1  258 192 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
2 2558  52 YOGA FOR CHRONIC LOW BACK PAIN IN A PREDOMINANTLY MINORITY POPULATION: A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: SEVERAL STUDIES SUGGEST YOGA MAY BE EFFECTIVE FOR CHRONIC LOW BACK PAIN; HOWEVER, TRIALS TARGETING MINORITIES HAVE NOT BEEN CONDUCTED. PRIMARY STUDY OBJECTIVES: ASSESS THE FEASIBILITY OF STUDYING YOGA IN A PREDOMINANTLY MINORITY POPULATION WITH CHRONIC LOW BACK PAIN. COLLECT PRELIMINARY DATA TO PLAN A LARGER POWERED STUDY. STUDY DESIGN: PILOT RANDOMIZED CONTROLLED TRIAL. SETTING: TWO COMMUNITY HEALTH CENTERS IN A RACIALLY DIVERSE NEIGHBORHOOD OF BOSTON, MASSACHUSETTS. PARTICIPANTS: THIRTY ENGLISH-SPEAKING ADULTS (MEAN AGE 44 YEARS, 83% FEMALE, 83% RACIAL/ETHNIC MINORITIES; 48% WITH INCOMES < OR = $30,000) WITH MODERATE-TO-SEVERE CHRONIC LOW BACK PAIN. INTERVENTIONS: STANDARDIZED SERIES OF WEEKLY HATHA YOGA CLASSES FOR 12 WEEKS COMPARED TO A WAITLIST USUAL CARE CONTROL. OUTCOME MEASURES: FEASIBILITY MEASURED BY TIME TO COMPLETE ENROLLMENT, PROPORTION OF RACIAL/ETHNIC MINORITIES ENROLLED, RETENTION RATES, AND ADVERSE EVENTS. PRIMARY EFFICACY OUTCOMES WERE CHANGES FROM BASELINE TO 12 WEEKS IN PAIN SCORE (0=NO PAIN TO 10=WORST POSSIBLE PAIN) AND BACK-RELATED FUNCTION USING THE MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE (0-23 POINT SCALE, HIGHER SCORES REFLECT POORER FUNCTION). SECONDARY EFFICACY OUTCOMES WERE ANALGESIC USE, GLOBAL IMPROVEMENT, AND QUALITY OF LIFE (SF-36). RESULTS: RECRUITMENT TOOK 2 MONTHS. RETENTION RATES WERE 97% AT 12 WEEKS AND 77% AT 26 WEEKS. MEAN PAIN SCORES FOR YOGA DECREASED FROM BASELINE TO 12 WEEKS (6.7 TO 4.4) COMPARED TO USUAL CARE, WHICH DECREASED FROM 7.5 TO 7.1 (P=.02). MEAN ROLAND SCORES FOR YOGA DECREASED FROM 14.5 TO 8.2 COMPARED TO USUAL CARE, WHICH DECREASED FROM 16.1 TO 12.5 (P=.28). AT 12 WEEKS, YOGA COMPARED TO USUAL CARE PARTICIPANTS REPORTED LESS ANALGESIC USE (13% VS 73%, P=.003), LESS OPIATE USE (0% VS 33%, P=.04), AND GREATER OVERALL IMPROVEMENT (73% VS 27%, P=.03). THERE WERE NO DIFFERENCES IN SF-36 SCORES AND NO SERIOUS ADVERSE EVENTS. CONCLUSION: A YOGA STUDY INTERVENTION IN A PREDOMINANTLY MINORITY POPULATION WITH CHRONIC LOW BACK PAIN WAS MODERATELY FEASIBLE AND MAY BE MORE EFFECTIVE THAN USUAL CARE FOR REDUCING PAIN AND PAIN MEDICATION USE.	2009	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
3  518  40 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
4  312  88 AN EXPLORATORY RANDOMIZED CONTROLLED TRIAL OF A 12-WEEK YOGA VERSUS EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME: FEASIBILITY AND ACCEPTABILITY. OBJECTIVES: THE PRIMARY OBJECTIVES OF THIS PILOT TRIAL WERE TO ASSESS THE STUDY FEASIBILITY AND ACCEPTABILITY OF THE 12-WEEK YOGA AND EDUCATIONAL FILM PROGRAMS FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME (RLS) IN PREPARATION FOR A FUTURE RANDOMIZED CONTROLLED TRIAL (RCT). MATERIALS AND METHODS: THIS PILOT, PARALLEL-ARM, RANDOMIZED FEASIBILITY TRIAL WAS CONDUCTED AT TWO SITES, MORGANTOWN, WV AND COLUMBUS, OH. YOGA GROUP PARTICIPANTS ATTENDED 75-MIN IYENGAR YOGA CLASSES, TWICE WEEKLY FOR 4 WEEKS, THEN ONCE A WEEK FOR 8 WEEKS (16 TOTAL CLASSES), AND COMPLETED A 30-MIN HOMEWORK ROUTINE ON NONCLASS DAYS. EDUCATIONAL FILM GROUP PARTICIPANTS ATTENDED ONCE WEEKLY, 75-MIN CLASSES (12 TOTAL CLASSES), WHICH INCLUDED INFORMATION ON RLS AND