1 1087 128 EFFECTS OF YOGA ON SYMPTOM MANAGEMENT IN BREAST CANCER PATIENTS: A RANDOMIZED CONTROLLED TRIAL. OBJECTIVES: THIS STUDY COMPARES THE EFFECTS OF AN INTEGRATED YOGA PROGRAM WITH BRIEF SUPPORTIVE THERAPY ON DISTRESSFUL SYMPTOMS IN BREAST CANCER OUTPATIENTS UNDERGOING ADJUVANT RADIOTHERAPY. MATERIALS AND METHODS: EIGHTY-EIGHT STAGE II AND III BREAST CANCER OUTPATIENTS WERE RANDOMLY ASSIGNED TO RECEIVE YOGA (N = 44) OR BRIEF SUPPORTIVE THERAPY (N = 44) PRIOR TO THEIR RADIOTHERAPY TREATMENT. INTERVENTION CONSISTED OF YOGA SESSIONS LASTING 60 MIN DAILY WHILE THE CONTROL GROUP WAS IMPARTED SUPPORTIVE THERAPY ONCE IN 10 DAYS DURING THE COURSE OF THEIR ADJUVANT RADIOTHERAPY. ASSESSMENTS INCLUDED ROTTERDAM SYMPTOM CHECK LIST AND EUROPEAN ORGANIZATION FOR RESEARCH IN THE TREATMENT OF CANCER-QUALITY OF LIFE (EORTC QOL C30) SYMPTOM SCALE. ASSESSMENTS WERE DONE AT BASELINE AND AFTER 6 WEEKS OF RADIOTHERAPY TREATMENT. RESULTS: A GLM REPEATED-MEASURES ANOVA SHOWED A SIGNIFICANT DECREASE IN PSYCHOLOGICAL DISTRESS (P = 0.01), FATIGUE (P = 0.007), INSOMNIA (P = 0.001), AND APPETITE LOSS (P = 0.002) OVER TIME IN THE YOGA GROUP AS COMPARED TO CONTROLS. THERE WAS SIGNIFICANT IMPROVEMENT IN THE ACTIVITY LEVEL (P = 0.02) IN THE YOGA GROUP AS COMPARED TO CONTROLS. THERE WAS A SIGNIFICANT POSITIVE CORRELATION BETWEEN PHYSICAL AND PSYCHOLOGICAL DISTRESS AND FATIGUE, NAUSEA AND VOMITING, PAIN, DYSPNEA, INSOMNIA, APPETITE LOSS, AND CONSTIPATION. THERE WAS A SIGNIFICANT NEGATIVE CORRELATION BETWEEN THE ACTIVITY LEVEL AND FATIGUE, NAUSEA AND VOMITING, PAIN, DYSPNEA, INSOMNIA, AND APPETITE LOSS. CONCLUSION: THE RESULTS SUGGEST BENEFICIAL EFFECTS WITH YOGA INTERVENTION IN MANAGING CANCER-AND TREATMENT-RELATED SYMPTOMS IN BREAST CANCER PATIENTS. 2009 2 1097 98 EFFECTS OF YOGA PROGRAM ON QUALITY OF LIFE AND AFFECT IN EARLY BREAST CANCER PATIENTS UNDERGOING ADJUVANT RADIOTHERAPY: A RANDOMIZED CONTROLLED TRIAL. OBJECTIVES: THIS STUDY COMPARES THE EFFECTS OF AN INTEGRATED YOGA PROGRAM WITH BRIEF SUPPORTIVE THERAPY IN BREAST CANCER OUTPATIENTS UNDERGOING ADJUVANT RADIOTHERAPY AT A CANCER CENTRE. METHODS: EIGHTY-EIGHT STAGE II AND III BREAST CANCER OUTPATIENTS WERE RANDOMLY ASSIGNED TO RECEIVE YOGA (N = 44) OR BRIEF SUPPORTIVE THERAPY (N = 44) PRIOR TO THEIR RADIOTHERAPY TREATMENT. INTERVENTION CONSISTED OF YOGA SESSIONS LASTING 60 MIN DAILY WHILE THE CONTROL GROUP WAS IMPARTED SUPPORTIVE THERAPY ONCE IN 10 DAYS. ASSESSMENTS INCLUDED EUROPEAN ORGANIZATION FOR RESEARCH IN THE TREATMENT OF CANCER-QUALITY OF LIFE (EORTCQOL C30) FUNCTIONAL SCALES AND POSITIVE AND NEGATIVE AFFECT SCHEDULE (PANAS). ASSESSMENTS WERE DONE AT BASELINE AND AFTER 6 WEEKS OF RADIOTHERAPY TREATMENT. RESULTS: AN INTENTION TO TREAT GLM REPEATED MEASURES ANOVA SHOWED SIGNIFICANT DIFFERENCE ACROSS GROUPS OVER TIME FOR POSITIVE AFFECT, NEGATIVE AFFECT AND EMOTIONAL FUNCTION AND SOCIAL FUNCTION. THERE WAS SIGNIFICANT IMPROVEMENT IN POSITIVE AFFECT (ES = 0.59, P = 0.007, 95%CI 1.25 TO 7.8), EMOTIONAL FUNCTION (ES = 0.71, P = 0.001, 95%CI 6.45 TO 25.33) AND COGNITIVE FUNCTION (ES = 0.48, P = 0.03, 95%CI 1.2 TO 18.5), AND DECREASE IN NEGATIVE AFFECT (ES = 0.84, P<0.001, 95%CI -13.4 TO -4.4) IN THE YOGA GROUP AS COMPARED TO CONTROLS. THERE WAS A SIGNIFICANT POSITIVE CORRELATION BETWEEN POSITIVE AFFECT WITH ROLE FUNCTION, SOCIAL FUNCTION AND GLOBAL QUALITY OF LIFE. THERE WAS A SIGNIFICANT NEGATIVE CORRELATION BETWEEN NEGATIVE AFFECT WITH PHYSICAL FUNCTION, ROLE FUNCTION, EMOTIONAL FUNCTION AND SOCIAL FUNCTION. CONCLUSION: THE RESULTS SUGGEST A POSSIBLE ROLE FOR YOGA TO IMPROVE QUALITY OF LIFE AND AFFECT IN BREAST CANCER OUTPATIENTS. 