1  195 129 A RANDOMIZED TRIAL OF YOGA FOR CHILDREN HOSPITALIZED WITH SICKLE CELL VASO-OCCLUSIVE CRISIS. CONTEXT: SICKLE CELL DISEASE (SCD) VASO-OCCLUSIVE CRISIS (VOC) REMAINS AN IMPORTANT CAUSE OF ACUTE PAIN IN PEDIATRICS AND THE MOST COMMON SCD COMPLICATION. PAIN MANAGEMENT RECOMMENDATIONS IN SCD INCLUDE NONPHARMACOLOGICAL INTERVENTIONS. YOGA IS ONE NONPHARMACOLOGICAL INTERVENTION THAT HAS BEEN SHOWN TO REDUCE PAIN IN SOME POPULATIONS; HOWEVER, EVIDENCE IS LACKING IN CHILDREN WITH VOC. OBJECTIVES: THE PRIMARY OBJECTIVE OF THIS STUDY WAS TO COMPARE THE EFFECT OF YOGA VS. AN ATTENTION CONTROL ON PAIN IN CHILDREN WITH VOC. THE SECONDARY OBJECTIVES WERE TO COMPARE THE EFFECT OF YOGA VS. AN ATTENTION CONTROL ON ANXIETY, LENGTHS OF STAY, AND OPIOID USE IN THIS POPULATION. METHODS: PATIENTS WERE ELIGIBLE IF THEY HAD A DIAGNOSIS OF SCD, WERE 5-21 YEARS OLD, WERE HOSPITALIZED FOR UNCOMPLICATED VOC, AND HAD AN ADMISSION PAIN SCORE OF >/=7. SUBJECTS WERE STRATIFIED BASED ON DISEASE SEVERITY AND RANDOMIZED TO THE YOGA OR CONTROL GROUP. RESULTS: EIGHTY-THREE PERCENT OF PATIENTS APPROACHED (N = 73) ENROLLED ON STUDY. THERE WERE NO SIGNIFICANT DIFFERENCES IN BASELINE CLINICAL OR DEMOGRAPHIC FACTORS BETWEEN GROUPS. COMPARED WITH THE CONTROL GROUP, CHILDREN RANDOMIZED TO YOGA HAD A SIGNIFICANTLY GREATER REDUCTION IN MEAN PAIN SCORE AFTER ONE YOGA SESSION (-0.6 +/- 0.96 VS. 0.0 +/- 1.37; P = 0.029). THERE WERE NO SIGNIFICANT DIFFERENCES IN ANXIETY, LENGTHS OF STAY, OR OPIOID USE BETWEEN THE TWO GROUPS. CONCLUSION: THIS STUDY PROVIDES EVIDENCE THAT YOGA IS AN ACCEPTABLE, FEASIBLE, AND HELPFUL INTERVENTION FOR HOSPITALIZED CHILDREN WITH VOC. FUTURE RESEARCH SHOULD FURTHER EXAMINE YOGA FOR CHILDREN WITH SCD PAIN IN THE INPATIENT AND OUTPATIENT SETTINGS.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
2  119  38 A PILOT STUDY OF THE ACCEPTABILITY, FEASIBILITY AND SAFETY OF YOGA FOR CHRONIC PAIN IN SICKLE CELL DISEASE. OBJECTIVES: TO DETERMINE THE ACCEPTABILITY, FEASIBILITY AND SAFETY OF YOGA FOR CHRONIC PAIN IN SICKLE CELL DISEASE. DESIGN AND SETTING: IN PART A OF THIS TWO-PART STUDY, ADOLESCENTS WITH SCD AND CHRONIC PAIN (GROUP 1) AND THEIR PARENT (GROUP 2) COMPLETED A SURVEY DESIGNED TO CAPTURE PAIN CHARACTERISTICS, ATTITUDES AND PRACTICES RELATED TO YOGA, AND POTENTIAL ACCEPTABILITY OF A YOGA PROGRAM. IN PART B, THE STUDY ASSESSED THE FEASIBILITY AND SAFETY OF AN INSTRUCTOR-LED GROUP YOGA PROGRAM. THE STUDY WAS REGISTERED ON CLINICALTRIALS.GOV (NCT03694548). INTERVENTION: EIGHT INSTRUCTOR-LED GROUP YOGA SESSIONS. MAIN OUTCOME MEASURES: FEASIBILITY AND SAFETY OUTCOMES WERE CHOSEN A PRIORI, AS FOLLOWS: 1) PROPORTION OF ADOLESCENT PATIENTS WITH SCD AND CHRONIC PAIN APPROACHED THAT CONSENT TO PARTICIPATE IN PART A, 2) PROPORTION OF ADOLESCENT PARTICIPANTS ENROLLED IN PART A THAT CONSENT TO PARTICIPATE IN PART B, 3) PROPORTION OF PARTICIPANTS ENROLLED IN PART