1 945 164 EFFECTS OF A 12-WEEK YOGA VERSUS A 12-WEEK EDUCATIONAL FILM INTERVENTION ON SYMPTOMS OF RESTLESS LEGS SYNDROME AND RELATED OUTCOMES: AN EXPLORATORY RANDOMIZED CONTROLLED TRIAL. STUDY OBJECTIVES: TO ASSESS THE EFFECTS OF A YOGA VERSUS EDUCATIONAL FILM (EF) PROGRAM ON RESTLESS LEGS SYNDROME (RLS) SYMPTOMS AND RELATED OUTCOMES IN ADULTS WITH RLS. METHODS: FORTY-ONE COMMUNITY-DWELLING, AMBULATORY NONPREGNANT ADULTS WITH MODERATE TO SEVERE RLS WERE RANDOMIZED TO A 12-WEEK YOGA (N = 19) OR EF PROGRAM (N = 22). IN ADDITION TO ATTENDING CLASSES, ALL PARTICIPANTS COMPLETED PRACTICE/TREATMENT LOGS. YOGA GROUP PARTICIPANTS WERE ASKED TO PRACTICE AT HOME 30 MINUTES PER DAY ON NONCLASS DAYS; EF PARTICIPANTS WERE INSTRUCTED TO RECORD ANY RLS TREATMENTS USED ON THEIR DAILY LOGS. CORE OUTCOMES ASSESSED PRETREATMENT AND POSTTREATMENT WERE RLS SYMPTOMS AND SYMPTOM SEVERITY (INTERNATIONAL RLS STUDY GROUP SCALE (IRLS) AND RLS ORDINAL SCALE), SLEEP QUALITY, MOOD, PERCEIVED STRESS, AND QUALITY OF LIFE (QOL). RESULTS: THIRTY ADULTS (13 YOGA, 17 EF), AGED 24 TO 73 (MEAN = 50.4 +/- 2.4 YEARS), COMPLETED THE 12-WEEK STUDY (78% FEMALE, 80.5% WHITE). POST-INTERVENTION, BOTH GROUPS SHOWED SIGNIFICANT IMPROVEMENT IN RLS SYMPTOMS AND SEVERITY, PERCEIVED STRESS, MOOD, AND QOL-MENTAL HEALTH (P /= 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 8 172 48 A RANDOMIZED CONTROLLED PILOT STUDY OF YOGA SKILLS TRAINING VERSUS AN ATTENTION CONTROL DELIVERED DURING CHEMOTHERAPY ADMINISTRATION. CONTEXT: IT IS IMPORTANT TO ADDRESS FATIGUE AND CO-OCCURRING SYMPTOMS DURING CHEMOTHERAPY TO PRESERVE QUALITY OF LIFE IN PATIENTS WITH GASTROINTESTINAL (GI) CANCER. OBJECTIVE: TO CONDUCT A RANDOMIZED CONTROLLED PILOT STUDY OF A YOGA SKILLS TRAINING (YST) INTERVENTION COMPARED TO AN ATTENTION CONTROL (AC) AMONG ADULTS DIAGNOSED WITH GI CANCER. METHODS: YST CONSISTED OF FOUR 30-MINUTE SESSIONS DELIVERED INDIVIDUALLY DURING CHEMOTHERAPY PLUS HOME PRACTICE. AC PROVIDED EMPATHIC ATTENTION PLUS HOME DIARIES. PATIENT-REPORTED (PROMIS T-SCORE) ASSESSMENTS OF FATIGUE, DEPRESSIVE SYMPTOMS, SLEEP DISTURBANCES, AND PSYCHOLOGICAL STRESS (PERCEIVED STRESS SCALE) WERE COLLECTED AT CHEMOTHERAPY VISITS: BASELINE, WEEK 8, WEEK 10 AND WEEK 14, AND ANALYZED USING A MIXED EFFECTS MODEL. INFLAMMATORY CYTOKINES WERE ASSESSED AT BASELINE AND WEEK 10. RESULTS: FORTY-FOUR OF 77 ADULTS