2009 3 329 73 ANXIOLYTIC EFFECTS OF A YOGA PROGRAM IN EARLY BREAST CANCER PATIENTS UNDERGOING CONVENTIONAL TREATMENT: A RANDOMIZED CONTROLLED TRIAL. OBJECTIVES: THIS STUDY COMPARES THE ANXIOLYTIC EFFECTS OF A YOGA PROGRAM AND SUPPORTIVE THERAPY IN BREAST CANCER OUTPATIENTS UNDERGOING CONVENTIONAL TREATMENT AT A CANCER CENTRE. METHODS: NINETY-EIGHT STAGE II AND III BREAST CANCER OUTPATIENTS WERE RANDOMLY ASSIGNED TO RECEIVE YOGA (N=45) OR BRIEF SUPPORTIVE THERAPY (N=53) PRIOR TO THEIR PRIMARY TREATMENT I.E., SURGERY. ONLY THOSE SUBJECTS WHO RECEIVED SURGERY FOLLOWED BY ADJUVANT RADIOTHERAPY AND SIX CYCLES OF CHEMOTHERAPY WERE CHOSEN FOR ANALYSIS FOLLOWING INTERVENTION (YOGA, N=18, CONTROL, N=20). INTERVENTION CONSISTED OF YOGA SESSIONS LASTING 60MIN DAILY WHILE THE CONTROL GROUP WAS IMPARTED SUPPORTIVE THERAPY DURING THEIR HOSPITAL VISITS AS A PART OF ROUTINE CARE. ASSESSMENTS INCLUDED SPEILBERGER'S STATE TRAIT ANXIETY INVENTORY AND SYMPTOM CHECKLIST. ASSESSMENTS WERE DONE AT BASELINE, AFTER SURGERY, BEFORE, DURING, AND AFTER RADIOTHERAPY AND CHEMOTHERAPY. RESULTS: A GLM-REPEATED MEASURES ANOVA SHOWED OVERALL DECREASE IN BOTH SELF-REPORTED STATE ANXIETY (P<0.001) AND TRAIT ANXIETY (P=0.005) IN YOGA GROUP AS COMPARED TO CONTROLS. THERE WAS A POSITIVE CORRELATION BETWEEN ANXIETY STATES AND TRAITS WITH SYMPTOM SEVERITY AND DISTRESS DURING CONVENTIONAL TREATMENT INTERVALS. CONCLUSION: THE RESULTS SUGGEST THAT YOGA CAN BE USED FOR MANAGING TREATMENT-RELATED SYMPTOMS AND ANXIETY IN BREAST CANCER OUTPATIENTS. 2009 4 975 63 EFFECTS OF AN INTEGRATED YOGA PROGRAMME ON CHEMOTHERAPY-INDUCED NAUSEA AND EMESIS IN BREAST CANCER PATIENTS. THIS STUDY EXAMINED THE EFFECT OF AN INTEGRATED YOGA PROGRAMME ON CHEMOTHERAPY-RELATED NAUSEA AND EMESIS IN EARLY OPERABLE BREAST CANCER OUTPATIENTS. SIXTY-TWO SUBJECTS WERE RANDOMLY ALLOCATED TO RECEIVE YOGA (N = 28) OR SUPPORTIVE THERAPY INTERVENTION (N = 34) DURING THE COURSE OF THEIR CHEMOTHERAPY. BOTH GROUPS HAD SIMILAR SOCIO-DEMOGRAPHIC AND MEDICAL CHARACTERISTICS. INTERVENTION CONSISTED OF BOTH SUPERVISED AND HOME PRACTICE OF YOGA SESSIONS LASTING FOR 60 MIN DAILY, WHILE THE CONTROL GROUP RECEIVED SUPPORTIVE THERAPY AND COPING PREPARATION DURING THEIR HOSPITAL VISITS OVER A COMPLETE COURSE OF CHEMOTHERAPY. THE PRIMARY OUTCOME MEASURE WAS THE MORROW ASSESSMENT OF NAUSEA AND EMESIS (MANE) ASSESSED AFTER THE FOURTH CYCLE OF CHEMOTHERAPY. SECONDARY OUTCOMES INCLUDED MEASURES FOR ANXIETY, DEPRESSION, QUALITY OF LIFE, DISTRESSFUL SYMPTOMS AND TREATMENT-RELATED TOXICITY ASSESSED BEFORE AND DURING THE COURSE OF CHEMOTHERAPY. FOLLOWING YOGA, THERE WAS A SIGNIFICANT DECREASE IN POST-CHEMOTHERAPY-INDUCED NAUSEA FREQUENCY (P = 0.01) AND NAUSEA INTENSITY (P = 0.01), AND INTENSITY OF ANTICIPATORY NAUSEA (P = 0.01) AND ANTICIPATORY VOMITING (P = 0.05) AS COMPARED WITH THE CONTROL GROUP. THERE WAS A SIGNIFICANT POSITIVE CORRELATION BETWEEN MANE SCORES AND ANXIETY, DEPRESSION AND DISTRESSFUL SYMPTOMS. IN CONCLUSION, THE RESULTS SUGGEST A POSSIBLE USE FOR STRESS REDUCTION INTERVENTIONS SUCH AS YOGA IN COMPLEMENTING CONVENTIONAL ANTIEMETICS TO MANAGE CHEMOTHERAPY-RELATED NAUSEA AND EMESIS. 