B THAT ATTEND AT LEAST 6 OF 8 YOGA SESSIONS, 4) PROPORTION OF PARTICIPANTS ENROLLED IN PART B WITH AN ED VISIT OR A HOSPITALIZATION FOR PAIN WITHIN 24 H OF COMPLETION OF EACH YOGA SESSION, 5) PROPORTION OF PARTICIPANTS IN PART B WHO COMPLETE ALL STUDY ASSESSMENTS BEFORE, AND AT THE END OF THE YOGA PROGRAM, 6) ADHERENCE TO SUBMISSION OF PAIN DIARY. RESULTS: THE MEDIAN AGE OF 15 PATIENT PARTICIPANTS IN PART A WAS 16 (IQR 14-17), AND 14 PARENTS WAS 43.5 (IQR 42-51). MOST PARTICIPANTS WERE FEMALE. MOST PARTICIPANT RESPONSES INDICATED A POSITIVE OPINION OF YOGA. NINE ADOLESCENTS (60 %) FROM PART A PARTICIPATED IN PART B OF THE STUDY. THE MEDIAN AGE OF 9 PARTICIPANTS IN PART B WAS 17 (IQR 15-18), AND 5 OF THE 9 PARTICIPANTS WERE FEMALE (53.3 %). ONLY ONE PARTICIPANT WAS ABLE TO ATTEND 3 OF THE 8 YOGA SESSIONS OFFERED, AND DID NOT EXPERIENCE ANY ED VISITS OR HOSPITALIZATIONS FOLLOWING THE YOGA SESSIONS. NONE OF THE OTHER FEASIBILITY ENDPOINTS WERE MET IN THIS STUDY. CONCLUSIONS: PATIENTS WITH SCD AND CHRONIC PAIN OVERALL HAVE A POSITIVE OPINION OF YOGA, BUT THERE ARE CHALLENGES WITH RECRUITMENT AND RETENTION OF PARTICIPANTS IN A CLINICAL TRIAL OF YOGA, AND BARRIERS TO FEASIBILITY OF AN IN-PERSON GROUP YOGA INTERVENTION.	2021	
                                                                                                                                                                                                                                  
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  127  40 A PILOT STUDY TO EVALUATE THE FEASIBILITY OF INDIVIDUALIZED YOGA FOR INPATIENT CHILDREN RECEIVING INTENSIVE CHEMOTHERAPY. BACKGROUND: FATIGUE IS AN IMPORTANT PROBLEM IN PAEDIATRIC CANCER PATIENTS AND YOGA MAY BE AN EFFECTIVE INTERVENTION. THE PRIMARY OBJECTIVE WAS TO DETERMINE THE FEASIBILITY OF INDIVIDUALIZED YOGA FOR HOSPITALIZED CHILDREN RECEIVING INTENSIVE CHEMOTHERAPY. METHODS: WE INCLUDED ENGLISH-SPEAKING CHILDREN AND ADOLESCENTS AGED 7-18 YEARS RECEIVING INTENSIVE CHEMOTHERAPY OR HAEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT). YOGA WAS CONDUCTED THREE TIMES WEEKLY FOR THREE WEEKS. THE PRIMARY OUTCOME WAS FEASIBILITY, DEFINED AS ABILITY TO DELIVER AT LEAST 60% OF PLANNED SESSIONS. SECONDARY OUTCOMES WERE PARENT-REPORTED PEDIATRIC QUALITY OF LIFE INVENTORY (PEDSQL) MULTIDIMENSIONAL FATIGUE SCALE, FATIGUE SCALE-PARENT, PEDSQL GENERIC CORE SCALES AND PEDSQL ACUTE CANCER MODULE. RESULTS: BETWEEN JANUARY AND OCTOBER 2013, 11 PATIENTS WERE ENROLLED. MEDIAN AGE WAS 14.0 (RANGE 7.7-16.4) YEARS AND 6 (55%) WERE BOYS. YOGA WAS FEASIBLE WITH 10/11 PARTICIPANTS MEETING THE THRESHOLD FOR FEASIBILITY. THE MEDIAN NUMBER OF YOGA SESSIONS WAS 9 (RANGE 3-13). NO ADVERSE EVENTS WERE ATTRIBUTED TO YOGA. MEAN+/-STANDARD DEVIATION FOR THE DAY 21 PROXY-REPORTED PEDSQL GENERAL FATIGUE SCORES WAS 55.6+/-15.5. QUALITATIVE COMMENTS SUGGESTED DESIGN CHANGES FOR FUTURE YOGA STUDIES. CONCLUSIONS: INDIVIDUALIZED YOGA IS FEASIBLE FOR INPATIENT CHILDREN RECEIVING INTENSIVE CHEMOTHERAPY. FUTURE WORK WILL INCLUDE DEVELOPMENT AND CONDUCT OF A RANDOMIZED TRIAL FOR FATIGUE AMELIORATION. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT02105389.	2015	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
