1  199 130 A RESEARCH PROTOCOL FOR A PILOT, RANDOMIZED CONTROLLED TRIAL DESIGNED TO EXAMINE THE FEASIBILITY OF A DYADIC VERSUS INDIVIDUAL YOGA PROGRAM FOR FAMILY CAREGIVERS OF GLIOMA PATIENTS UNDERGOING RADIOTHERAPY. BACKGROUND: ALTHOUGH THE DIAGNOSIS AND TREATMENT OF A PRIMARY BRAIN TUMOR PRESENT UNIQUE CHALLENGES TO PATIENTS AND THEIR FAMILY CAREGIVERS, EVIDENCE-BASED SUPPORTIVE CARE INTERVENTIONS ARE GENERALLY LACKING. THE PRIMARY AIM OF THIS RESEARCH PROTOCOL IS TO DETERMINE THE FEASIBILITY OF IMPLEMENTING A DYADIC YOGA (DY) VERSUS A CAREGIVER YOGA (CY) INTERVENTION OR A WAIT-LIST CONTROL (WLC) GROUP USING A RANDOMIZED CONTROLLED TRIAL DESIGN. METHODS: SEVENTY-FIVE GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR FAMILY CAREGIVERS ARE RANDOMIZED TO THE DY, CY, OR A WLC GROUP. PATIENT-CAREGIVER DYADS IN THE DY GROUP AND CAREGIVERS IN THE CY GROUP RECEIVE 15 SESSIONS (45 MIN EACH) OVER THE COURSE OF PATIENTS' STANDARD RADIOTHERAPY (6 WEEKS). PATIENTS AND CAREGIVERS IN ALL GROUPS COMPLETE BASELINE ASSESSMENTS OF SYMPTOMS, QUALITY OF LIFE (QOL), AND HEALTH UTILIZATION OUTCOMES PRIOR TO RANDOMIZATION. FOLLOW-UP ASSESSMENTS ARE PERFORMED 6 WEEKS AND THEN AGAIN 3 MONTHS LATER. THE PRIMARY OUTCOME IS FEASIBILITY (I.E., >/= 50% OF ELIGIBLE DYADS CONSENT, >/= 70% OF ENROLLED DYADS COMPLETE ALL ASSESSMENTS, AND >/= 50% OF ALL PRACTICE SESSIONS ARE ATTENDED). WE WILL ALSO PERFORM PRIMARILY DESCRIPTIVE ANALYSES OF THE SELF-REPORTED OUTCOMES (E.G., FATIGUE, OVERALL QOL) AND EXPLORE POTENTIAL INTERVENTION MODERATORS (E.G., PERFORMANCE STATUS) TO INFORM A LARGER FUTURE TRIAL. CONCLUSION: THIS TRIAL WILL PROVIDE IMPORTANT INFORMATION REGARDING THE FEASIBILITY OF A DYADIC VERSUS A CAREGIVER YOGA INTERVENTION REGARDING SYMPTOM, QOL, AND HEALTH UTILIZATION OUTCOMES IN GLIOMA PATIENTS AND THEIR CAREGIVERS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT02481349.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
2 1748  57 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
3   74  41 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
4 2701  45 YOGA INTERVENTION FOR PATIENTS WITH PROSTATE CANCER UNDERGOING EXTERNAL BEAM RADIATION THERAPY: A PILOT FEASIBILITY STUDY. PURPOSE: STUDIES HAVE DEMONSTRATED BENEFICIAL HEALTH EFFECTS FROM YOGA INTERVENTIONS IN CANCER PATIENTS, BUT PREDOMINANTLY IN BREAST CANCER. RESEARCH ON ITS ROLE IN ALLEVIATING PROSTATE CANCER (PC) PATIENTS' SIDE EFFECTS HAS BEEN LACKING. OUR PRIMARY GOAL WAS TO DETERMINE THE FEASIBILITY OF RECRUITING PC PATIENTS ON A CLINICAL TRIAL OF YOGA WHILE THEY UNDERWENT EXTERNAL BEAM RADIATION THERAPY (RT). METHODS: TWICE-WEEKLY YOGA INTERVENTIONS WERE OFFERED THROUGHOUT THE RT COURSE (6-9 WEEKS). BASELINE DEMOGRAPHIC INFORMATION WAS COLLECTED. FEASIBILITY WAS DECLARED IF 15 OF THE FIRST 75 ELIGIBLE PC PATIENTS APPROACHED (20%) WERE SUCCESSFULLY ACCRUED AND COMPLETED THE INTERVENTION. ADDITIONAL END POINTS INCLUDED STANDARDIZED ASSESSMENTS OF FATIGUE, ERECTILE DYSFUNCTION (ED), URINARY INCONTINENCE (UI), AND QUALITY OF LIFE (QOL) AT TIME POINTS BEFORE, DURING, AND AFTER RT. RESULTS: BETWEEN MAY 2013 AND JUNE 2014, 68 ELIGIBLE PC PATIENTS WERE IDENTIFIED. 23 PATIENTS (34%) DECLINED, AND 45 (56%) CONSENTED TO THE STUDY. 18 (40%) WERE VOLUNTARILY WITHDRAWN DUE TO TREATMENT CONFLICTS. OF THE REMAINING 27, 12 (30%) PARTICIPATED IN >/=50% OF CLASSES, AND 15 (59%) WERE EVALUABLE. SEVERITY OF FATIGUE SCORES DEMONSTRATED SIGNIFICANT VARIABILITY, WITH FATIGUE INCREASING BY WEEK 4, BUT THEN IMPROVING OVER THE COURSE OF TREATMENT (P = .008). ED, UI, AND GENERAL QOL SCORES DEMONSTRATED REASSURINGLY STABLE, ALBEIT NOT SIGNIFICANT TRENDS. CONCLUSIONS: A STRUCTURED YOGA INTERVENTION OF TWICE-WEEKLY CLASSES IS FEASIBLE FOR PC PATIENTS DURING A 6- TO 9-WEEK COURSE OF OUTPATIENT RADIOTHERAPY. PRELIMINARY RESULTS ARE PROMISING, SHOWING STABLE MEASUREMENTS IN FATIGUE, SEXUAL HEALTH, UI, AND GENERAL QOL.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