2007 5 193 36 A RANDOMIZED TRIAL COMPARING YOGA, STRETCHING, AND A SELF-CARE BOOK FOR CHRONIC LOW BACK PAIN. BACKGROUND: CHRONIC LOW BACK PAIN IS A COMMON PROBLEM LACKING HIGHLY EFFECTIVE TREATMENT OPTIONS. SMALL TRIALS SUGGEST THAT YOGA MAY HAVE BENEFITS FOR THIS CONDITION. THIS TRIAL WAS DESIGNED TO DETERMINE WHETHER YOGA IS MORE EFFECTIVE THAN CONVENTIONAL STRETCHING EXERCISES OR A SELF-CARE BOOK FOR PRIMARY CARE PATIENTS WITH CHRONIC LOW BACK PAIN. METHODS: A TOTAL OF 228 ADULTS WITH CHRONIC LOW BACK PAIN WERE RANDOMIZED TO 12 WEEKLY CLASSES OF YOGA (92 PATIENTS) OR CONVENTIONAL STRETCHING EXERCISES (91 PATIENTS) OR A SELF-CARE BOOK (45 PATIENTS). BACK-RELATED FUNCTIONAL STATUS (MODIFIED ROLAND DISABILITY QUESTIONNAIRE, A 23-POINT SCALE) AND BOTHERSOMENESS OF PAIN (AN 11-POINT NUMERICAL SCALE) AT 12 WEEKS WERE THE PRIMARY OUTCOMES. OUTCOMES WERE ASSESSED AT BASELINE, 6, 12, AND 26 WEEKS BY INTERVIEWERS UNAWARE OF TREATMENT GROUP. RESULTS: AFTER ADJUSTMENT FOR BASELINE VALUES, 12-WEEK OUTCOMES FOR THE YOGA GROUP WERE SUPERIOR TO THOSE FOR THE SELF-CARE GROUP (MEAN DIFFERENCE FOR FUNCTION, -2.5 [95% CI, -3.7 TO -1.3]; P < .001; MEAN DIFFERENCE FOR SYMPTOMS, -1.1 [95% CI, -1.7 TO -0.4]; P < .001). AT 26 WEEKS, FUNCTION FOR THE YOGA GROUP REMAINED SUPERIOR (MEAN DIFFERENCE, -1.8 [95% CI, -3.1 TO -0.5]; P < .001). YOGA WAS NOT SUPERIOR TO CONVENTIONAL STRETCHING EXERCISES AT ANY TIME POINT. CONCLUSION: YOGA CLASSES WERE MORE EFFECTIVE THAN A SELF-CARE BOOK, BUT NOT MORE EFFECTIVE THAN STRETCHING CLASSES, IN IMPROVING FUNCTION AND REDUCING SYMPTOMS DUE TO CHRONIC LOW BACK PAIN, WITH BENEFITS LASTING AT LEAST SEVERAL MONTHS. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT00447668. 2011 6 962 64 EFFECTS OF A YOGA PROGRAM ON CORTISOL RHYTHM AND MOOD STATES IN EARLY BREAST CANCER PATIENTS UNDERGOING ADJUVANT RADIOTHERAPY: A RANDOMIZED CONTROLLED TRIAL. UNLABELLED: OBJECTIVES. THIS STUDY COMPARES THE EFFECTS OF AN INTEGRATED YOGA PROGRAM WITH BRIEF SUPPORTIVE THERAPY IN BREAST CANCER OUTPATIENTS UNDERGOING ADJUVANT RADIOTHERAPY AT A CANCER CENTER. METHODS: EIGHTY-EIGHT STAGE II AND III BREAST CANCER OUTPATIENTS ARE RANDOMLY ASSIGNED TO RECEIVE YOGA (N = 44) OR BRIEF SUPPORTIVE THERAPY (N = 44) PRIOR TO RADIOTHERAPY TREATMENT. ASSESSMENTS INCLUDE DIURNAL SALIVARY CORTISOL LEVELS 3 DAYS BEFORE AND AFTER RADIOTHERAPY AND SELF-RATINGS OF ANXIETY, DEPRESSION, AND STRESS COLLECTED BEFORE AND AFTER 6 WEEKS OF RADIOTHERAPY. RESULTS: ANALYSIS OF COVARIANCE REVEALS SIGNIFICANT DECREASES IN ANXIETY (P < .001), DEPRESSION (P = .002), PERCEIVED STRESS (P < .001), 6 A.M. SALIVARY CORTISOL (P = .009), AND POOLED MEAN CORTISOL (P = .03) IN THE YOGA GROUP COMPARED WITH CONTROLS. THERE IS A SIGNIFICANT POSITIVE CORRELATION BETWEEN MORNING SALIVARY CORTISOL LEVEL AND ANXIETY AND DEPRESSION. CONCLUSION: YOGA MIGHT HAVE A ROLE IN MANAGING SELF-REPORTED PSYCHOLOGICAL DISTRESS AND MODULATING CIRCADIAN PATTERNS OF STRESS HORMONES IN EARLY BREAST CANCER PATIENTS UNDERGOING ADJUVANT RADIOTHERAPY. 2009 7 521 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 8 189 54 A RANDOMIZED STUDY OF YOGA FOR FATIGUE AND QUALITY OF LIFE IN WOMEN WITH BREAST CANCER UNDERGOING (NEO) ADJUVANT CHEMOTHERAPY. OBJECTIVES: TO COMPARE THE EFFECTIVENESS OF YOGA ADDED TO STANDARD CARE (SC) VERSUS SC ONLY, IN WOMEN WITH BREAST CANCER DURING CHEMOTHERAPY. DESIGN: A MULTICENTER PRAGMATIC, RANDOMIZED CONTROLLED STUDY. SETTINGS/LOCATION: THREE HOSPITALS IN THE NETHERLANDS. SUBJECTS: WOMEN WITH STAGE I-III BREAST CANCER UNDERGOING CHEMOTHERAPY. INTERVENTIONS: WOMEN WERE RANDOMIZED EITHER TO A PROGRAM BASED ON DRU YOGA, ONCE A WEEK YOGA SESSIONS FOR 12 WEEKS (N = 47), OR SC ONLY (N = 36). OUTCOME MEASURES: PRIMARY OUTCOME FATIGUE (MULTIDIMENSIONAL FATIGUE INVENTORY [MFI]; GENERAL FATIGUE) AND SECONDARY OUTCOMES FATIGUE (MFI, FATIGUE QUALITY LIST [FQL]), QUALITY OF LIFE (30-ITEM QUALITY