1 2811 148 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 2 608 48 DEVELOPMENT OF A FALLS REDUCTION YOGA PROGRAM FOR OLDER ADULTS-A PILOT STUDY. OBJECTIVES: WORK WITH LOCAL RURAL ORGANIZATIONS TO DEVELOP AN EVIDENCE-BASED HATHA YOGA PROGRAM INTENDED TO IMPROVE CORE STRENGTH AND BALANCE TO REDUCE FALLS RISK. FEASIBILITY DETERMINED BY SUCCESSFUL RECRUITING, INTERVENTION AND EVALUATION OF PARTICIPANTS AND ACCEPTABLE FREQUENCY OF ADVERSE EVENTS. DESIGN: SINGLE-ARM PILOT STUDY. SETTING: RURAL WISCONSIN TOWN OF 4200 PEOPLE. INTERVENTION: EIGHT WEEK YOGA PROGRAM WITH WEEKLY GROUP CLASSES AND HOME YOGA PRACTICE THREE TIMES PER WEEK. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOMES WERE (1) ABILITY TO ENROLL AT LEAST 20 PARTICIPANTS, (2) PARTICIPANT COMPLETION OF INTERVENTION AND POST-INTERVENTION EVALUATION, AND (3) ADVERSE EVENT DESCRIPTION AND FREQUENCY. RESULTS: A CONVENIENCE SAMPLE OF 20 ADULTS OVER AGE 59 WAS ENROLLED AND STARTED THE PROGRAM WITH ONE DROP OUT. PARTICIPANTS ATTENDED A MEAN OF 7.1 (SD 1.47) OF THE 8 CLASSES AND A TOTAL OF 141 OUT OF 160 (88.1%) CLASSES. NINETEEN (95%) COMPLETED FOLLOW UP EVALUATION. PARTICIPANTS REPORTED 4 FALLS IN THE MONTH BEFORE THE INTERVENTION AND 1 FALL THE MONTH BEFORE THE POST-INTERVENTION EVALUATION (P=0.34). NO OTHER SERIOUS ADVERSE EVENTS OCCURRED. CONCLUSIONS: THIS PROJECT SUGGESTS AN EVIDENCE-BASED YOGA PROGRAM DESIGNED TO IMPROVE CORE STRENGTH AND BALANCE IS FEASIBLE AND ACCEPTABLE TO PARTICIPANTS. FUTURE RESEARCH WILL INCLUDE A RANDOMIZED TRIAL TO ASSESS IMPACT ON FALLS RISK. 2017 3 2596 51 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 4 34 56 A 12-WEEK IYENGAR YOGA PROGRAM IMPROVED BALANCE AND MOBILITY IN OLDER COMMUNITY-DWELLING PEOPLE: A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: EXERCISE THAT CHALLENGES BALANCE CAN IMPROVE MOBILITY AND PREVENT FALLS IN OLDER ADULTS. YOGA AS A PHYSICAL ACTIVITY OPTION FOR OLDER ADULTS IS NOT WELL STUDIED. THIS TRIAL EVALUATED THE FEASIBILITY AND EFFECT OF A 12-WEEK IYENGAR YOGA PROGRAM ON BALANCE AND MOBILITY IN OLDER PEOPLE. METHODS: WE CONDUCTED A BLINDED, PILOT RANDOMIZED CONTROLLED TRIAL WITH INTENTION-TO-TREAT ANALYSIS. PARTICIPANTS WERE 54 COMMUNITY DWELLERS (MEAN AGE 68 YEARS, SD 7.1) NOT CURRENTLY PARTICIPATING IN YOGA OR TAI CHI. THE INTERVENTION GROUP (N = 27) PARTICIPATED IN A 12-WEEK, TWICE-WEEKLY YOGA PROGRAM FOCUSED ON STANDING POSTURES AND RECEIVED A FALL PREVENTION EDUCATION BOOKLET. THE CONTROL GROUP (N = 27) RECEIVED THE EDUCATION BOOKLET ONLY. PRIMARY OUTCOME WAS STANDING BALANCE COMPONENT OF THE SHORT PHYSICAL PERFORMANCE BATTERY WITH ADDITION OF ONE-LEGGED STANCE TIME (STANDING BALANCE). SECONDARY OUTCOMES WERE THE TIMED SIT-TO-STAND TEST, TIMED 4-M WALK, ONE-LEGGED STAND WITH EYES CLOSED, AND SHORT FALLS EFFICACY SCALE-INTERNATIONAL. FEASIBILITY WAS MEASURED BY RECORDING CLASS ATTENDANCE AND ADVERSE EVENTS. RESULTS: FIFTY-TWO PARTICIPANTS COMPLETED FOLLOW-UP ASSESSMENTS. THE INTERVENTION GROUP SIGNIFICANTLY IMPROVED COMPARED WITH CONTROL GROUP ON STANDING BALANCE (MEAN DIFFERENCE = 1.52 SECONDS, 95% CI 0.10-2.96, P = .04), SIT-TO-STAND TEST (MEAN DIFFERENCE = -3.43 SECONDS, 95% CI -5.23 TO -1.64, P < .001), 4-M WALK (MEAN DIFFERENCE = -0.50 SECONDS, 95% CI -0.72 TO -0.28, P < .001), AND ONE-LEGGED STAND WITH EYES CLOSED (MEAN DIFFERENCE = 1.93 SECONDS, 95% CI 0.40-3.46, P = .02). AVERAGE CLASS ATTENDANCE WAS 20 OF 24 CLASSES (83%). NO SERIOUS ADVERSE EVENTS OCCURRED. CONCLUSIONS: THIS TRIAL DEMONSTRATES THE BALANCE AND MOBILITY-RELATED BENEFITS AND FEASIBILITY OF IYENGAR YOGA FOR OLDER PEOPLE. THE FALL PREVENTION EFFECT OF IYENGAR YOGA WARRANTS FURTHER INVESTIGATION. 