APPROACHED AGREED TO PARTICIPATE (57%; YST N = 23; AC N = 21). PARTICIPANTS' MEAN AGE WAS 58 YEARS AND 48% WERE MEN. PARTICIPANTS RANDOMIZED TO YST REPORTED A LARGER DECLINE IN FATIGUE (-2.4 DIFFERENCE, D = 0.30) AND DEPRESSIVE SYMPTOMS (-2.5 DIFFERENCE, D = 0.30) THAN AC PARTICIPANTS FROM BASELINE TO WEEK 10 AND SLEEP DISTURBANCES AT WEEK 8 (-3.9 DIFFERENCE, D = 0.50). DIFFERENCES IN MAGNITUDE OF CHANGE IN SYMPTOMS WERE CONSISTENT WITH OR EXCEEDED A MINIMALLY IMPORTANT DIFFERENCE. PSYCHOLOGICAL STRESS DECREASED MORE IN THE AC AT WEEK 10 (D = 0.30). REDUCTIONS IN INFLAMMATORY CYTOKINES (IL-6, STNF R1) WERE LARGER IN THE YST GROUP THAN AC. CONCLUSION: YST SHOWED PROMISE FOR IMPROVING FATIGUE, DEPRESSIVE SYMPTOMS, SLEEP DISTURBANCES, AND INFLAMMATION. YST IS ALSO FEASIBLE AND REACHES PATIENTS UNDERREPRESENTED IN YOGA RESEARCH (I.E., GI CANCER, MEN), THUS WARRANTING FURTHER EXAMINATION. 2022 9 2843 36 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 10 2628 43 YOGA FOR THE MANAGEMENT OF PAIN AND SLEEP IN RHEUMATOID ARTHRITIS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: THE AIM OF THE PRESENT STUDY WAS TO DETERMINE THE FEASIBILITY OF A RELAXATION-BASED YOGA INTERVENTION FOR RHEUMATOID ARTHRITIS, DESIGNED AND REPORTED IN ACCORDANCE WITH DELPHI RECOMMENDATIONS FOR YOGA INTERVENTIONS FOR MUSCULOSKELETAL CONDITIONS. METHODS: PARTICIPANTS WERE RECRUITED FROM A HOSPITAL DATABASE, AND RANDOMIZED TO EITHER EIGHT WEEKLY 75-MIN YOGA CLASSES OR A USUAL CARE CONTROL. FEASIBILITY WAS DETERMINED BY RECRUITMENT RATES, RETENTION, PROTOCOL ADHERENCE, PARTICIPANT SATISFACTION AND ADVERSE EVENTS. SECONDARY PHYSICAL AND PSYCHOSOCIAL OUTCOMES WERE ASSESSED USING SELF-REPORTED QUESTIONNAIRES AT BASELINE (WEEK 0), WEEK 9 (PRIMARY TIME POINT) AND WEEK 12 (FOLLOW-UP). RESULTS: OVER A 3-MONTH PERIOD, 26 PARTICIPANTS WITH MILD PAIN, MILD TO MODERATE FUNCTIONAL DISABILITY AND MODERATE DISEASE ACTIVITY WERE RECRUITED INTO THE STUDY (25% RECRUITMENT RATE). RETENTION RATES WERE 100% FOR YOGA PARTICIPANTS AND 92% FOR USUAL CARE PARTICIPANTS AT BOTH WEEKS 9 AND 12. PROTOCOL ADHERENCE AND PARTICIPANT SATISFACTION WERE HIGH. YOGA PARTICIPANTS ATTENDED A MEDIAN OF SEVEN CLASSES; ADDITIONALLY, SEVEN OF THE YOGA PARTICIPANTS (54%) REPORTED CONTINUING YOGA AT HOME DURING THE FOLLOW-UP PERIOD. NO SERIOUS ADVERSE EVENTS WERE RELATED TO THE STUDY. SECONDARY