1 2455 191 YOGA AS A COMPLEMENTARY THERAPY FOR SMOKING CESSATION: RESULTS FROM BREATHEASY, A RANDOMIZED CLINICAL TRIAL. INTRODUCTION: THERE IS EVIDENCE THAT YOGA MAY BE HELPFUL AS AN AID FOR SMOKING CESSATION. YOGA HAS BEEN SHOWN TO REDUCE STRESS AND NEGATIVE MOOD AND MAY AID WEIGHT CONTROL, ALL OF WHICH HAVE PROVEN TO BE BARRIERS TO QUITTING SMOKING. THIS STUDY IS THE FIRST RIGOROUS, RANDOMIZED CLINICAL TRIAL OF YOGA AS A COMPLEMENTARY THERAPY FOR SMOKERS ATTEMPTING TO QUIT. METHODS: ADULT SMOKERS (N = 227; 55.5% WOMEN) WERE RANDOMIZED TO AN 8-WEEK PROGRAM OF COGNITIVE-BEHAVIORAL SMOKING CESSATION AND EITHER TWICE-WEEKLY IYENGAR YOGA OR GENERAL WELLNESS CLASSES (CONTROL). ASSESSMENTS INCLUDED COTININE-VERIFIED 7-DAY POINT PREVALENCE ABSTINENCE AT WEEK 8, 3-MONTH, AND 6-MONTH FOLLOW-UPS. RESULTS: AT BASELINE, PARTICIPANTS' MEAN AGE WAS 46.2 (SD = 12.0) YEARS AND SMOKING RATE WAS 17.3 (SD = 7.6) CIGARETTES/DAY. LONGITUDINALLY ADJUSTED MODELS OF ABSTINENCE OUTCOMES DEMONSTRATED SIGNIFICANT GROUP EFFECTS FAVORING YOGA. YOGA PARTICIPANTS HAD 37% GREATER ODDS OF ACHIEVING ABSTINENCE THAN WELLNESS PARTICIPANTS AT THE END OF TREATMENT (EOT). LOWER BASELINE SMOKING RATES (/=5 CIGARETTES/DAY, AGE 18-65) TO RECEIVE COGNITIVE BEHAVIORAL THERAPY FOR SC, PLUS A YOGA OR WELLNESS PROGRAM. MEASURES INCLUDED FEASIBILITY (RECRUITMENT, CLASS ATTENDANCE) AND ACCEPTABILITY (CUSTOMER SATISFACTION). WE ENROLLED 38 OF 49 ELIGIBLE MEN OF 167 SCREENED IN RESPONSE TO ADS (MEAN AGE 39.9 YEARS, +/-13.7) WHO SMOKED ON AVERAGE 18.6 CIGARETTES/DAY (+/-8.3). WELLNESS (75.8 %) VERSUS YOGA (56 %) MEN ATTENDED MORE SC CLASSES, P < 0.01. SIXTY PERCENT ATTENDED >/=1 YOGA CLASS. MEN REPORTED GREATER SATISFACTION WITH IN-HOUSE VERSUS COMMUNITY YOGA CLASSES. WELLNESS APPEARS TO BE THE PREFERRED INTERVENTION; RESULTS INDICATED THAT IT MAY BE MORE FEASIBLE AND SHOWED INCREASED ATTENDANCE AT SMOKING CLASSES. TO BE FULLY FEASIBLE, YOGA + SC MAY NEED TO BE A UNIFIED PROGRAM OFFERING ALL CLASSES TAILORED FOR MEN AND IN THE SAME LOCATION. 2015 13 74 47 A GROUP-BASED YOGA THERAPY INTERVENTION FOR URINARY INCONTINENCE IN WOMEN: A PILOT RANDOMIZED TRIAL. OBJECTIVE: THE AIM OF THIS STUDY IS TO EXAMINE THE FEASIBILITY, EFFICACY, AND SAFETY OF A GROUP-BASED YOGA THERAPY INTERVENTION FOR MIDDLE-AGED AND OLDER WOMEN WITH URINARY INCONTINENCE. METHODS: WE CONDUCTED A PILOT RANDOMIZED TRIAL OF AMBULATORY WOMEN AGED 40 YEARS AND OLDER WITH STRESS, URGENCY, OR MIXED-TYPE INCONTINENCE. WOMEN WERE RANDOMIZED TO A 6-WEEK YOGA THERAPY PROGRAM (N = 10) CONSISTING OF TWICE WEEKLY GROUP CLASSES AND ONCE WEEKLY HOME PRACTICE OR A WAIT-LIST CONTROL