5  193  35 A RANDOMIZED TRIAL COMPARING YOGA, STRETCHING, AND A SELF-CARE BOOK FOR CHRONIC LOW BACK PAIN. BACKGROUND: CHRONIC LOW BACK PAIN IS A COMMON PROBLEM LACKING HIGHLY EFFECTIVE TREATMENT OPTIONS. SMALL TRIALS SUGGEST THAT YOGA MAY HAVE BENEFITS FOR THIS CONDITION. THIS TRIAL WAS DESIGNED TO DETERMINE WHETHER YOGA IS MORE EFFECTIVE THAN CONVENTIONAL STRETCHING EXERCISES OR A SELF-CARE BOOK FOR PRIMARY CARE PATIENTS WITH CHRONIC LOW BACK PAIN. METHODS: A TOTAL OF 228 ADULTS WITH CHRONIC LOW BACK PAIN WERE RANDOMIZED TO 12 WEEKLY CLASSES OF YOGA (92 PATIENTS) OR CONVENTIONAL STRETCHING EXERCISES (91 PATIENTS) OR A SELF-CARE BOOK (45 PATIENTS). BACK-RELATED FUNCTIONAL STATUS (MODIFIED ROLAND DISABILITY QUESTIONNAIRE, A 23-POINT SCALE) AND BOTHERSOMENESS OF PAIN (AN 11-POINT NUMERICAL SCALE) AT 12 WEEKS WERE THE PRIMARY OUTCOMES. OUTCOMES WERE ASSESSED AT BASELINE, 6, 12, AND 26 WEEKS BY INTERVIEWERS UNAWARE OF TREATMENT GROUP. RESULTS: AFTER ADJUSTMENT FOR BASELINE VALUES, 12-WEEK OUTCOMES FOR THE YOGA GROUP WERE SUPERIOR TO THOSE FOR THE SELF-CARE GROUP (MEAN DIFFERENCE FOR FUNCTION, -2.5 [95% CI, -3.7 TO -1.3]; P < .001; MEAN DIFFERENCE FOR SYMPTOMS, -1.1 [95% CI, -1.7 TO -0.4]; P < .001). AT 26 WEEKS, FUNCTION FOR THE YOGA GROUP REMAINED SUPERIOR (MEAN DIFFERENCE, -1.8 [95% CI, -3.1 TO -0.5]; P < .001). YOGA WAS NOT SUPERIOR TO CONVENTIONAL STRETCHING EXERCISES AT ANY TIME POINT. CONCLUSION: YOGA CLASSES WERE MORE EFFECTIVE THAN A SELF-CARE BOOK, BUT NOT MORE EFFECTIVE THAN STRETCHING CLASSES, IN IMPROVING FUNCTION AND REDUCING SYMPTOMS DUE TO CHRONIC LOW BACK PAIN, WITH BENEFITS LASTING AT LEAST SEVERAL MONTHS. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT00447668.	2011	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
6 2273  44 THE ROLE OF YOGA IN THE MANAGEMENT OF BLADDER PAIN SYNDROME: A SINGLE-ARM PILOT STUDY. BACKGROUND: BLADDER PAIN SYNDROME (BPS) IS A DEVASTATING UROLOGIC CONDITION CHARACTERIZED BY IRRITATIVE BLADDER SYMPTOMS, PELVIC PAIN, AND DYSPAREUNIA. FIRST-LINE TREATMENT INCLUDES DIETARY, SELF-CARE AND BEHAVIORAL MODIFICATIONS. THE ANCIENT PRACTICE OF YOGA IS WELL SUITED TO TREAT BPS, BUT EVIDENCE IS LACKING ON ITS USE. AIMS: TO INVESTIGATE THE FEASIBILITY AND EFFICACY OF AN INTEGRATED YOGA MODULE ON BPS OUTCOMES AS MEASURED BY SELF-REPORTED QUESTIONNAIRES FROM BASELINE TO 3 MONTHS AFTER THERAPY. METHODS AND MATERIALS: THIS WAS A PROSPECTIVE SINGLE-ARM STUDY OF 8 PATIENTS WHO UNDERWENT 3 MONTHS OF INTEGRATED YOGA THERAPY. THE TREATMENT MODULE WAS PERFORMED 3 TO 4 TIMES WEEKLY AT HOME WITH 1 SESSION PERFORMED WEEKLY IN-OFFICE DURING THE FIRST MONTH TO ENSURE PROPER PERFORMANCE OF POSTURES. PATIENTS COMPLETED QUESTIONNAIRES (PELVIC PAIN AND URGENCY/FREQUENCY PATIENT SYMPTOM SCALE [PUF], PELVIC FLOOR IMPACT QUESTIONNAIRE - SHORT FORM 7 [PFIQ-7], SHORT FORM 36 QUESTIONNAIRE [SF-36], PITTSBURGH SLEEP QUALITY INDEX [PSQI]) AT BASELINE AND 3 MONTHS, INCLUDING PATIENT GLOBAL IMPRESSION OF IMPROVEMENT (PGI-I) AT THE 3-MONTH FOLLOW-UP VISIT. VOIDING DIARIES WERE ALSO REQUESTED AT BASELINE AND AT THE 3-MONTH ASSESSMENT. RESULTS: THERE WAS A TREND TOWARD IMPROVEMENT REGARDING PATIENTS' RESPONSES TO ALL QUESTIONNAIRES 3 MONTHS AFTER YOGA THERAPY, WITH THE ONLY STATISTICALLY SIGNIFICANT IMPROVEMENTS NOTED IN SOCIAL FUNCTION AND PAIN COMPONENTS OF THE SF-36. THERE WERE NO SIGNIFICANT CHANGES NOTED ON THE VOIDING DIARIES EXCEPT A NON-STATISTICALLY SIGNIFICANT TREND TOWARD INCREASED VOIDED VOLUMES. PATIENTS RATED THEIR EXPERIENCES WITH YOGA THERAPY POSITIVELY. CONCLUSIONS: YOGA THERAPY FOR BPS SHOWED EVIDENCE OF BENEFIT FOR IMPROVING BOTHERSOME BLADDER SYMPTOMS, PAIN AND VOIDING. A RANDOMIZED CONTROLLED TRIAL WILL FOLLOW TO INVESTIGATE THE EFFICACY OF THIS YOGA MODULE AGAINST A CONTROL GROUP.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