2013 5 282 44 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 6 1180 44 EVALUATION OF THE EFFECTIVENESS AND EFFICACY OF IYENGAR YOGA THERAPY ON CHRONIC LOW BACK PAIN. STUDY DESIGN: THE EFFECTIVENESS AND EFFICACY OF IYENGAR YOGA FOR CHRONIC LOW BACK PAIN (CLBP) WERE ASSESSED WITH INTENTION-TO-TREAT AND PER-PROTOCOL ANALYSIS. NINETY SUBJECTS WERE RANDOMIZED TO A YOGA (N = 43) OR CONTROL GROUP (N = 47) RECEIVING STANDARD MEDICAL CARE. PARTICIPANTS WERE FOLLOWED 6 MONTHS AFTER COMPLETION OF THE INTERVENTION. OBJECTIVE: THIS STUDY AIMED TO EVALUATE IYENGAR YOGA THERAPY ON CHRONIC LOW BACK PAIN. YOGA SUBJECTS WERE HYPOTHESIZED TO REPORT GREATER REDUCTIONS IN FUNCTIONAL DISABILITY, PAIN INTENSITY, DEPRESSION, AND PAIN MEDICATION USAGE THAN CONTROLS. SUMMARY OF BACKGROUND DATA: CLBP IS A MUSCULOSKELETAL DISORDER WITH PUBLIC HEALTH AND ECONOMIC IMPACT. PILOT STUDIES OF YOGA AND BACK PAIN HAVE REPORTED SIGNIFICANT CHANGES IN CLINICALLY IMPORTANT OUTCOMES. METHODS: SUBJECTS WERE RECRUITED THROUGH SELF-REFERRAL AND HEALTH PROFESSIONAL REFERRALS ACCORDING TO EXPLICIT INCLUSION/EXCLUSION CRITERIA. YOGA SUBJECTS PARTICIPATED IN 24 WEEKS OF BIWEEKLY YOGA CLASSES DESIGNED FOR CLBP. OUTCOMES WERE ASSESSED AT 12 (MIDWAY), 24 (IMMEDIATELY AFTER), AND 48 WEEKS (6-MONTH FOLLOW-UP) AFTER THE START OF THE INTERVENTION USING THE OSWESTRY DISABILITY QUESTIONNAIRE, A VISUAL ANALOG SCALE, THE BECK DEPRESSION INVENTORY, AND A PAIN MEDICATION-USAGE QUESTIONNAIRE. RESULTS: USING INTENTION-TO-TREAT ANALYSIS WITH REPEATED MEASURES ANOVA (GROUP X TIME), SIGNIFICANTLY GREATER REDUCTIONS IN FUNCTIONAL DISABILITY AND PAIN INTENSITY WERE OBSERVED IN THE YOGA GROUP WHEN COMPARED TO THE CONTROL GROUP AT 24 WEEKS. A SIGNIFICANTLY GREATER PROPORTION OF YOGA SUBJECTS ALSO REPORTED CLINICAL IMPROVEMENTS AT BOTH 12 AND 24 WEEKS. IN ADDITION, DEPRESSION WAS SIGNIFICANTLY LOWER IN YOGA SUBJECTS. FURTHERMORE, WHILE A REDUCTION IN PAIN MEDICATION OCCURRED, THIS WAS COMPARABLE IN BOTH GROUPS. WHEN RESULTS WERE ANALYZED USING PER-PROTOCOL ANALYSIS, IMPROVEMENTS WERE OBSERVED FOR ALL OUTCOMES IN THE YOGA GROUP, INCLUDING AGREATER TREND FOR REDUCED PAIN MEDICATION USAGE. ALTHOUGH SLIGHTLY LESS THAN AT 24 WEEKS, THE YOGA GROUP HAD STATISTICALLY SIGNIFICANT REDUCTIONS IN FUNCTIONAL DISABILITY, PAIN INTENSITY, AND DEPRESSION COMPARED TO STANDARD MEDICAL CARE 6-MONTHS POSTINTERVENTION. CONCLUSION: YOGA IMPROVES FUNCTIONAL DISABILITY, PAIN INTENSITY, AND DEPRESSION IN ADULTS WITH CLBP. THERE WAS ALSO A CLINICALLY IMPORTANT TREND FOR THE YOGA GROUP TO REDUCE THEIR PAIN MEDICATION USAGE COMPARED TO THE CONTROL GROUP. 2009 7 2415 43 YOGA AND MEDITATION FOR MENOPAUSAL SYMPTOMS IN BREAST CANCER SURVIVORS-A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: BREAST CANCER SURVIVORS HAVE ONLY VERY LIMITED TREATMENT OPTIONS FOR MENOPAUSAL SYMPTOMS. THE OBJECTIVE OF THIS TRIAL WAS TO EVALUATE THE EFFECTS OF A 12-WEEK TRADITIONAL HATHA YOGA AND MEDITATION INTERVENTION ON MENOPAUSAL SYMPTOMS IN BREAST CANCER SURVIVORS. METHODS: PATIENTS WERE RANDOMLY ASSIGNED EITHER TO A 12-WEEK YOGA AND MEDITATION INTERVENTION OR TO USUAL CARE. THE PRIMARY OUTCOME MEASURE WAS TOTAL MENOPAUSAL SYMPTOMS (MENOPAUSE RATING SCALE [MRS] TOTAL SCORE). SECONDARY OUTCOME MEASURES INCLUDED MRS SUBSCALES, QUALITY OF LIFE (FUNCTIONAL ASSESSMENT OF CANCER THERAPY-BREAST), FATIGUE (FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATIGUE), DEPRESSION, AND ANXIETY (HOSPITAL ANXIETY AND DEPRESSION SCALE). OUTCOMES WERE ASSESSED AT WEEK 12 AND WEEK 24 AFTER RANDOMIZATION. RESULTS: IN TOTAL, 40 WOMEN (MEAN AGE +/- STANDARD DEVIATION, 49.2 +/- 5.9 YEARS) WERE RANDOMIZED TO YOGA (N = 19) OR TO USUAL CARE (N = 21). WOMEN IN THE YOGA GROUP REPORTED SIGNIFICANTLY LOWER TOTAL MENOPAUSAL SYMPTOMS COMPARED WITH THE USUAL CARE GROUP AT WEEK 12 (MEAN DIFFERENCE, -5.6; 95% CONFIDENCE INTERVAL, -9.2 TO -1.9; P = .004) AND AT WEEK 24 (MEAN DIFFERENCE, -4.5; 95% CONFIDENCE INTERVAL, -8.3 TO -0.7; P = .023). AT WEEK 12, THE YOGA GROUP REPORTED LESS SOMATOVEGETATIVE, PSYCHOLOGICAL, AND UROGENITAL MENOPAUSAL SYMPTOMS; LESS FATIGUE; AND IMPROVED QUALITY OF LIFE (ALL P < .05). AT WEEK 24, ALL EFFECTS PERSISTED EXCEPT FOR PSYCHOLOGICAL MENOPAUSAL SYMPTOMS. SHORT-TERM EFFECTS ON MENOPAUSAL SYMPTOMS REMAINED SIGNIFICANT WHEN ONLY WOMEN WHO WERE RECEIVING ANTIESTROGEN MEDICATION (N = 36) WERE ANALYZED. SIX MINOR ADVERSE EVENTS OCCURRED IN EACH GROUP. CONCLUSIONS: YOGA COMBINED WITH MEDITATION CAN BE CONSIDERED A SAFE AND EFFECTIVE COMPLEMENTARY INTERVENTION FOR MENOPAUSAL SYMPTOMS IN BREAST CANCER SURVIVORS. THE EFFECTS SEEM TO PERSIST FOR AT LEAST 3 MONTHS. 2015 8 2560 50 YOGA FOR CHRONIC LOW BACK PAIN: A RANDOMIZED TRIAL. BACKGROUND: PREVIOUS STUDIES INDICATE THAT YOGA MAY BE AN EFFECTIVE TREATMENT FOR CHRONIC OR RECURRENT LOW BACK PAIN. OBJECTIVE: TO COMPARE THE EFFECTIVENESS OF YOGA AND USUAL CARE FOR CHRONIC OR RECURRENT LOW BACK PAIN. DESIGN: PARALLEL-GROUP, RANDOMIZED, CONTROLLED TRIAL USING COMPUTER-GENERATED RANDOMIZATION CONDUCTED FROM APRIL 2007 TO MARCH 2010. OUTCOMES WERE ASSESSED BY POSTAL QUESTIONNAIRE. (INTERNATIONAL STANDARD RANDOMISED CONTROLLED TRIAL NUMBER REGISTER: ISRCTN 81079604) SETTING: 13 NON-NATIONAL HEALTH SERVICE PREMISES IN THE UNITED KINGDOM. PATIENTS: 313 ADULTS WITH CHRONIC OR RECURRENT LOW BACK PAIN. INTERVENTION: YOGA (N = 156) OR USUAL CARE (N = 157). ALL PARTICIPANTS RECEIVED A BACK PAIN EDUCATION BOOKLET. THE INTERVENTION GROUP WAS OFFERED A 12-CLASS, GRADUALLY PROGRESSING YOGA PROGRAM DELIVERED BY 12 TEACHERS OVER 3 MONTHS. MEASUREMENTS: SCORES ON THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE (RMDQ) AT 3 (PRIMARY OUTCOME), 6, AND 12 (SECONDARY OUTCOMES) MONTHS; PAIN, PAIN SELF-EFFICACY, AND GENERAL HEALTH MEASURES AT 3, 6, AND 12 MONTHS (SECONDARY OUTCOMES). RESULTS: 93 (60%) PATIENTS OFFERED YOGA ATTENDED AT LEAST 3 OF THE FIRST 6 SESSIONS AND AT LEAST 3 OTHER SESSIONS. THE YOGA GROUP HAD BETTER BACK FUNCTION AT 3, 6, AND 12 MONTHS THAN THE USUAL CARE GROUP. THE ADJUSTED MEAN RMDQ SCORE WAS 2.17 POINTS (95% CI, 1.03 TO 3.31 POINTS) LOWER IN THE YOGA GROUP AT 3 MONTHS, 1.48 POINTS (CI, 0.33 TO 2.62 POINTS) LOWER AT 6 MONTHS, AND 1.57 POINTS (CI, 0.42 TO 2.71 POINTS) LOWER AT 12 MONTHS. THE YOGA AND USUAL CARE GROUPS HAD SIMILAR BACK PAIN AND GENERAL HEALTH SCORES AT 3, 6, AND 12 MONTHS, AND THE YOGA GROUP HAD HIGHER PAIN SELF-EFFICACY SCORES AT 3 AND 6 MONTHS BUT NOT AT 12 MONTHS. TWO OF THE 157 USUAL CARE PARTICIPANTS AND 12 OF THE 156 YOGA PARTICIPANTS REPORTED ADVERSE EVENTS, MOSTLY INCREASED PAIN. LIMITATION: THERE WERE MISSING DATA FOR THE PRIMARY OUTCOME (YOGA GROUP, N = 21; USUAL CARE GROUP, N = 18) AND DIFFERENTIAL MISSING DATA (MORE IN THE YOGA GROUP) FOR SECONDARY OUTCOMES. CONCLUSION: OFFERING A 12-WEEK YOGA PROGRAM TO ADULTS WITH CHRONIC OR RECURRENT LOW BACK PAIN LED TO GREATER IMPROVEMENTS IN BACK FUNCTION THAN DID USUAL CARE. PRIMARY FUNDING SOURCE: ARTHRITIS RESEARCH UK. 2011 9 388 44 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 10 1787 37 PREFERENCE AND EXPECTATION FOR TREATMENT ASSIGNMENT IN A RANDOMIZED CONTROLLED TRIAL OF ONCE- VS TWICE-WEEKLY YOGA FOR CHRONIC LOW BACK PAIN. BACKGROUND: IN STUDIES INVOLVING NONPHARMACOLOGICAL COMPLEMENTARY AND ALTERNATIVE MEDICINE INTERVENTIONS, PARTICIPANT BLINDING IS VERY DIFFICULT. PARTICIPANT EXPECTATIONS MAY AFFECT PERCEIVED BENEFIT OF THERAPY. IN STUDIES OF YOGA AS TREATMENT FOR CHRONIC LOW BACK PAIN, LITTLE IS KNOWN ABOUT THE RELATIONSHIP BETWEEN PATIENT EXPECTATIONS AND PREFERENCES ON OUTCOMES. THIS STUDY WAS DESIGNED TO IDENTIFY BASELINE PREDICTORS OF PREFERENCE AND TO DETERMINE IF EXPECTATIONS AND PREFERENCES FOR DIFFERENT DOSES OF YOGA AFFECT BACK-RELATED FUNCTION AND LOW BACK PAIN INTENSITY. METHODS: THIS WAS A SECONDARY