OTHER SLEEP DISORDERS, RLS MANAGEMENT INCLUDING SLEEP HYGIENE PRACTICES, AND COMPLEMENTARY THERAPIES. FEASIBILITY AND ACCEPTABILITY OUTCOMES INCLUDED PROGRAM SATISFACTION AND RECRUITMENT, RETENTION, AND ADHERENCE RATES. IN ADDITION, PARTICIPANTS WERE ASKED THEIR PREFERENCES REGARDING THREE YOGA CLASS SCHEDULE SCENARIOS FOR A FUTURE STUDY. ATTENDANCE, YOGA, AND TREATMENT LOGS WERE COLLECTED WEEKLY. PROGRAM EVALUATION AND YOGA SCHEDULING QUESTIONNAIRES WERE COLLECTED AT WEEK 12. RESULTS: FORTY-ONE ADULTS WITH MODERATE TO SEVERE RLS WERE RANDOMIZED TO A 12-WEEK YOGA (N = 19) OR EDUCATIONAL FILM (N = 22) PROGRAM. THIRTY PARTICIPANTS (73%) COMPLETED THE PROGRAM. YOGA AND EDUCATION GROUP PARTICIPANTS ATTENDED AN AVERAGE OF 13.0 +/- 0.84 (81%) AND 10.3 +/- 0.3 CLASSES (85%), RESPECTIVELY. PARTICIPANTS FROM BOTH GROUPS INDICATED SATISFACTION WITH THE STUDY. ALL YOGA GROUP RESPONDENTS TO THE PROGRAM EVALUATION REPORTED THEY WOULD LIKELY (N = 6) OR VERY LIKELY (N = 7) CONTINUE YOGA PRACTICE; 86.7% OF EDUCATION GROUP RESPONDENTS (13 OF 15) INDICATED THAT THEY WERE LIKELY (N = 7) OR VERY LIKELY (N = 6) TO MAKE LASTING CHANGES BASED ON WHAT THEY HAD LEARNED. THE PREFERRED SCHEDULE FOR A FUTURE STUDY WAS A 16-WEEK STUDY WITH ONCE-WEEKLY YOGA CLASSES. CONCLUSIONS: THE FINDINGS OF THIS STUDY SUGGEST THAT A LARGER RCT COMPARING YOGA WITH AN EDUCATIONAL FILM GROUP FOR THE MANAGEMENT OF RLS IS FEASIBLE. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT03570515; 02/01/2017.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
5  945  72 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 </= .04). RELATIVE TO THE EF GROUP, YOGA PARTICIPANTS DEMONSTRATED SIGNIFICANTLY GREATER REDUCTIONS IN RLS SYMPTOMS AND SYMPTOM SEVERITY (P </= .01), AND GREATER IMPROVEMENTS IN PERCEIVED STRESS AND MOOD (P </= .04), AS WELL AS SLEEP QUALITY (P = .09); RLS SYMPTOMS DECREASED TO MINIMAL/MILD IN 77% OF YOGA GROUP PARTICIPANTS, WITH NONE SCORING IN THE SEVERE RANGE BY WEEK 12, VERSUS 24% AND 12%, RESPECTIVELY, IN EF PARTICIPANTS. IN THE YOGA GROUP, IRLS AND RLS SEVERITY SCORES DECLINED WITH INCREASING MINUTES OF HOMEWORK PRACTICE (R = .7, P = .009 AND R = .6, P = .03, RESPECTIVELY), SUGGESTING A POSSIBLE DOSE-RESPONSE RELATIONSHIP. CONCLUSIONS: FINDINGS OF THIS EXPLORATORY RCT SUGGEST THAT YOGA MAY BE EFFECTIVE IN REDUCING RLS SYMPTOMS AND SYMPTOM SEVERITY, DECREASING PERCEIVED STRESS, AND IMPROVING MOOD AND SLEEP IN ADULTS WITH RLS. CLINICAL TRIAL REGISTRATION: REGISTRY: CLINICALTRIALS.GOV; TITLE: YOGA VS. EDUCATION FOR RESTLESS LEGS: A FEASIBILITY STUDY; IDENTIFIER: NCT03570515; URL: HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT03570515.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
6 2830  47 YOGA VS STRETCHING IN VETERANS WITH CHRONIC LOWER BACK PAIN AND THE ROLE OF MINDFULNESS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE FEASIBILITY OF RECRUITING, RANDOMIZING, ENROLLING, AND COLLECTING OUTCOME DATA ON VETERAN PATIENTS WITH CHRONIC LOW BACK PAIN (CLBP) WHO UNDERGO AN 8-WEEK, ACTIVE EXERCISE CLASS WITH MINDFULNESS (YOGA CLASS) AND WITHOUT (STRETCHING CLASS). METHODS: UNITED STATES VETERANS WITH CLBP BASED ON INCLUSION/EXCLUSION CRITERIA WERE RANDOMIZED TO 1 OF 2 GROUPS. THE STUDY DESIGN WAS A PILOT RANDOMIZED CONTROLLED TRIAL. TWENTY CLBP PATIENTS ATTENDED A YOGA CLASS OR STRETCHING CLASS ONCE PER WEEK FOR 8 WEEKS AT THE VETERANS