7   73  52 A GROUP-BASED YOGA PROGRAM FOR URINARY INCONTINENCE IN AMBULATORY WOMEN: FEASIBILITY, TOLERABILITY, AND CHANGE IN INCONTINENCE FREQUENCY OVER 3 MONTHS IN A SINGLE-CENTER RANDOMIZED TRIAL. BACKGROUND: BECAUSE OF THE LIMITATIONS OF EXISTING CLINICAL TREATMENTS FOR URINARY INCONTINENCE, MANY WOMEN WITH INCONTINENCE ARE INTERESTED IN COMPLEMENTARY STRATEGIES FOR MANAGING THEIR SYMPTOMS. YOGA HAS BEEN RECOMMENDED AS A BEHAVIORAL SELF-MANAGEMENT STRATEGY FOR INCONTINENCE, BUT EVIDENCE OF ITS FEASIBILITY, TOLERABILITY, AND EFFICACY IS LACKING. OBJECTIVE: TO EVALUATE THE FEASIBILITY AND TOLERABILITY OF A GROUP-BASED THERAPEUTIC YOGA PROGRAM FOR AMBULATORY MIDDLE-AGED AND OLDER WOMEN WITH INCONTINENCE, AND TO EXAMINE PRELIMINARY CHANGES IN INCONTINENCE FREQUENCY AS THE PRIMARY EFFICACY OUTCOME AFTER 3 MONTHS. MATERIALS AND METHODS: AMBULATORY WOMEN AGED 50 YEARS OR OLDER WHO REPORTED AT LEAST DAILY STRESS-, URGENCY-, OR MIXED-TYPE INCONTINENCE, WERE NOT ALREADY ENGAGED IN YOGA, AND WERE WILLING TO TEMPORARILY FORGO CLINICAL INCONTINENCE TREATMENTS WERE RECRUITED INTO A RANDOMIZED TRIAL IN THE SAN FRANCISCO BAY AREA. WOMEN WERE RANDOMLY ASSIGNED TO TAKE PART IN A PROGRAM OF TWICE-WEEKLY GROUP CLASSES AND ONCE-WEEKLY HOME PRACTICE FOCUSED ON IYENGAR-BASED YOGA TECHNIQUES SELECTED BY AN EXPERT YOGA PANEL (YOGA GROUP), OR A NONSPECIFIC MUSCLE STRETCHING AND STRENGTHENING PROGRAM DESIGNED TO PROVIDE A RIGOROUS TIME-AND-ATTENTION CONTROL (CONTROL GROUP) FOR 3 MONTHS. ALL PARTICIPANTS ALSO RECEIVED WRITTEN, EVIDENCE-BASED INFORMATION ABOUT BEHAVIORAL INCONTINENCE SELF-MANAGEMENT TECHNIQUES (PELVIC FLOOR EXERCISES, BLADDER TRAINING) CONSISTENT WITH USUAL FIRST-LINE CARE. INCONTINENCE FREQUENCY AND TYPE WERE ASSESSED BY VALIDATED VOIDING DIARIES. ANALYSIS OF COVARIANCE MODELS EXAMINED WITHIN- AND BETWEEN-GROUP CHANGES IN INCONTINENCE FREQUENCY AS THE PRIMARY EFFICACY OUTCOME OVER 3 MONTHS. RESULTS: OF THE 56 WOMEN RANDOMIZED (28 TO YOGA, 28 TO CONTROL), THE MEAN AGE WAS 65.4 (+/-8.1) YEARS (RANGE, 55-83 YEARS), THE MEAN BASELINE INCONTINENCE FREQUENCY WAS 3.5 (+/-2.0) EPISODES/D, AND 37 WOMEN (66%) HAD URGENCY-PREDOMINANT INCONTINENCE. A TOTAL OF 50 WOMEN COMPLETED THEIR ASSIGNED 3-MONTH INTERVENTION PROGRAM (89%), INCLUDING 27 IN THE YOGA AND 23 IN THE CONTROL GROUP (P = .19). OF THOSE, 24 (89%) IN THE YOGA AND 20 (87%) IN THE CONTROL GROUP ATTENDED AT LEAST 80% OF GROUP CLASSES. OVER 3 MONTHS, TOTAL INCONTINENCE FREQUENCY DECREASED BY AN AVERAGE OF 76% FROM BASELINE IN THE YOGA AND 56% IN THE CONTROL GROUP (P = .07 FOR BETWEEN-GROUP DIFFERENCE). STRESS INCONTINENCE FREQUENCY ALSO DECREASED BY AN AVERAGE OF 61% IN THE YOGA GROUP AND 35% IN CONTROLS (P = .045 FOR BETWEEN-GROUP DIFFERENCE), BUT CHANGES IN URGENCY INCONTINENCE FREQUENCY DID NOT DIFFER SIGNIFICANTLY BETWEEN GROUPS. A TOTAL OF 48 NONSERIOUS ADVERSE EVENTS WERE REPORTED, INCLUDING 23 IN THE YOGA AND 25 IN THE CONTROL GROUP, BUT NONE WERE DIRECTLY ATTRIBUTABLE TO YOGA OR CONTROL PROGRAM PRACTICE. CONCLUSION: FINDINGS DEMONSTRATE THE FEASIBILITY OF RECRUITING AND RETAINING INCONTINENT WOMEN ACROSS THE AGING SPECTRUM INTO A THERAPEUTIC YOGA PROGRAM, AND PROVIDE PRELIMINARY EVIDENCE OF REDUCTION IN TOTAL AND STRESS-TYPE INCONTINENCE FREQUENCY AFTER 3 MONTHS OF YOGA PRACTICE. WHEN TAUGHT WITH ATTENTION TO WOMEN'S CLINICAL NEEDS, YOGA MAY OFFER A POTENTIAL COMMUNITY-BASED BEHAVIORAL SELF-MANAGEMENT STRATEGY FOR INCONTINENCE TO ENHANCE CLINICAL TREATMENT, ALTHOUGH FUTURE RESEARCH SHOULD ASSESS WHETHER YOGA OFFERS UNIQUE BENEFITS FOR INCONTINENCE ABOVE AND BEYOND OTHER PHYSICAL ACTIVITY-BASED INTERVENTIONS.	2019	