5  199  33 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
6 1748  36 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
7   70  41 A FEASIBILITY STUDY EXAMINING THE IMPACT OF YOGA ON PSYCHOSOCIAL HEALTH AND SYMPTOMS IN PEDIATRIC OUTPATIENTS RECEIVING CHEMOTHERAPY. PURPOSE: PEDIATRIC CANCER PATIENTS EXPERIENCE SYMPTOMS THAT NEGATIVELY IMPACT QUALITY OF LIFE; YOGA MAY BE AN EFFECTIVE INTERVENTION. THE PRIMARY OBJECTIVE WAS TO DETERMINE THE FEASIBILITY OF A 10-WEEK, WEEKLY INDIVIDUALIZED YOGA INTERVENTION FOR CHILDREN AND ADOLESCENTS RECEIVING OUTPATIENT CANCER THERAPY PRIMARILY DELIVERED REMOTELY USING SKYPE. SECONDARY OBJECTIVES WERE TO DESCRIBE DEPRESSION, ANXIETY, ANGER, FATIGUE, QUALITY OF LIFE, AND SYMPTOMS AT 5 AND 10 WEEKS AFTER ENROLLMENT. METHODS: WE INCLUDED ENGLISH-SPEAKING PATIENTS AGED 10 TO 18 YEARS RECEIVING OUTPATIENT CHEMOTHERAPY FOR CANCER. WEEKLY INDIVIDUALIZED YOGA SESSIONS WERE OFFERED FOR 10 WEEKS. WEEKS 1, 5, AND 10 WERE IN-HOSPITAL WHILE THE REMAINING SESSIONS WERE DELIVERED REMOTELY USING SKYPE. TWICE WEEKLY, HOMEWORK WAS ASSIGNED BETWEEN EACH SESSION. THE PRIMARY OUTCOME WAS FEASIBILITY, DEFINED AS 80% OF PARTICIPANTS COMPLETING AT LEAST 60% OF PLANNED IN-HOSPITAL OR REMOTE YOGA SESSIONS. RESULTS: BETWEEN MARCH AND NOVEMBER 2017, 10 PATIENTS WERE ENROLLED. TWO PATIENTS DISCONTINUED THE STUDY AFTER ONE AND TWO SESSIONS. ONLY SIX PARTICIPANTS ACHIEVED AT LEAST 60% OF PLANNED YOGA SESSIONS AND THUS, THE STUDY DID NOT MEET THE A PRIORI DEFINED FEASIBILITY THRESHOLD. AMONG ALL PARTICIPANTS, ONLY ONE HOMEWORK SESSION WAS PERFORMED. CONCLUSIONS: A 10-WEEK INDIVIDUALIZED IN-PERSON AND REMOTELY CONDUCTED YOGA INTERVENTION WAS NOT FEASIBLE IN CHILDREN RECEIVING CANCER TREATMENTS BECAUSE OF FAILURE TO ACHIEVE THE DESIRED FREQUENCY OF YOGA SESSIONS IN A SUFFICIENT NUMBER OF PARTICIPANTS. FUTURE RESEARCH SHOULD IDENTIFY APPROACHES TO IMPROVE COMPLIANCE WITH REMOTE YOGA SESSIONS AND HOME PRACTICE. TRIAL REGISTRATION: NCT03318068.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
8  312  39 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	
                                                                                                                                               
9 2558  41 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	
                                                                                                                                                                                                                                                                                    