AFFAIRS ROCHESTER OUTPATIENT CENTER, ROCHESTER, NEW YORK. THE FOLLOWING MEASUREMENTS WERE OBTAINED: RECRUITMENT OR ENROLLMENT DATA, COMPLIANCE DATA TO INCLUDE CLASS ATTENDANCE AND HOME EXERCISE, AND COMPLIANCE DATA REGARDING ABILITY TO COLLECT OUTCOME MEASURES AT BASELINE AND AT COMPLETION. OUTCOME MEASURES INCLUDED PAIN (PEG), QUALITY OF LIFE (PROMIS GLOBAL HEALTH SURVEY), SELF-EFFICACY (2-ITEM QUESTIONNAIRE), FEAR AVOIDANCE BELIEF, CATASTROPHIZING, AND SOCIAL ENGAGEMENT IN ADDITION TO QUALITATIVE CLINICIAN OPEN-ENDED QUESTIONS POSTINTERVENTION. RESULTS: FORTY-FIVE VETERANS WERE QUERIED REGARDING INTEREST IN PARTICIPATION. OF THESE, 34 (76%) MET THE STUDY'S CRITERIA. TWENTY (44%) AGREED TO PARTICIPATE AND WERE CONSENTED, RANDOMIZED, AND ENROLLED IN THE STUDY. INITIAL AND FINAL OUTCOME MEASURES WERE OBTAINED FOR EACH PARTICIPANT (100%). FORTY PERCENT ATTENDED MORE THAN 80% OF THE SESSIONS FOR BOTH YOGA AND STRETCHING GROUPS. CONCLUSION: THIS PILOT STUDY DEMONSTRATED FEASIBILITY OF RECRUITING, ENROLLING, AND COLLECTING OUTCOME DATA ON CLBP VETERAN PATIENTS PARTICIPATING IN YOGA AND STRETCHING CLASS. THE DATA FROM THIS PILOT WILL INFORM THE DEVELOPMENT OF A RANDOMIZED, COMPARATIVE EFFECTIVENESS STUDY OF YOGA WITH AND WITHOUT MINDFULNESS IN THE MANAGEMENT OF CLBP.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
7 2852  49 YOGA, PHYSICAL THERAPY, OR EDUCATION FOR CHRONIC LOW BACK PAIN: A RANDOMIZED NONINFERIORITY TRIAL. BACKGROUND: YOGA IS EFFECTIVE FOR MILD TO MODERATE CHRONIC LOW BACK PAIN (CLBP), BUT ITS COMPARATIVE EFFECTIVENESS WITH PHYSICAL THERAPY (PT) IS UNKNOWN. MOREOVER, LITTLE IS KNOWN ABOUT YOGA'S EFFECTIVENESS IN UNDERSERVED PATIENTS WITH MORE SEVERE FUNCTIONAL DISABILITY AND PAIN. OBJECTIVE: TO DETERMINE WHETHER YOGA IS NONINFERIOR TO PT FOR CLBP. DESIGN: 12-WEEK, SINGLE-BLIND, 3-GROUP RANDOMIZED NONINFERIORITY TRIAL AND SUBSEQUENT 40-WEEK MAINTENANCE PHASE. (CLINICALTRIALS.GOV: NCT01343927). SETTING: ACADEMIC SAFETY-NET HOSPITAL AND 7 AFFILIATED COMMUNITY HEALTH CENTERS. PARTICIPANTS: 320 PREDOMINANTLY LOW-INCOME, RACIALLY DIVERSE ADULTS WITH NONSPECIFIC CLBP. INTERVENTION: PARTICIPANTS RECEIVED 12 WEEKLY YOGA CLASSES, 15 PT VISITS, OR AN EDUCATIONAL BOOK AND NEWSLETTERS. THE MAINTENANCE PHASE COMPARED YOGA DROP-IN CLASSES VERSUS HOME PRACTICE AND PT BOOSTER SESSIONS VERSUS HOME PRACTICE. MEASUREMENTS: PRIMARY OUTCOMES WERE BACK-RELATED FUNCTION, MEASURED BY THE ROLAND MORRIS DISABILITY QUESTIONNAIRE (RMDQ), AND PAIN, MEASURED BY AN 11-POINT SCALE, AT 12 WEEKS. PRESPECIFIED NONINFERIORITY MARGINS WERE 1.5 (RMDQ) AND 1.0 (PAIN). SECONDARY OUTCOMES INCLUDED PAIN MEDICATION USE, GLOBAL IMPROVEMENT, SATISFACTION WITH INTERVENTION, AND HEALTH-RELATED QUALITY OF LIFE. RESULTS: ONE-SIDED 95% LOWER CONFIDENCE LIMITS WERE 0.83 (RMDQ) AND 0.97 (PAIN), DEMONSTRATING NONINFERIORITY OF YOGA TO PT. HOWEVER, YOGA WAS NOT SUPERIOR TO EDUCATION FOR EITHER OUTCOME. YOGA AND PT WERE SIMILAR FOR MOST SECONDARY OUTCOMES. YOGA AND PT PARTICIPANTS WERE 21 AND 22 PERCENTAGE POINTS LESS LIKELY, RESPECTIVELY, THAN EDUCATION PARTICIPANTS TO USE PAIN MEDICATION AT 12 WEEKS. IMPROVEMENTS IN YOGA AND PT GROUPS WERE MAINTAINED AT 1 YEAR WITH NO DIFFERENCES BETWEEN MAINTENANCE STRATEGIES. FREQUENCY OF ADVERSE EVENTS, MOSTLY MILD SELF-LIMITED JOINT AND BACK PAIN, DID NOT DIFFER BETWEEN THE YOGA AND PT GROUPS. LIMITATIONS: PARTICIPANTS WERE NOT BLINDED TO TREATMENT ASSIGNMENT. THE PT GROUP HAD DISPROPORTIONATE LOSS TO FOLLOW-UP. CONCLUSION: A MANUALIZED YOGA PROGRAM FOR NONSPECIFIC CLBP WAS NONINFERIOR TO PT FOR FUNCTION AND PAIN. PRIMARY FUNDING SOURCE: NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH OF THE NATIONAL INSTITUTES OF HEALTH.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