DATA ANALYSIS OF A 12-WEEK RANDOMIZED CONTROLLED TRIAL COMPARING ONCE-WEEKLY VS TWICE-WEEKLY YOGA FOR TREATMENT OF CHRONIC LOW BACK PAIN IN 93 ADULTS FROM A PREDOMINANTLY LOW-INCOME MINORITY POPULATION. AT BASELINE, PARTICIPANTS WERE ASKED ABOUT BACK FUNCTION, BACK PAIN, TREATMENT EXPECTATIONS, AND TREATMENT PREFERENCES. WE CREATED A VARIABLE "CONCORDANCE" TO DESCRIBE THE MATCHING OF PARTICIPANT PREFERENCE TO RANDOMIZED TREATMENT. OUR OUTCOME VARIABLES WERE CHANGE IN BACK FUNCTION AND PAIN INTENSITY AFTER 12 WEEKS OF YOGA INSTRUCTION. WE PERFORMED LOGISTIC REGRESSION TO IDENTIFY PREDICTORS OF PREFERENCE FOR ONCE- OR TWICE-WEEKLY YOGA INSTRUCTION. WE CREATED LINEAR REGRESSION MODELS TO IDENTIFY INDEPENDENT ASSOCIATIONS BETWEEN EXPECTATIONS, PREFERENCE, CONCORDANCE, AND OUTCOMES. RESULTS: WORSE BACK FUNCTION AT BASELINE WAS ASSOCIATED WITH 20% HIGHER ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 1.2, CI 1.1, 1.3). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR TWICE-WEEKLY YOGA HAD 90% HIGHER ODDS OF PREFERRING TWICE-WEEKLY VS ONCE-WEEKLY YOGA (OR 1.9, CI 1.3, 2.7). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR ONCE-WEEKLY YOGA HAD 40% LESS ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 0.6, CI 0.5, 0.9). AFTER CONTROLLING FOR BASELINE CHARACTERISTICS, WE FOUND NO STATISTICALLY SIGNIFICANT RELATIONSHIP BETWEEN TREATMENT OUTCOMES, PREFERENCE, EXPECTATION SCORES, OR CONCORDANCE. CONCLUSION: IN A POPULATION OF PREDOMINANTLY LOW-INCOME MINORITY PARTICIPANTS WITH CHRONIC LOW BACK PAIN, WORSE BACK FUNCTION WAS ASSOCIATED WITH PREFERENCE FOR MORE FREQUENT YOGA CLASSES. THOSE WHO PREFERRED MORE YOGA CLASSES HAD HIGHER EXPECTATIONS FOR THOSE CLASSES. TWELVE-WEEK CHANGE IN BACK PAIN INTENSITY AND BACK FUNCTION WERE NOT AFFECTED BY DOSING PREFERENCE, EXPECTATION SCORE, OR CONCORDANCE. MORE RESEARCH IS NEEDED TO BETTER MEASURE AND QUANTIFY PREFERENCE, EXPECTATIONS, AND THEIR RELATIONSHIP TO OUTCOMES IN YOGA RESEARCH. 2015 11 2628 56 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 12 162 55 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 13 521 43 COMPARING YOGA, EXERCISE, AND A SELF-CARE BOOK FOR CHRONIC LOW BACK PAIN: A RANDOMIZED, CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN IS A COMMON PROBLEM THAT HAS ONLY MODESTLY EFFECTIVE TREATMENT OPTIONS. OBJECTIVE: TO DETERMINE WHETHER YOGA IS MORE EFFECTIVE THAN CONVENTIONAL THERAPEUTIC EXERCISE OR A SELF-CARE BOOK FOR PATIENTS WITH CHRONIC LOW BACK PAIN. DESIGN: RANDOMIZED, CONTROLLED TRIAL. SETTING: A NONPROFIT, INTEGRATED HEALTH CARE SYSTEM. PATIENTS: 101 ADULTS WITH CHRONIC LOW BACK PAIN. INTERVENTION: 12-WEEK SESSIONS OF YOGA OR CONVENTIONAL THERAPEUTIC EXERCISE CLASSES OR A SELF-CARE BOOK. MEASUREMENTS: PRIMARY OUTCOMES WERE BACK-RELATED FUNCTIONAL STATUS (MODIFIED 24-POINT ROLAND DISABILITY SCALE) AND "BOTHERSOMENESS" OF PAIN (11-POINT NUMERICAL SCALE). THE PRIMARY TIME POINT WAS 12 WEEKS. CLINICALLY SIGNIFICANT CHANGE WAS CONSIDERED TO BE 2.5 POINTS ON THE FUNCTIONAL STATUS SCALE AND 1.5 POINTS ON THE BOTHERSOMENESS SCALE. SECONDARY OUTCOMES WERE DAYS OF RESTRICTED ACTIVITY, GENERAL HEALTH STATUS, AND MEDICATION USE. RESULTS: AFTER ADJUSTMENT FOR BASELINE VALUES, BACK-RELATED FUNCTION IN THE YOGA GROUP WAS SUPERIOR TO THE BOOK AND EXERCISE GROUPS AT 12 WEEKS (YOGA VS. BOOK: MEAN DIFFERENCE, -3.4 [95% CI, -5.1 TO - 1.6] [P < 0.001]; YOGA VS. EXERCISE: MEAN DIFFERENCE, -1.8 [CI, -3.5 TO - 0.1] [P = 0.034]). NO SIGNIFICANT DIFFERENCES IN SYMPTOM BOTHERSOMENESS WERE FOUND BETWEEN ANY 2 GROUPS AT 12 WEEKS; AT 26 WEEKS, THE YOGA GROUP WAS SUPERIOR TO THE BOOK GROUP WITH RESPECT TO THIS MEASURE (MEAN DIFFERENCE, -2.2 [CI, -3.2 TO - 1.2]; P < 0.001). AT 26 WEEKS, BACK-RELATED FUNCTION IN THE YOGA GROUP WAS SUPERIOR TO THE BOOK GROUP (MEAN DIFFERENCE, -3.6 [CI, -5.4 TO - 1.8]; P < 0.001). LIMITATIONS: PARTICIPANTS IN THIS STUDY WERE FOLLOWED FOR ONLY 26 WEEKS AFTER RANDOMIZATION. ONLY 1 INSTRUCTOR DELIVERED EACH INTERVENTION. CONCLUSIONS: YOGA WAS MORE EFFECTIVE THAN A SELF-CARE BOOK FOR IMPROVING FUNCTION AND REDUCING CHRONIC LOW BACK PAIN, AND THE BENEFITS PERSISTED FOR AT LEAST SEVERAL MONTHS. 