10 1235  40 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	

11 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	
                                                                                                                                                                            
12 2557  42 YOGA FOR CHRONIC CHEMOTHERAPY-INDUCED PERIPHERAL NEUROPATHY PAIN: A PILOT, RANDOMIZED CONTROLLED TRIAL. PURPOSE: TO DETERMINE THE FEASIBILITY OF IMPLEMENTING A YOGA INTERVENTION FOR CANCER SURVIVORS WITH CHRONIC CIPN PAIN, AS WELL AS THE IMPACT OF THE INTERVENTION ON PATIENT-REPORTED OUTCOMES. METHODS: CANCER SURVIVORS WITH CHRONIC CIPN PAIN WERE RECRUITED FROM THE BREAST, GASTROINTESTINAL, AND GYNECOLOGICAL ONCOLOGY CENTERS AT DANA-FARBER CANCER INSTITUTE. PARTICIPANTS WERE RANDOMIZED (2:1) TO RECEIVE AN 8-WEEK YOGA INTERVENTION OR USUAL CARE. AFTER 21/50 OF PARTICIPANTS WERE ENROLLED, THE COVID-19 PANDEMIC REQUIRED THE YOGA INTERVENTION TO BE DELIVERED VIRTUALLY (I.E., ZOOM). PRE- AND POST-INTERVENTION, PARTICIPANTS SELF-REPORTED CIPN AND CO-OCCURRING SYMPTOM SEVERITY. ADHERENCE TO THE INTERVENTION WAS DEFINED AS PRACTICING >/= 12 YOGA SESSIONS OVER THE 8-WEEK INTERVENTION PERIOD. CHANGES IN PATIENT-REPORTED OUTCOMES BETWEEN GROUPS WERE COMPARED USING WILCOXON'S RANK-SUM TESTS. RESULTS: PARTICIPANTS (N = 28 YOGA, N = 16 CONTROL) WERE MAINLY FEMALE (96%) AND DIAGNOSED WITH STAGE III/IV DISEASE (66%). OVERALL, 19/28 (67.8%) OF YOGA GROUP PARTICIPANTS WERE ADHERENT TO THE YOGA PROTOCOL. YOGA GROUP PARTICIPANTS EXPERIENCED SIGNIFICANT WITHIN-GROUP IMPROVEMENTS IN ALL PATIENT-REPORTED OUTCOMES, INCLUDING WORST CIPN PAIN (MEDIAN CHANGE = - 1.7, P < 0.0001) AND SENSORY CIPN (MEDIAN CHANGE = - 14.8, P < 0.0001), BUT ONLY IMPROVEMENTS IN FATIGUE (P = 0.05) AND DEPRESSION (P = 0.04) WERE SIGNIFICANT COMPARED TO THE CONTROL. THERE WERE NO DIFFERENCES (P > 0.05) IN CHANGES IN PATIENT-REPORTED OUTCOMES BETWEEN IN-PERSON (N = 6) OR VIRTUAL (N = 15) YOGA GROUP PARTICIPANTS. CONCLUSIONS: YOGA IS A FEASIBLE NON-PHARMACOLOGICAL MODALITY FOR CANCER SURVIVORS WITH CIPN, BUT MORE INFORMATION IS NEEDED REGARDING ITS IMPACT ON CIPN AND OTHER SYMPTOMS. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT03824860 IMPLICATIONS FOR CANCER SURVIVORS: ONCOLOGY CLINICIANS MAY CONSIDER REFERRING CANCER SURVIVORS TO YOGA FOR CHRONIC CIPN PAIN, BUT YOGA CANNOT BE CURRENTLY RECOMMENDED AS AN EFFICACIOUS TREATMENT.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                  