OUTCOMES SHOWED NO GROUP EFFECTS OF YOGA COMPARED WITH USUAL CARE. CONCLUSIONS: A RELAXATION-BASED YOGA PROGRAMME WAS FOUND TO BE FEASIBLE AND SAFE FOR PARTICIPANTS WITH RHEUMATOID ARTHRITIS-RELATED PAIN AND FUNCTIONAL DISABILITY. ADVERSE EVENTS WERE MINOR, AND NOT UNEXPECTED FROM AN INTERVENTION INCLUDING PHYSICAL COMPONENTS. THIS PILOT PROVIDES A FRAMEWORK FOR LARGER INTERVENTION STUDIES, AND SUPPORTS FURTHER EXPLORATION OF YOGA AS A COMPLEX INTERVENTION TO ASSIST WITH THE MANAGEMENT OF RHEUMATOID ARTHRITIS. 2018 11 2323 57 TREATMENT OF CHRONIC PRIMARY SLEEP ONSET INSOMNIA WITH KUNDALINI YOGA: A RANDOMIZED CONTROLLED TRIAL WITH ACTIVE SLEEP HYGIENE COMPARISON. STUDY OBJECTIVES: PRIOR STUDIES HAVE SUGGESTED A BENEFIT OF YOGA FOR ALLEVIATING SLEEP DISTURBANCE; HOWEVER, MANY STUDIES HAVE HAD METHODOLOGICAL LIMITATIONS. THIS TRIAL STUDY AIMED TO EXTEND THAT LITERATURE BY INCLUDING AN ACTIVE SLEEP HYGIENE COMPARISON. METHODS: PARTICIPANTS AGED 25-59 YEARS WITH A PRIMARY COMPLAINT OF SLEEP ONSET INSOMNIA LASTING AT LEAST 6 MONTHS WERE BLOCK RANDOMIZED TO AN 8-WEEK KUNDALINI YOGA OR SLEEP HYGIENE INTERVENTION, BOTH CONSISTING OF INITIAL 60-MINUTE INSTRUCTION AND WEEKLY CHECK-INS. DAILY SLEEP DIARIES AND QUESTIONNAIRES WERE COLLECTED AT BASELINE, THROUGHOUT THE INTERVENTION, AND AT 6-MONTH FOLLOW-UP. DATA WERE ANALYZED USING LINEAR MIXED MODELS (N = 20 IN EACH GROUP). RESULTS: PARTICIPANT RATINGS OF THE INTERVENTIONS DID NOT SIGNIFICANTLY DIFFER. SLEEP HYGIENE IMPROVED SEVERAL DIARY AND QUESTIONNAIRE OUTCOMES, HOWEVER, YOGA RESULTED IN EVEN GREATER IMPROVEMENTS CORRESPONDING TO MEDIUM-TO-LARGE BETWEEN-GROUP EFFECT SIZES. TOTAL SLEEP TIME INCREASED PROGRESSIVELY ACROSS YOGA TREATMENT (D = 0.95, P = .002), CONCURRENT WITH INCREASED SLEEP EFFICIENCY (D = 1.36, P < .001) AND DECREASED SLEEP ONSET LATENCY (D = -1.16, P < .001), BUT WITHOUT CHANGES IN PRE-SLEEP AROUSAL (D =-0.30, P = .59). REMISSION RATES WERE ALSO HIGHER FOR YOGA COMPARED TO SLEEP HYGIENE, WITH >/= 80% OF YOGA PARTICIPANTS REPORTING AVERAGE SLEEP ONSET LATENCY < 30 MINUTES AND SLEEP EFFICIENCY > 80% AT 6-MONTH FOLLOW-UP. FOR OVER 50% OF YOGA PARTICIPANTS, THE INSOMNIA SEVERITY INDEX DECREASED BY AT LEAST 8 POINTS AT END OF TREATMENT AND FOLLOW-UP. CONCLUSIONS: YOGA, TAUGHT IN A SELF-CARE FRAMEWORK WITH MINIMAL INSTRUCTOR BURDEN, WAS ASSOCIATED WITH SELF-REPORTED IMPROVEMENTS