2005 14 1902 54 RESTORATIVE YOGA IN ADULTS WITH METABOLIC SYNDROME: A RANDOMIZED, CONTROLLED PILOT TRIAL. BACKGROUND: METABOLIC SYNDROME INCREASES THE RISK OF DIABETES AND CARDIOVASCULAR DISEASE. YOGA IMPROVES SOME METABOLIC PARAMETERS, BUT IT HAS NOT BEEN STUDIED IN PERSONS WITH METABOLIC SYNDROME. WE CONDUCTED A RANDOMIZED CONTROLLED PILOT TRIAL TO DETERMINE WHETHER A RESTORATIVE YOGA INTERVENTION WAS FEASIBLE AND ACCEPTABLE IN UNDERACTIVE, OVERWEIGHT ADULTS WITH METABOLIC SYNDROME. METHODS: TWENTY SIX UNDERACTIVE, OVERWEIGHT ADULT MEN AND WOMEN WITH METABOLIC SYNDROME WERE RANDOMIZED TO ATTEND 15 YOGA SESSIONS OF 90 MINUTES EACH OVER 10 WEEKS OR TO A WAIT-LIST CONTROL GROUP. FEASIBILITY WAS MEASURED BY RECRUITMENT RATES, SUBJECT RETENTION, AND ADHERENCE. ACCEPTABILITY WAS ASSESSED BY INTERVIEW AND QUESTIONNAIRES. CHANGES IN METABOLIC OUTCOMES AND QUESTIONNAIRE MEASURES FROM BASELINE TO WEEK 10 WERE CALCULATED. RESULTS: A TOTAL OF 280 PEOPLE WERE SCREENED BY PHONE, AND 93 WITH HIGH LIKELIHOOD OF METABOLIC SYNDROME WERE INVITED TO A SCREENING VISIT. OF THE 68 WHO ATTENDED SCREENING VISITS, 26 (38%) WERE RANDOMIZED, AND 24 (92%) COMPLETED THE TRIAL. ATTENDANCE AT YOGA CLASSES AND ADHERENCE TO HOME PRACTICE EXCEEDED OUR GOALS. IN THE YOGA GROUP, ALL PARTICIPANTS GAVE THE STUDY THE HIGHEST POSSIBLE SATISFACTION RATING, AND THE MAJORITY (87%) FELT THAT THE YOGA POSES WERE EASY TO PERFORM. THERE WAS TREND TO REDUCED BLOOD PRESSURE (P = 0.07), A SIGNIFICANT INCREASE IN ENERGY LEVEL (P < 0.009), AND TRENDS TO IMPROVEMENT IN WELL-BEING (P < 0.12) AND STRESS (P < 0.22) IN THE YOGA VERSUS CONTROL GROUP. CONCLUSIONS: RESTORATIVE YOGA WAS A FEASIBLE AND ACCEPTABLE INTERVENTION IN OVERWEIGHT ADULTS WITH METABOLIC SYNDROME. THE EFFICACY OF YOGA FOR IMPROVING METABOLIC PARAMETERS IN THIS POPULATION SHOULD BE EXPLORED IN A LARGER RANDOMIZED CONTROLLED TRIAL. 2008 15 1699 46 PARTICIPANT CHARACTERISTICS ASSOCIATED WITH SYMPTOMATIC IMPROVEMENT FROM YOGA FOR CHRONIC LOW BACK PAIN. CONTEXT: STUDIES SUGGEST THAT YOGA IS EFFECTIVE FOR MODERATE TO SEVERE CHRONIC LOW BACK PAIN (CLBP) IN DIVERSE PREDOMINANTLY LOWER SOCIOECONOMIC STATUS POPULATIONS. HOWEVER, LITTLE IS KNOWN ABOUT FACTORS ASSOCIATED WITH BENEFIT FROM THE YOGA INTERVENTION. OBJECTIVE: IDENTIFY FACTORS AT BASELINE INDEPENDENTLY ASSOCIATED WITH GREATER EFFICACY AMONG PARTICIPANTS IN A STUDY OF YOGA FOR CLBP. DESIGN: FROM SEPTEMBER-DECEMBER 2011, A 12-WEEK RANDOMIZED DOSING TRIAL WAS CONDUCTED COMPARING WEEKLY VS. TWICE-WEEKLY 75-MINUTE HATHA YOGA CLASSES FOR 95 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH NONSPECIFIC CLBP. PARTICIPANT CHARACTERISTICS COLLECTED AT BASELINE WERE USED TO DETERMINE FACTORS BEYOND TREATMENT ASSIGNMENT (REPORTED IN THE INITIAL STUDY) THAT PREDICTED OUTCOME. WE USED BIVARIATE TESTING TO IDENTIFY BASELINE CHARACTERISTICS ASSOCIATED WITH IMPROVEMENT IN FUNCTION AND PAIN, AND INCLUDED SELECT FACTORS IN A MULTIVARIATE LINEAR REGRESSION. SETTING: RECRUITMENT AND CLASSES OCCURRED IN AN ACADEMIC SAFETY-NET HOSPITAL AND FIVE AFFILIATED COMMUNITY HEALTH CENTERS IN BOSTON, MASSACHUSETTS. PARTICIPANTS: NINETY-FIVE ADULTS WITH NONSPECIFIC CLBP, AGES RANGING FROM 20-64 (MEAN 48) YEARS; 72 WOMEN AND 23 MEN. OUTCOME MEASURES: PRIMARY OUTCOMES WERE CHANGES IN BACK-RELATED FUNCTION (MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE, RMDQ; 0-23) AND MEAN LOW BACK PAIN INTENSITY (0-10) IN THE PREVIOUS WEEK, FROM BASELINE TO WEEK 12. RESULTS: ADJUSTING