13   91  42 A MULTICOMPONENT YOGA-BASED, BREATH INTERVENTION PROGRAM AS AN ADJUNCTIVE TREATMENT IN PATIENTS SUFFERING FROM GENERALIZED ANXIETY DISORDER WITH OR WITHOUT COMORBIDITIES. OBJECTIVES: THE AIM OF THIS STUDY IS TO EVALUATE THE EFFICACY AND TOLERABILITY OF SUDARSHAN KRIYA YOGA (SKY) COURSE IN GENERALIZED ANXIETY DISORDER (GAD) OUTPATIENTS, WHO AFTER EIGHT WEEKS OF AN APPROPRIATE DOSE OF TRADITIONAL THERAPY HAD NOT YET ACHIEVED REMISSION. SUBJECTS: THE ADULT PARTICIPANTS (18-65 YEARS) WERE OUTPATIENTS WITH A PRIMARY DIAGNOSIS OF GAD WITH OR WITHOUT COMORBIDITIES ON THE MINI-INTERNATIONAL NEUROPSYCHIATRIC INTERVIEW (MINI). PARTICIPANTS HAD A MINIMUM OF EIGHT WEEKS STANDARD TREATMENT WITH AN APPROPRIATE DOSE OF A STANDARD PRESCRIPTION ANXIOLYTIC, A CLINICIAN GLOBAL IMPRESSION-SEVERITY (CGI-S) SCORE OF 5-7, A HAMILTON ANXIETY SCALE (HAM-A) TOTAL SCORE >/=20 INCLUDING A SCORE OF >2 ON THE ANXIOUS MOOD AND TENSION ITEMS. MATERIALS AND METHODS: FORTY-ONE PATIENTS WERE ENROLLED IN AN OPEN-LABEL TRIAL OF THE SKY COURSE AS AN ADJUNCT TO STANDARD TREATMENT OF GAD AT THE START CLINIC FOR MOOD AND ANXIETY DISORDERS, A TERTIARY CARE MOOD AND ANXIETY DISORDER CLINIC IN TORONTO. THE SKY COURSE WAS ADMINISTERED OVER FIVE DAYS (22 H TOTAL). SUBJECTS WERE ENCOURAGED TO PRACTICE THE YOGA BREATHING TECHNIQUES AT HOME FOR 20 MIN PER DAY AFTER THE COURSE AND WERE OFFERED GROUP PRACTICE SESSIONS FOR 2 H ONCE A WEEK LED BY CERTIFIED YOGA INSTRUCTORS. THE PRIMARY OUTCOME MEASURE WAS THE MEAN CHANGE FROM PRE-TREATMENT ON THE HAM-A SCALE. PSYCHOLOGICAL MEASURES WERE OBTAINED AT BASELINE AND FOUR WEEKS AFTER COMPLETING THE INTERVENTION. RESULTS: THIRTY-ONE PATIENTS COMPLETED THE PROGRAM (MEAN AGE 42.6 +/- 13.3 YEARS). AMONG COMPLETERS, SIGNIFICANT REDUCTIONS OCCURRED IN THE PRE- AND POST-INTERVENTION MEAN HAM-A TOTAL SCORE (T=4.59; P<0.01) AND PSYCHIC SUBSCALE (T=5.00; P</=0.01). THE RESPONSE RATE WAS 73% AND THE REMISSION RATE 41% AS MEASURED ON THE HAM-A. CONCLUSION: THE RESULTS OF THIS SMALL PILOT TRIAL SUGGEST THAT THE SKY COURSE REPRESENTS A POTENTIALLY VALUABLE ADJUNCT TO STANDARD PHARMACOTHERAPY IN PATIENTS WITH GAD OR TREATMENT-RESISTANT GAD, AND WARRANTS FURTHER INVESTIGATION. IN PARTICULAR, CHANGES IN WORRY AND BODY SYMPTOMS SHOWED SIGNIFICANT IMPROVEMENTS THAT MAY FURTHER OUR UNDERSTANDING OF THE MECHANISM OF CHANGE IN THE TOLERANCE OF ANXIETY AND WORRY.	2012	
                                                                                                                                                     
14  524  43 COMPARISON OF COGNITIVE-BEHAVIORAL THERAPY AND YOGA FOR THE TREATMENT OF LATE-LIFE WORRY: A RANDOMIZED PREFERENCE TRIAL. BACKGROUND: THE PURPOSE OF THIS STUDY WAS TO COMPARE THE EFFECTS OF COGNITIVE-BEHAVIORAL THERAPY (CBT) AND YOGA ON LATE-LIFE WORRY, ANXIETY, AND SLEEP; AND EXAMINE PREFERENCE AND SELECTION EFFECTS ON THESE OUTCOMES. METHODS: A RANDOMIZED PREFERENCE TRIAL OF CBT AND YOGA WAS CONDUCTED IN COMMUNITY-DWELLING ADULTS 60 YEARS OR OLDER, WHO SCORED 26 OR ABOVE ON THE PENN STATE WORRY QUESTIONNAIRE-ABBREVIATED (PSWQ-A). CBT CONSISTED OF 10 WEEKLY TELEPHONE SESSIONS. YOGA CONSISTED OF 20 BIWEEKLY GROUP YOGA CLASSES. THE PRIMARY OUTCOME WAS WORRY (PSWQ-A); THE