1 1748 152 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
2 199 57 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
3 163 38 A RANDOMIZED CONTROL TRIAL OF THE EFFECT OF YOGA ON GUNAS (PERSONALITY) AND HEALTH IN NORMAL HEALTHY VOLUNTEERS. OBJECTIVE: TO STUDY THE EFFICACY OF YOGA ON GUNA (YOGIC PERSONALITY MEASURE) AND GENERAL HEALTH IN NORMAL ADULTS. METHODS: OF THE 1228 PERSONS WHO ATTENDED INTRODUCTORY LECTURES, 226 SUBJECTS AGED 18-71 YEARS, OF BOTH SEXES, WHO SATISFIED THE INCLUSION AND EXCLUSION CRITERIA AND WHO CONSENTED TO PARTICIPATE IN THE STUDY WERE RANDOMLY ALLOCATED INTO TWO GROUPS. THE YOGA(Y) GROUP PRACTISED AN INTEGRATED YOGA MODULE THAT INCLUDED ASANAS, PRANAYAMA, MEDITATION, NOTIONAL CORRECTION AND DEVOTIONAL SESSIONS. THE CONTROL GROUP PRACTISED MILD TO MODERATE PHYSICAL EXERCISES (PE). BOTH GROUPS HAD SUPERVISED PRACTICE SESSIONS (BY TRAINED EXPERTS) FOR ONE HOUR DAILY, SIX DAYS A WEEK FOR EIGHT WEEKS. GUNA (YOGIC PERSONALITY) WAS ASSESSED BEFORE AND AFTER EIGHT WEEKS USING THE SELF-ADMINISTERED VEDIC PERSONALITY INVENTORY (VPI) WHICH ASSESSES SATTVA (GENTLE AND CONTROLLED), RAJAS (VIOLENT AND UNCONTROLLED) AND TAMAS (DULL AND UNCONTROLLED). THE GENERAL HEALTH STATUS (TOTAL HEALTH), WHICH INCLUDES FOUR DOMAINS NAMELY SOMATIC SYMPTOMS (SS), ANXIETY AND INSOMNIA (AI), SOCIAL DYSFUNCTION (SF) AND SEVERE DEPRESSION (SP), WAS ASSESSED USING A GENERAL HEALTH QUESTIONNAIRE (GHQ). RESULTS: BASELINE SCORES FOR ALL THE DOMAINS FOR BOTH THE GROUPS DID NOT DIFFER SIGNIFICANTLY (P > 0.05, INDEPENDENT SAMPLES T TEST). SATTVA SHOWED A SIGNIFICANT DIFFERENCE WITHIN THE GROUPS AND THE EFFECT SIZE WAS MORE IN THE Y THAN IN THE PE GROUP. RAJAS SHOWED A SIGNIFICANT DECREASE WITHIN AND BETWEEN THE GROUPS WITH A HIGHER EFFECT SIZE IN THE PE GROUP. TAMAS SHOWED SIGNIFICANT REDUCTION WITHIN THE PE GROUP ONLY. THE GHQ REVEALED THAT THERE WAS SIGNIFICANT DECREASE IN SS, AI, SF AND SP IN BOTH Y AND PE GROUPS (WILCOXCON SINGED RANK T TEST). SS SHOWED A SIGNIFICANT DIFFERENCE BETWEEN THE GROUPS (MANN WHITNEY U TEST). CONCLUSIONS: THERE WAS AN IMPROVEMENT IN SATTVA IN BOTH THE YOGA AND CONTROL GROUPS WITH A TREND OF HIGHER EFFECT SIZE IN YOGA; RAJAS REDUCED IN BOTH BUT SIGNIFICANTLY BETTER IN PE THAN IN YOGA AND TAMAS REDUCED IN PE. THE GENERAL HEALTH STATUS IMPROVED IN BOTH THE YOGA AND CONTROL GROUPS. 2008
4 2701 40 YOGA INTERVENTION FOR PATIENTS WITH PROSTATE CANCER UNDERGOING EXTERNAL BEAM RADIATION THERAPY: A PILOT FEASIBILITY STUDY. PURPOSE: STUDIES HAVE DEMONSTRATED BENEFICIAL HEALTH EFFECTS FROM YOGA INTERVENTIONS IN CANCER PATIENTS, BUT PREDOMINANTLY IN BREAST CANCER. RESEARCH ON ITS ROLE IN ALLEVIATING PROSTATE CANCER (PC) PATIENTS' SIDE EFFECTS HAS BEEN LACKING. OUR PRIMARY GOAL WAS TO DETERMINE THE FEASIBILITY OF RECRUITING PC PATIENTS ON