ABOVE AND BEYOND AN ACTIVE SLEEP HYGIENE COMPARISON, SUSTAINED AT 6-MONTH FOLLOW-UP. FOLLOW-UP STUDIES ARE NEEDED TO ASSESS ACTIGRAPHY AND POLYSOMNOGRAPHY OUTCOMES, AS WELL AS POSSIBLE MECHANISMS OF CHANGE. CLINICAL TRIAL REGISTRATION: REGISTRY: CLINICALTRIALS.GOV; NAME: YOGA AS A TREATMENT FOR INSOMNIA; URL: HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT00033865; IDENTIFIER: NCT00033865. CITATION: KHALSA SBS, GOLDSTEIN MR. TREATMENT OF CHRONIC PRIMARY SLEEP ONSET INSOMNIA WITH KUNDALINI YOGA: A RANDOMIZED CONTROLLED TRIAL WITH ACTIVE SLEEP HYGIENE COMPARISON. J CLIN SLEEP MED. 2021;17(9):1841-1852. 2021 12 1650 48 MULTICENTER, RANDOMIZED CONTROLLED TRIAL OF YOGA FOR SLEEP QUALITY AMONG CANCER SURVIVORS. PURPOSE: THIRTY PERCENT TO 90% OF CANCER SURVIVORS REPORT IMPAIRED SLEEP QUALITY POST-TREATMENT, WHICH CAN BE SEVERE ENOUGH TO INCREASE MORBIDITY AND MORTALITY. LIFESTYLE INTERVENTIONS, SUCH AS EXERCISE, ARE RECOMMENDED IN CONJUNCTION WITH DRUGS AND COGNITIVE BEHAVIORAL THERAPY FOR THE TREATMENT OF IMPAIRED SLEEP. PRELIMINARY EVIDENCE INDICATES THAT YOGA-A MIND-BODY PRACTICE AND FORM OF EXERCISE-MAY IMPROVE SLEEP AMONG CANCER SURVIVORS. THE PRIMARY AIM OF THIS RANDOMIZED, CONTROLLED CLINICAL TRIAL WAS TO DETERMINE THE EFFICACY OF A STANDARDIZED YOGA INTERVENTION COMPARED WITH STANDARD CARE FOR IMPROVING GLOBAL SLEEP QUALITY (PRIMARY OUTCOME) AMONG POST-TREATMENT CANCER SURVIVORS. PATIENTS AND METHODS: IN ALL, 410 SURVIVORS SUFFERING FROM MODERATE OR GREATER SLEEP DISRUPTION BETWEEN 2 AND 24 MONTHS AFTER SURGERY, CHEMOTHERAPY, AND/OR RADIATION THERAPY WERE RANDOMLY ASSIGNED TO STANDARD CARE OR STANDARD CARE PLUS THE 4-WEEK YOGA INTERVENTION. THE YOGA INTERVENTION USED THE YOGA FOR CANCER SURVIVORS (YOCAS) PROGRAM CONSISTING OF PRANAYAMA (BREATHING EXERCISES), 16 GENTLE HATHA AND RESTORATIVE YOGA ASANAS (POSTURES), AND MEDITATION. PARTICIPANTS ATTENDED TWO 75-MINUTE SESSIONS PER WEEK. SLEEP QUALITY WAS ASSESSED BY USING THE PITTSBURGH SLEEP QUALITY INDEX AND ACTIGRAPHY PRE- AND POSTINTERVENTION. RESULTS: IN ALL, 410 SURVIVORS WERE ACCRUED (96% FEMALE; MEAN AGE, 54 YEARS; 75% HAD BREAST CANCER). YOGA PARTICIPANTS DEMONSTRATED GREATER IMPROVEMENTS IN GLOBAL SLEEP QUALITY AND, SECONDARILY, SUBJECTIVE SLEEP QUALITY, DAYTIME DYSFUNCTION, WAKE AFTER SLEEP ONSET, SLEEP EFFICIENCY, AND MEDICATION USE AT POSTINTERVENTION (ALL P