GROUP (N = 9). ALL PARTICIPANTS ALSO RECEIVED WRITTEN PAMPHLETS ABOUT STANDARD BEHAVIORAL SELF-MANAGEMENT STRATEGIES FOR INCONTINENCE. CHANGES IN INCONTINENCE WERE ASSESSED WITH 7-DAY VOIDING DIARIES. RESULTS: THE MEAN (SD) AGE WAS 61.4 (8.2) YEARS, AND THE MEAN BASELINE FREQUENCY OF INCONTINENCE WAS 2.5 (1.3) EPISODES/D. AFTER 6 WEEKS, THE TOTAL INCONTINENCE FREQUENCY DECREASED BY 70% (1.8 [0.9] FEWER EPISODES/D) IN THE YOGA THERAPY VERSUS 13% (0.3 [1.7] FEWER EPISODES/D) IN THE CONTROL GROUP (P = 0.049). PARTICIPANTS IN THE YOGA THERAPY GROUP ALSO REPORTED AN AVERAGE OF 71% DECREASE IN STRESS INCONTINENCE FREQUENCY (0.7 [0.8] FEWER EPISODES/D) COMPARED WITH A 25% INCREASE IN CONTROLS (0.2 [1.1] MORE EPISODES/D) (P = 0.039). NO SIGNIFICANT DIFFERENCES IN REDUCTION IN URGENCY INCONTINENCE WERE DETECTED BETWEEN THE YOGA THERAPY VERSUS CONTROL GROUPS (1.0 [1.0] VERSUS 0.5 [0.5] FEWER EPISODES/D; P = 0.20). ALL WOMEN STARTING THE YOGA THERAPY PROGRAM COMPLETED AT LEAST 90% OF THE GROUP CLASSES AND PRACTICE SESSIONS. TWO PARTICIPANTS IN EACH GROUP REPORTED ADVERSE EVENTS UNRELATED TO THE INTERVENTION. CONCLUSIONS: FINDINGS PROVIDE PRELIMINARY EVIDENCE TO SUPPORT THE FEASIBILITY, EFFICACY, AND SAFETY OF A GROUP-BASED YOGA THERAPY INTERVENTION TO IMPROVE URINARY INCONTINENCE IN WOMEN. 2014 14 396 27 BETWEEN INHALE AND EXHALE: YOGA AS AN INTERVENTION IN SMOKING CESSATION. THE CURRENT STUDY PROVIDED A REVIEW OF EVIDENCE-BASED YOGA INTERVENTIONS' IMPACT ON SMOKING CESSATION. THE RESEARCHERS REVIEWED ARTICLES OBTAINED FROM MEDLINE (PUBMED), EBSCOHOST, PROQUEST, MEDINDIA, CINAHL, ALT HEALTHWATCH, AND AMED DATABASES. INCLUSION CRITERIA WERE AS FOLLOWS: (A) STUDY PUBLISHED BETWEEN 2004 AND 2013, (B) STUDY PUBLISHED IN ENGLISH LANGUAGE, (C) STUDY USED YOGA-BASED INTERVENTIONS, (D) STUDY INVOLVED SMOKERS WITH VARYING LEVEL OF SMOKING, (E) STUDY USED ANY QUANTITATIVE DESIGN, AND (F) STUDY HAD PHYSIOLOGICAL AND/OR PSYCHOLOGICAL OUTCOMES. A TOTAL OF 10 STUDIES MET THE INCLUSION CRITERIA. DESIGNS WERE 2 PRE-POST TESTS AND 8 RANDOMIZED CONTROLLED TRIALS. MAJORITY OF THE INTERVENTIONS WERE ABLE TO ENHANCE QUITTING SMOKING RATES IN THE PARTICIPANTS UNDER STUDY. YOGA-BASED INTERVENTIONS HOLD PROMISE FOR SMOKING CESSATION. SOME OF THE LIMITATIONS INCLUDE SHORT FOLLOW-UP MEASUREMENTS AND SHORT DURATION OF INTERVENTION. 