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 2628  53 YOGA FOR THE MANAGEMENT OF PAIN AND SLEEP IN RHEUMATOID ARTHRITIS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: THE AIM OF THE PRESENT STUDY WAS TO DETERMINE THE FEASIBILITY OF A RELAXATION-BASED YOGA INTERVENTION FOR RHEUMATOID ARTHRITIS, DESIGNED AND REPORTED IN ACCORDANCE WITH DELPHI RECOMMENDATIONS FOR YOGA INTERVENTIONS FOR MUSCULOSKELETAL CONDITIONS. METHODS: PARTICIPANTS WERE RECRUITED FROM A HOSPITAL DATABASE, AND RANDOMIZED TO EITHER EIGHT WEEKLY 75-MIN YOGA CLASSES OR A USUAL CARE CONTROL. FEASIBILITY WAS DETERMINED BY RECRUITMENT RATES, RETENTION, PROTOCOL ADHERENCE, PARTICIPANT SATISFACTION AND ADVERSE EVENTS. SECONDARY PHYSICAL AND PSYCHOSOCIAL OUTCOMES WERE ASSESSED USING SELF-REPORTED QUESTIONNAIRES AT BASELINE (WEEK 0), WEEK 9 (PRIMARY TIME POINT) AND WEEK 12 (FOLLOW-UP). RESULTS: OVER A 3-MONTH PERIOD, 26 PARTICIPANTS WITH MILD PAIN, MILD TO MODERATE FUNCTIONAL DISABILITY AND MODERATE DISEASE ACTIVITY WERE RECRUITED INTO THE STUDY (25% RECRUITMENT RATE). RETENTION RATES WERE 100% FOR YOGA PARTICIPANTS AND 92% FOR USUAL CARE PARTICIPANTS AT BOTH WEEKS 9 AND 12. PROTOCOL ADHERENCE AND PARTICIPANT SATISFACTION WERE HIGH. YOGA PARTICIPANTS ATTENDED A MEDIAN OF SEVEN CLASSES; ADDITIONALLY, SEVEN OF THE YOGA PARTICIPANTS (54%) REPORTED CONTINUING YOGA AT HOME DURING THE FOLLOW-UP PERIOD. NO SERIOUS ADVERSE EVENTS WERE RELATED TO THE STUDY. SECONDARY OUTCOMES SHOWED NO GROUP EFFECTS OF YOGA COMPARED WITH USUAL CARE. CONCLUSIONS: A RELAXATION-BASED YOGA PROGRAMME WAS FOUND TO BE FEASIBLE AND SAFE FOR PARTICIPANTS WITH RHEUMATOID ARTHRITIS-RELATED PAIN AND FUNCTIONAL DISABILITY. ADVERSE EVENTS WERE MINOR, AND NOT UNEXPECTED FROM AN INTERVENTION INCLUDING PHYSICAL COMPONENTS. THIS PILOT PROVIDES A FRAMEWORK FOR LARGER INTERVENTION STUDIES, AND SUPPORTS FURTHER EXPLORATION OF YOGA AS A COMPLEX INTERVENTION TO ASSIST WITH THE MANAGEMENT OF RHEUMATOID ARTHRITIS.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
3 2132  42 THE EFFECTS OF A GENTLE YOGA PROGRAM ON SLEEP, MOOD, AND BLOOD PRESSURE IN OLDER WOMEN WITH RESTLESS LEGS SYNDROME (RLS): A PRELIMINARY RANDOMIZED CONTROLLED TRIAL. OBJECTIVE. TO EXAMINE THE EFFECTS OF YOGA VERSUS AN EDUCATIONAL FILM PROGRAM ON SLEEP, MOOD, PERCEIVED STRESS, AND SYMPATHETIC ACTIVATION IN OLDER WOMEN WITH RLS. METHODS. PARTICIPANTS WERE DRAWN FROM A LARGER TRIAL REGARDING THE EFFECTS OF YOGA ON CARDIOVASCULAR DISEASE RISK PROFILES IN OVERWEIGHT, SEDENTARY POSTMENOPAUSAL WOMEN. SEVENTY-FIVE WOMEN WERE RANDOMIZED TO RECEIVE EITHER AN 8-WEEK YOGA (N = 38) OR EDUCATIONAL FILM (N = 37) PROGRAM. ALL 75 PARTICIPANTS COMPLETED AN RLS SCREENING QUESTIONNAIRE. THE 20 WOMEN WHO MET ALL FOUR DIAGNOSTIC CRITERIA FOR RLS (N = 10 YOGA, 10 FILM GROUP) COMPRISED THE POPULATION FOR THIS NESTED STUDY. MAIN OUTCOMES ASSESSED PRE- AND POST-TREATMENT INCLUDED: SLEEP (PITTSBURGH SLEEP QUALITY INDEX), STRESS (PERCEIVED STRESS SCALE), MOOD (PROFILE OF MOOD STATES, STATE-TRAIT ANXIETY INVENTORY), BLOOD PRESSURE, AND HEART RATE. RESULTS. THE YOGA GROUP DEMONSTRATED SIGNIFICANTLY GREATER IMPROVEMENTS THAN CONTROLS IN MULTIPLE DOMAINS OF SLEEP QUALITY AND MOOD, AND SIGNIFICANTLY GREATER REDUCTIONS IN INSOMNIA PREVALENCE, ANXIETY, PERCEIVED STRESS, AND BLOOD PRESSURE (ALL P'S</=0.05). ADJUSTED INTERGROUP EFFECT SIZES FOR PSYCHOSOCIAL VARIABLES WERE LARGE, RANGING FROM 1.9 FOR STATE ANXIETY TO 2.6 FOR SLEEP QUALITY. CONCLUSIONS. THESE PRELIMINARY FINDINGS SUGGEST YOGA MAY OFFER AN EFFECTIVE INTERVENTION FOR IMPROVING SLEEP, MOOD, PERCEIVED STRESS, AND BLOOD PRESSURE IN OLDER WOMEN WITH RLS.	2012	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
4   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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
5  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	
                                                                                                                                                                                                                                                                                    
6 2811  51 YOGA TO PREVENT MOBILITY LIMITATIONS IN OLDER ADULTS: FEASIBILITY OF A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: THE LOSS OF MOBILITY DURING AGING IMPACTS INDEPENDENCE AND LEADS TO FURTHER DISABILITY, MORBIDITY, AND REDUCED LIFE EXPECTANCY. OUR OBJECTIVE WAS TO EXAMINE THE FEASIBILITY AND SAFETY OF CONDUCTING A RANDOMIZED CONTROLLED TRIAL OF YOGA FOR OLDER ADULTS AT RISK FOR MOBILITY LIMITATIONS. METHODS: SEDENTARY OLDER ADULTS (N = 46; AGE 60-89) WERE RECRUITED AND RANDOMIZED TO EITHER YOGA OR A HEALTH EDUCATION COMPARISON GROUP. YOGA SESSIONS (60-MIN) OCCURRED 2X WEEKLY, AND 90-MIN HEALTH EDUCATION SESSIONS OCCURRED WEEKLY, FOR 10 WEEKS. THE PRIMARY OUTCOMES WERE RECRUITMENT RATE, INTERVENTION ATTENDANCE, AND RETENTION AT ASSESSMENTS. ADVERSE EVENT RATES AND PARTICIPANT SATISFACTION WERE ALSO MEASURED. PHYSICAL PERFORMANCE MEASURES OF GAIT, BALANCE, AND STRENGTH AND SELF-REPORT OUTCOME MEASURES WERE ADMINISTERED AT BASELINE AND 10-WEEKS. RESULTS: RECRUITMENT LASTED 6 MONTHS. RETENTION OF PARTICIPANTS AT THE 10-WEEK