A CLINICAL TRIAL OF YOGA WHILE THEY UNDERWENT EXTERNAL BEAM RADIATION THERAPY (RT). METHODS: TWICE-WEEKLY YOGA INTERVENTIONS WERE OFFERED THROUGHOUT THE RT COURSE (6-9 WEEKS). BASELINE DEMOGRAPHIC INFORMATION WAS COLLECTED. FEASIBILITY WAS DECLARED IF 15 OF THE FIRST 75 ELIGIBLE PC PATIENTS APPROACHED (20%) WERE SUCCESSFULLY ACCRUED AND COMPLETED THE INTERVENTION. ADDITIONAL END POINTS INCLUDED STANDARDIZED ASSESSMENTS OF FATIGUE, ERECTILE DYSFUNCTION (ED), URINARY INCONTINENCE (UI), AND QUALITY OF LIFE (QOL) AT TIME POINTS BEFORE, DURING, AND AFTER RT. RESULTS: BETWEEN MAY 2013 AND JUNE 2014, 68 ELIGIBLE PC PATIENTS WERE IDENTIFIED. 23 PATIENTS (34%) DECLINED, AND 45 (56%) CONSENTED TO THE STUDY. 18 (40%) WERE VOLUNTARILY WITHDRAWN DUE TO TREATMENT CONFLICTS. OF THE REMAINING 27, 12 (30%) PARTICIPATED IN >/=50% OF CLASSES, AND 15 (59%) WERE EVALUABLE. SEVERITY OF FATIGUE SCORES DEMONSTRATED SIGNIFICANT VARIABILITY, WITH FATIGUE INCREASING BY WEEK 4, BUT THEN IMPROVING OVER THE COURSE OF TREATMENT (P = .008). ED, UI, AND GENERAL QOL SCORES DEMONSTRATED REASSURINGLY STABLE, ALBEIT NOT SIGNIFICANT TRENDS. CONCLUSIONS: A STRUCTURED YOGA INTERVENTION OF TWICE-WEEKLY CLASSES IS FEASIBLE FOR PC PATIENTS DURING A 6- TO 9-WEEK COURSE OF OUTPATIENT RADIOTHERAPY. PRELIMINARY RESULTS ARE PROMISING, SHOWING STABLE MEASUREMENTS IN FATIGUE, SEXUAL HEALTH, UI, AND GENERAL QOL. 2016
5 161 36 A RANDOMISED CONTROLLED TRIAL OF ADJUNCTIVE YOGA AND ADJUNCTIVE PHYSICAL EXERCISE TRAINING FOR COGNITIVE DYSFUNCTION IN SCHIZOPHRENIA. BACKGROUND: YOGA AND PHYSICAL EXERCISE HAVE BEEN USED AS ADJUNCTIVE INTERVENTION FOR COGNITIVE DYSFUNCTION IN SCHIZOPHRENIA (SZ), BUT CONTROLLED COMPARISONS ARE LACKING. AIMS A SINGLE-BLIND RANDOMISED CONTROLLED TRIAL WAS DESIGNED TO EVALUATE WHETHER YOGA TRAINING OR PHYSICAL EXERCISE TRAINING ENHANCE COGNITIVE FUNCTIONS IN SZ, BASED ON A PRIOR PILOT STUDY. METHODS: CONSENTING, CLINICALLY STABLE, ADULT OUTPATIENTS WITH SZ (N=286) COMPLETED BASELINE ASSESSMENTS AND WERE RANDOMISED TO TREATMENT AS USUAL (TAU), SUPERVISED YOGA TRAINING WITH TAU (YT) OR SUPERVISED PHYSICAL EXERCISE TRAINING WITH TAU (PE). BASED ON THE PILOT STUDY, THE PRIMARY OUTCOME MEASURE WAS SPEED INDEX FOR THE COGNITIVE DOMAIN OF 'ATTENTION' IN THE PENN COMPUTERISED NEUROCOGNITIVE BATTERY. USING MIXED MODELS AND CONTRASTS, COGNITIVE FUNCTIONS AT BASELINE, 21 DAYS (END OF TRAINING), 3 AND 6 MONTHS POST-TRAINING WERE EVALUATED WITH INTENTION-TO-TREAT PARADIGM. RESULTS: SPEED INDEX OF ATTENTION DOMAIN IN THE YT GROUP SHOWED GREATER IMPROVEMENT THAN PE AT 6 MONTHS FOLLOW-UP (P<0.036, EFFECT SIZE 0.51). IN THE PE GROUP, 'ACCURACY INDEX OF ATTENTION DOMAIN SHOWED GREATER IMPROVEMENT THAN TAU ALONE AT 6-MONTH FOLLOW-UP (P<0.025, EFFECT SIZE 0.61). FOR SEVERAL OTHER COGNITIVE DOMAINS, SIGNIFICANT IMPROVEMENTS WERE OBSERVED WITH YT OR PE COMPARED WITH TAU ALONE (P<0.05, EFFECT SIZES 0.30-1.97). CONCLUSIONS: BOTH YT AND PE IMPROVED ATTENTION AND ADDITIONAL COGNITIVE DOMAINS WELL PAST THE TRAINING PERIOD, SUPPORTING OUR PRIOR REPORTED BENEFICIAL EFFECT OF YT ON SPEED INDEX OF ATTENTION DOMAIN. AS ADJUNCTS, YT OR PE CAN BENEFIT INDIVIDUALS WITH SZ. 2017