8 1822  39 PROTOCOL TO EVALUATE THE IMPACT OF YOGA SUPPLEMENTATION ON COGNITIVE FUNCTION IN SCHIZOPHRENIA: A RANDOMISED CONTROLLED TRIAL. BACKGROUND: SCHIZOPHRENIA (SZ) IS A CHRONIC ILLNESS THAT IS TREATED SYMPTOMATICALLY. COGNITIVE DYSFUNCTION IS A CORE FEATURE OF SZ THAT IS RELATIVELY INTRACTABLE TO PHARMACOTHERAPY. YOGA CAN IMPROVE COGNITIVE FUNCTION AMONG HEALTHY INDIVIDUALS. A RECENT OPEN TRIAL INDICATED SIGNIFICANT BENEFITS OF YOGA TRAINING (YT) IN CONJUNCTION WITH CONVENTIONAL PHARMACOTHERAPY AMONG PATIENTS WITH SZ. AIMS: TO DESCRIBE THE PROTOCOL FOR AN ONGOING RANDOMISED CONTROLLED TRIAL DESIGNED TO TEST WHETHER THE REPORTED BENEFICIAL EFFECTS OF YT ON COGNITIVE FUNCTION AMONG SZ PATIENTS CAN BE REPLICATED. SECONDARILY, THE EFFECTS OF YT ON DAILY FUNCTIONING LIVING SKILLS ARE EVALUATED. METHODS: CONSENTING PATIENTS WITH SZ RECEIVE ROUTINE CLINICAL TREATMENT AND ARE RANDOMISED TO ADJUNCTIVE YT, ADJUNCTIVE PHYSICAL EXERCISE (PE) OR TREATMENT AS USUAL (PROPOSED N = 234 TOTAL, N = 78 IN EACH GROUP). THE TRIAL INVOLVES YT OR PE 5 DAYS A WEEK AND LASTS 3 WEEKS. PARTICIPANTS ARE EVALUATED THRICE OVER 6 MONTHS. COGNITIVE FUNCTIONS MEASURED BY TRAIL MAKING TEST, UNIVERSITY OF PENNSYLVANIA NEUROCOGNITIVE COMPUTERISED BATTERY WERE PRIMARY OUTCOME MEASURES WHILE CLINICAL SEVERITY AND DAILY FUNCTIONING MEASURED BY INDEPENDENT LIVING SKILLS SURVEY WERE SECONDARY OUTCOME MEASURES. RESULTS: A TOTAL OF 309 PARTICIPANTS HAVE BEEN RANDOMISED AS OF 31 AUGUST 2013, WHICH EXCEEDED BEYOND 294 PROPOSED AFTER ATTRITION. ONCE PARTICIPANTS BEGIN YT OR PE THEY GENERALLY COMPLETE THE PROTOCOL. NO INJURIES HAVE BEEN REPORTED. CONCLUSIONS: SHORT TERM YT IS FEASIBLE AND ACCEPTABLE TO INDIAN SZ PATIENTS. IF BENEFICIAL EFFECTS OF YT ARE DETECTED, IT WILL PROVIDE A NOVEL ADJUNCTIVE COGNITIVE REMEDIATION STRATEGY FOR SZ PATIENTS.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
9 1787  32 PREFERENCE AND EXPECTATION FOR TREATMENT ASSIGNMENT IN A RANDOMIZED CONTROLLED TRIAL OF ONCE- VS TWICE-WEEKLY YOGA FOR CHRONIC LOW BACK PAIN. BACKGROUND: IN STUDIES INVOLVING NONPHARMACOLOGICAL COMPLEMENTARY AND ALTERNATIVE MEDICINE INTERVENTIONS, PARTICIPANT BLINDING IS VERY DIFFICULT. PARTICIPANT EXPECTATIONS MAY AFFECT PERCEIVED BENEFIT OF THERAPY. IN STUDIES OF YOGA AS TREATMENT FOR CHRONIC LOW BACK PAIN, LITTLE IS KNOWN ABOUT THE RELATIONSHIP BETWEEN PATIENT EXPECTATIONS AND PREFERENCES ON OUTCOMES. THIS STUDY WAS DESIGNED TO IDENTIFY BASELINE PREDICTORS OF PREFERENCE AND TO DETERMINE IF EXPECTATIONS AND PREFERENCES FOR DIFFERENT DOSES OF YOGA AFFECT BACK-RELATED FUNCTION AND LOW BACK PAIN INTENSITY. METHODS: THIS WAS A SECONDARY DATA ANALYSIS OF A 12-WEEK RANDOMIZED CONTROLLED TRIAL COMPARING ONCE-WEEKLY VS TWICE-WEEKLY YOGA FOR TREATMENT OF CHRONIC LOW BACK PAIN IN 93 ADULTS FROM A PREDOMINANTLY LOW-INCOME MINORITY POPULATION. AT BASELINE, PARTICIPANTS WERE ASKED ABOUT BACK FUNCTION, BACK PAIN, TREATMENT EXPECTATIONS, AND TREATMENT PREFERENCES. WE CREATED A VARIABLE "CONCORDANCE" TO DESCRIBE THE MATCHING OF PARTICIPANT PREFERENCE TO RANDOMIZED TREATMENT. OUR OUTCOME VARIABLES WERE CHANGE IN BACK FUNCTION AND PAIN INTENSITY AFTER 12 WEEKS OF YOGA INSTRUCTION. WE PERFORMED LOGISTIC REGRESSION TO IDENTIFY PREDICTORS OF PREFERENCE FOR ONCE- OR TWICE-WEEKLY YOGA INSTRUCTION. WE CREATED LINEAR REGRESSION MODELS TO IDENTIFY INDEPENDENT ASSOCIATIONS BETWEEN EXPECTATIONS, PREFERENCE, CONCORDANCE, AND OUTCOMES. RESULTS: WORSE BACK FUNCTION AT BASELINE WAS ASSOCIATED WITH 20% HIGHER ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 1.2, CI 1.1, 1.3). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR TWICE-WEEKLY YOGA HAD 90% HIGHER ODDS OF PREFERRING TWICE-WEEKLY VS ONCE-WEEKLY YOGA (OR 1.9, CI 1.3, 2.7). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR ONCE-WEEKLY YOGA HAD 40% LESS ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 0.6, CI 0.5, 0.9). AFTER CONTROLLING FOR BASELINE CHARACTERISTICS, WE FOUND NO STATISTICALLY SIGNIFICANT RELATIONSHIP BETWEEN TREATMENT OUTCOMES, PREFERENCE, EXPECTATION SCORES, OR CONCORDANCE. CONCLUSION: IN A POPULATION OF PREDOMINANTLY LOW-INCOME MINORITY PARTICIPANTS WITH CHRONIC LOW BACK PAIN, WORSE BACK FUNCTION WAS ASSOCIATED WITH PREFERENCE FOR MORE FREQUENT YOGA CLASSES. THOSE WHO PREFERRED MORE YOGA CLASSES HAD HIGHER EXPECTATIONS FOR THOSE CLASSES. TWELVE-WEEK CHANGE IN BACK PAIN INTENSITY AND BACK FUNCTION WERE NOT AFFECTED BY DOSING PREFERENCE, EXPECTATION SCORE, OR CONCORDANCE. MORE RESEARCH IS NEEDED TO BETTER MEASURE AND QUANTIFY PREFERENCE, EXPECTATIONS, AND THEIR RELATIONSHIP TO OUTCOMES IN YOGA RESEARCH.	2015	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