FOLLOW-UP WAS HIGH (89% - PERFORMANCE MEASURES; 98% - SELF-REPORT QUESTIONNAIRES). ATTENDANCE WAS GOOD WITH 82% OF YOGA AND 74% OF HEALTH EDUCATION PARTICIPANTS ATTENDING AT LEAST 50% OF THE SESSIONS. NO SERIOUS ADVERSE EVENTS WERE REPORTED. PATIENT SATISFACTION WITH THE INTERVENTIONS WAS HIGH. THE MEAN EFFECT SIZE FOR THE PHYSICAL PERFORMANCE MEASURES WAS 0.35 WITH SOME OVER 0.50. THE MEAN EFFECT SIZE FOR SELF-REPORT OUTCOME MEASURES WAS 0.36. CONCLUSIONS: RESULTS INDICATE THAT IT IS FEASIBLE TO CONDUCT A LARGER RCT OF YOGA FOR SEDENTARY OLDER ADULTS AT RISK FOR MOBILITY PROBLEMS. THE YOGA AND COMPARISON INTERVENTIONS WERE SAFE, WELL ACCEPTED, AND WELL ATTENDED. EFFECT SIZES SUGGEST YOGA MAY HAVE IMPORTANT BENEFITS FOR THIS POPULATION AND SHOULD BE STUDIED FURTHER. TRIAL REGISTRATION: CLINICALTRIALS # NCT03544879 ; RETROSPECTIVELY REGISTERED 4 JUNE, 2018.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
7 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
8 1541  34 KRIPALU YOGA FOR MILITARY VETERANS WITH PTSD: A RANDOMIZED TRIAL. OBJECTIVES: THIS RANDOMIZED CONTROLLED TRIAL OF YOGA FOR MILITARY VETERANS AND ACTIVE DUTY PERSONNEL WITH POSTTRAUMATIC STRESS DISORDER (PTSD) EVALUATED THE EFFICACY OF A 10-WEEK YOGA INTERVENTION ON PTSD. METHOD: FIFTY-ONE PARTICIPANTS WERE RANDOMIZED INTO YOGA OR NO-TREATMENT ASSESSMENT-ONLY CONTROL GROUPS. PRIMARY OUTCOME MEASURES INCLUDED QUESTIONNAIRES AND THE CLINICIAN ADMINISTERED PTSD SCALE. RESULTS: BOTH YOGA (N = 9) AND CONTROL (N = 6) PARTICIPANTS SHOWED SIGNIFICANT DECREASES IN REEXPERIENCING SYMPTOMS, WITH NO SIGNIFICANT BETWEEN-GROUP DIFFERENCES. SECONDARY WITHIN-GROUP ANALYSES OF A SELF-SELECTED WAIT-LIST YOGA GROUP (N = 7) SHOWED SIGNIFICANT REDUCTIONS IN PTSD SYMPTOMS AFTER YOGA PARTICIPATION, IN CONTRAST TO THEIR CONTROL GROUP PARTICIPATION. CONSISTENT WITH CURRENT LITERATURE REGARDING HIGH RATES OF PTSD TREATMENT DROPOUT FOR VETERANS, THIS STUDY FACED CHALLENGES RETAINING PARTICIPANTS ACROSS CONDITIONS. CONCLUSION: THESE RESULTS ARE CONSISTENT WITH RECENT LITERATURE INDICATING THAT YOGA MAY HAVE POTENTIAL AS A PTSD THERAPY IN A VETERAN OR MILITARY POPULATION. HOWEVER, ADDITIONAL LARGER SAMPLE SIZE TRIALS ARE NECESSARY TO CONFIRM THIS CONCLUSION.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
9 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
10  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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