8 2316  51 TRAUMA-SENSITIVE YOGA FOR POST-TRAUMATIC STRESS DISORDER IN WOMEN VETERANS WHO EXPERIENCED MILITARY SEXUAL TRAUMA: INTERIM RESULTS FROM A RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TO CONDUCT AN INTERIM ANALYSIS OF DATA COLLECTED FROM AN ONGOING MULTISITE RANDOMIZED CLINICAL TRIAL (RCT) ASSESSING THE EFFECTIVENESS OF TRAUMA CENTER TRAUMA-SENSITIVE YOGA (TCTSY) FOR POST-TRAUMATIC STRESS DISORDER (PTSD) AMONG WOMEN VETERANS WITH PTSD RELATED TO MILITARY SEXUAL TRAUMA (MST). THE PURPOSE OF THE INTERIM ANALYSIS WAS TO ASSESS OUTCOMES FROM THE PRIMARY SITE, WHICH IS GEOGRAPHICALLY, DEMOGRAPHICALLY, CULTURALLY, AND PROCEDURALLY DISTINCT FROM THE SECOND SITE. DESIGN: RCT WAS CONDUCTED WITHIN A VETERANS ADMINISTRATION HEALTH CARE SYSTEM. DATA COLLECTION INCLUDED PREINTERVENTION THROUGH 3 MONTHS POSTINTERVENTION. PARTICIPANTS: ENROLLMENT FOR THE MAIN SITE WAS 152 WOMEN. THE SAMPLE SIZE FOR THE INTENT-TO-TREAT ANALYSIS WAS 104. THE MAJORITY WERE AFRICAN AMERICAN (91.3%) WITH A MEAN AGE OF 48.46 YEARS. INTERVENTION: THE TCTSY INTERVENTION (N = 58) WAS CONDUCTED BY TCTSY-CERTIFIED YOGA FACILITATORS AND CONSISTED OF 10 WEEKLY 60-MIN GROUP SESSIONS. THE CONTROL INTERVENTION, COGNITIVE PROCESSING THERAPY (CPT; N = 46), CONSISTED OF 12 90-MIN WEEKLY GROUP SESSIONS CONDUCTED PER VETERANS ADMINISTRATION PROTOCOL BY CLINICIANS IN THE PTSD CLINIC. OUTCOME MEASURES: THE CLINICIAN ADMINISTERED PTSD SCALE FOR DSM-5 (CAPS-5) WAS USED TO ASSESS CURRENT PTSD DIAGNOSIS AND SYMPTOM SEVERITY, INCLUDING OVERALL PTSD AND FOUR SYMPTOM CLUSTERS. THE PTSD CHECKLIST FOR DSM-5 (PCL-5) WAS USED TO OBTAIN SELF-REPORT OF PTSD SYMPTOM SEVERITY, INCLUDING TOTAL SCORE AND FOUR SYMPTOM CLUSTERS. RESULTS: THE FINDINGS REPORTED HERE ARE INTERIM RESULTS FROM ONE CLINICAL SITE. FOR BOTH THE CAPS-5 AND PCL-5, TOTAL SCORES AND ALL FOUR CRITERION SCORES DECREASED SIGNIFICANTLY (P < 0.01) OVER TIME IN ALL FIVE MULTILEVEL LINEAR MODELS WITHIN BOTH TCTSY AND CPT GROUPS, WITHOUT SIGNIFICANT DIFFERENCES BETWEEN GROUPS. THERE WERE CLINICALLY MEANINGFUL IMPROVEMENTS SEEN FOR BOTH TCTSY AND CPT WITH 51.1%-64.3% OF TCTSY SUBJECTS AND 43.5%-73.7% OF CPT DECREASING THEIR CAPS-5 SCORES BY 10 POINTS OR MORE. EFFECT SIZES FOR TOTAL SYMPTOM SEVERITY WERE LARGE FOR TCTSY (COHEN'S D = 1.10-1.18) AND CPT (COHEN'S D = 0.90-1.40). INTERVENTION COMPLETION WAS HIGHER IN TCTSY (60.3%) THAN IN CPT (34.8%). SYMPTOM IMPROVEMENT OCCURRED EARLIER FOR TCTSY (MIDINTERVENTION) THAN FOR CPT (2 WEEKS POSTINTERVENTION). SAFETY: THERE WERE NO UNANTICIPATED ADVERSE EVENTS IN THIS STUDY. CONCLUSION: THE RESULTS OF THIS STUDY DEMONSTRATE THAT TCTSY MAY BE AN EFFECTIVE TREATMENT FOR PTSD THAT YIELDS SYMPTOM IMPROVEMENT MORE QUICKLY, HAS HIGHER RETENTION THAN CPT, AND HAS A SUSTAINED EFFECT. TCTSY MAY BE AN EFFECTIVE ALTERNATIVE TO TRAUMA-FOCUSED THERAPY FOR WOMEN VETERANS WITH PTSD RELATED TO MST. THE STUDY IS REGISTERED IN CLINICALTRIALS.GOV (CTR NO.: NCT02640690).	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