FOR GROUP ASSIGNMENT, BASELINE RMDQ, AGE, AND GENDER, FOREIGN NATIONALITY AND LOWER BASELINE SF36 PHYSICAL COMPONENT SCORE (PCS) WERE INDEPENDENTLY ASSOCIATED WITH IMPROVEMENT IN RMDQ. GREATER THAN HIGH SCHOOL EDUCATION LEVEL, CLBP LESS THAN 1 YEAR, AND LOWER BASELINE SF36 PCS WERE INDEPENDENTLY ASSOCIATED WITH IMPROVEMENT IN PAIN INTENSITY. OTHER DEMOGRAPHICS INCLUDING RACE, INCOME, GENDER, BMI, AND USE OF PAIN MEDICATIONS WERE NOT ASSOCIATED WITH EITHER OUTCOME. CONCLUSIONS: POOR PHYSICAL HEALTH AT BASELINE IS ASSOCIATED WITH GREATER IMPROVEMENT FROM YOGA IN BACK-RELATED FUNCTION AND PAIN. RACE, INCOME, AND BODY MASS INDEX DO NOT AFFECT THE POTENTIAL FOR A PERSON WITH LOW BACK PAIN TO EXPERIENCE BENEFIT FROM YOGA. 2014 16 2660 38 YOGA IN ARTERIAL HYPERTENSION. BACKGROUND: YOGA SEEMS TO EXERT ITS EFFECT AGAINST ARTERIAL HYPERTENSION MAINLY THROUGH THE ASSOCIATED BREATHING AND MEDITATION TECHNIQUES, AND LESS SO THROUGH YOGA POSTURES. THE GOAL OF THIS TRIAL WAS TO COMPARE THE BLOOD PRESSURE-LOWERING EFFECT OF YOGA INTERVENTIONS WITH AND WITHOUT YOGA POSTURES IN PATIENTS WITH ARTERIAL HYPERTENSION. METHODS: 75 PATIENTS TAKING MEDICATIONS FOR ARTERIAL HYPERTENSION (72% WOMEN, MEAN AGE 58.7 +/- 9.5 YEARS) WERE RANDOMIZED INTO THREE GROUPS: A YOGA INTERVENTION GROUP WITH YOGA POSTURES (25 PATIENTS, OF WHOM 5 DROPPED OUT OF THE TRIAL BEFORE ITS END), A YOGA INTERVENTION GROUP WITHOUT YOGA POSTURES (25 PATIENTS, 3 DROPOUTS), AND A WAIT LIST CONTROL GROUP (25 PATIENTS, ONE DROPOUT). THE INTERVENTIONS CONSISTED OF 90 MINUTES OF YOGA PRACTICE PER WEEK FOR TWELVE WEEKS. THE DATA COLLECTORS, WHO WERE BLINDED TO THE INTERVENTION RECEIVED, ASSESSED THE PRIMARY OUTCOME MEASURES "SYSTOLIC 24-HOUR BLOOD PRESSURE" AND "DIASTOLIC 24-HOUR BLOOD PRESSURE" BEFORE AND AFTER THE INTERVENTION. IN THIS REPORT, WE ALSO PRESENT THE FINDINGS ON SECONDARY OUTCOME MEASURES, INCLUDING FOLLOW-UP DATA. RESULTS: AFTER THE INTERVENTION, THE SYSTOLIC 24-HOUR BLOOD PRESSURE IN THE YOGA INTERVENTION GROUP WITHOUT YOGA POSTURES WAS SIGNIFICANTLY LOWER THAN IN THE CONTROL GROUP (GROUP DIFFERENCE [DELTA]= -3.8 MMHG; [95% CONFIDENCE INTERVAL (CI): (-0.3; -7.4) P = 0.035]); IT WAS ALSO SIGNIFICANTLY LOWER THAN IN THE YOGA INTERVENTION GROUP WITH YOGA POSTURES (DELTA = -3.2 MMHG; 95% CI: [-6.3; -0.8]; P = 0.045). DIASTOLIC BLOOD PRESSURES DID NOT DIFFER SIGNIFICANTLY ACROSS GROUPS. NO SERIOUS ADVERSE EVENTS WERE ENCOUNTERED IN THE COURSE OF THE TRIAL. CONCLUSION: IN ACCORDANCE WITH THE FINDINGS OF EARLIER STUDIES, WE FOUND THAT ONLY YOGA WITHOUT YOGA POSTURES INDUCED A SHORT-TERM LOWERING OF AMBULATORY SYSTOLIC BLOOD PRESSURE. YOGA IS SAFE AND EFFECTIVE IN PATIENTS TAKING MEDICATIONS FOR ARTERIAL HYPERTENSION AND THUS CAN BE RECOMMENDED AS AN ADDITIONAL TREATMENT OPTION FOR PERSONS IN THIS CATEGORY. 2018 17 193 42 A RANDOMIZED TRIAL COMPARING YOGA, STRETCHING, AND A SELF-CARE BOOK FOR CHRONIC LOW BACK PAIN. BACKGROUND: CHRONIC LOW BACK PAIN IS A COMMON PROBLEM LACKING HIGHLY EFFECTIVE TREATMENT OPTIONS. SMALL TRIALS SUGGEST THAT YOGA MAY HAVE BENEFITS FOR THIS CONDITION. THIS TRIAL WAS DESIGNED TO DETERMINE WHETHER YOGA IS MORE EFFECTIVE THAN CONVENTIONAL STRETCHING EXERCISES OR A SELF-CARE BOOK FOR PRIMARY CARE PATIENTS WITH CHRONIC LOW BACK PAIN. METHODS: A TOTAL OF 228 ADULTS WITH CHRONIC LOW BACK PAIN WERE RANDOMIZED TO 12 WEEKLY CLASSES OF YOGA (92 PATIENTS) OR CONVENTIONAL STRETCHING EXERCISES (91 PATIENTS) OR A SELF-CARE BOOK (45 PATIENTS). BACK-RELATED FUNCTIONAL STATUS (MODIFIED ROLAND DISABILITY QUESTIONNAIRE, A 23-POINT SCALE) AND BOTHERSOMENESS OF PAIN (AN 11-POINT NUMERICAL SCALE) AT 12 WEEKS WERE THE PRIMARY OUTCOMES. OUTCOMES WERE ASSESSED AT BASELINE, 6, 12, AND 26 WEEKS BY INTERVIEWERS UNAWARE OF TREATMENT GROUP. RESULTS: AFTER ADJUSTMENT FOR BASELINE VALUES, 12-WEEK OUTCOMES