11 1379  44 IMPACT OF IYENGAR YOGA ON QUALITY OF LIFE IN YOUNG WOMEN WITH RHEUMATOID ARTHRITIS. OBJECTIVE: RHEUMATOID ARTHRITIS (RA) IS A CHRONIC, DISABLING DISEASE THAT CAN GREATLY COMPROMISE HEALTH-RELATED QUALITY OF LIFE (HRQOL). THE AIM OF THIS STUDY WAS TO ASSESS THE IMPACT OF A 6-WEEK TWICE/WEEK IYENGAR YOGA PROGRAM ON HRQOL OF YOUNG ADULTS WITH RA COMPARED WITH A USUAL-CARE WAITLIST CONTROL GROUP. METHODS: THE PROGRAM WAS DESIGNED TO IMPROVE THE PRIMARY OUTCOME OF HRQOL INCLUDING PAIN AND DISABILITY AND PSYCHOLOGICAL FUNCTIONING IN PATIENTS. ASSESSMENTS WERE COLLECTED PRETREATMENT, POSTTREATMENT, AND AT 2 MONTHS AFTER TREATMENT. WEEKLY RATINGS OF ANXIETY, DEPRESSION, PAIN, AND SLEEP WERE ALSO RECORDED. A TOTAL OF 26 PARTICIPANTS COMPLETED THE INTERVENTION (YOGA=11; USUAL-CARE WAITLIST=15). ALL PARTICIPANTS WERE FEMALE (MEAN AGE=28 Y). RESULTS: OVERALL ATTRITION WAS LOW AT 15%. ON AVERAGE, WOMEN IN THE YOGA GROUP ATTENDED 96% OF THE YOGA CLASSES. NO ADVERSE EVENTS WERE REPORTED. RELATIVE TO THE USUAL-CARE WAITLIST, WOMEN ASSIGNED TO THE YOGA PROGRAM SHOWED SIGNIFICANTLY GREATER IMPROVEMENT ON STANDARDIZED MEASURES OF HRQOL, PAIN DISABILITY, GENERAL HEALTH, MOOD, FATIGUE, ACCEPTANCE OF CHRONIC PAIN, AND SELF-EFFICACY REGARDING PAIN AT POSTTREATMENT. ALMOST HALF OF THE YOGA GROUP REPORTED CLINICALLY MEANINGFUL SYMPTOM IMPROVEMENT. ANALYSIS OF THE UNCONTROLLED EFFECTS AND MAINTENANCE OF TREATMENT EFFECTS SHOWED IMPROVEMENTS IN HRQOL GENERAL HEALTH, PAIN DISABILITY, AND WEEKLY RATINGS OF PAIN, ANXIETY, AND DEPRESSION WERE MAINTAINED AT FOLLOW-UP. CONCLUSIONS: THE FINDINGS SUGGEST THAT A BRIEF IYENGAR YOGA INTERVENTION IS A FEASIBLE AND SAFE ADJUNCTIVE TREATMENT FOR YOUNG PEOPLE WITH RA, LEADING TO HRQOL, PAIN DISABILITY, FATIGUE, AND MOOD BENEFITS. MOREOVER, IMPROVEMENTS IN QUALITY OF LIFE, PAIN DISABILITY, AND MOOD PERSISTED AT THE 2-MONTH FOLLOW-UP.	2013	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
12  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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
13 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	
                                                                                                                                                                                                                                                                                                                                                                                                                        