9  551  43 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
10 1165  66 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	

11   70  43 A FEASIBILITY STUDY EXAMINING THE IMPACT OF YOGA ON PSYCHOSOCIAL HEALTH AND SYMPTOMS IN PEDIATRIC OUTPATIENTS RECEIVING CHEMOTHERAPY. PURPOSE: PEDIATRIC CANCER PATIENTS EXPERIENCE SYMPTOMS THAT NEGATIVELY IMPACT QUALITY OF LIFE; YOGA MAY BE AN EFFECTIVE INTERVENTION. THE PRIMARY OBJECTIVE WAS TO DETERMINE THE FEASIBILITY OF A 10-WEEK, WEEKLY INDIVIDUALIZED YOGA INTERVENTION FOR CHILDREN AND ADOLESCENTS RECEIVING OUTPATIENT CANCER THERAPY PRIMARILY DELIVERED REMOTELY USING SKYPE. SECONDARY OBJECTIVES WERE TO DESCRIBE DEPRESSION, ANXIETY, ANGER, FATIGUE, QUALITY OF LIFE, AND SYMPTOMS AT 5 AND 10 WEEKS AFTER ENROLLMENT. METHODS: WE INCLUDED ENGLISH-SPEAKING PATIENTS AGED 10 TO 18 YEARS RECEIVING OUTPATIENT CHEMOTHERAPY FOR CANCER. WEEKLY INDIVIDUALIZED YOGA SESSIONS WERE OFFERED FOR 10 WEEKS. WEEKS 1, 5, AND 10 WERE IN-HOSPITAL WHILE THE REMAINING SESSIONS WERE DELIVERED REMOTELY USING SKYPE. TWICE WEEKLY, HOMEWORK WAS ASSIGNED BETWEEN EACH SESSION. THE PRIMARY OUTCOME WAS FEASIBILITY, DEFINED AS 80% OF PARTICIPANTS COMPLETING AT LEAST 60% OF PLANNED IN-HOSPITAL OR REMOTE YOGA SESSIONS. RESULTS: BETWEEN MARCH AND NOVEMBER 2017, 10 PATIENTS WERE ENROLLED. TWO PATIENTS DISCONTINUED THE STUDY AFTER ONE AND TWO SESSIONS. ONLY SIX PARTICIPANTS ACHIEVED AT LEAST 60% OF PLANNED YOGA SESSIONS AND THUS, THE STUDY DID NOT MEET THE A PRIORI DEFINED FEASIBILITY THRESHOLD. AMONG ALL PARTICIPANTS, ONLY ONE HOMEWORK SESSION WAS PERFORMED. CONCLUSIONS: A 10-WEEK INDIVIDUALIZED IN-PERSON AND REMOTELY CONDUCTED YOGA INTERVENTION WAS NOT FEASIBLE IN CHILDREN RECEIVING CANCER TREATMENTS BECAUSE OF FAILURE TO ACHIEVE THE DESIRED FREQUENCY OF YOGA SESSIONS IN A SUFFICIENT NUMBER OF PARTICIPANTS. FUTURE RESEARCH SHOULD IDENTIFY APPROACHES TO IMPROVE COMPLIANCE WITH REMOTE YOGA SESSIONS AND HOME PRACTICE. TRIAL REGISTRATION: NCT03318068.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
12 2604  48 YOGA FOR PERSISTENT FATIGUE IN BREAST CANCER SURVIVORS: A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CANCER-RELATED FATIGUE AFFLICTS UP TO 33% OF BREAST CANCER SURVIVORS, YET THERE ARE NO EMPIRICALLY VALIDATED TREATMENTS FOR THIS SYMPTOM. METHODS: THE AUTHORS CONDUCTED A 2-GROUP RANDOMIZED CONTROLLED TRIAL TO DETERMINE THE FEASIBILITY AND EFFICACY OF AN IYENGAR YOGA INTERVENTION FOR BREAST CANCER SURVIVORS WITH PERSISTENT POST-TREATMENT FATIGUE. PARTICIPANTS WERE BREAST CANCER SURVIVORS WHO HAD COMPLETED CANCER TREATMENTS (OTHER THAN ENDOCRINE THERAPY) AT LEAST 6 MONTHS BEFORE ENROLLMENT, REPORTED SIGNIFICANT CANCER-RELATED FATIGUE, AND HAD NO OTHER MEDICAL CONDITIONS THAT WOULD ACCOUNT FOR FATIGUE SYMPTOMS OR INTERFERE WITH YOGA PRACTICE. BLOCK RANDOMIZATION WAS USED TO ASSIGN PARTICIPANTS TO A 12-WEEK, IYENGAR-BASED YOGA INTERVENTION OR TO 12 WEEKS OF HEALTH EDUCATION (CONTROL). THE PRIMARY OUTCOME WAS CHANGE IN FATIGUE MEASURED AT BASELINE, IMMEDIATELY POST-TREATMENT, AND 3 MONTHS AFTER TREATMENT COMPLETION. ADDITIONAL OUTCOMES INCLUDED CHANGES IN VIGOR, DEPRESSIVE SYMPTOMS, SLEEP, PERCEIVED STRESS, AND PHYSICAL PERFORMANCE. INTENT-TO-TREAT ANALYSES WERE CONDUCTED WITH ALL RANDOMIZED PARTICIPANTS USING LINEAR MIXED MODELS. RESULTS: THIRTY-ONE WOMEN WERE RANDOMLY ASSIGNED TO YOGA (N = 16) OR HEALTH EDUCATION (N = 15). FATIGUE SEVERITY DECLINED SIGNIFICANTLY FROM BASELINE TO POST-TREATMENT AND OVER A 3-MONTH FOLLOW-UP IN THE YOGA GROUP RELATIVE TO CONTROLS (P = .032). IN ADDITION, THE YOGA GROUP HAD SIGNIFICANT INCREASES IN VIGOR RELATIVE TO CONTROLS (P = .011). BOTH GROUPS HAD POSITIVE CHANGES IN DEPRESSIVE SYMPTOMS AND PERCEIVED STRESS (P < .05). NO SIGNIFICANT CHANGES IN SLEEP OR PHYSICAL PERFORMANCE WERE OBSERVED. CONCLUSIONS: A TARGETED YOGA INTERVENTION LED TO SIGNIFICANT IMPROVEMENTS IN FATIGUE AND VIGOR AMONG BREAST CANCER SURVIVORS WITH PERSISTENT FATIGUE SYMPTOMS.	2012	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
13  162  46 A RANDOMISED CONTROLLED TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN: RESULTS OF A PILOT STUDY. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN (LBP) TO INFORM THE FEASIBILITY AND PRACTICALITY OF CONDUCTING A FULL-SCALE TRIAL IN THE UK; AND TO ASSESS THE EFFICACY OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN. DESIGN: A PRAGMATIC RANDOMISED CONTROLLED TRIAL WAS UNDERTAKEN COMPARING YOGA TO USUAL CARE. PARTICIPANTS: TWENTY PARTICIPANTS WHO HAD PRESENTED TO THEIR GP WITH CHRONIC LOW BACK PAIN IN THE PREVIOUS 18 MONTHS WERE RECRUITED VIA GP RECORDS FROM ONE PRACTICE IN YORK, UK. INTERVENTIONS: TWENTY PATIENTS WERE RANDOMISED TO EITHER 12 WEEKLY 75-MIN SESSIONS OF SPECIALISED YOGA PLUS WRITTEN ADVICE, OR USUAL CARE PLUS WRITTEN ADVICE. ALLOCATION WAS 50/50. MAIN OUTCOME MEASURES: RECRUITMENT RATE, LEVELS OF INTERVENTION ATTENDANCE, AND LOSS TO FOLLOW-UP WERE THE MAIN NON-CLINICAL OUTCOMES. CHANGE AS MEASURED BY THE ROLAND AND MORRIS DISABILITY QUESTIONNAIRE WAS THE PRIMARY CLINICAL OUTCOME. CHANGES IN THE ABERDEEN BACK PAIN SCALE, SF-12, EQ-5D, AND PAIN SELF-EFFICACY WERE SECONDARY CLINICAL OUTCOMES. DATA WERE COLLECTED VIA POSTAL QUESTIONNAIRE AT BASELINE, 4 WEEKS, AND 12 WEEKS FOLLOW-UP. RESULTS: OF THE 286 PATIENTS IDENTIFIED FROM THE GP DATABASE, 52 (18%) CONSENTED AND RETURNED THE ELIGIBILITY QUESTIONNAIRE, OUT OF THESE 20 (6.9%) WERE ELIGIBLE AND RANDOMISED. THE TOTAL PERCENTAGE OF PATIENTS RANDOMISED FROM THE GP PRACTICE POPULATION WAS 0.28%. TEN PATIENTS WERE RANDOMISED TO YOGA, RECEIVING AN AVERAGE OF 1.7 SESSIONS (RANGE 0-5), AND 10 WERE RANDOMISED TO USUAL CARE. AT 12 WEEKS FOLLOW-UP DATA WAS RECEIVED FROM 60% OF PATIENTS IN THE YOGA GROUP AND 90% OF PATIENTS IN THE USUAL CARE GROUP (75% OVERALL). NO SIGNIFICANT DIFFERENCES WERE SEEN BETWEEN GROUPS IN CLINICAL OUTCOMES APART FROM ON THE ABERDEEN BACK PAIN SCALE AT FOUR WEEKS FOLLOW-UP WHERE THE YOGA GROUP REPORTED SIGNIFICANTLY LESS PAIN. CONCLUSION: THIS PILOT STUDY PROVIDED USEFUL DATA AND INFORMATION TO INFORM THE DESIGN AND DEVELOPMENT OF A FULL-SCALE TRIAL OF YOGA FOR CLBP IN THE UK. A KEY FINDING IS THE CALCULATION OF GP PRACTICE TOTAL LIST SIZE REQUIRED FOR PATIENT RECRUITMENT IN A FULL-SCALE TRIAL, AND THE NEED TO IMPLEMENT METHODS TO INCREASE CLASS ATTENDANCE.	2010	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
14   74  37 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
15   41  52 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
16  388  45 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
17  172  39 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