6 1822 39 PROTOCOL TO EVALUATE THE IMPACT OF YOGA SUPPLEMENTATION ON COGNITIVE FUNCTION IN SCHIZOPHRENIA: A RANDOMISED CONTROLLED TRIAL. BACKGROUND: SCHIZOPHRENIA (SZ) IS A CHRONIC ILLNESS THAT IS TREATED SYMPTOMATICALLY. COGNITIVE DYSFUNCTION IS A CORE FEATURE OF SZ THAT IS RELATIVELY INTRACTABLE TO PHARMACOTHERAPY. YOGA CAN IMPROVE COGNITIVE FUNCTION AMONG HEALTHY INDIVIDUALS. A RECENT OPEN TRIAL INDICATED SIGNIFICANT BENEFITS OF YOGA TRAINING (YT) IN CONJUNCTION WITH CONVENTIONAL PHARMACOTHERAPY AMONG PATIENTS WITH SZ. AIMS: TO DESCRIBE THE PROTOCOL FOR AN ONGOING RANDOMISED CONTROLLED TRIAL DESIGNED TO TEST WHETHER THE REPORTED BENEFICIAL EFFECTS OF YT ON COGNITIVE FUNCTION AMONG SZ PATIENTS CAN BE REPLICATED. SECONDARILY, THE EFFECTS OF YT ON DAILY FUNCTIONING LIVING SKILLS ARE EVALUATED. METHODS: CONSENTING PATIENTS WITH SZ RECEIVE ROUTINE CLINICAL TREATMENT AND ARE RANDOMISED TO ADJUNCTIVE YT, ADJUNCTIVE PHYSICAL EXERCISE (PE) OR TREATMENT AS USUAL (PROPOSED N = 234 TOTAL, N = 78 IN EACH GROUP). THE TRIAL INVOLVES YT OR PE 5 DAYS A WEEK AND LASTS 3 WEEKS. PARTICIPANTS ARE EVALUATED THRICE OVER 6 MONTHS. COGNITIVE FUNCTIONS MEASURED BY TRAIL MAKING TEST, UNIVERSITY OF PENNSYLVANIA NEUROCOGNITIVE COMPUTERISED BATTERY WERE PRIMARY OUTCOME MEASURES WHILE CLINICAL SEVERITY AND DAILY FUNCTIONING MEASURED BY INDEPENDENT LIVING SKILLS SURVEY WERE SECONDARY OUTCOME MEASURES. RESULTS: A TOTAL OF 309 PARTICIPANTS HAVE BEEN RANDOMISED AS OF 31 AUGUST 2013, WHICH EXCEEDED BEYOND 294 PROPOSED AFTER ATTRITION. ONCE PARTICIPANTS BEGIN YT OR PE THEY GENERALLY COMPLETE THE PROTOCOL. NO INJURIES HAVE BEEN REPORTED. CONCLUSIONS: SHORT TERM YT IS FEASIBLE AND ACCEPTABLE TO INDIAN SZ PATIENTS. IF BENEFICIAL EFFECTS OF YT ARE DETECTED, IT WILL PROVIDE A NOVEL ADJUNCTIVE COGNITIVE REMEDIATION STRATEGY FOR SZ PATIENTS. 2014
7 2782 32 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
8 599 43 DEVELOPMENT AND TESTING OF AN AUDIO-VISUAL SELF-HELP YOGA MANUAL FOR INDIAN CAREGIVERS OF PERSONS WITH SCHIZOPHRENIA LIVING IN THE COMMUNITY: A SINGLE-BLIND RANDOMIZED CONTROLLED TRIAL. BACKGROUND: TO TEST THE FEASIBILITY AND EFFECTIVENESS OF AN AUDIO-VISUAL SELF-HELP AUDIO-VISUAL YOGA MANUAL ON BURDEN OF INDIAN CAREGIVERS OF PERSONS WITH SCHIZOPHRENIA, LIVING IN THE COMMUNITY. METHODS: AN EARLIER DEVELOPED YOGA PROGRAM FOR CAREGIVERS OF SCHIZOPHRENIA WAS REMODELED INTO AN AUDIO-VISUAL SELF-HELP MANUAL IN THREE LANGUAGES AND VALIDATED BY MENTAL HEALTH AND YOGA EXPERTS. 