OF LIFE QUESTIONNAIRE-C OF THE EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER [EORTC-QLQ-C-30]) AND PSYCHOLOGICAL DISTRESS (HOSPITAL ANXIETY DEPRESSION SCALE [HADS], IMPACT OF EVENTS SCALE [IES]) WERE MEASURED AT BASELINE (T0), 3 MONTHS (T1), AND 6 MONTHS (T2) AND ANALYZED ON OBSERVED CASES. OTHER OUTCOMES WERE ADEQUATE RELIEF, REINTEGRATION TO WORK, AND ADVERSE EVENTS. RESULTS: NO SIGNIFICANT DIFFERENCES WERE FOUND IN GENERAL FATIGUE AT T1 (MFI: YOGA; 14.6 +/- 4.5 VS. SC; 14.2 +/- 4.2, P = 0.987). SIMILAR FINDINGS WERE OBSERVED FOR OTHER FATIGUE (SUB)SCALES OF MFI AND FQL AND FUNCTIONAL DOMAINS OF EORTC. WITH RESPECT TO EORTCS SYMPTOM SCALES, WOMEN IN THE YOGA GROUP REPORTED SIGNIFICANTLY LESS NAUSEA AND VOMITING COMPARED WITH SC AT T2 (P = 0.004), BUT NOT AT T1 (P = 0.807). DEPRESSIVE SYMPTOMS WERE SIGNIFICANTLY LOWER WITH YOGA AT T1 (HADS: YOGA; 4.7 +/- 4.1 VS. SC; 5.1 +/- 4.2, P = 0.031). MORE WOMEN IN THE YOGA GROUP EXPERIENCED ADEQUATE RELIEF COMPARED WITH SC AT T1 (YOGA; 51% VS. SC; 19%) AND HAD RETURNED TO WORK AT T2 (YOGA; 53% VS. SC; 23%). NO ADVERSE EVENTS WERE REPORTED WITH YOGA. CONCLUSIONS: A DRU-BASED YOGA PROGRAM FAILED TO DEMONSTRATE A SIGNIFICANT BENEFICIAL EFFECT ON FATIGUE. POSSIBLE FAVORABLE EFFECTS OF THE YOGA PROGRAM ON NAUSEA AND VOMITING AND EARLY RETURN TO WORK IN BREAST CANCER SURVIVORS WARRANT FURTHER RESEARCH. 2018 9 2323 43 TREATMENT OF CHRONIC PRIMARY SLEEP ONSET INSOMNIA WITH KUNDALINI YOGA: A RANDOMIZED CONTROLLED TRIAL WITH ACTIVE SLEEP HYGIENE COMPARISON. STUDY OBJECTIVES: PRIOR STUDIES HAVE SUGGESTED A BENEFIT OF YOGA FOR ALLEVIATING SLEEP DISTURBANCE; HOWEVER, MANY STUDIES HAVE HAD METHODOLOGICAL LIMITATIONS. THIS TRIAL STUDY AIMED TO EXTEND THAT LITERATURE BY INCLUDING AN ACTIVE SLEEP HYGIENE COMPARISON. METHODS: PARTICIPANTS AGED 25-59 YEARS WITH A PRIMARY COMPLAINT OF SLEEP ONSET INSOMNIA LASTING AT LEAST 6 MONTHS WERE BLOCK RANDOMIZED TO AN 8-WEEK KUNDALINI YOGA OR SLEEP HYGIENE INTERVENTION, BOTH CONSISTING OF INITIAL 60-MINUTE INSTRUCTION AND WEEKLY CHECK-INS. DAILY SLEEP DIARIES AND QUESTIONNAIRES WERE COLLECTED AT BASELINE, THROUGHOUT THE INTERVENTION, AND AT 6-MONTH FOLLOW-UP. DATA WERE ANALYZED USING LINEAR MIXED MODELS (N = 20 IN EACH GROUP). RESULTS: PARTICIPANT RATINGS OF THE INTERVENTIONS DID NOT SIGNIFICANTLY DIFFER. SLEEP HYGIENE IMPROVED SEVERAL DIARY AND QUESTIONNAIRE OUTCOMES, HOWEVER, YOGA RESULTED IN EVEN GREATER IMPROVEMENTS CORRESPONDING TO MEDIUM-TO-LARGE BETWEEN-GROUP EFFECT SIZES. TOTAL SLEEP TIME INCREASED PROGRESSIVELY ACROSS YOGA TREATMENT (D = 0.95, P = .002), CONCURRENT WITH INCREASED SLEEP EFFICIENCY (D = 1.36, P < .001) AND DECREASED SLEEP ONSET LATENCY (D = -1.16, P < .001), BUT WITHOUT CHANGES IN PRE-SLEEP AROUSAL (D =-0.30, P = .59). REMISSION RATES WERE ALSO HIGHER FOR YOGA COMPARED TO SLEEP HYGIENE, WITH >/= 80% OF YOGA PARTICIPANTS REPORTING AVERAGE SLEEP ONSET LATENCY < 30 MINUTES AND SLEEP EFFICIENCY > 80% AT 6-MONTH FOLLOW-UP. FOR OVER 50% OF YOGA PARTICIPANTS, THE INSOMNIA SEVERITY INDEX DECREASED BY AT LEAST 8 POINTS AT END OF TREATMENT AND FOLLOW-UP. CONCLUSIONS: YOGA, TAUGHT IN A SELF-CARE FRAMEWORK WITH MINIMAL INSTRUCTOR BURDEN, WAS ASSOCIATED WITH SELF-REPORTED IMPROVEMENTS ABOVE AND BEYOND AN ACTIVE SLEEP HYGIENE COMPARISON, SUSTAINED AT 6-MONTH FOLLOW-UP. FOLLOW-UP STUDIES ARE NEEDED TO ASSESS ACTIGRAPHY AND POLYSOMNOGRAPHY OUTCOMES, AS WELL AS POSSIBLE MECHANISMS OF CHANGE. CLINICAL TRIAL REGISTRATION: REGISTRY: CLINICALTRIALS.GOV; NAME: YOGA AS A TREATMENT FOR INSOMNIA; URL: HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT00033865; IDENTIFIER: NCT00033865. CITATION: KHALSA SBS, GOLDSTEIN MR. TREATMENT OF CHRONIC PRIMARY SLEEP ONSET INSOMNIA WITH KUNDALINI YOGA: A RANDOMIZED CONTROLLED TRIAL WITH ACTIVE SLEEP HYGIENE COMPARISON. J CLIN SLEEP MED. 2021;17(9):1841-1852. 