SECONDARY OUTCOMES WERE ANXIETY (PROMIS-ANXIETY) AND SLEEP (INSOMNIA SEVERITY INDEX [ISI]). WE EXAMINED BOTH PREFERENCE EFFECTS (AVERAGE EFFECT FOR THOSE WHO RECEIVED THEIR PREFERRED INTERVENTION [REGARDLESS OF WHETHER IT WAS CBT OR YOGA] MINUS THE AVERAGE FOR THOSE WHO DID NOT RECEIVE THEIR PREFERRED INTERVENTION [REGARDLESS OF THE INTERVENTION]) AND SELECTION EFFECT (WHICH ADDRESSES THE QUESTION OF WHETHER THERE IS A BENEFIT TO GETTING TO SELECT ONE INTERVENTION OVER THE OTHER, AND MEASURES THE EFFECT ON OUTCOMES OF SELF-SELECTION TO A SPECIFIC INTERVENTION). RESULTS: FIVE HUNDRED OLDER ADULTS WERE RANDOMIZED TO THE RANDOMIZED TRIAL (125 EACH IN CBT AND YOGA) OR THE PREFERENCE TRIAL (120 CHOSE CBT; 130 CHOSE YOGA). IN THE RANDOMIZED TRIAL, THE INTERVENTION EFFECT OF YOGA COMPARED WITH CBT ADJUSTED FOR BASELINE PSYCHOTROPIC MEDICATION USE, GENDER, AND RACE WAS 1.6 (-0.2, 3.3), P = .08 FOR THE PSWQ-A. SIMILAR RESULTS WERE OBSERVED WITH PROMIS-ANXIETY (ADJUSTED INTERVENTION EFFECT: 0.3 [-1.5, 2.2], P = .71). PARTICIPANTS RANDOMIZED TO CBT EXPERIENCED A GREATER REDUCTION IN THE ISI COMPARED WITH YOGA (ADJUSTED INTERVENTION EFFECT: 2.4 [1.2, 3.7], P < .01]). ESTIMATED IN THE COMBINED DATA SET (N = 500), THE PREFERENCE AND SELECTION EFFECTS WERE NOT SIGNIFICANT FOR THE PSWQ-A, PROMIS-ANXIETY, AND ISI. OF THE 52 ADVERSE EVENTS, ONLY TWO WERE POSSIBLY RELATED TO THE INTERVENTION. NONE OF THE 26 SERIOUS ADVERSE EVENTS WERE RELATED TO THE STUDY INTERVENTIONS. CONCLUSIONS: CBT AND YOGA WERE BOTH EFFECTIVE AT REDUCING LATE-LIFE WORRY AND ANXIETY. HOWEVER, A GREATER IMPACT WAS SEEN FOR CBT COMPARED WITH YOGA FOR IMPROVING SLEEP. NEITHER PREFERENCE NOR SELECTION EFFECTS WAS FOUND.	2020	
                                                                                                                                                    
15 2782  33 YOGA THERAPY AS AN ADD-ON TREATMENT IN THE MANAGEMENT OF PATIENTS WITH SCHIZOPHRENIA--A RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TREATMENT OF SCHIZOPHRENIA HAS REMAINED UNSATISFACTORY DESPITE THE AVAILABILITY OF ANTIPSYCHOTICS. THIS STUDY EXAMINED THE EFFICACY OF YOGA THERAPY (YT) AS AN ADD-ON TREATMENT TO THE ONGOING ANTIPSYCHOTIC TREATMENT. METHOD: SIXTY-ONE MODERATELY ILL SCHIZOPHRENIA PATIENTS WERE RANDOMLY ASSIGNED TO YT (N = 31) AND PHYSICAL EXERCISE THERAPY (PT; N = 30) FOR 4 MONTHS. THEY WERE ASSESSED AT BASELINE AND 4 MONTHS AFTER THE START OF INTERVENTION, BY A RATER WHO WAS BLIND TO THEIR GROUP STATUS. RESULTS: FORTY-ONE SUBJECTS (YT = 21; PT = 20) WERE AVAILABLE AT THE END OF 4 MONTHS FOR ASSESSMENT. SUBJECTS IN THE YT GROUP HAD SIGNIFICANTLY LESS PSYCHOPATHOLOGY THAN THOSE IN THE PT GROUP AT THE END OF 4 MONTHS. THEY ALSO HAD SIGNIFICANTLY GREATER SOCIAL AND OCCUPATIONAL FUNCTIONING AND QUALITY OF LIFE. CONCLUSION: BOTH NON-PHARMACOLOGICAL INTERVENTIONS CONTRIBUTE TO REDUCTION IN SYMPTOMS, WITH YT HAVING BETTER EFFICACY.	2007	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