14  345  42 ASSESSING FEASIBILITY AND ACCEPTABILITY OF YOGA AND GROUP CBT FOR ADOLESCENTS WITH DEPRESSION: A PILOT RANDOMIZED CLINICAL TRIAL. PURPOSE: GIVEN INCREASING RATES OF DEPRESSION IN ADOLESCENTS, THERE IS A CLEAR NEED FOR INNOVATIVE TREATMENTS. IN THIS PILOT RANDOMIZED CLINICAL TRIAL, WE ASSESSED ACCEPTABILITY AND FEASIBILITY OF TWO GROUP-BASED INTERVENTIONS: YOGA AND COGNITIVE-BEHAVIORAL THERAPY (CBT). THE GOAL OF THIS WORK IS TO PREPARE FOR A FUTURE FULLY POWERED RANDOMIZED TRIAL TO TEST THE HYPOTHESIS THAT YOGA IS NOT INFERIOR TO AN ESTABLISHED ADOLESCENT DEPRESSION TREATMENT, NAMELY, GROUP CBT. METHODS: WE ENROLLED 42 ADOLESCENTS WITH ELEVATED DEPRESSION SYMPTOMS. PARTICIPANTS WERE RANDOMLY ASSIGNED TO A 12-WEEK GROUP-BASED INTERVENTION, YOGA OR CBT. WE HAD A PRIORI FEASIBILITY AND ACCEPTABILITY TARGETS, INCLUDING FOR RECRUITMENT RATE, RETENTION RATE, EXPECTANCY, CREDIBILITY, PROGRAM SATISFACTION, CLASS ATTENDANCE, ENGAGEMENT IN HOME PRACTICE, AND INSTRUCTOR/LEADER MANUAL ADHERENCE. WE ASSESSED ADVERSE EVENTS, AND WITHIN-SUBJECT CHANGES IN OUTCOMES (DEPRESSION, ANXIETY, IMPAIRMENT, SLEEP DISTURBANCE) AND POSSIBLE MEDIATORS (MINDFULNESS, SELF-COMPASSION). RESULTS: BOTH INTERVENTIONS MET MOST ACCEPTABILITY AND FEASIBILITY TARGETS. THE ONLY TARGET NOT MET RELATED TO LOW ENGAGEMENT IN HOME PRACTICE. PARTICIPANTS WITHIN EACH STUDY ARM SHOWED DECREASED DEPRESSION SYMPTOMS OVER TIME AND INCREASED SELF-COMPASSION. CONCLUSIONS: A YOGA INTERVENTION APPEARS TO BE ACCEPTABLE AND FEASIBLE TO ADOLESCENTS WITH DEPRESSION. HOWEVER, IT MAY BE CHALLENGING FOR THIS GROUP TO ENGAGE IN UNSTRUCTURED HOME PRACTICE.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
15  282  48 ADHERENCE TO YOGA AND EXERCISE INTERVENTIONS IN A 6-MONTH CLINICAL TRIAL. BACKGROUND: TO DETERMINE FACTORS THAT PREDICT ADHERENCE TO A MIND-BODY INTERVENTION IN A RANDOMIZED TRIAL. DESIGN: WE ANALYZED ADHERENCE DATA FROM A 3-ARM TRIAL INVOLVING 135 GENERALLY HEALTHY SENIORS 65-85 YEARS OF AGE RANDOMIZED TO A 6-MONTH INTERVENTION CONSISTING OF: AN IYENGAR YOGA CLASS WITH HOME PRACTICE, AN EXERCISE CLASS WITH HOME PRACTICE, OR A WAIT-LIST CONTROL GROUP. OUTCOME MEASURES INCLUDED COGNITIVE FUNCTION, MOOD, FATIGUE, ANXIETY, HEALTH-RELATED QUALITY OF LIFE, AND PHYSICAL MEASURES. ADHERENCE TO THE INTERVENTION WAS OBTAINED BY CLASS ATTENDANCE AND BIWEEKLY HOME PRACTICE LOGS. RESULTS: THE DROP-OUT RATE WAS 13%. AMONG THE COMPLETERS OF THE TWO ACTIVE INTERVENTIONS, AVERAGE YOGA CLASS ATTENDANCE WAS 77% AND HOME PRACTICE OCCURRED 64% OF ALL DAYS. AVERAGE EXERCISE CLASS ATTENDANCE WAS 69% AND HOME EXERCISE OCCURRED 54% OF ALL DAYS. THERE WERE NO CLEAR EFFECTS OF ADHERENCE ON THE SIGNIFICANT STUDY OUTCOMES (QUALITY OF LIFE AND PHYSICAL MEASURES). CLASS ATTENDANCE WAS SIGNIFICANTLY CORRELATED WITH BASELINE MEASURES OF