIA: A QUALITATIVE STUDY TO EXPLORE PARTICIPANTS' TRIAL- AND INTERVENTION-RELATED BARRIERS AND FACILITATORS. YOGA-BASED INTERVENTIONS CAN BE EFFECTIVE IN PREVENTING TYPE 2 DIABETES MELLITUS (T2DM). WE DEVELOPED A YOGA PROGRAMME FOR T2DM PREVENTION (YOGA-DP) AND CONDUCTED A FEASIBILITY RANDOMISED CONTROLLED TRIAL (RCT) AMONG HIGH-RISK PEOPLE IN INDIA. THIS QUALITATIVE STUDY'S OBJECTIVE WAS TO IDENTIFY AND EXPLORE PARTICIPANTS' TRIAL- AND INTERVENTION-RELATED BARRIERS AND FACILITATORS. THE FEASIBILITY TRIAL WAS CONDUCTED AT TWO YOGA CENTRES IN NEW DELHI AND BENGALURU, INDIA. IN THIS QUALITATIVE STUDY, 25 TRIAL PARTICIPANTS (13 INTERVENTION GROUP, 12 CONTROL GROUP) WERE RECRUITED FOR SEMI-STRUCTURED INTERVIEWS. DATA WERE ANALYSED USING DEDUCTIVE LOGIC AND AN INTERPRETATIVE PHENOMENOLOGICAL APPROACH. AMONGST INTERVENTION AND CONTROL PARTICIPANTS, KEY BARRIERS TO TRIAL PARTICIPATION WERE INADEQUATE INFORMATION ABOUT RECRUITMENT AND RANDOMISATION PROCESSES AND THE NEGATIVE INFLUENCE OF NON-PARTICIPANTS. FREE BLOOD TESTS TO AID T2DM PREVENTION, SITE STAFF'S FRIENDLY BEHAVIOUR AND FRIENDS' POSITIVE INFLUENCE FACILITATED TRIAL PARTICIPATION. AMONGST INTERVENTION PARTICIPANTS, READABILITY AND UNDERSTANDING OF THE PROGRAMME BOOKLETS, DISLIKE OF THE YOGA DIARY, POOR QUALITY YOGA MATS, DIFFICULTY IN USING THE PROGRAMME VIDEO, HOUSEHOLD COMMITMENT DURING HOME SESSIONS, UNPLANNED TRAVEL, DIFFICULTY IN PRACTISING YOGA POSES, HESITATION IN ATTENDING PROGRAMME SESSIONS WITH THE YOGA-DP INSTRUCTOR OF THE OPPOSITE SEX AND MIXED-SEX GROUP PROGRAMME SESSIONS WERE KEY BARRIERS TO INTERVENTION PARTICIPATION. ADEQUATE INFORMATION WAS PROVIDED ON T2DM PREVENTION AND SELF-CARE, GOOD VENUE AND OTHER SUPPORT PROVIDED FOR PROGRAMME SESSIONS, YOGA-DP INSTRUCTORS' POSITIVE BEHAVIOUR AND IMPROVEMENTS IN PHYSICAL AND MENTAL WELL-BEING FACILITATED INTERVENTION PARTICIPATION. IN CONCLUSION, WE IDENTIFIED AND EXPLORED PARTICIPANTS' TRIAL- AND INTERVENTION-RELATED BARRIERS AND FACILITATORS. WE IDENTIFIED AN ALMOST EQUAL NUMBER OF BARRIERS (N = 12) AND FACILITATORS (N = 13); HOWEVER, INTERVENTION-RELATED BARRIERS AND FACILITATORS WERE GREATER THAN FOR PARTICIPATING IN THE TRIAL. THESE FINDINGS WILL INFORM THE DESIGN OF THE PLANNED DEFINITIVE RCT DESIGN AND INTERVENTION AND CAN ALSO BE USED TO DESIGN OTHER YOGA INTERVENTIONS AND RCTS. 2022