18 2596  46 YOGA FOR MILITARY VETERANS WITH CHRONIC LOW BACK PAIN: A RANDOMIZED CLINICAL TRIAL. INTRODUCTION: CHRONIC LOW BACK PAIN (CLBP) IS PREVALENT, ESPECIALLY AMONG MILITARY VETERANS. MANY CLBP TREATMENT OPTIONS HAVE LIMITED BENEFITS AND ARE ACCOMPANIED BY SIDE EFFECTS. MAJOR EFFORTS TO REDUCE OPIOID USE AND EMBRACE NONPHARMACOLOGICAL PAIN TREATMENTS HAVE RESULTED. RESEARCH WITH COMMUNITY CLBP PATIENTS INDICATES THAT YOGA CAN IMPROVE HEALTH OUTCOMES AND HAS FEW SIDE EFFECTS. THE BENEFITS OF YOGA AMONG MILITARY VETERANS WERE EXAMINED. DESIGN: PARTICIPANTS WERE RANDOMIZED TO EITHER YOGA OR DELAYED YOGA TREATMENT IN 2013-2015. OUTCOMES WERE ASSESSED AT BASELINE, 6 WEEKS, 12 WEEKS, AND 6 MONTHS. INTENTION-TO-TREAT ANALYSES OCCURRED IN 2016. SETTING/PARTICIPANTS: ONE HUNDRED AND FIFTY MILITARY VETERANS WITH CLBP WERE RECRUITED FROM A MAJOR VETERANS AFFAIRS MEDICAL CENTER IN CALIFORNIA. INTERVENTION: YOGA CLASSES (WITH HOME PRACTICE) WERE LED BY A CERTIFIED INSTRUCTOR TWICE WEEKLY FOR 12 WEEKS, AND CONSISTED PRIMARILY OF PHYSICAL POSTURES, MOVEMENT, AND BREATHING TECHNIQUES. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES AFTER 12 WEEKS. PAIN INTENSITY WAS IDENTIFIED AS AN IMPORTANT SECONDARY OUTCOME. RESULTS: PARTICIPANT CHARACTERISTICS WERE MEAN AGE 53 YEARS, 26% WERE FEMALE, 35% WERE UNEMPLOYED OR DISABLED, AND MEAN BACK PAIN DURATION WAS 15 YEARS. IMPROVEMENTS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES DID NOT DIFFER BETWEEN THE TWO GROUPS AT 12 WEEKS, BUT YOGA PARTICIPANTS HAD GREATER REDUCTIONS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES THAN DELAYED TREATMENT PARTICIPANTS AT 6 MONTHS -2.48 (95% CI= -4.08, -0.87). YOGA PARTICIPANTS IMPROVED MORE ON PAIN INTENSITY AT 12 WEEKS AND AT 6 MONTHS. OPIOID MEDICATION USE DECLINED AMONG ALL PARTICIPANTS, BUT GROUP DIFFERENCES WERE NOT FOUND. CONCLUSIONS: YOGA IMPROVED HEALTH OUTCOMES AMONG VETERANS DESPITE EVIDENCE THEY HAD FEWER RESOURCES, WORSE HEALTH, AND MORE CHALLENGES ATTENDING YOGA SESSIONS THAN COMMUNITY SAMPLES STUDIED PREVIOUSLY. THE MAGNITUDE OF PAIN INTENSITY DECLINE WAS SMALL, BUT OCCURRED IN THE CONTEXT OF REDUCED OPIOID USE. THE FINDINGS SUPPORT WIDER IMPLEMENTATION OF YOGA PROGRAMS FOR VETERANS. TRIAL REGISTRATION: THIS STUDY IS REGISTERED AT WWW.CLINICALTRIALS.GOV NCT02524158.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
19 1794  54 PRENATAL YOGA FOR BACK PAIN, BALANCE, AND MATERNAL WELLNESS: A RANDOMIZED, CONTROLLED PILOT STUDY. BACKGROUND: THE OBJECTIVE WAS TO ASSESS THE FEASIBILITY OF A PRENATAL YOGA RANDOMIZED CONTROLLED TRIAL (RCT) FOR GESTATIONAL LOW BACK PAIN (LBP), MOBILITY, AND MATERNAL WELL-BEING. METHODS: IN THIS PILOT, WOMEN AGED 18 TO 39 YEARS WITH UNCOMPLICATED PREGNANCIES AT 12 TO 26 WEEKS WERE RANDOMIZED, STRATIFIED BY PRESENCE OF LBP, TO ATTEND A WEEKLY YOGA CLASS OR A TIME-MATCHED EDUCATIONAL SUPPORT GROUP FOR 12 WEEKS. SAMPLE SIZE WAS BASED ON ANTICIPATED ENROLLMENT OF 2 SUBJECTS PER MONTH. PRIMARY OUTCOMES WERE MEASURES OF FEASIBILITY AND ACCEPTABILITY. SECONDARY OUTCOMES INCLUDED LBP DISABILITY, PREGNANCY SYMPTOM BURDEN, CHILDBIRTH SELF-EFFICACY, INSTRUMENTED GAIT, BALANCE, AND FALLS AT BASELINE, EVERY 4 WEEKS, AND 6 WEEKS POSTPARTUM. RESULTS: FROM APRIL 2015 TO DECEMBER 2015, 168 WOMEN WERE CONTACTED AND 115 (68%) WERE ELIGIBLE. TWENTY WOMEN ENROLLED (N = 11 YOGA; N = 9 CONTROL; MEAN GESTATIONAL AGE 20.2 WEEKS). RETENTION AT 12 WEEKS WAS 81% IN YOGA AND 77% IN CONTROL. THERE WERE NO YOGA-RELATED ADVERSE EVENTS. EXPLORATORY