10  521  36 COMPARING YOGA, EXERCISE, AND A SELF-CARE BOOK FOR CHRONIC LOW BACK PAIN: A RANDOMIZED, CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN IS A COMMON PROBLEM THAT HAS ONLY MODESTLY EFFECTIVE TREATMENT OPTIONS. OBJECTIVE: TO DETERMINE WHETHER YOGA IS MORE EFFECTIVE THAN CONVENTIONAL THERAPEUTIC EXERCISE OR A SELF-CARE BOOK FOR PATIENTS WITH CHRONIC LOW BACK PAIN. DESIGN: RANDOMIZED, CONTROLLED TRIAL. SETTING: A NONPROFIT, INTEGRATED HEALTH CARE SYSTEM. PATIENTS: 101 ADULTS WITH CHRONIC LOW BACK PAIN. INTERVENTION: 12-WEEK SESSIONS OF YOGA OR CONVENTIONAL THERAPEUTIC EXERCISE CLASSES OR A SELF-CARE BOOK. MEASUREMENTS: PRIMARY OUTCOMES WERE BACK-RELATED FUNCTIONAL STATUS (MODIFIED 24-POINT ROLAND DISABILITY SCALE) AND "BOTHERSOMENESS" OF PAIN (11-POINT NUMERICAL SCALE). THE PRIMARY TIME POINT WAS 12 WEEKS. CLINICALLY SIGNIFICANT CHANGE WAS CONSIDERED TO BE 2.5 POINTS ON THE FUNCTIONAL STATUS SCALE AND 1.5 POINTS ON THE BOTHERSOMENESS SCALE. SECONDARY OUTCOMES WERE DAYS OF RESTRICTED ACTIVITY, GENERAL HEALTH STATUS, AND MEDICATION USE. RESULTS: AFTER ADJUSTMENT FOR BASELINE VALUES, BACK-RELATED FUNCTION IN THE YOGA GROUP WAS SUPERIOR TO THE BOOK AND EXERCISE GROUPS AT 12 WEEKS (YOGA VS. BOOK: MEAN DIFFERENCE, -3.4 [95% CI, -5.1 TO - 1.6] [P < 0.001]; YOGA VS. EXERCISE: MEAN DIFFERENCE, -1.8 [CI, -3.5 TO - 0.1] [P = 0.034]). NO SIGNIFICANT DIFFERENCES IN SYMPTOM BOTHERSOMENESS WERE FOUND BETWEEN ANY 2 GROUPS AT 12 WEEKS; AT 26 WEEKS, THE YOGA GROUP WAS SUPERIOR TO THE BOOK GROUP WITH RESPECT TO THIS MEASURE (MEAN DIFFERENCE, -2.2 [CI, -3.2 TO - 1.2]; P < 0.001). AT 26 WEEKS, BACK-RELATED FUNCTION IN THE YOGA GROUP WAS SUPERIOR TO THE BOOK GROUP (MEAN DIFFERENCE, -3.6 [CI, -5.4 TO - 1.8]; P < 0.001). LIMITATIONS: PARTICIPANTS IN THIS STUDY WERE FOLLOWED FOR ONLY 26 WEEKS AFTER RANDOMIZATION. ONLY 1 INSTRUCTOR DELIVERED EACH INTERVENTION. CONCLUSIONS: YOGA WAS MORE EFFECTIVE THAN A SELF-CARE BOOK FOR IMPROVING FUNCTION AND REDUCING CHRONIC LOW BACK PAIN, AND THE BENEFITS PERSISTED FOR AT LEAST SEVERAL MONTHS.	2005	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
11  461  31 CHANGES IN PERCEIVED STRESS AFTER YOGA, PHYSICAL THERAPY, AND EDUCATION INTERVENTIONS FOR CHRONIC LOW BACK PAIN: A SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: PERCEIVED STRESS AND MUSCULOSKELETAL PAIN ARE COMMON, ESPECIALLY IN LOW-INCOME POPULATIONS. STUDIES EVALUATING TREATMENTS TO REDUCE STRESS IN PATIENTS WITH CHRONIC PAIN ARE LACKING. WE AIMED TO QUANTIFY THE EFFECT OF TWO EVIDENCE-BASED INTERVENTIONS FOR CHRONIC LOW BACK PAIN (CLBP), YOGA AND PHYSICAL THERAPY (PT), ON PERCEIVED STRESS IN ADULTS WITH CLBP. METHODS: WE USED DATA FROM AN ASSESSOR-BLINDED, PARALLEL-GROUP RANDOMIZED CONTROLLED TRIAL, WHICH RECRUITED PREDOMINANTLY LOW-INCOME AND RACIALLY DIVERSE ADULTS WITH CLBP. PARTICIPANTS (N = 320) WERE RANDOMLY ASSIGNED TO 12 WEEKS OF YOGA, PT, OR BACK PAIN EDUCATION. WE COMPARED CHANGES IN THE 10-ITEM PERCEIVED STRESS SCALE (PSS-10) FROM BASELINE TO 12- AND 52-WEEK FOLLOW-UP AMONG YOGA AND PT PARTICIPANTS WITH THOSE RECEIVING EDUCATION. SUBANALYSES WERE CONDUCTED FOR PARTICIPANTS WITH ELEVATED PRE-INTERVENTION PERCEIVED STRESS (PSS-10 SCORE >/=17). WE CONDUCTED SENSITIVITY ANALYSES USING VARIOUS IMPUTATION METHODS TO ACCOUNT FOR POTENTIAL BIASES IN OUR ESTIMATES DUE