48 CONSENTING PRIMARY FAMILY CAREGIVERS OF OUTPATIENTS WITH SCHIZOPHRENIA WERE SCREENED, RECRUITED, AND ALLOTTED RANDOMLY TO YOGA OR CARE AS USUAL GROUP. PARTICIPANTS IN YOGA GROUP WERE TAUGHT YOGA FROM THE SELF-HELP MANUAL (1 SESSION OF 1 H EVERY MONTH FOR 5 MONTHS). THE CAREGIVERS WERE ASKED TO FOLLOW THE MANUAL FOR THE REMAINING MONTH AT HOME. ASSESSMENTS OF BURDEN, PERCEIVED STRESS, QUALITY OF LIFE, AND ANXIETY-DEPRESSION WERE CONDUCTED BY A RATER BLIND TO THE GROUP STATUS AT BASELINE AND AT THE END OF EVERY MONTH. RESULTS: POST FACTORING FOR MISSING DATA, REPEATEDMEASURE ANOVA WAS CONDUCTED; WHICH SHOWED THAT THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE GROUP THAT PRACTICED THE SELFHELP YOGA MANUAL AND THE CARE AS USUAL GROUP. THE CAREGIVERS WHO PRACTICED YOGA AT HOME MAINTAINED AN AVERAGE OF 50% ATTENDANCE AND "VERY WELL" LEVEL OF YOGA PERFORMANCE. CONCLUSION: THE AUDIO-VISUAL SELF-HELP YOGA MANUAL WAS FOUND TO BE FEASIBLE TO USE BY THE CAREGIVERS EVEN THOUGH ITS EFFECTIVENESS COULD NOT BE ASCERTAINED DUE TO HIGH ATTRITION. 2020
9 165 38 A RANDOMIZED CONTROL TRIAL OF THE EFFECT OF YOGA ON VERBAL AGGRESSIVENESS IN NORMAL HEALTHY VOLUNTEERS. OBJECTIVE: TO STUDY THE EFFECT OF YOGA ON VERBAL AGGRESSIVENESS IN NORMAL HEALTHY ADULTS. METHODS: OF THE 1228 PERSONS WHO ATTENDED INTRODUCTORY LECTURES, 226 SUBJECTS OF BOTH SEXES WHO SATISFIED THE INCLUSION AND EXCLUSION CRITERIA AND WHO CONSENTED TO PARTICIPATE IN THE STUDY WERE RANDOMLY ALLOCATED INTO TWO GROUPS. THESE 226 SUBJECTS WERE BETWEEN THE AGES OF 17 AND 62 YEARS AND 173/226 COMPLETED THE EIGHT WEEKS OF INTERVENTION. THE YOGA (Y) GROUP PRACTISED AN INTEGRATED YOGA MODULE THAT INCLUDED ASANAS, PRANAYAMA, MEDITATION, NOTIONAL CORRECTION, AND DEVOTIONAL SESSIONS. THE CONTROL GROUP PRACTISED MILD TO MODERATE PHYSICAL EXERCISES (PE). BOTH GROUPS HAD SUPERVISED PRACTICES (BY TRAINED EXPERTS) FOR ONE HOUR DAILY, SIX DAYS A WEEK FOR EIGHT WEEKS. VERBAL AGGRESSIVENESS WAS ASSESSED BEFORE AND AFTER EIGHT WEEKS USING THE SELF-ADMINISTERED VERBAL AGGRESSIVE SCALE. RESULTS: THE BASELINE SCORE OF THE TWO GROUPS DID NOT DIFFER SIGNIFICANTLY (P = 0.66). THERE WAS A SIGNIFICANT DECREASE IN VERBAL AGGRESSIVENESS IN THE YOGA GROUP (P = 0.01 PAIRED SAMPLES T-TEST) WITH A NONSIGNIFICANT INCREASE IN THE PE GROUP. ANCOVA USING PRE- VALUES AS COVARIATES SHOWED A SIGNIFICANT DIFFERENCE BETWEEN THE GROUPS (P = 0.013). RMANOVA FOR INTERACTION BETWEEN THE SEXES OR AGE GROUPS IN CHANGE SCORES WERE NOT SIGNIFICANT. CONCLUSIONS: THIS STUDY HAS DEMONSTRATED THAT AN EIGHT WEEK INTERVENTION OF AN INTEGRATED YOGA MODULE DECREASED VERBAL AGGRESSIVENESS IN THE YOGA GROUP (IN MALES AND THOSE BELOW 25 YEARS OF AGE), WITH A NONSIGNIFICANT INCREASE IN THE PE GROUP. 2008