ANALYSES SHOW NO DIFFERENCES IN BACK PAIN DISABILITY BETWEEN GROUPS. SIGNIFICANT GROUPS EFFECTS WERE FOUND ON BIOMECHANICAL ASSESSMENTS, INCLUDING PERCENTAGE CHANGE IN GAIT SPEED (F = 4.4, P = .04), DOUBLE SUPPORT TIME (F = 23.6, P < .01), INSTRUMENTED TIMED-UP-AND-GO (F = 8.6, P < .01), AND TURN TIME (F = 5.7, P = .02) SUGGESTING CLINICALLY RELEVANT IMPROVEMENTS WITH YOGA. PREGNANCY SYMPTOM INVENTORY (PSI) SCORES IMPROVED (13.1 POINT DIFFERENCE, 95% CONFIDENCE INTERVAL, 5.1-21.1) AT 12 WEEKS IN YOGA COMPARED TO CONTROL, ADJUSTED FOR BASELINE GESTATIONAL AGE. CONCLUSION: CONDUCTING AN RCT OF PRENATAL YOGA TO IMPROVE GESTATIONAL LBP AND MATERNAL WELL-BEING IS FEASIBLE AND SAFE. WHILE NO DIFFERENCES IN BACK PAIN WERE OBSERVED, BIOMECHANICAL MEASURES WERE SENSITIVE ASSESSMENTS FOR EVALUATING GESTATIONAL LBP-RELATED MOBILITY IMPAIRMENT AND SHOWED GROUP DIFFERENCES. ADDITIONALLY, THE PSI SHOWED SIGNIFICANT DIFFERENCES IN SYMPTOM BURDEN OVER 12 WEEKS, SUPPORTING THE ONGOING CLAIMS THAT YOGA IMPROVES A PREGNANT WOMAN'S OVERALL WELL-BEING.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
20 2851  43 YOGA, PHYSICAL THERAPY, AND BACK PAIN EDUCATION FOR SLEEP QUALITY IN LOW-INCOME RACIALLY DIVERSE ADULTS WITH CHRONIC LOW BACK PAIN: A SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: POOR SLEEP IS COMMON AMONG ADULTS WITH CHRONIC LOW BACK PAIN (CLBP), BUT THE INFLUENCE OF CLBP TREATMENTS, SUCH AS YOGA AND PHYSICAL THERAPY (PT), ON SLEEP QUALITY IS UNDER STUDIED. OBJECTIVE: EVALUATE THE EFFECTIVENESS OF YOGA AND PT FOR IMPROVING SLEEP QUALITY IN ADULTS WITH CLBP. DESIGN: SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. SETTING: ACADEMIC SAFETY-NET HOSPITAL AND 7 AFFILIATED COMMUNITY HEALTH CENTERS. PARTICIPANTS: A TOTAL OF 320 ADULTS WITH CLBP. INTERVENTION: TWELVE WEEKLY YOGA CLASSES, 1-ON-1 PT SESSIONS, OR AN EDUCATIONAL BOOK. MAIN MEASURES: SLEEP QUALITY WAS MEASURED USING THE PITTSBURGH SLEEP QUALITY INDEX (PSQI) GLOBAL SCORE (0-21) AT BASELINE, 12 WEEKS, AND 52 WEEKS. ADDITIONALLY, WE ALSO EVALUATED HOW THE PROPORTION OF PARTICIPANTS WHO ACHIEVED A CLINICALLY MEANINGFUL IMPROVEMENT IN SLEEP QUALITY (> 3-POINT REDUCTION IN PSQI) AT 12 WEEKS VARIED BY CHANGES IN PAIN AND PHYSICAL FUNCTION AT 6 WEEKS. KEY RESULTS: AMONG PARTICIPANTS (MEAN AGE = 46.0, 64% FEMALE, 82% NON-WHITE), NEARLY ALL (92%) REPORTED POOR SLEEP QUALITY (PSQI > 5) AT BASELINE. AT 12 WEEKS, MODEST IMPROVEMENTS IN SLEEP QUALITY WERE OBSERVED AMONG THE YOGA (PSQI MEAN DIFFERENCE [MD] = - 1.19, 95% CONFIDENCE INTERVAL [CI] - 1.82, - 0.55) AND PT (PSQI MD = - 0.91, 95% CI - 1.61, - 0.20) GROUPS. PARTICIPANTS WHO REPORTED A >/= 30% IMPROVEMENT IN PAIN OR PHYSICAL FUNCTION AT 6 WEEKS, COMPARED WITH THOSE WHO IMPROVED < 10%, WERE MORE LIKELY TO BE A SLEEP QUALITY RESPONDER AT 12 WEEKS (ODDS RATIO [OR] = 3.51, 95% CI 1.73, 7.11 AND OR = 2.16, 95% CI 1.18, 3.95, RESPECTIVELY). RESULTS WERE SIMILAR AT 52 WEEKS. CONCLUSION: IN A SAMPLE OF ADULTS WITH CLBP, VIRTUALLY ALL WITH POOR SLEEP QUALITY PRIOR TO INTERVENTION, MODEST BUT STATISTICALLY SIGNIFICANT IMPROVEMENTS IN SLEEP QUALITY WERE OBSERVED WITH BOTH YOGA AND PT. IRRESPECTIVE OF TREATMENT, CLINICALLY IMPORTANT SLEEP IMPROVEMENTS AT THE END OF THE INTERVENTION WERE ASSOCIATED WITH MID-INTERVENTION PAIN AND PHYSICAL FUNCTION IMPROVEMENTS. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT01343927.	2020