2014 15 34 49 A 12-WEEK IYENGAR YOGA PROGRAM IMPROVED BALANCE AND MOBILITY IN OLDER COMMUNITY-DWELLING PEOPLE: A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: EXERCISE THAT CHALLENGES BALANCE CAN IMPROVE MOBILITY AND PREVENT FALLS IN OLDER ADULTS. YOGA AS A PHYSICAL ACTIVITY OPTION FOR OLDER ADULTS IS NOT WELL STUDIED. THIS TRIAL EVALUATED THE FEASIBILITY AND EFFECT OF A 12-WEEK IYENGAR YOGA PROGRAM ON BALANCE AND MOBILITY IN OLDER PEOPLE. METHODS: WE CONDUCTED A BLINDED, PILOT RANDOMIZED CONTROLLED TRIAL WITH INTENTION-TO-TREAT ANALYSIS. PARTICIPANTS WERE 54 COMMUNITY DWELLERS (MEAN AGE 68 YEARS, SD 7.1) NOT CURRENTLY PARTICIPATING IN YOGA OR TAI CHI. THE INTERVENTION GROUP (N = 27) PARTICIPATED IN A 12-WEEK, TWICE-WEEKLY YOGA PROGRAM FOCUSED ON STANDING POSTURES AND RECEIVED A FALL PREVENTION EDUCATION BOOKLET. THE CONTROL GROUP (N = 27) RECEIVED THE EDUCATION BOOKLET ONLY. PRIMARY OUTCOME WAS STANDING BALANCE COMPONENT OF THE SHORT PHYSICAL PERFORMANCE BATTERY WITH ADDITION OF ONE-LEGGED STANCE TIME (STANDING BALANCE). SECONDARY OUTCOMES WERE THE TIMED SIT-TO-STAND TEST, TIMED 4-M WALK, ONE-LEGGED STAND WITH EYES CLOSED, AND SHORT FALLS EFFICACY SCALE-INTERNATIONAL. FEASIBILITY WAS MEASURED BY RECORDING CLASS ATTENDANCE AND ADVERSE EVENTS. RESULTS: FIFTY-TWO PARTICIPANTS COMPLETED FOLLOW-UP ASSESSMENTS. THE INTERVENTION GROUP SIGNIFICANTLY IMPROVED COMPARED WITH CONTROL GROUP ON STANDING BALANCE (MEAN DIFFERENCE = 1.52 SECONDS, 95% CI 0.10-2.96, P = .04), SIT-TO-STAND TEST (MEAN DIFFERENCE = -3.43 SECONDS, 95% CI -5.23 TO -1.64, P < .001), 4-M WALK (MEAN DIFFERENCE = -0.50 SECONDS, 95% CI -0.72 TO -0.28, P < .001), AND ONE-LEGGED STAND WITH EYES CLOSED (MEAN DIFFERENCE = 1.93 SECONDS, 95% CI 0.40-3.46, P = .02). AVERAGE CLASS ATTENDANCE WAS 20 OF 24 CLASSES (83%). NO SERIOUS ADVERSE EVENTS OCCURRED. CONCLUSIONS: THIS TRIAL DEMONSTRATES THE BALANCE AND MOBILITY-RELATED BENEFITS AND FEASIBILITY OF IYENGAR YOGA FOR OLDER PEOPLE. THE FALL PREVENTION EFFECT OF IYENGAR YOGA WARRANTS FURTHER INVESTIGATION. 2013 16 524 46 COMPARISON OF COGNITIVE-BEHAVIORAL THERAPY AND YOGA FOR THE TREATMENT OF LATE-LIFE WORRY: A RANDOMIZED PREFERENCE TRIAL. BACKGROUND: THE PURPOSE OF THIS STUDY WAS TO COMPARE THE EFFECTS OF COGNITIVE-BEHAVIORAL THERAPY (CBT) AND YOGA ON LATE-LIFE WORRY, ANXIETY, AND SLEEP; AND EXAMINE PREFERENCE AND SELECTION EFFECTS ON THESE OUTCOMES. METHODS: A RANDOMIZED PREFERENCE TRIAL OF CBT AND YOGA WAS CONDUCTED IN COMMUNITY-DWELLING ADULTS 60 YEARS OR OLDER, WHO SCORED 26 OR ABOVE ON THE PENN STATE WORRY QUESTIONNAIRE-ABBREVIATED (PSWQ-A). CBT CONSISTED OF 10 WEEKLY TELEPHONE SESSIONS. YOGA CONSISTED OF 20 BIWEEKLY GROUP YOGA CLASSES. THE PRIMARY OUTCOME WAS WORRY (PSWQ-A); THE SECONDARY OUTCOMES WERE ANXIETY (PROMIS-ANXIETY) AND SLEEP (INSOMNIA SEVERITY INDEX [ISI]). WE EXAMINED BOTH PREFERENCE EFFECTS (AVERAGE EFFECT FOR THOSE WHO RECEIVED THEIR