10 2293 42 THERAPEUTIC EFFICACY OF ADD-ON YOGASANA INTERVENTION IN STABILIZED OUTPATIENT SCHIZOPHRENIA: RANDOMIZED CONTROLLED COMPARISON WITH EXERCISE AND WAITLIST. BACKGROUND: SCHIZOPHRENIA IS A HIGHLY DISABLING ILLNESS. PREVIOUS STUDIES HAVE SHOWN YOGA TO BE A FEASIBLE ADD-ON THERAPY IN SCHIZOPHRENIA. AIMS: THE CURRENT STUDY AIMED TO TEST THE EFFICACY OF YOGA AS AN ADD-ON TREATMENT IN OUTPATIENTS WITH SCHIZOPHRENIA. SETTINGS AND DESIGN: THE STUDY DONE AT A TERTIARY PSYCHIATRY CENTER USED A SINGLE BLIND RANDOMIZED CONTROLLED DESIGN WITH ACTIVE CONTROL AND WAITLIST GROUPS. MATERIALS AND METHODS: CONSENTING PATIENTS WITH SCHIZOPHRENIA WERE RANDOMIZED INTO YOGA, EXERCISE, OR WAITLIST GROUP. THEY CONTINUED TO RECEIVE PHARMACOLOGICAL THERAPY THAT WAS UNCHANGED DURING THE STUDY. PATIENTS IN THE YOGA OR EXERCISE GROUP WERE OFFERED SUPERVISED DAILY PROCEDURES FOR ONE MONTH. ALL PATIENTS WERE ASSESSED BY A BLIND RATER AT THE START OF THE INTERVENTION AND AT THE END OF 4 MONTHS. RESULTS: KENDALL TAU, A NONPARAMETRIC STATISTICAL TEST, SHOWED THAT SIGNIFICANTLY MORE PATIENTS IN THE YOGA GROUP IMPROVED IN POSITIVE AND NEGATIVE SYNDROME SCALE (PANSS) NEGATIVE AND TOTAL PANSS SCORES AS WELL AS SOCIAL FUNCTIONING SCORES COMPARED WITH THE EXERCISE AND WAITLIST GROUP. ODDS RATIO ANALYSIS SHOWED THAT THE LIKELIHOOD OF IMPROVEMENT IN YOGA GROUP IN TERMS OF NEGATIVE SYMPTOMS WAS ABOUT FIVE TIMES GREATER THAN EITHER THE EXERCISE OR WAITLIST GROUPS. CONCLUSION: IN SCHIZOPHRENIA PATIENTS WITH SEVERAL YEARS OF ILLNESS AND ON STABILIZED PHARMACOLOGICAL THERAPY, ONE-MONTH TRAINING FOLLOWED BY THREE MONTHS OF HOME PRACTICES OF YOGA AS AN ADD-ON TREATMENT OFFERED SIGNIFICANT ADVANTAGE OVER EXERCISE OR TREATMENT AS USUAL. YOGA HOLDS PROMISE AS A COMPLEMENTARY INTERVENTION IN THE MANAGEMENT OF SCHIZOPHRENIA. 2012
11 2830 41 YOGA VS STRETCHING IN VETERANS WITH CHRONIC LOWER BACK PAIN AND THE ROLE OF MINDFULNESS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE FEASIBILITY OF RECRUITING, RANDOMIZING, ENROLLING, AND COLLECTING OUTCOME DATA ON VETERAN PATIENTS WITH CHRONIC LOW BACK PAIN (CLBP) WHO UNDERGO AN 8-WEEK, ACTIVE EXERCISE CLASS WITH MINDFULNESS (YOGA CLASS) AND WITHOUT (STRETCHING CLASS). METHODS: UNITED STATES VETERANS WITH CLBP BASED ON INCLUSION/EXCLUSION CRITERIA WERE RANDOMIZED TO 1 OF 2 GROUPS. THE STUDY DESIGN WAS A PILOT RANDOMIZED CONTROLLED TRIAL. TWENTY CLBP PATIENTS ATTENDED A YOGA CLASS OR STRETCHING CLASS ONCE PER WEEK FOR 8 WEEKS AT THE VETERANS AFFAIRS ROCHESTER OUTPATIENT CENTER, ROCHESTER, NEW YORK. THE FOLLOWING MEASUREMENTS WERE OBTAINED: RECRUITMENT OR ENROLLMENT DATA, COMPLIANCE DATA TO INCLUDE CLASS ATTENDANCE AND HOME EXERCISE, AND COMPLIANCE DATA REGARDING ABILITY TO COLLECT OUTCOME MEASURES AT BASELINE AND AT COMPLETION. OUTCOME MEASURES INCLUDED