FOR THE YOGA GROUP WERE SUPERIOR TO THOSE FOR THE SELF-CARE GROUP (MEAN DIFFERENCE FOR FUNCTION, -2.5 [95% CI, -3.7 TO -1.3]; P < .001; MEAN DIFFERENCE FOR SYMPTOMS, -1.1 [95% CI, -1.7 TO -0.4]; P < .001). AT 26 WEEKS, FUNCTION FOR THE YOGA GROUP REMAINED SUPERIOR (MEAN DIFFERENCE, -1.8 [95% CI, -3.1 TO -0.5]; P < .001). YOGA WAS NOT SUPERIOR TO CONVENTIONAL STRETCHING EXERCISES AT ANY TIME POINT. CONCLUSION: YOGA CLASSES WERE MORE EFFECTIVE THAN A SELF-CARE BOOK, BUT NOT MORE EFFECTIVE THAN STRETCHING CLASSES, IN IMPROVING FUNCTION AND REDUCING SYMPTOMS DUE TO CHRONIC LOW BACK PAIN, WITH BENEFITS LASTING AT LEAST SEVERAL MONTHS. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT00447668. 2011 18 269 55 ADAPTED YOGA TO IMPROVE PHYSICAL FUNCTION AND HEALTH-RELATED QUALITY OF LIFE IN PHYSICALLY-INACTIVE OLDER ADULTS: A RANDOMISED CONTROLLED PILOT TRIAL. BACKGROUND: YOGA IS A HOLISTIC THERAPY OF EXPANDING POPULARITY, WHICH HAS THE POTENTIAL TO PRODUCE A RANGE OF PHYSICAL, MENTAL AND SOCIAL BENEFITS. THIS TRIAL EVALUATED THE FEASIBILITY AND EFFECTS OF AN ADAPTED YOGA PROGRAMME ON PHYSICAL FUNCTION AND HEALTH-RELATED QUALITY OF LIFE IN PHYSICALLY-INACTIVE OLDER ADULTS. METHODS: IN THIS RANDOMISED CONTROLLED PILOT TRIAL, 52 OLDER ADULTS (90% FEMALE; MEAN AGE 74.8 YEARS, SD 7.2) WERE RANDOMISED 1:1 TO A YOGA PROGRAMME OR WAIT-LIST CONTROL. THE YOGA GROUP (N = 25) RECEIVED A PHYSICAL ACTIVITY EDUCATION BOOKLET AND WERE INVITED TO ATTEND TEN YOGA SESSIONS DURING A 12-WEEK PERIOD. THE CONTROL GROUP (N = 27) RECEIVED THE EDUCATION BOOKLET ONLY. MEASURES OF PHYSICAL FUNCTION (E.G., SHORT PHYSICAL PERFORMANCE BATTERY; SPPB), HEALTH STATUS (EQ-5D) AND MENTAL WELL-BEING (WARWICK-EDINBURGH MENTAL WELL-BEING SCALE; WEMWBS) WERE ASSESSED AT BASELINE AND 3 MONTHS. FEASIBILITY WAS ASSESSED USING COURSE ATTENDANCE AND ADVERSE EVENT DATA, AND PARTICIPANT INTERVIEWS. RESULTS: FORTY-SEVEN PARTICIPANTS COMPLETED FOLLOW-UP ASSESSMENTS. MEDIAN CLASS ATTENDANCE WAS 8 (RANGE 3 TO 10). AT THE 3-MONTH FOLLOW-UP, THE YOGA GROUP HAD A HIGHER SPPB TOTAL SCORE COMPARED WITH THE CONTROL GROUP (MEAN DIFFERENCE 0.9, 95% CONFIDENCE INTERVAL [CI] -0.3 TO 2.0), A FASTER TIME TO RISE FROM A CHAIR FIVE TIMES (MEAN DIFFERENCE - 1.73 S, 95% CI -4.08 TO 0.62), AND BETTER PERFORMANCE ON THE CHAIR SIT-AND-REACH LOWER-LIMB FLEXIBILITY TEST (MEAN DIFFERENCE 5 CM, 95% CI 0 TO 10). THE YOGA GROUP ALSO HAD SUPERIOR HEALTH STATUS AND MENTAL WELL-BEING (VS. CONTROL) AT 3 MONTHS, WITH MEAN DIFFERENCES IN EQ-5D AND WEMWBS SCORES OF 0.12 (95% CI, 0.03 TO 0.21) AND 6 (95% CI, 1 TO 11), RESPECTIVELY. THE INTERVIEWS INDICATED THAT PARTICIPANTS VALUED ATTENDING THE YOGA PROGRAMME, AND THAT THEY EXPERIENCED A RANGE OF BENEFITS. CONCLUSIONS: THE ADAPTED YOGA PROGRAMME APPEARED TO BE FEASIBLE AND POTENTIALLY BENEFICIAL IN TERMS OF IMPROVING MENTAL AND SOCIAL WELL-BEING AND ASPECTS OF PHYSICAL FUNCTION IN PHYSICALLY-INACTIVE OLDER ADULTS. AN APPROPRIATELY-POWERED TRIAL IS REQUIRED TO CONFIRM THE FINDINGS OF THE PRESENT STUDY AND TO DETERMINE LONGER-TERM EFFECTS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT02663726 . 2017 19 2279 32 THE SAFETY OF YOGA: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS. AS YOGA HAS GAINED POPULARITY AS A THERAPEUTIC INTERVENTION, ITS SAFETY HAS BEEN QUESTIONED IN THE LAY PRESS. THUS, THIS REVIEW AIMED TO SYSTEMATICALLY ASSESS AND META-ANALYZE THE FREQUENCY OF ADVERSE EVENTS IN RANDOMIZED CONTROLLED TRIALS OF YOGA. MEDLINE/PUBMED, SCOPUS, THE COCHRANE LIBRARY, AND INDMED WERE SCREENED THROUGH FEBRUARY 2014. OF 301 IDENTIFIED RANDOMIZED CONTROLLED TRIALS OF YOGA, 94 (1975-2014; TOTAL OF 8,430 PARTICIPANTS) REPORTED ON ADVERSE EVENTS. LIFE-THREATENING, DISABLING ADVERSE EVENTS OR THOSE REQUIRING INTENSIVE TREATMENT WERE DEFINED AS SERIOUS AND ALL OTHER EVENTS AS