DEPRESSION, FATIGUE, AND PHYSICAL COMPONENTS OF HEALTH-RELATED QUALITY OF LIFE. SIGNIFICANT DIFFERENCES IN BASELINE MEASURES WERE ALSO FOUND BETWEEN STUDY COMPLETERS AND DROP-OUTS IN THE ACTIVE INTERVENTIONS. ADHERENCE WAS NOT RELATED TO AGE, GENDER, OR EDUCATION LEVEL. CONCLUSION: HEALTHY SENIORS HAVE GOOD ATTENDANCE AT CLASSES WITH A PHYSICALLY ACTIVE INTERVENTION. HOME PRACTICE TAKES PLACE OVER HALF OF THE TIME. DECREASED ADHERENCE TO A POTENTIALLY BENEFICIAL INTERVENTION HAS THE POTENTIAL TO DECREASE THE EFFECT OF THE INTERVENTION IN A CLINICAL TRIAL BECAUSE SUBJECTS WHO MIGHT SUSTAIN THE GREATEST BENEFIT WILL RECEIVE A LOWER DOSE OF THE INTERVENTION AND SUBJECTS WITH HIGHER ADHERENCE RATES MAY BE FUNCTIONING CLOSER TO MAXIMUM ABILITY BEFORE THE INTERVENTION. STRATEGIES TO MAXIMIZE ADHERENCE AMONG SUBJECTS AT GREATER RISK FOR LOW ADHERENCE WILL BE IMPORTANT FOR FUTURE TRIALS, ESPECIALLY COMPLEMENTARY TREATMENTS REQUIRING GREATER EFFORT THAN SIMPLE PILL-TAKING.	2007	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
16 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
17 1859  44 RANDOMIZED CONTROLLED PILOT TRIAL OF YOGA IN OVERWEIGHT AND OBESE BREAST CANCER SURVIVORS: EFFECTS ON QUALITY OF LIFE AND ANTHROPOMETRIC MEASURES. PURPOSE: TO OBTAIN ESTIMATES OF TIME TO RECRUIT THE STUDY SAMPLE, RETENTION, FACILITY-BASED CLASS ATTENDANCE AND HOME PRACTICE FOR A STUDY OF YOGA IN BREAST CANCER SURVIVORS, AND ITS EFFICACY ON FATIGUE, QUALITY OF LIFE (QOL), AND WEIGHT CHANGE. METHODS: SIXTY-THREE POST-TREATMENT STAGES 0-III BORDERLINE OVERWEIGHT AND OBESE (BODY MASS INDEX >/= 24 KG/M(2)) BREAST CANCER SURVIVORS WERE RANDOMLY ASSIGNED TO A 6-MONTH, FACILITY- AND HOME-BASED VINIYOGA INTERVENTION (N = 32) OR A WAITLIST CONTROL GROUP (N = 31). THE YOGA GOAL WAS FIVE PRACTICES PER WEEK. PRIMARY OUTCOME MEASURES WERE CHANGES IN QOL, FATIGUE, AND WEIGHT FROM BASELINE TO 6 MONTHS. SECONDARY OUTCOMES INCLUDED CHANGES IN WAIST AND HIP CIRCUMFERENCE. RESULTS: IT TOOK 12 MONTHS TO COMPLETE RECRUITMENT. PARTICIPANTS ATTENDED A MEAN OF 19.6 CLASSES AND PRACTICED AT HOME A MEAN OF 55.8 TIMES DURING THE 6-MONTH PERIOD. AT FOLLOW-UP, 90% OF PARTICIPANTS COMPLETED QUESTIONNAIRES AND 87% COMPLETED ANTHROPOMETRIC MEASUREMENTS. QOL AND FATIGUE IMPROVED TO A GREATER EXTENT AMONG WOMEN IN THE YOGA GROUP RELATIVE TO WOMEN IN THE CONTROL GROUP, ALTHOUGH NO DIFFERENCES WERE STATISTICALLY SIGNIFICANT. WAIST CIRCUMFERENCE DECREASED 3.1 CM (95% CI, -5.7 AND -0.4) MORE AMONG WOMEN IN THE YOGA COMPARED WITH THE CONTROL GROUP, WITH NO DIFFERENCE IN WEIGHT CHANGE. CONCLUSIONS: THIS STUDY PROVIDES IMPORTANT INFORMATION REGARDING RECRUITMENT, RETENTION, AND PRACTICE LEVELS ACHIEVED DURING A 6-MONTH, INTENSIVE YOGA INTERVENTION IN OVERWEIGHT AND OBESE BREAST CANCER SURVIVORS. YOGA MAY HELP DECREASE WAIST CIRCUMFERENCE AND IMPROVE QUALITY OF LIFE; FUTURE STUDIES ARE NEEDED TO CONFIRM THESE RESULTS.	2012	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