PAIN (PEG), QUALITY OF LIFE (PROMIS GLOBAL HEALTH SURVEY), SELF-EFFICACY (2-ITEM QUESTIONNAIRE), FEAR AVOIDANCE BELIEF, CATASTROPHIZING, AND SOCIAL ENGAGEMENT IN ADDITION TO QUALITATIVE CLINICIAN OPEN-ENDED QUESTIONS POSTINTERVENTION. RESULTS: FORTY-FIVE VETERANS WERE QUERIED REGARDING INTEREST IN PARTICIPATION. OF THESE, 34 (76%) MET THE STUDY'S CRITERIA. TWENTY (44%) AGREED TO PARTICIPATE AND WERE CONSENTED, RANDOMIZED, AND ENROLLED IN THE STUDY. INITIAL AND FINAL OUTCOME MEASURES WERE OBTAINED FOR EACH PARTICIPANT (100%). FORTY PERCENT ATTENDED MORE THAN 80% OF THE SESSIONS FOR BOTH YOGA AND STRETCHING GROUPS. CONCLUSION: THIS PILOT STUDY DEMONSTRATED FEASIBILITY OF RECRUITING, ENROLLING, AND COLLECTING OUTCOME DATA ON CLBP VETERAN PATIENTS PARTICIPATING IN YOGA AND STRETCHING CLASS. THE DATA FROM THIS PILOT WILL INFORM THE DEVELOPMENT OF A RANDOMIZED, COMPARATIVE EFFECTIVENESS STUDY OF YOGA WITH AND WITHOUT MINDFULNESS IN THE MANAGEMENT OF CLBP. 2020
12 851 39 EFFECT OF YOGA ON SLEEP QUALITY AND NEUROENDOCRINE IMMUNE RESPONSE IN METASTATIC BREAST CANCER PATIENTS. BACKGROUND: STUDIES HAVE SHOWN THAT DISTRESS AND ACCOMPANYING NEUROENDOCRINE STRESS RESPONSES AS IMPORTANT PREDICTOR OF SURVIVAL IN ADVANCED BREAST CANCER PATIENTS. SOME PSYCHOTHERAPEUTIC INTERVENTION STUDIES HAVE SHOWN HAVE MODULATION OF NEUROENDOCRINE-IMMUNE RESPONSES IN ADVANCED BREAST CANCER PATIENTS. IN THIS STUDY, WE EVALUATE THE EFFECTS OF YOGA ON PERCEIVED STRESS, SLEEP, DIURNAL CORTISOL, AND NATURAL KILLER (NK) CELL COUNTS IN PATIENTS WITH METASTATIC CANCER. METHODS: IN THIS STUDY, 91 PATIENTS WITH METASTATIC BREAST CANCER WHO SATISFIED SELECTION CRITERIA AND CONSENTED TO PARTICIPATE WERE RECRUITED AND RANDOMIZED TO RECEIVE "INTEGRATED YOGA BASED STRESS REDUCTION PROGRAM" (N = 45) OR STANDARD "EDUCATION AND SUPPORTIVE THERAPY SESSIONS" (N = 46) OVER A 3 MONTH PERIOD. PSYCHOMETRIC ASSESSMENTS FOR SLEEP QUALITY WERE DONE BEFORE AND AFTER INTERVENTION. BLOOD DRAWS FOR NK CELL COUNTS WERE COLLECTED BEFORE AND AFTER THE INTERVENTION. SALIVA SAMPLES WERE COLLECTED FOR THREE CONSECUTIVE DAYS BEFORE AND AFTER INTERVENTION. DATA WERE ANALYZED USING THE ANALYSIS OF COVARIANCE ON POSTMEASURES USING RESPECTIVE BASELINE MEASURE AS A COVARIATE. RESULTS: THERE WAS A SIGNIFICANT DECREASE IN SCALES OF SYMPTOM DISTRESS (P < 0.001), SLEEP PARAMETERS (P = 0.02), AND IMPROVEMENT IN QUALITY OF SLEEP (P = 0.001) AND INSOMNIA RATING SCALE SLEEP SCORE (P = 0.001) FOLLOWING INTERVENTION. THERE WAS A DECREASE IN MORNING WAKING CORTISOL IN YOGA GROUP (P = 0.003) ALONE FOLLOWING INTERVENTION. THERE WAS A SIGNIFICANT IMPROVEMENT IN NK CELL PERCENT (P = 0.03) FOLLOWING INTERVENTION IN YOGA GROUP COMPARED TO CONTROL GROUP. CONCLUSION: THE RESULTS SUGGEST MODULATION OF NEUROENDOCRINE RESPONSES AND IMPROVEMENT IN SLEEP IN PATIENTS WITH ADVANCED BREAST CANCER FOLLOWING YOGA INTERVENTION. 2017