TO MISSING DATA. RESULTS: AMONG 248 PARTICIPANTS (MEAN AGE = 46.4 YEARS, 80% NONWHITE) COMPLETING ALL THREE SURVEYS, YOGA AND PT SHOWED GREATER REDUCTIONS IN PSS-10 SCORES COMPARED WITH EDUCATION AT 12 WEEKS (MEAN BETWEEN-GROUP DIFFERENCE = -2.6, 95% CONFIDENCE INTERVAL [CI] = -4.5 TO -0.66, AND MEAN BETWEEN-GROUP DIFFERENCE = -2.4, 95% CI = -4.4 TO -0.48, RESPECTIVELY). THIS EFFECT WAS STRONGER AMONG PARTICIPANTS WITH ELEVATED PRE-INTERVENTION PERCEIVED STRESS. BETWEEN-GROUP EFFECTS HAD ATTENUATED BY 52 WEEKS. RESULTS WERE SIMILAR IN SENSITIVITY ANALYSES. CONCLUSIONS: YOGA AND PT WERE MORE EFFECTIVE THAN BACK PAIN EDUCATION FOR REDUCING PERCEIVED STRESS AMONG LOW-INCOME ADULTS WITH CLBP.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
12 2851  34 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
13  161  36 A RANDOMISED CONTROLLED TRIAL OF ADJUNCTIVE YOGA AND ADJUNCTIVE PHYSICAL EXERCISE TRAINING FOR COGNITIVE DYSFUNCTION IN SCHIZOPHRENIA. BACKGROUND: YOGA AND PHYSICAL EXERCISE HAVE BEEN USED AS ADJUNCTIVE INTERVENTION FOR COGNITIVE DYSFUNCTION IN SCHIZOPHRENIA (SZ), BUT CONTROLLED COMPARISONS ARE LACKING. AIMS A SINGLE-BLIND RANDOMISED CONTROLLED TRIAL WAS DESIGNED TO EVALUATE WHETHER YOGA TRAINING OR PHYSICAL EXERCISE TRAINING ENHANCE COGNITIVE FUNCTIONS IN SZ, BASED ON A PRIOR PILOT STUDY. METHODS: CONSENTING, CLINICALLY STABLE, ADULT OUTPATIENTS WITH SZ (N=286) COMPLETED BASELINE ASSESSMENTS AND WERE RANDOMISED TO TREATMENT AS USUAL (TAU), SUPERVISED YOGA TRAINING WITH TAU (YT) OR SUPERVISED PHYSICAL EXERCISE TRAINING WITH TAU (PE). BASED ON THE PILOT STUDY, THE PRIMARY OUTCOME MEASURE WAS SPEED INDEX FOR THE COGNITIVE DOMAIN OF 'ATTENTION' IN THE PENN COMPUTERISED NEUROCOGNITIVE BATTERY. USING MIXED MODELS AND CONTRASTS, COGNITIVE FUNCTIONS AT BASELINE, 21 DAYS (END OF TRAINING), 3 AND 6 MONTHS POST-TRAINING WERE EVALUATED WITH INTENTION-TO-TREAT PARADIGM. RESULTS: SPEED INDEX OF ATTENTION DOMAIN IN THE YT GROUP SHOWED GREATER IMPROVEMENT THAN PE AT 6 MONTHS FOLLOW-UP (P<0.036, EFFECT SIZE 0.51). IN THE PE GROUP, 'ACCURACY INDEX OF ATTENTION DOMAIN SHOWED GREATER IMPROVEMENT THAN TAU ALONE AT 6-MONTH FOLLOW-UP (P<0.025, EFFECT SIZE 0.61). FOR SEVERAL OTHER COGNITIVE DOMAINS, SIGNIFICANT IMPROVEMENTS WERE OBSERVED WITH YT OR PE COMPARED WITH TAU ALONE (P<0.05, EFFECT SIZES 0.30-1.97). CONCLUSIONS: BOTH YT AND PE IMPROVED ATTENTION AND ADDITIONAL COGNITIVE DOMAINS WELL PAST THE TRAINING PERIOD, SUPPORTING OUR PRIOR REPORTED BENEFICIAL EFFECT OF YT ON SPEED INDEX OF ATTENTION DOMAIN. AS ADJUNCTS, YT OR PE CAN BENEFIT INDIVIDUALS WITH SZ.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
14 2852  36 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
15 2596  43 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
16 1240  44 FEASIBILITY OF A MINDFUL YOGA PROGRAM FOR WOMEN WITH METASTATIC BREAST CANCER: RESULTS OF A RANDOMIZED PILOT STUDY. PURPOSE: PATIENTS WITH METASTATIC BREAST CANCER (MBC) EXPERIENCE HIGH LEVELS OF SYMPTOMS. YOGA INTERVENTIONS HAVE SHOWN PROMISE FOR IMPROVING CANCER SYMPTOMS BUT HAVE RARELY BEEN TESTED IN PATIENTS WITH ADVANCED DISEASE. THIS STUDY EXAMINED THE ACCEPTABILITY OF A COMPREHENSIVE YOGA PROGRAM FOR MBC AND THE FEASIBILITY OF CONDUCTING A RANDOMIZED TRIAL TESTING THE INTERVENTION. METHODS: SIXTY-THREE WOMEN WITH MBC WERE RANDOMIZED WITH A 2:1 ALLOCATION TO YOGA OR A SUPPORT GROUP COMPARISON CONDITION. BOTH INTERVENTIONS INVOLVED EIGHT WEEKLY GROUP SESSIONS. FEASIBILITY WAS QUANTIFIED USING RATES OF ACCRUAL, ATTRITION, AND SESSION ATTENDANCE. ACCEPTABILITY WAS ASSESSED WITH A STANDARDIZED SELF-REPORT MEASURE. PAIN, FATIGUE, SLEEP QUALITY, PSYCHOLOGICAL DISTRESS, MINDFULNESS, AND FUNCTIONAL CAPACITY WERE ASSESSED AT BASELINE, POST-INTERVENTION, AND 3 AND 6 MONTHS POST-INTERVENTION. RESULTS: WE MET GOALS FOR ACCRUAL AND RETENTION, WITH 50% OF ELIGIBLE PATIENTS ENROLLED