2021 10 964 71 EFFECTS OF A YOGA PROGRAM ON MOOD STATES, QUALITY OF LIFE, AND TOXICITY IN BREAST CANCER PATIENTS RECEIVING CONVENTIONAL TREATMENT: A RANDOMIZED CONTROLLED TRIAL. AIMS: THE AIM OF THIS STUDY IS TO COMPARE THE EFFECTS OF YOGA PROGRAM WITH SUPPORTIVE THERAPY COUNSELING ON MOOD STATES, TREATMENT-RELATED SYMPTOMS, TOXICITY, AND QUALITY OF LIFE IN STAGE II AND III BREAST CANCER PATIENTS ON CONVENTIONAL TREATMENT. METHODS: NINETY-EIGHT STAGE II AND III BREAST CANCER PATIENTS UNDERWENT SURGERY FOLLOWED BY ADJUVANT RADIOTHERAPY (RT) OR CHEMOTHERAPY (CT) OR BOTH AT A CANCER CENTER WERE RANDOMLY ASSIGNED TO RECEIVE YOGA (N = 45) AND SUPPORTIVE THERAPY COUNSELING (N = 53) OVER A 24-WEEK PERIOD. INTERVENTION CONSISTED OF 60-MIN YOGA SESSIONS, DAILY WHILE THE CONTROL GROUP WAS IMPARTED SUPPORTIVE THERAPY DURING THEIR HOSPITAL VISITS. ASSESSMENTS INCLUDED STATE-TRAIT ANXIETY INVENTORY, BECK'S DEPRESSION INVENTORY, SYMPTOM CHECKLIST, COMMON TOXICITY CRITERIA, AND FUNCTIONAL LIVING INDEX-CANCER. ASSESSMENTS WERE DONE AT BASELINE, AFTER SURGERY, BEFORE, DURING, AND AFTER RT AND SIX CYCLES OF CT. RESULTS: BOTH GROUPS HAD SIMILAR BASELINE SCORES. THERE WERE 29 DROPOUTS 12 (YOGA) AND 17 (CONTROLS) FOLLOWING SURGERY. SIXTY-NINE PARTICIPANTS CONTRIBUTED DATA TO THE CURRENT ANALYSIS (33 IN YOGA, AND 36 IN CONTROLS). AN ANCOVA, ADJUSTING FOR BASELINE DIFFERENCES, SHOWED A SIGNIFICANT DECREASE FOR THE YOGA INTERVENTION AS COMPARED TO THE CONTROL GROUP DURING RT (FIRST RESULT) AND CT (SECOND RESULT), IN (I) ANXIETY STATE BY 4.72 AND 7.7 POINTS, (II) DEPRESSION BY 5.74 AND 7.25 POINTS, (III) TREATMENT-RELATED SYMPTOMS BY 2.34 AND 2.97 POINTS, (IV) SEVERITY OF SYMPTOMS BY 6.43 AND 8.83 POINTS, (V) DISTRESS BY 7.19 AND 13.11 POINTS, AND (VI) AND IMPROVED OVERALL QUALITY OF LIFE BY 23.9 AND 31.2 POINTS AS COMPARED TO CONTROLS. TOXICITY WAS SIGNIFICANTLY LESS IN THE YOGA GROUP (P = 0.01) DURING CT. CONCLUSION: THE RESULTS SUGGEST A POSSIBLE USE FOR YOGA AS A PSYCHOTHERAPEUTIC INTERVENTION IN BREAST CANCER PATIENTS UNDERGOING CONVENTIONAL TREATMENT. 2017 11 974 70 EFFECTS OF AN INTEGRATED YOGA PROGRAM ON SELF-REPORTED DEPRESSION SCORES IN BREAST CANCER PATIENTS UNDERGOING CONVENTIONAL TREATMENT: A RANDOMIZED CONTROLLED TRIAL. AIM: TO COMPARE THE EFFECTS OF YOGA PROGRAM WITH SUPPORTIVE THERAPY ON SELF-REPORTED SYMPTOMS OF DEPRESSION IN BREAST CANCER PATIENTS UNDERGOING CONVENTIONAL TREATMENT. PATIENTS AND METHODS: NINETY-EIGHT BREAST CANCER PATIENTS WITH STAGE II AND III DISEASE FROM A CANCER CENTER WERE RANDOMLY ASSIGNED TO RECEIVE YOGA (N = 45) AND SUPPORTIVE THERAPY (N = 53) OVER A 24-WEEK PERIOD DURING WHICH THEY UNDERWENT SURGERY FOLLOWED BY ADJUVANT RADIOTHERAPY (RT) OR CHEMOTHERAPY (CT) OR BOTH. THE STUDY STOPPAGE CRITERIA WAS PROGRESSIVE DISEASE RENDERING THE PATIENT BEDRIDDEN OR ANY PHYSICAL MUSCULOSKELETAL INJURY RESULTING FROM INTERVENTION OR LESS THAN 60% ATTENDANCE TO YOGA INTERVENTION. SUBJECTS UNDERWENT YOGA INTERVENTION FOR 60 MIN DAILY WITH CONTROL GROUP UNDERGOING SUPPORTIVE THERAPY DURING THEIR HOSPITAL VISITS. BECK'S DEPRESSION INVENTORY (BDI) AND SYMPTOM CHECKLIST WERE ASSESSED AT BASELINE, AFTER SURGERY, BEFORE, DURING, AND AFTER RT AND SIX CYCLES OF CT. WE USED ANALYSIS OF COVARIANCE (INTENT-TO-TREAT) TO STUDY THE