PREFERRED INTERVENTION [REGARDLESS OF WHETHER IT WAS CBT OR YOGA] MINUS THE AVERAGE FOR THOSE WHO DID NOT RECEIVE THEIR PREFERRED INTERVENTION [REGARDLESS OF THE INTERVENTION]) AND SELECTION EFFECT (WHICH ADDRESSES THE QUESTION OF WHETHER THERE IS A BENEFIT TO GETTING TO SELECT ONE INTERVENTION OVER THE OTHER, AND MEASURES THE EFFECT ON OUTCOMES OF SELF-SELECTION TO A SPECIFIC INTERVENTION). RESULTS: FIVE HUNDRED OLDER ADULTS WERE RANDOMIZED TO THE RANDOMIZED TRIAL (125 EACH IN CBT AND YOGA) OR THE PREFERENCE TRIAL (120 CHOSE CBT; 130 CHOSE YOGA). IN THE RANDOMIZED TRIAL, THE INTERVENTION EFFECT OF YOGA COMPARED WITH CBT ADJUSTED FOR BASELINE PSYCHOTROPIC MEDICATION USE, GENDER, AND RACE WAS 1.6 (-0.2, 3.3), P = .08 FOR THE PSWQ-A. SIMILAR RESULTS WERE OBSERVED WITH PROMIS-ANXIETY (ADJUSTED INTERVENTION EFFECT: 0.3 [-1.5, 2.2], P = .71). PARTICIPANTS RANDOMIZED TO CBT EXPERIENCED A GREATER REDUCTION IN THE ISI COMPARED WITH YOGA (ADJUSTED INTERVENTION EFFECT: 2.4 [1.2, 3.7], P < .01]). ESTIMATED IN THE COMBINED DATA SET (N = 500), THE PREFERENCE AND SELECTION EFFECTS WERE NOT SIGNIFICANT FOR THE PSWQ-A, PROMIS-ANXIETY, AND ISI. OF THE 52 ADVERSE EVENTS, ONLY TWO WERE POSSIBLY RELATED TO THE INTERVENTION. NONE OF THE 26 SERIOUS ADVERSE EVENTS WERE RELATED TO THE STUDY INTERVENTIONS. CONCLUSIONS: CBT AND YOGA WERE BOTH EFFECTIVE AT REDUCING LATE-LIFE WORRY AND ANXIETY. HOWEVER, A GREATER IMPACT WAS SEEN FOR CBT COMPARED WITH YOGA FOR IMPROVING SLEEP. NEITHER PREFERENCE NOR SELECTION EFFECTS WAS FOUND. 2020 17 1862 54 RANDOMIZED CONTROLLED TRIAL OF YOGA AMONG A MULTIETHNIC SAMPLE OF BREAST CANCER PATIENTS: EFFECTS ON QUALITY OF LIFE. PURPOSE: THIS STUDY EXAMINES THE IMPACT OF YOGA, INCLUDING PHYSICAL POSES, BREATHING, AND MEDITATION EXERCISES, ON QUALITY OF LIFE (QOL), FATIGUE, DISTRESSED MOOD, AND SPIRITUAL WELL-BEING AMONG A MULTIETHNIC SAMPLE OF BREAST CANCER PATIENTS. PATIENTS AND METHODS: ONE HUNDRED TWENTY-EIGHT PATIENTS (42% AFRICAN AMERICAN, 31% HISPANIC) RECRUITED FROM AN URBAN CANCER CENTER WERE RANDOMLY ASSIGNED (2:1 RATIO) TO A 12-WEEK YOGA INTERVENTION (N = 84) OR A 12-WEEK WAITLIST CONTROL GROUP (N = 44). CHANGES IN QOL (EG, FUNCTIONAL ASSESSMENT OF CANCER THERAPY) FROM BEFORE RANDOM ASSIGNMENT (T1) TO THE 3-MONTH FOLLOW-UP (T3) WERE EXAMINED; PREDICTORS OF ADHERENCE WERE ALSO ASSESSED. NEARLY HALF OF ALL PATIENTS WERE RECEIVING MEDICAL TREATMENT. RESULTS: REGRESSION ANALYSES INDICATED THAT THE CONTROL GROUP HAD A GREATER DECREASE IN SOCIAL WELL-BEING COMPARED WITH THE INTERVENTION GROUP AFTER CONTROLLING FOR BASELINE SOCIAL WELL-BEING AND COVARIATES (P < .0001). SECONDARY