AND 87% OF RANDOMIZED PARTICIPANTS COMPLETING POST-INTERVENTION SURVEYS. SIXTY-FIVE PERCENT OF WOMEN IN THE YOGA CONDITION AND 90% IN THE SUPPORT GROUP ATTENDED >/= 4 SESSIONS. EIGHTY PERCENT OF PARTICIPANTS IN THE YOGA CONDITION AND 65% IN THE SUPPORT GROUP INDICATED THAT THEY WERE HIGHLY SATISFIED WITH THE INTERVENTION. FOLLOWING TREATMENT, WOMEN IN THE YOGA INTERVENTION HAD MODEST IMPROVEMENTS IN SOME OUTCOMES; HOWEVER, OVERALL SYMPTOM LEVELS WERE LOW FOR WOMEN IN BOTH CONDITIONS. CONCLUSIONS: FINDINGS SUGGEST THAT THE YOGA INTERVENTION CONTENT WAS HIGHLY ACCEPTABLE TO PATIENTS WITH MBC, BUT THAT THERE ARE CHALLENGES TO IMPLEMENTING AN INTERVENTION INVOLVING EIGHT GROUP-BASED IN-PERSON SESSIONS. ALTERNATIVE MODES OF DELIVERY MAY BE NECESSARY TO REACH PATIENTS MOST IN NEED OF INTERVENTION.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
17  187  36 A RANDOMIZED PREFERENCE TRIAL COMPARING COGNITIVE-BEHAVIORAL THERAPY AND YOGA FOR THE TREATMENT OF LATE-LIFE WORRY: EXAMINATION OF IMPACT ON DEPRESSION, GENERALIZED ANXIETY, FATIGUE, PAIN, SOCIAL PARTICIPATION, AND PHYSICAL FUNCTION. BACKGROUND: DEPRESSION, GENERALIZED ANXIETY, FATIGUE, DIMINISHED PHYSICAL FUNCTION, REDUCED SOCIAL PARTICIPATION, AND PAIN ARE COMMON FOR MANY OLDER ADULTS AND NEGATIVELY IMPACT QUALITY OF LIFE. THE PURPOSE OF THE OVERALL TRIAL 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. OBJECTIVE: THE PRESENT ANALYSES COMPARED EFFECTS OF THE 2 INTERVENTIONS ON ADDITIONAL OUTCOMES (DEPRESSIVE SYMPTOMS, GENERALIZED ANXIETY SYMPTOMS, FATIGUE, PAIN INTERFERENCE/INTENSITY, PHYSICAL FUNCTION, SOCIAL PARTICIPATION); AND EXAMINED WHETHER THERE ARE PREFERENCE AND SELECTION EFFECTS FOR THESE TREATMENTS. METHODS: A RANDOMIZED PREFERENCE TRIAL OF CBT AND YOGA WAS CONDUCTED IN ADULTS >/=60 YEARS WHO SCORED >/=26 ON THE PENN STATE WORRY QUESTIONNAIRE-ABBREVIATED (PSWQ-A), RECRUITED FROM OUTPATIENT MEDICAL CLINICS, MAILINGS, AND ADVERTISEMENTS. COGNITIVE-BEHAVIORAL THERAPY CONSISTED OF 10 WEEKLY TELEPHONE SESSIONS. YOGA CONSISTED OF 20 BI-WEEKLY GROUP YOGA CLASSES. PARTICIPANTS WERE RANDOMIZED TO(1): A RANDOMIZED CONTROLLED TRIAL (RCT) OF CBT OR YOGA (N = 250); OR (2) A PREFERENCE TRIAL IN WHICH THEY SELECTED THEIR TREATMENT (CBT OR YOGA; N = 250). OUTCOMES WERE MEASURED AT BASELINE AND POST-INTERVENTION. RESULTS: WITHIN THE RCT, THERE WERE SIGNIFICANT BETWEEN-GROUP DIFFERENCES FOR BOTH PAIN INTERFERENCE AND INTENSITY. THE PAIN INTERFERENCE SCORE IMPROVED MORE FOR THE CBT GROUP COMPARED WITH THE YOGA GROUP [INTERVENTION EFFECT OF (MEAN (95% CI) = 2.5 (.5, 4.6), P = .02]. FOR THE PAIN INTENSITY SCORE, THE INTERVENTION EFFECT ALSO FAVORED CBT OVER YOGA [.7 (.2, 1.3), P < .01]. DEPRESSIVE SYMPTOMS, GENERALIZED ANXIETY, AND FATIGUE SHOWED CLINICALLY MEANINGFUL WITHIN-GROUP CHANGES IN BOTH GROUPS. THERE WERE NO CHANGES IN OR DIFFERENCE BETWEEN PHYSICAL FUNCTION OR SOCIAL PARTICIPATION FOR EITHER GROUP. NO PREFERENCE OR SELECTION EFFECTS WERE FOUND. CONCLUSION: BOTH CBT AND YOGA MAY BE USEFUL FOR OLDER ADULTS FOR IMPROVING PSYCHOLOGICAL SYMPTOMS AND FATIGUE. COGNITIVE-BEHAVIORAL THERAPY MAY OFFER EVEN GREATER BENEFIT THAN YOGA FOR DECREASING PAIN.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
18  162  41 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
19 2824  46 YOGA VERSUS EDUCATION FOR VETERANS WITH CHRONIC LOW BACK PAIN: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN IS THE MOST FREQUENT PAIN CONDITION IN VETERANS AND CAUSES SUBSTANTIAL SUFFERING, DECREASED FUNCTIONAL CAPACITY, AND LOWER QUALITY OF LIFE. SYMPTOMS OF POST-TRAUMATIC STRESS, DEPRESSION, AND MILD TRAUMATIC BRAIN INJURY ARE HIGHLY PREVALENT IN VETERANS WITH BACK PAIN. YOGA FOR LOW BACK PAIN HAS BEEN DEMONSTRATED TO BE EFFECTIVE FOR CIVILIANS IN RANDOMIZED CONTROLLED TRIALS. HOWEVER, IT IS UNKNOWN IF RESULTS FROM PREVIOUSLY PUBLISHED TRIALS GENERALIZE TO MILITARY