EFFECTS OF INTERVENTION ON DEPRESSION SCORES AND PEARSON CORRELATION ANALYSES TO EVALUATE THE BIVARIATE RELATIONSHIPS. RESULTS: A TOTAL OF 69 PARTICIPANTS CONTRIBUTED DATA TO THE CURRENT ANALYSIS (YOGA, N = 33, AND CONTROLS, N = 36). THERE WAS 29% ATTRITION IN THIS STUDY. THE RESULTS SUGGEST AN OVERALL DECREASE IN SELF-REPORTED DEPRESSION WITH TIME IN BOTH THE GROUPS. THERE WAS A SIGNIFICANT DECREASE IN DEPRESSION SCORES IN THE YOGA GROUP AS COMPARED TO CONTROLS FOLLOWING SURGERY, RT, AND CT (P < 0.01). THERE WAS A POSITIVE CORRELATION (P < 0.001) BETWEEN DEPRESSION SCORES WITH SYMPTOM SEVERITY AND DISTRESS DURING SURGERY, RT, AND CT. CONCLUSION: THE RESULTS SUGGEST POSSIBLE ANTIDEPRESSANT EFFECTS WITH YOGA INTERVENTION IN BREAST CANCER PATIENTS UNDERGOING CONVENTIONAL TREATMENT. 2015 12 1020 38 EFFECTS OF YOGA AND AEROBIC EXERCISE ON ACTIGRAPHIC SLEEP PARAMETERS IN MENOPAUSAL WOMEN WITH HOT FLASHES. STUDY OBJECTIVES: TO DETERMINE EFFECTS OF YOGA AND AEROBIC EXERCISE COMPARED WITH USUAL ACTIVITY ON OBJECTIVE ASSESSMENTS OF SLEEP IN MIDLIFE WOMEN. METHODS: SECONDARY ANALYSES OF A RANDOMIZED CONTROLLED TRIAL IN THE MENOPAUSE STRATEGIES: FINDING LASTING ANSWERS FOR SYMPTOMS AND HEALTH (MSFLASH) NETWORK CONDUCTED AMONG 186 LATE TRANSITION AND POSTMENOPAUSAL WOMEN AGED 40-62 Y WITH HOT FLASHES. WOMEN WERE RANDOMIZED TO 12 W OF YOGA, SUPERVISED AEROBIC EXERCISE, OR USUAL ACTIVITY. THE MEAN AND COEFFICIENT OF VARIATION (CV) OF CHANGE IN ACTIGRAPH SLEEP MEASURES FROM EACH INTERVENTION GROUP WERE COMPARED TO THE USUAL ACTIVITY GROUP USING LINEAR REGRESSION MODELS. RESULTS: BASELINE VALUES OF THE PRIMARY SLEEP MEASURES FOR THE ENTIRE SAMPLE WERE MEAN TOTAL SLEEP TIME (TST) = 407.5 +/- 56.7 MIN; MEAN WAKE AFTER SLEEP ONSET (WASO) = 54.6 +/- 21.8 MIN; MEAN CV FOR WASO = 37.7 +/- 18.7 AND MEAN CV FOR NUMBER OF LONG AWAKENINGS > 5 MIN = 81.5 +/- 46.9. CHANGES IN THE ACTIGRAPHIC SLEEP OUTCOMES FROM BASELINE TO WEEKS 11-12 WERE SMALL, AND NONE DIFFERED BETWEEN GROUPS. IN AN EXPLORATORY ANALYSIS, WOMEN WITH BASELINE PITTSBURGH SLEEP QUALITY INDEX HIGHER THAN 8 HAD SIGNIFICANTLY REDUCED TST-CV FOLLOWING YOGA COMPARED WITH USUAL ACTIVITY. CONCLUSIONS: THIS STUDY ADDS TO THE CURRENTLY SCANT LITERATURE ON OBJECTIVE SLEEP OUTCOMES FROM YOGA AND AEROBIC EXERCISE INTERVENTIONS FOR THIS POPULATION. ALTHOUGH SMALL EFFECTS ON SELF-REPORTED SLEEP QUALITY WERE PREVIOUSLY REPORTED, THE INTERVENTIONS HAD NO STATISTICALLY SIGNIFICANT EFFECTS ON ACTIGRAPH MEASURES, EXCEPT FOR POTENTIALLY IMPROVED SLEEP STABILITY WITH YOGA IN WOMEN WITH POOR SELF-REPORTED SLEEP QUALITY. 2017 13 2415 44 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 14 1863 38 RANDOMIZED CONTROLLED TRIAL OF YOGA AND EXERCISE IN MULTIPLE SCLEROSIS. OBJECTIVE: TO DETERMINE THE EFFECT OF YOGA AND OF AEROBIC EXERCISE ON COGNITIVE FUNCTION, FATIGUE, MOOD, AND QUALITY OF LIFE IN MULTIPLE SCLEROSIS (MS). METHODS: SUBJECTS WITH CLINICALLY DEFINITE MS AND EXPANDED DISABILITY STATUS SCORE LESS THAN OR EQUAL TO 6.0 WERE RANDOMLY ASSIGNED TO ONE OF THREE GROUPS LASTING 6 MONTHS: WEEKLY IYENGAR YOGA CLASS ALONG WITH HOME PRACTICE, WEEKLY EXERCISE CLASS USING A STATIONARY BICYCLE ALONG WITH HOME EXERCISE, OR A WAITING-LIST CONTROL GROUP. OUTCOME ASSESSMENTS PERFORMED AT BASELINE AND AT THE END OF THE 6-MONTH PERIOD INCLUDED A BATTERY OF COGNITIVE MEASURES FOCUSED ON ATTENTION, PHYSIOLOGIC MEASURES OF ALERTNESS, PROFILE OF MOOD STATES, STATE-TRAIT ANXIETY INVENTORY, MULTI-DIMENSIONAL FATIGUE INVENTORY (MFI), AND SHORT FORM (SF)-36 HEALTH-RELATED QUALITY OF LIFE. RESULTS: SIXTY-NINE SUBJECTS WERE RECRUITED AND RANDOMIZED. TWELVE SUBJECTS DID NOT FINISH THE 6-MONTH INTERVENTION. THERE WERE NO ADVERSE EVENTS RELATED TO THE INTERVENTION. THERE WERE NO EFFECTS FROM EITHER OF THE ACTIVE INTERVENTIONS ON EITHER OF THE PRIMARY OUTCOME MEASURES OF ATTENTION OR ALERTNESS. BOTH ACTIVE INTERVENTIONS PRODUCED IMPROVEMENT IN SECONDARY MEASURES OF FATIGUE COMPARED TO THE CONTROL GROUP: ENERGY AND FATIGUE (VITALITY) ON THE SF-36 AND GENERAL FATIGUE ON THE MFI. THERE WERE NO CLEAR CHANGES IN MOOD RELATED TO YOGA OR EXERCISE. CONCLUSION: SUBJECTS WITH MS PARTICIPATING IN EITHER A 6-MONTH YOGA CLASS OR EXERCISE CLASS SHOWED SIGNIFICANT IMPROVEMENT IN MEASURES OF FATIGUE COMPARED TO A WAITING-LIST CONTROL GROUP. THERE WAS NO RELATIVE IMPROVEMENT OF COGNITIVE FUNCTION IN EITHER OF THE INTERVENTION GROUPS. 2004 15 2654 41 YOGA IMPROVES QUALITY OF LIFE AND BENEFIT FINDING IN WOMEN UNDERGOING RADIOTHERAPY FOR BREAST CANCER. THIS STUDY EXAMINED THE EFFECTS OF YOGA ON QUALITY OF LIFE (QOL) AND PSYCHOSOCIAL OUTCOMES IN WOMEN WITH BREAST CANCER UNDERGOING RADIOTHERAPY. SIXTY-ONE WOMEN WERE RANDOMLY ASSIGNED TO EITHER A YOGA OR A WAIT-LIST GROUP. YOGA CLASSES WERE TAUGHT BIWEEKLY DURING THE 6 WEEKS OF RADIOTHERAPY. PARTICIPANTS COMPLETED MEASURES OF QOL, FATIGUE, BENEFIT FINDING (FINDING MEANING IN THE CANCER EXPERIENCE), INTRUSIVE THOUGHTS, SLEEP DISTURBANCES, DEPRESSIVE SYMPTOMS, AND ANXIETY BEFORE RADIOTHERAPY AND THEN AGAIN 1 WEEK, 1 MONTH, AND 3 MONTHS AFTER THE END OF RADIOTHERAPY. GENERAL LINEAR MODEL ANALYSES REVEALED THAT COMPARED TO THE CONTROL GROUP, THE YOGA GROUP REPORTED SIGNIFICANTLY BETTER GENERAL HEALTH PERCEPTION (P = .005) AND PHYSICAL FUNCTIONING SCORES (P = .04) 1 WEEK POSTRADIOTHERAPY; HIGHER LEVELS OF INTRUSIVE THOUGHTS 1 MONTH POSTRADIOTHERAPY (P = .01); AND GREATER BENEFIT FINDING 3 MONTHS POSTRADIOTHERAPY (P = .01). THERE WERE NO OTHER GROUP DIFFERENCES IN OTHER QOL SUBSCALES FOR FATIGUE, DEPRESSION, OR SLEEP SCORES. EXPLORATORY ANALYSES INDICATED THAT INTRUSIVE THOUGHTS 1 MONTH AFTER RADIOTHERAPY WERE SIGNIFICANTLY POSITIVELY CORRELATED WITH BENEFIT FINDING 3 MONTHS AFTER RADIOTHERAPY (R = .36, P = .011). OUR RESULTS INDICATED THAT THE YOGA PROGRAM WAS ASSOCIATED WITH STATISTICALLY AND CLINICALLY SIGNIFICANT IMPROVEMENTS IN ASPECTS OF QOL. 2010 16 2604 48 YOGA FOR PERSISTENT FATIGUE IN BREAST CANCER SURVIVORS: A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CANCER-RELATED FATIGUE AFFLICTS UP TO 33% OF BREAST CANCER SURVIVORS, YET THERE ARE NO EMPIRICALLY VALIDATED TREATMENTS FOR THIS SYMPTOM. METHODS: THE AUTHORS CONDUCTED A 2-GROUP RANDOMIZED CONTROLLED TRIAL TO DETERMINE THE FEASIBILITY AND EFFICACY OF AN IYENGAR YOGA INTERVENTION FOR BREAST CANCER SURVIVORS WITH PERSISTENT POST-TREATMENT FATIGUE. PARTICIPANTS WERE BREAST CANCER SURVIVORS WHO HAD COMPLETED CANCER TREATMENTS (OTHER THAN ENDOCRINE THERAPY) AT LEAST 6 MONTHS BEFORE ENROLLMENT, REPORTED SIGNIFICANT CANCER-RELATED FATIGUE, AND HAD NO OTHER MEDICAL CONDITIONS THAT WOULD ACCOUNT FOR FATIGUE SYMPTOMS OR INTERFERE WITH YOGA PRACTICE. BLOCK RANDOMIZATION WAS USED TO ASSIGN PARTICIPANTS TO A 12-WEEK, IYENGAR-BASED YOGA INTERVENTION OR TO 12 WEEKS OF HEALTH EDUCATION (CONTROL). THE PRIMARY OUTCOME WAS CHANGE IN FATIGUE MEASURED AT BASELINE, IMMEDIATELY POST-TREATMENT, AND 3 MONTHS AFTER TREATMENT COMPLETION. ADDITIONAL OUTCOMES INCLUDED CHANGES IN VIGOR, DEPRESSIVE SYMPTOMS, SLEEP, PERCEIVED STRESS, AND PHYSICAL PERFORMANCE. INTENT-TO-TREAT ANALYSES WERE CONDUCTED WITH ALL RANDOMIZED PARTICIPANTS USING LINEAR