ANALYSES OF 71 PATIENTS NOT RECEIVING CHEMOTHERAPY DURING THE INTERVENTION PERIOD INDICATED FAVORABLE OUTCOMES FOR THE INTERVENTION GROUP COMPARED WITH THE CONTROL GROUP IN OVERALL QOL (P < .008), EMOTIONAL WELL-BEING (P < .015), SOCIAL WELL-BEING (P < .004), SPIRITUAL WELL-BEING (P < .009), AND DISTRESSED MOOD (P < .031). SIXTY-NINE PERCENT OF INTERVENTION PARTICIPANTS ATTENDED CLASSES (MEAN NUMBER OF CLASSES ATTENDED BY ACTIVE CLASS PARTICIPANTS = 7.00 +/- 3.80), WITH LOWER ADHERENCE ASSOCIATED WITH INCREASED FATIGUE (P < .001), RADIOTHERAPY (P < .0001), YOUNGER AGE (P < .008), AND NO ANTIESTROGEN THERAPY (P < .02). CONCLUSION: DESPITE LIMITED ADHERENCE, THIS INTENT-TO-TREAT ANALYSIS SUGGESTS THAT YOGA IS ASSOCIATED WITH BENEFICIAL EFFECTS ON SOCIAL FUNCTIONING AMONG A MEDICALLY DIVERSE SAMPLE OF BREAST CANCER SURVIVORS. AMONG PATIENTS NOT RECEIVING CHEMOTHERAPY, YOGA APPEARS TO ENHANCE EMOTIONAL WELL-BEING AND MOOD AND MAY SERVE TO BUFFER DETERIORATION IN BOTH OVERALL AND SPECIFIC DOMAINS OF QOL. 2007 18 1748 42 PILOT RANDOMIZED, CONTROLLED TRIAL OF A DYADIC YOGA PROGRAM FOR GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR FAMILY CAREGIVERS. BACKGROUND: WHILE THE USE OF BEHAVIORAL MEDICINE IN MANAGING GLIOMA PATIENTS' SYMPTOMS IS NOT WELL STUDIED, THE HIGH SYMPTOM BURDEN IN PATIENTS AND THEIR FAMILY CAREGIVERS IS WELL ESTABLISHED. WE CONDUCTED A PILOT RANDOMIZED, CONTROLLED TRIAL TO EXAMINE THE FEASIBILITY AND PRELIMINARY EFFICACY OF A DYADIC YOGA (DY) INTERVENTION AS A SUPPORTIVE CARE STRATEGY. METHODS: GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR CAREGIVERS WERE RANDOMIZED TO A 12-SESSION DY OR WAITLIST CONTROL (WLC) GROUP. PRIOR TO RADIOTHERAPY AND RANDOMIZATION, BOTH GROUPS COMPLETED MEASURES OF CANCER-RELATED SYMPTOMS (MD ANDERSON SYMPTOM INVENTORY-BRAIN TUMOR MODULE), DEPRESSIVE SYMPTOMS (CENTER FOR EPIDEMIOLOGICAL STUDIES-DEPRESSION MEASURE), FATIGUE (BRIEF FATIGUE INVENTORY), AND OVERALL QUALITY OF LIFE (QOL; MEDICAL OUTCOMES STUDY 36-ITEM SHORT-FORM SURVEY). DYADS WERE REASSESSED AT THE LAST DAY OF RADIOTHERAPY. RESULTS: TWENTY PATIENTS (MEAN AGE: 46 YEARS, 50% FEMALE, 80% WHO GRADE IV AND CAREGIVERS (MEAN AGE: 50 YEARS, 70% FEMALE, 50% SPOUSES) PARTICIPATED IN THE TRIAL. A PRIORI FEASIBILITY CRITERIA WERE MET REGARDING CONSENT (70%), ADHERENCE (88%), AND RETENTION (95%) RATES. CONTROLLING FOR RELEVANT COVARIATES, CHANGE SCORE ANALYSES REVEALED CLINICALLY SIGNIFICANT IMPROVEMENTS FOR PATIENTS IN THE DY COMPARED WITH THE WLC GROUP FOR OVERALL CANCER SYMPTOM SEVERITY (D = 0.96) AND SYMPTOM INTERFERENCE (D = 0.74), DEPRESSIVE SYMPTOMS (D = 0.71), AND