18  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	
                                                                                                                                                                                                                                                                                                                                                
19 1235  52 FEASIBILITY AND SAFETY OF INTRADIALYSIS YOGA AND EDUCATION IN MAINTENANCE HEMODIALYSIS PATIENTS. OBJECTIVE: PATIENTS WITH END-STAGE RENAL DISEASE ON MAINTENANCE HEMODIALYSIS ARE MUCH MORE SEDENTARY THAN HEALTHY INDIVIDUALS. THE PURPOSE OF THIS STUDY WAS TO ASSESS THE FEASIBILITY AND SAFETY OF A 12-WEEK INTRADIALYSIS YOGA INTERVENTION VERSUS A KIDNEY EDUCATION INTERVENTION ON THE PROMOTION OF PHYSICAL ACTIVITY. DESIGN AND METHODS: WE RANDOMIZED PARTICIPANTS BY DIALYSIS SHIFT TO EITHER 12-WEEK INTRADIALYSIS YOGA OR AN EDUCATIONAL INTERVENTION. INTRADIALYSIS YOGA WAS PROVIDED BY YOGA TEACHERS TO PARTICIPANTS WHILE RECEIVING HEMODIALYSIS. PARTICIPANTS RECEIVING THE 12-WEEK EDUCATIONAL INTERVENTION RECEIVED A MODIFICATION OF A PREVIOUSLY DEVELOPED COMPREHENSIVE EDUCATIONAL PROGRAM FOR PATIENTS WITH KIDNEY DISEASE (KIDNEY SCHOOL). THE PRIMARY OUTCOME FOR THIS STUDY WAS FEASIBILITY BASED ON RECRUITMENT AND ADHERENCE TO THE INTERVENTIONS AND SAFETY OF INTRADIALYSIS YOGA. SECONDARY OUTCOMES WERE TO DETERMINE THE FEASIBILITY OF ADMINISTERING QUESTIONNAIRES AT BASELINE AND 12 WEEKS INCLUDING THE KIDNEY DISEASE-RELATED QUALITY OF LIFE-36. RESULTS: AMONG 56 ELIGIBLE PATIENTS WHO APPROACHED FOR THE STUDY, 31 (55%) WERE INTERESTED AND CONSENTED TO PARTICIPATION, WITH 18 ASSIGNED TO INTRADIALYSIS YOGA AND 13 TO THE EDUCATIONAL PROGRAM. A TOTAL OF 5 PARTICIPANTS WITHDREW FROM THE PILOT STUDY, ALL FROM THE INTRADIALYSIS YOGA GROUP. TWO OF THESE PARTICIPANTS REPORTED NO FURTHER INTEREST IN PARTICIPATION. THREE WITHDRAWN PARTICIPANTS SWITCHED DIALYSIS TIMES AND THEREFORE COULD NO LONGER RECEIVE INTRADIALYSIS YOGA. AS A RESULT, 13 OF 18 (72%) AND 13 OF 13 (100%) PARTICIPANTS COMPLETED 12-WEEK INTRADIALYSIS YOGA AND EDUCATIONAL PROGRAMS, RESPECTIVELY. THERE WERE NO ADVERSE EVENTS RELATED TO INTRADIALYSIS YOGA. INTERVENTION