MIXED MODELS. RESULTS: THIRTY-ONE WOMEN WERE RANDOMLY ASSIGNED TO YOGA (N = 16) OR HEALTH EDUCATION (N = 15). FATIGUE SEVERITY DECLINED SIGNIFICANTLY FROM BASELINE TO POST-TREATMENT AND OVER A 3-MONTH FOLLOW-UP IN THE YOGA GROUP RELATIVE TO CONTROLS (P = .032). IN ADDITION, THE YOGA GROUP HAD SIGNIFICANT INCREASES IN VIGOR RELATIVE TO CONTROLS (P = .011). BOTH GROUPS HAD POSITIVE CHANGES IN DEPRESSIVE SYMPTOMS AND PERCEIVED STRESS (P < .05). NO SIGNIFICANT CHANGES IN SLEEP OR PHYSICAL PERFORMANCE WERE OBSERVED. CONCLUSIONS: A TARGETED YOGA INTERVENTION LED TO SIGNIFICANT IMPROVEMENTS IN FATIGUE AND VIGOR AMONG BREAST CANCER SURVIVORS WITH PERSISTENT FATIGUE SYMPTOMS. 2012 17 312 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 18 2156 43 THE EFFECTS OF THE BALI YOGA PROGRAM FOR BREAST CANCER PATIENTS ON CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING: RESULTS OF A PARTIALLY RANDOMIZED AND BLINDED CONTROLLED TRIAL. COMPLEMENTARY AND ALTERNATIVE MEDICINE HAS BEEN SHOWN TO BE BENEFICIAL IN REDUCING CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING. HOWEVER, CONCLUSIVE RESULTS ARE LACKING IN ORDER TO CONFIRM ITS USEFULNESS. THE PURPOSE OF THIS STUDY WAS TO DETERMINE WHETHER A STANDARDIZED YOGA INTERVENTION COULD REDUCE THESE ADVERSE SYMPTOMS. THIS WAS A PARTIALLY RANDOMIZED AND BLINDED CONTROLLED TRIAL COMPARING A STANDARDIZED YOGA INTERVENTION WITH STANDARD CARE. ELIGIBLE PATIENTS WERE ADULTS DIAGNOSED WITH STAGES I TO III BREAST CANCER RECEIVING CHEMOTHERAPY. PATIENTS RANDOMIZED TO THE EXPERIMENTAL GROUP PARTICIPATED IN AN 8-WEEK YOGA PROGRAM. THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE EXPERIMENTAL AND CONTROL GROUPS ON CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING AFTER 8 WEEKS. RESULTS SUGGEST THE YOGA PROGRAM IS NOT BENEFICIAL IN MANAGING THESE ADVERSE SYMPTOMS. HOWEVER, CONSIDERING PRELIMINARY EVIDENCE SUGGESTING YOGA'S BENEFICIAL IMPACT IN CANCER SYMPTOM MANAGEMENT, METHODOLOGICAL LIMITATIONS SHOULD BE EXPLORED AND ADDITIONAL STUDIES SHOULD BE CONDUCTED. 2017 19 162 42 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 20 1036 53 EFFECTS OF YOGA IN MANAGING FATIGUE IN BREAST CANCER PATIENTS: A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CANCER-RELATED FATIGUE IS WIDELY PREVALENT IN CANCER PATIENTS AND AFFECTS QUALITY OF LIFE IN ADVANCED CANCER PATIENTS. FATIGUE IS CAUSED DUE TO BOTH PSYCHOLOGIC DISTRESS AND PHYSIOLOGICAL SEQUEL FOLLOWING CANCER PROGRESSION AND ITS TREATMENT. IN THIS STUDY, WE EVALUATE THE EFFECTS OF YOGIC INTERVENTION IN MANAGING FATIGUE IN METASTATIC BREAST CANCER PATIENTS. METHODS: NINETY-ONE PATIENTS WITH METASTATIC BREAST CANCER WERE RANDOMIZED TO RECEIVE INTEGRATED YOGA PROGRAM (N = 46) OR SUPPORTIVE THERAPY AND EDUCATION (N = 45) OVER A 3-MONTH PERIOD. ASSESSMENTS SUCH AS PERCEIVED STRESS, FATIGUE SYMPTOM INVENTORY, DIURNAL SALIVARY CORTISOL, AND NATURAL KILLER CELL COUNTS WERE CARRIED OUT BEFORE AND AFTER INTERVENTION. ANALYSIS WAS DONE USING AN INTENTION-TO-TREAT APPROACH. POSTMEASURES FOR THE ABOVE OUTCOMES WERE ASSESSED USING ANCOVA WITH RESPECTIVE BASELINE MEASURE AS A COVARIATE. RESULTS: THE RESULTS SUGGEST THAT YOGA REDUCES PERCEIVED STRESS (P = 0.001), FATIGUE FREQUENCY (P < 0.001), FATIGUE SEVERITY (P < 0.001), INTERFERENCE (P < 0.001), AND DIURNAL VARIATION (P < 0.001) WHEN COMPARED TO SUPPORTIVE THERAPY. THERE WAS A POSITIVE CORRELATION OF CHANGE IN FATIGUE SEVERITY WITH 9 A.M. SALIVARY CORTISOL LEVELS. CONCLUSION: THE RESULTS SUGGEST THAT YOGA REDUCES FATIGUE IN ADVANCED BREAST CANCER PATIENTS. 2017