16 2467  39 YOGA AS A THERAPY FOR ADOLESCENTS AND YOUNG ADULTS WITH CYSTIC FIBROSIS: A PILOT STUDY. RATIONALE: YOGA HAS BEEN SHOWN TO IMPROVE OUTCOMES IN PATIENTS WITH ASTHMA BUT HAS NOT BEEN INVESTIGATED IN CYSTIC FIBROSIS (CF) PATIENTS. METHODS: THIS WAS A PROSPECTIVE PILOT STUDY TO EVALUATE THE SAFETY OF A STANDARDIZED YOGA PROGRAM AMONG CF PATIENTS AGED 12 TO 25 YEARS. PARTICIPANTS ENGAGED IN A 50-MINUTE YOGA SESSION TWICE WEEKLY FOR 8 WEEKS CONDUCTED BY A CERTIFIED YOGA INSTRUCTOR USING A STANDARDIZED PROGRAM DESIGNED TO BE SAFE FOR HEALTH-COMPROMISED INDIVIDUALS. YOGA SESSIONS WERE INDIVIDUAL TO AVOID TRANSMISSION OF INFECTIONS. PRIMARY OUTCOME WAS SAFETY AND TOLERABILITY. SECONDARY OUTCOME MEASURES INCLUDED RESPIRATORY SYMPTOMS, THE CYSTIC FIBROSIS QUALITY OF LIFE INSTRUMENT (CFQ-R), LUNG FUNCTION, EASE OF BREATHING SCORE (MEASURE OF EXERCISE TOLERANCE), AND WEIGHT. RESULTS: ELEVEN PARTICIPANTS WERE ENROLLED, AND 10 COMPLETED THE STUDY. ADHERENCE WAS VERY GOOD; THE MEAN (SD) NUMBER OF SESSIONS COMPLETED WAS 14.2 (1.3) OUT OF 16 SESSIONS. EIGHT PATIENTS REPORTED 25 ADVERSE EVENTS. THE MOST COMMON WAS COUGH, REPORTED IN 7. TWO EVENTS WERE POSSIBLY RELATED TO STUDY PROCEDURES: CALF PAIN AND HEADACHE. THERE WERE NO SIGNIFICANT CHANGES IN DYSPNEA OR PAIN SCALES. THE MEAN (SD) CFQ-R RESPIRATORY DOMAIN SCORE INCREASED FROM SCREENING TO END OF STUDY: 67.9 (11.4) TO 82.1 (9.9), P=.04. THERE WERE NO SIGNIFICANT CHANGES IN THE OTHER OUTCOME MEASURES. CONCLUSIONS: IN THIS PILOT STUDY, A STANDARDIZED 8-WEEK YOGA PROGRAM WAS SAFE AND WELL TOLERATED AMONG ADOLESCENT AND YOUNG ADULT CF PATIENTS WITH MILD TO MODERATE LUNG DISEASE. THIS STUDY MAY BE HELPFUL TO YOGA INSTRUCTORS WHO ARE INTERESTED IN WORKING WITH CF PATIENTS. LARGER CONTROLLED TRIALS ARE WARRANTED TO DETERMINE FURTHER BENEFITS.	2015	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
17  107  39 A PILOT RANDOMIZED CONTROLLED TRIAL OF THE EFFECTS OF CHAIR YOGA ON PAIN AND PHYSICAL FUNCTION AMONG COMMUNITY-DWELLING OLDER ADULTS WITH LOWER EXTREMITY OSTEOARTHRITIS. OBJECTIVES: TO DETERMINE EFFECTS OF SIT 'N' FIT CHAIR YOGA, COMPARED TO A HEALTH EDUCATION PROGRAM (HEP), ON PAIN AND PHYSICAL FUNCTION IN OLDER ADULTS WITH LOWER EXTREMITY OSTEOARTHRITIS (OA) WHO COULD NOT PARTICIPATE IN STANDING EXERCISE. DESIGN: TWO-ARM RANDOMIZED CONTROLLED TRIAL. SETTING: ONE HUD SENIOR HOUSING FACILITY AND ONE DAY SENIOR CENTER IN SOUTH FLORIDA. PARTICIPANTS: COMMUNITY-DWELLING OLDER ADULTS (N = 131) WERE RANDOMLY ASSIGNED TO CHAIR YOGA (N = 66) OR HEP (N = 65). THIRTEEN DROPPED AFTER ASSIGNMENT BUT PRIOR TO THE INTERVENTION; SIX DROPPED DURING THE INTERVENTION; 106 OF 112 COMPLETED AT LEAST 12 OF 16 SESSIONS (95% RETENTION RATE). INTERVENTIONS: PARTICIPANTS ATTENDED EITHER CHAIR YOGA OR HEP. BOTH INTERVENTIONS