PARTICIPANTS PRACTICED YOGA FOR A MEDIAN OF 21 SESSIONS (70% PARTICIPATION FREQUENCY), WITH 60% OF PARTICIPANTS PRACTICING AT LEAST 2 TIMES A WEEK. PARTICIPANTS IN THE EDUCATIONAL PROGRAM COMPLETED A MEDIAN OF 30 SESSIONS (83% PARTICIPATION FREQUENCY). OF PARTICIPANTS WHO COMPLETED THE STUDY (N = 26), BASELINE AND 12-WEEK QUESTIONNAIRES WERE OBTAINED FROM 85%. CONCLUSIONS: OUR PILOT STUDY OF 12-WEEK INTRADIALYSIS YOGA AND 12-WEEK EDUCATIONAL INTERVENTION REACHED RECRUITMENT GOALS BUT WITH LESS THAN TARGETED COMPLETION AND ADHERENCE TO INTERVENTION RATES. THIS STUDY PROVIDED VALUABLE FEASIBILITY DATA TO INCREASE FOLLOW-UP AND ADHERENCE FOR FUTURE CLINICAL TRIALS TO COMPARE EFFICACY.	2015	
                                                                                                                                     
20  201  46 A RESTORATIVE YOGA INTERVENTION FOR AFRICAN-AMERICAN BREAST CANCER SURVIVORS: A PILOT STUDY. BACKGROUND: DATA SHOW THAT YOGA IS EFFECTIVE FOR IMPROVING HEALTH-RELATED OUTCOMES IN BREAST CANCER SURVIVORS. WHILE BREAST CANCER IS THE MOST COMMONLY DIAGNOSED CANCER AMONG AFRICAN-AMERICAN WOMEN (AAW), AAW ARE LESS LIKELY TO ENGAGE IN YOGA COMPARED TO OTHER ETHNIC GROUPS. THE GOALS OF THE CURRENT STUDY WERE TO ASSESS THE FEASIBILITY OF AN 8-WEEK RESTORATIVE YOGA PROGRAM AMONG AFRICAN-AMERICAN BREAST CANCER SURVIVORS (AA BCS). SPECIFICALLY, STUDY AIMS WERE TO (1) MEASURE CHANGES IN STUDY OUTCOMES IN A RESTORATIVE YOGA (RY) GROUP COMPARED TO A WAIT LIST CONTROL GROUP, (2) ASSESS ADHERENCE TO THE RY PROGRAM, AND (3) ASSESS PROGRAM SATISFACTION AMONG STUDY PARTICIPANTS. METHODS: THIRTY-THREE AA BCS WERE RANDOMLY ASSIGNED TO EITHER THE RY INTERVENTION (N = 18) OR WAIT LIST CONTROL GROUP (N = 15). RY CLASSES MET ONCE PER WEEK FOR 8 WEEKS. PRE- AND POST-TESTING ASSESSMENTS WERE MEASURED AT 0 AND 8 WEEKS (IMMEDIATELY POST-INTERVENTION). RESULTS: DEPRESSION SCORES AT FOLLOW-UP WERE SIGNIFICANTLY LOWER IN THE YOGA GROUP (M = 4.78, SD = 3.56) COMPARED TO THE CONTROL GROUP (M = 6.91, SD = 5.86). NO SIGNIFICANT GROUP DIFFERENCES WERE OBSERVED FOR SLEEP QUALITY, FATIGUE, OR PERCEIVED STRESS. YOGA PROGRAM PARTICIPANTS COMPLETING BASELINE ASSESSMENTS DEMONSTRATED 61% ADHERENCE TO THE YOGA CLASSES. AVERAGE RATING OF THE YOGA PROGRAM WAS "VERY USEFUL." RECOMMENDATIONS FOR FUTURE YOGA PROGRAMS WERE PROVIDED. CONCLUSIONS: THIS STUDY SUGGESTS THAT YOGA HAS A BENEFICIAL EFFECT ON DEPRESSION IN AA BCS. THERE IS, HOWEVER, A NEED TO FURTHER EXPLORE THE BENEFITS OF YOGA AMONG MINORITY BREAST CANCER SURVIVORS USING A STUDY WITH LARGER SAMPLE SIZES.	2018