POPULATIONS. METHODS/DESIGN: THIS STUDY IS A PARALLEL RANDOMIZED CONTROLLED TRIAL COMPARING YOGA TO EDUCATION FOR 120 VETERANS WITH CHRONIC LOW BACK PAIN. PARTICIPANTS ARE VETERANS >/=18 YEARS OLD WITH LOW BACK PAIN PRESENT ON AT LEAST HALF THE DAYS IN THE PAST SIX MONTHS AND A SELF-REPORTED AVERAGE PAIN INTENSITY IN THE PREVIOUS WEEK OF >/=4 ON A 0-10 SCALE. THE 24-WEEK STUDY HAS AN INITIAL 12-WEEK INTERVENTION PERIOD, WHERE PARTICIPANTS ARE RANDOMIZED EQUALLY INTO (1) A STANDARDIZED WEEKLY GROUP YOGA CLASS WITH HOME PRACTICE OR (2) EDUCATION DELIVERED WITH A SELF-CARE BOOK. PRIMARY OUTCOME MEASURES ARE CHANGE AT 12 WEEKS IN LOW BACK PAIN INTENSITY MEASURED BY THE DEFENSE AND VETERANS PAIN RATING SCALE (0-10) AND BACK-RELATED FUNCTION USING THE 23-POINT ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 12-WEEK FOLLOW-UP PERIOD, YOGA PARTICIPANTS ARE ENCOURAGED TO CONTINUE HOME YOGA PRACTICE AND EDUCATION PARTICIPANTS CONTINUE FOLLOWING RECOMMENDATIONS FROM THE BOOK. QUALITATIVE INTERVIEWS WITH VETERANS IN THE YOGA GROUP AND THEIR PARTNERS EXPLORE THE IMPACT OF CHRONIC LOW BACK PAIN AND YOGA ON FAMILY RELATIONSHIPS. WE ALSO ASSESS COST-EFFECTIVENESS FROM THREE PERSPECTIVES: THE VETERAN, THE VETERANS HEALTH ADMINISTRATION, AND SOCIETY USING ELECTRONIC MEDICAL RECORDS, SELF-REPORTED COST DATA, AND STUDY RECORDS. DISCUSSION: THIS STUDY WILL HELP DETERMINE IF YOGA CAN BECOME AN EFFECTIVE TREATMENT FOR VETERANS WITH CHRONIC LOW BACK PAIN AND PSYCHOLOGICAL COMORBIDITIES. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT02224183.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
20 2831  33 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN CAUSES SUBSTANTIAL MORBIDITY AND COST TO SOCIETY WHILE DISPROPORTIONATELY IMPACTING LOW-INCOME AND MINORITY ADULTS. SEVERAL RANDOMIZED CONTROLLED TRIALS SHOW YOGA IS AN EFFECTIVE TREATMENT. HOWEVER, THE COMPARATIVE EFFECTIVENESS OF YOGA AND PHYSICAL THERAPY, A COMMON MAINSTREAM TREATMENT FOR CHRONIC LOW BACK PAIN, IS UNKNOWN. METHODS/DESIGN: THIS IS A RANDOMIZED CONTROLLED TRIAL FOR 320 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN, COMPARING YOGA, PHYSICAL THERAPY, AND EDUCATION. INCLUSION CRITERIA ARE ADULTS 18-64 YEARS OLD WITH NON-SPECIFIC LOW BACK PAIN LASTING >/= 12 WEEKS AND A SELF-REPORTED AVERAGE PAIN INTENSITY OF >/= 4 ON A 0-10 SCALE. RECRUITMENT TAKES PLACE AT BOSTON MEDICAL CENTER, AN URBAN ACADEMIC SAFETY-NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS LOCATED IN DIVERSE NEIGHBORHOODS. THE 52-WEEK STUDY HAS AN INITIAL 12-WEEK TREATMENT PHASE WHERE PARTICIPANTS ARE RANDOMIZED IN A 2:2:1 RATIO INTO I) A STANDARDIZED WEEKLY HATHA YOGA CLASS SUPPLEMENTED BY HOME PRACTICE; II) A STANDARDIZED EVIDENCE-BASED EXERCISE THERAPY PROTOCOL ADAPTED FROM THE TREATMENT BASED CLASSIFICATION METHOD, INDIVIDUALLY DELIVERED BY A PHYSICAL THERAPIST AND SUPPLEMENTED BY HOME PRACTICE; AND III) EDUCATION DELIVERED THROUGH A SELF-CARE BOOK. CO-PRIMARY OUTCOME MEASURES ARE 12-WEEK PAIN INTENSITY MEASURED ON AN 11-POINT NUMERICAL RATING SCALE AND BACK-SPECIFIC FUNCTION MEASURED USING THE MODIFIED ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 40-WEEK MAINTENANCE PHASE, YOGA PARTICIPANTS ARE RE-RANDOMIZED IN A 1:1 RATIO TO EITHER STRUCTURED MAINTENANCE YOGA CLASSES OR HOME PRACTICE ONLY. PHYSICAL THERAPY PARTICIPANTS ARE SIMILARLY RE-RANDOMIZED TO EITHER FIVE BOOSTER SESSIONS OR HOME PRACTICE ONLY. EDUCATION PARTICIPANTS CONTINUE TO FOLLOW RECOMMENDATIONS OF EDUCATIONAL MATERIALS. WE WILL ALSO ASSESS COST EFFECTIVENESS FROM THE PERSPECTIVES OF THE INDIVIDUAL, INSURERS, AND SOCIETY USING CLAIMS DATABASES, ELECTRONIC MEDICAL RECORDS, SELF-REPORT COST DATA, AND STUDY RECORDS. QUALITATIVE DATA FROM INTERVIEWS WILL ADD SUBJECTIVE DETAIL TO COMPLEMENT QUANTITATIVE DATA. TRIAL REGISTRATION: THIS TRIAL IS REGISTERED IN CLINICALTRIALS.GOV, WITH THE ID NUMBER: NCT01343927.	2014