NONSERIOUS. NO DIFFERENCES IN THE FREQUENCY OF INTERVENTION-RELATED, NONSERIOUS, OR SERIOUS ADVERSE EVENTS AND OF DROPOUTS DUE TO ADVERSE EVENTS WERE FOUND WHEN COMPARING YOGA WITH USUAL CARE OR EXERCISE. COMPARED WITH PSYCHOLOGICAL OR EDUCATIONAL INTERVENTIONS (E.G., HEALTH EDUCATION), MORE INTERVENTION-RELATED ADVERSE EVENTS (ODDS RATIO = 4.21, 95% CONFIDENCE INTERVAL: 1.01, 17.67; P = 0.05) AND MORE NONSERIOUS ADVERSE EVENTS (ODDS RATIO = 7.30, 95% CONFIDENCE INTERVAL: 1.91, 27.92; P < 0.01) OCCURRED IN THE YOGA GROUP; SERIOUS ADVERSE EVENTS AND DROPOUTS DUE TO ADVERSE EVENTS WERE COMPARABLE BETWEEN GROUPS. FINDINGS FROM THIS REVIEW INDICATE THAT YOGA APPEARS AS SAFE AS USUAL CARE AND EXERCISE. THE ADEQUATE REPORTING OF SAFETY DATA IN FUTURE RANDOMIZED TRIALS OF YOGA IS CRUCIAL TO CONCLUSIVELY JUDGE ITS SAFETY. 2015 20 724 51 EFFECT OF LAUGHTER YOGA ON MOOD AND HEART RATE VARIABILITY IN PATIENTS AWAITING ORGAN TRANSPLANTATION: A PILOT STUDY. CONTEXT: RESEARCH SHOWS THAT LAUGHTER HAS MYRIAD HEALTH BENEFITS, YET THE MEDICAL COMMUNITY HAS NOT IMPLEMENTED IT FORMALLY AS A TREATMENT. PATIENTS AWAITING ORGAN TRANSPLANTATION HAVE SIGNIFICANT PHYSICAL DISABILITIES AND ARE AT RISK FOR PSYCHOLOGICAL DISTRESS. ATTENUATED HEART RATE VARIABILITY (HRV) IS A RISK FACTOR FOR A NEGATIVE LONG-TERM OUTCOME IN SOME PATIENTS. OBJECTIVE: THE STUDY INTENDED TO EVALUATE THE CLINICAL UTILITY OF LAUGHTER YOGA IN IMPROVING PSYCHOLOGICAL AND PHYSIOLOGICAL MEASURES IN OUTPATIENTS AWAITING ORGAN TRANSPLANTATION. POSITIVE RESULTS WOULD INDICATE PROMISING AREAS TO PURSUE IN A FOLLOW-UP STUDY. DESIGN: SIX PARTICIPANTS MET FOR 10 SESSIONS OVER 4 WEEKS. THE RESEARCH TEAM MEASURED EACH PARTICIPANT'S HEART RATE, HRV, BLOOD PRESSURE (BP), AND IMMEDIATE MOOD BEFORE AND AFTER THE LAUGHTER AND CONTROL INTERVENTIONS. THE TEAM ASSESSED PARTICIPANTS' LONGER-TERM MOOD (ANXIETY AND DEPRESSION) AT THE STUDY'S INITIATION, AFTER A NO-TREATMENT CONTROL WEEK, AND AT THE END OF THE STUDY. SETTING: THE STUDY OCCURRED AT THE DEPARTMENT OF SURGERY AND MEDICINE AT THE UNIVERSITY OF ARIZONA HEALTH SCIENCES CENTER, TUCSON. PARTICIPANTS: PARTICIPANTS WERE PATIENTS AWAITING TRANSPLANTS (THREE HEART AND THREE LUNG), TWO WOMEN AND FOUR MEN (AGES 51-69 Y). PARTICIPANTS HAD RECEIVED NO MAJOR SURGERY IN THE 3 MONTHS PRIOR TO THE INTERVENTION, DID NOT HAVE A HERNIA OR UNCONTROLLED HYPERTENSION, AND DID NOT FALL INTO THE NEW YORK HEART ASSOCIATION FUNCTION CLASS 4. INTERVENTION: THE 20-MINUTE LAUGHTER INTERVENTION INVOLVED BREATHING AND STRETCHING EXERCISES, SIMULATED LAUGHTER (IE, UNCONDITIONAL LAUGHTER THAT IS NOT CONTINGENT ON THE ENVIRONMENT), CHANTING, CLAPPING, AND A MEDITATION. THE 20-MINUTE CONTROL INTERVENTION INVOLVED THE STUDY'S PERSONNEL DISCUSSING HEALTH AND STUDY-RELATED TOPICS WITH THE PARTICIPANTS. OUTCOME MEASURES: THE RESEARCH TEAM MEASURED BP, HEART RATE, AND HRV AND ADMINISTERED THE PROFILE OF MOOD STATES, BECK ANXIETY INVENTORY, AND BECK DEPRESSION INVENTORY-II TO EVALUATE IMMEDIATE AND LONGER-TERM MOOD. THE TEAM HAD PLANNED QUANTITATIVE STATISTICAL ANALYSIS OF THE DATA AT THE STUDY'S INITIATION BUT DID NOT COMPLETE IT BECAUSE THE NUMBER OF ENROLLED PARTICIPANTS WAS TOO LOW FOR THE ANALYSIS TO BE MEANINGFUL. THE TEAM VISUALLY EXAMINED THE DATA, HOWEVER, FOR TRENDS THAT WOULD INDICATE AREAS TO EXAMINE FURTHER IN A FOLLOW-UP STUDY. RESULTS: PARTICIPANTS SHOWED IMPROVED IMMEDIATE MOOD (VIGOR-ACTIVITY AND FRIENDLINESS) AND INCREASED HRV AFTER THE LAUGHTER INTERVENTION. BOTH THE LAUGHTER AND CONTROL INTERVENTIONS APPEARED TO IMPROVE LONGER-TERM ANXIETY. TWO PARTICIPANTS AWAITING A LUNG TRANSPLANT DROPPED OUT OF THE STUDY, AND NO ADVERSE EVENTS OCCURRED. CONCLUSION: THIS PILOT STUDY SUGGESTS THAT LAUGHTER YOGA MAY IMPROVE HRV AND SOME ASPECTS OF MOOD, AND THIS TOPIC WARRANTS FURTHER RESEARCH. 2012