CONSISTED OF TWICE-WEEKLY 45-MINUTE SESSIONS FOR 8 WEEKS. MEASUREMENTS: PRIMARY: PAIN, PAIN INTERFERENCE; SECONDARY: BALANCE, GAIT SPEED, FATIGUE, FUNCTIONAL ABILITY MEASURED AT BASELINE, AFTER 4 WEEKS OF INTERVENTION, AT THE END OF THE 8-WEEK INTERVENTION, AND POST-INTERVENTION (1 AND 3 MONTHS). RESULTS: THE CHAIR YOGA GROUP SHOWED GREATER REDUCTION IN PAIN INTERFERENCE DURING THE INTERVENTION (P = .01), SUSTAINED THROUGH 3 MONTHS (P = .022). WOMAC PAIN (P = .048), GAIT SPEED (P = .024), AND FATIGUE (P = .037) WERE IMPROVED IN THE YOGA GROUP DURING THE INTERVENTION (P = .048) BUT IMPROVEMENTS WERE NOT SUSTAINED POST INTERVENTION. CHAIR YOGA HAD NO EFFECT ON BALANCE. CONCLUSION: AN 8-WEEK CHAIR YOGA PROGRAM WAS ASSOCIATED WITH REDUCTION IN PAIN, PAIN INTERFERENCE, AND FATIGUE, AND IMPROVEMENT IN GAIT SPEED, BUT ONLY THE EFFECTS ON PAIN INTERFERENCE WERE SUSTAINED 3 MONTHS POST INTERVENTION. CHAIR YOGA SHOULD BE FURTHER EXPLORED AS A NONPHARMACOLOGIC INTERVENTION FOR OLDER PEOPLE WITH OA IN THE LOWER EXTREMITIES. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT02113410.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
18  345  34 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
19 2550  42 YOGA FOR CANCER-RELATED FATIGUE IN SURVIVORS OF HEMATOPOIETIC CELL TRANSPLANTATION: A FEASIBILITY STUDY. CONTEXT: CANCER-RELATED FATIGUE (CRF) IS ONE OF THE MOST COMMON SYMPTOMS EXPERIENCED BY CANCER PATIENTS AFTER HEMATOPOIETIC CELL TRANSPLANTATION (HCT). YOGA IS AN APPROACH WITH SUPPORTIVE EVIDENCE TO IMPROVE CRF IN DIFFERENT CANCER POPULATIONS, BUT TO OUR KNOWLEDGE, IT HAS NOT BEEN TESTED IN AN ADULT HCT POPULATION. OBJECTIVES: THE AIM OF THIS STUDY WAS TO EVALUATE THE FEASIBILITY OF A YOGA INTERVENTION OFFERED TO ADULT HCT SURVIVORS WITH MODERATE-TO-SEVERE CRF. METHODS: THIS FEASIBILITY STUDY USED A SINGLE-ARM, PRETEST-POSTTEST DESIGN. ADULT HCT SURVIVORS WERE ENROLLED IN A SIX-WEEK RESTORATIVE YOGA INTERVENTION THAT CONSISTED OF A ONE-HOUR ONCE-WEEKLY CLASS WITH TWICE-WEEKLY HOME PRACTICE USING A DVD. RESULTS: TWENTY PARTICIPANTS (13 WOMEN AND SEVEN MEN) ENROLLED IN THIS STUDY WITH A MEAN AGE OF 51 YEARS (SD = 12.5). THE SAMPLE CONSISTED OF 19 ALLOGENEIC HCT SURVIVORS, SEVEN OF WHOM HAD A HISTORY OF ACUTE GRAFT-VS.-HOST DISEASE (GVHD), SIX WITH ACTIVE, EXTENSIVE CHRONIC GVHD, AND ONE AUTOLOGOUS HCT SURVIVOR. THE ACCRUAL ACCEPTANCE RATE WAS 23.2% (20/86 HCT SURVIVORS) AND RETENTION RATE WAS 60% (12/20). OVERALL ADHERENCE WAS 45.4%. NO ADVERSE EVENTS WERE REPORTED. CONCLUSION: THE RESULTS OF THIS STUDY SUGGEST THAT A RESTORATIVE YOGA INTERVENTION IN ADULT HCT SURVIVORS IS SAFE AND FEASIBLE. THE INCIDENCE OF GVHD MAY HAVE IMPACTED ADHERENCE. STRATEGIES TO IMPROVE ACCRUAL ACCEPTANCE, RETENTION, AND ADHERENCE ARE NEEDED.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
20 2596  52 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