MENTAL QOL (D = 0.69). CAREGIVERS IN THE DY GROUP REPORTED CLINICALLY SIGNIFICANT IMPROVEMENTS IN DEPRESSIVE SYMPTOMS (D = 1.12), FATIGUE (D = 0.89), AND MENTAL QOL (D = 0.49) RELATIVE TO THOSE IN THE WLC GROUP. CONCLUSION: A DY INTERVENTION APPEARS TO BE A FEASIBLE AND BENEFICIAL SYMPTOM AND QOL MANAGEMENT STRATEGY FOR GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR CAREGIVERS. AN EFFICACY TRIAL WITH A MORE STRINGENT CONTROL GROUP IS WARRANTED. CLINICAL TRIAL NUMBER: NCT02481349. 2019 19 388 51 BENEFITS OF THE RESTORATIVE EXERCISE AND STRENGTH TRAINING FOR OPERATIONAL RESILIENCE AND EXCELLENCE YOGA PROGRAM FOR CHRONIC LOW BACK PAIN IN SERVICE MEMBERS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TO EXAMINE THE FEASIBILITY AND PRELIMINARY EFFECTIVENESS OF AN INDIVIDUALIZED YOGA PROGRAM. DESIGN: PILOT RANDOMIZED CONTROLLED TRIAL. SETTING: MILITARY MEDICAL CENTER. PARTICIPANTS: PATIENTS (N=68) WITH CHRONIC LOW BACK PAIN. INTERVENTIONS: RESTORATIVE EXERCISE AND STRENGTH TRAINING FOR OPERATIONAL RESILIENCE AND EXCELLENCE (RESTORE) PROGRAM (9-12 INDIVIDUAL YOGA SESSIONS) OR TREATMENT AS USUAL (CONTROL) FOR AN 8-WEEK PERIOD. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS PAST 24-HOUR PAIN (DEFENSE & VETERANS PAIN RATING SCALE 2.0). SECONDARY OUTCOMES INCLUDED DISABILITY (ROLAND-MORRIS DISABILITY QUESTIONNAIRE) AND PHYSICAL FUNCTIONING AND SYMPTOM BURDEN (PATIENT-REPORTED OUTCOMES MEASUREMENT INFORMATION SYSTEM-29 SUBSCALES). ASSESSMENT OCCURRED AT BASELINE, WEEK 4, WEEK 8, 3-MONTH FOLLOW-UP, AND 6-MONTH FOLLOW-UP. EXPLORATORY OUTCOMES INCLUDED THE PROPORTION OF PARTICIPANTS IN EACH GROUP REPORTING CLINICALLY MEANINGFUL CHANGES AT 3- AND 6-MONTH FOLLOW-UPS. RESULTS: GENERALIZED LINEAR MIXED MODELS WITH SEQUENTIAL BONFERRONI-ADJUSTED PAIRWISE SIGNIFICANCE TESTS AND CHI-SQUARE ANALYSES EXAMINED LONGITUDINAL OUTCOMES. SECONDARY OUTCOME SIGNIFICANCE TESTS WERE BONFERRONI ADJUSTED FOR MULTIPLE OUTCOMES. THE RESTORE GROUP REPORTED IMPROVED PAIN COMPARED WITH THE CONTROL GROUP. SECONDARY OUTCOMES DID NOT RETAIN SIGNIFICANCE AFTER BONFERRONI ADJUSTMENTS FOR MULTIPLE OUTCOMES, ALTHOUGH A HIGHER PROPORTION OF RESTORE PARTICIPANTS REPORTED CLINICALLY MEANINGFULLY CHANGES IN ALL OUTCOMES AT 3-MONTH FOLLOW-UP AND IN SYMPTOM BURDEN AT 6-MONTH FOLLOW-UP. CONCLUSIONS: RESTORE MAY BE A VIABLE NONPHARMACOLOGICAL TREATMENT FOR LOW BACK PAIN WITH MINIMAL SIDE EFFECTS, AND RESEARCH EFFORTS ARE NEEDED TO COMPARE THE EFFECTIVENESS OF RESTORE DELIVERY FORMATS (EG, GROUP VS INDIVIDUAL) WITH THAT OF OTHER TREATMENT MODALITIES. 2018 20 258 46 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