13 2864 46 YOGA-BASED INTERVENTION FOR CAREGIVERS OF OUTPATIENTS WITH PSYCHOSIS: A RANDOMIZED CONTROLLED PILOT STUDY. PURPOSE OF THE STUDY: THE USE OF YOGA AS AN INTERVENTION FOR CAREGIVERS OF PATIENTS WITH PSYCHOSIS HAS BEEN POORLY STUDIED. THE CURRENT STUDY AIMED TO TEST THE EFFICACY OF A BRIEF YOGA PROGRAM AS AN INTERVENTION IN CAREGIVERS OF OUTPATIENTS WITH FUNCTIONAL PSYCHOTIC DISORDERS USING A RANDOMIZED CONTROLLED RESEARCH DESIGN. MATERIALS AND METHODS: CAREGIVERS WHO AGREED TO PARTICIPATE IN THE STUDY (N=29) WERE RANDOMIZED INTO YOGA (N=15) OR WAIT-LIST GROUP (N=14). THEY WERE ASSESSED AT BASELINE AND AT THE END OF 3 MONTHS. PATIENTS WHO WERE RANDOMIZED INTO THE YOGA GROUP WERE OFFERED SUPERVISED YOGA TRAINING THRICE A WEEK FOR 4 WEEKS, AFTER WHICH THEY WERE INSTRUCTED TO PRACTICE AT HOME FOR THE NEXT 2 MONTHS. DUE TO THE SMALL SAMPLE SIZE AND SOME VARIABLES NOT BEING NORMALLY DISTRIBUTED, NON-PARAMETRIC STATISTICAL ANALYSIS WAS USED. RESULTS: RESULTS SHOWED SIGNIFICANTLY REDUCED BURDEN SCORES AND IMPROVED QUALITY OF LIFE SCORES IN THE YOGA GROUP AS COMPARED TO THE WAIT-LIST GROUP AT THE END OF 3 MONTHS. THERE WERE NO SIGNIFICANT CHANGES IN ANXIETY AND DEPRESSION SCORES IN CAREGIVERS, OR PSYCHOPATHOLOGY SCORES IN PATIENTS. CONCLUSION: IN CAREGIVERS OF OUTPATIENTS WITH FUNCTIONAL PSYCHOSIS, 4 WEEKS OF TRAINING FOLLOWED BY 3 MONTHS OF HOME PRACTICE OF A YOGA MODULE OFFERED SIGNIFICANT ADVANTAGE OVER WAITLIST. YOGA CAN BE OFFERED AS AN INTERVENTION FOR CAREGIVERS OF PATIENTS WITH SEVERE MENTAL DISORDERS. METHODS OF PROVIDING YOGA INTERVENTION CLOSER TO THE COMMUNITY OR USE OF FLEXIBLE MODULES AT HOSPITALS NEEDS FURTHER STUDY. 2013
14 2604 49 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
15 2361 57 VIVEKANANDA YOGA PROGRAM FOR PATIENTS WITH ADVANCED LUNG CANCER AND THEIR FAMILY CAREGIVERS. BACKGROUND: THE PRIMARY PURPOSE OF THIS STUDY WAS TO ESTABLISH THE FEASIBILITY OF A COUPLE-BASED VIVEKANANDA YOGA (VKC) INTERVENTION IN LUNG CANCER PATIENTS AND CAREGIVERS. SECONDLY, WE EXAMINED PRELIMINARY EFFICACY REGARDING QUALITY OF LIFE (QOL) OUTCOMES. METHOD: IN THIS SINGLE-ARM FEASIBILITY TRIAL, PATIENTS WITH LUNG CANCER UNDERGOING RADIOTHERAPY AND THEIR CAREGIVERS PARTICIPATED IN A 15-SESSION VKC PROGRAM THAT FOCUSED ON THE INTERCONNECTEDNESS OF THE DYAD. WE ASSESSED PRE-AND POST-INTERVENTION LEVELS OF FATIGUE, SLEEP DISTURBANCES, PSYCHOLOGICAL DISTRESS, OVERALL QOL, SPIRITUALITY, AND RELATIONAL CLOSENESS. WE TRACKED FEASIBILITY DATA, AND PARTICIPANTS COMPLETED PROGRAM EVALUATIONS. RESULTS: WE APPROACHED 28 ELIGIBLE DYADS OF WHICH 15 (53%) CONSENTED AND 9 (60%) COMPLETED THE INTERVENTION. PATIENTS (MEAN AGE = 73 YEARS, 63% FEMALE, ALL STAGE III) AND CAREGIVERS (MEAN AGE = 62 YEARS, 38% FEMALE, 63% SPOUSES) COMPLETED A MEAN OF 10 SESSIONS AND 95.5% OF THEM RATED THE PROGRAM AS VERY USEFUL. PAIRED T TESTS REVEALED A SIGNIFICANT INCREASE IN PATIENTS' MENTAL HEALTH (D = 0.84; P = .04) AND A SIGNIFICANT DECREASE IN CAREGIVERS' SLEEP DISTURBANCES (D = 1.44; P = .02). ALTHOUGH NOT STATISTICALLY SIGNIFICANT, FOR PATIENTS, EFFECT SIZES FOR CHANGE SCORES WERE MEDIUM FOR BENEFIT FINDING AND SMALL FOR DISTRESS (D = 0.65 AND 0.37, RESPECTIVELY). FOR CAREGIVERS, MEDIUM EFFECTS WERE FOUND FOR IMPROVEMENT IN PHYSICAL FUNCTIONING (D = 0.50). CONCLUSION: THIS NOVEL SUPPORTIVE CARE PROGRAM APPEARS TO BE SAFE, FEASIBLE, ACCEPTABLE, AND SUBJECTIVELY USEFUL FOR LUNG CANCER PATIENTS AND THEIR CAREGIVERS AND LENDS SUPPORT FOR FURTHER STUDY. 2015
16 1087 46 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
17 162 43 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
18 1865 41 RANDOMIZED PILOT TRIAL OF YOGA VERSUS STRENGTHENING EXERCISES IN BREAST CANCER SURVIVORS WITH CANCER-RELATED FATIGUE. PURPOSE: FATIGUE IS ONE OF THE MOST COMMON AND BOTHERSOME REFRACTORY SYMPTOMS EXPERIENCED BY CANCER SURVIVORS. MINDFUL EXERCISE INTERVENTIONS SUCH AS YOGA IMPROVE CANCER-RELATED FATIGUE; HOWEVER, STUDIES OF YOGA HAVE INCLUDED HETEROGENEOUS SURVIVORSHIP POPULATIONS, AND THE EFFECT OF YOGA ON FATIGUED SURVIVORS REMAINS UNCLEAR. METHODS: WE RANDOMLY ASSIGNED 34 EARLY-STAGE BREAST CANCER SURVIVORS WITH CANCER-RELATED FATIGUE (>/=4 ON A LIKERT SCALE FROM 1-10) WITHIN 1 YEAR FROM DIAGNOSIS TO A 12-WEEK INTERVENTION OF HOME-BASED YOGA VERSUS STRENGTHENING EXERCISES, BOTH PRESENTED ON A DVD. THE PRIMARY ENDPOINTS WERE FEASIBILITY AND CHANGES IN FATIGUE, AS MEASURED BY THE MULTIDIMENSIONAL FATIGUE SYMPTOM INVENTORY-SHORT FORM (MFSI-SF). SECONDARY ENDPOINT WAS QUALITY OF LIFE, ASSESSED BY THE FUNCTIONAL ASSESSMENT OF CANCER THERAPIES-BREAST (FACT-B). RESULTS: WE INVITED 401 WOMEN TO PARTICIPATE IN THE STUDY; 78 RESPONDED, AND WE ENROLLED 34. BOTH GROUPS HAD SIGNIFICANT WITHIN-GROUP IMPROVEMENT IN MULTIPLE DOMAINS OF THE FATIGUE AND QUALITY OF LIFE SCORES FROM BASELINE TO POST-INTERVENTION, AND THESE BENEFITS WERE MAINTAINED AT 3 MONTHS POST-INTERVENTION. HOWEVER, THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN GROUPS IN FATIGUE OR QUALITY OF LIFE AT ANY ASSESSMENT TIME. SIMILARLY, THERE WAS NO DIFFERENCE BETWEEN GROUPS IN ADHERENCE TO THE EXERCISE INTERVENTION. CONCLUSIONS: BOTH DVD-BASED YOGA AND STRENGTHENING EXERCISES DESIGNED FOR CANCER SURVIVORS MAY BE GOOD OPTIONS TO ADDRESS FATIGUE IN BREAST CANCER SURVIVORS. BOTH HAVE REASONABLE UPTAKE, ARE CONVENIENT AND REPRODUCIBLE, AND MAY BE HELPFUL IN DECREASING FATIGUE AND IMPROVING QUALITY OF LIFE IN THE FIRST YEAR POST-DIAGNOSIS IN BREAST CANCER PATIENTS WITH CANCER-RELATED FATIGUE. 2016
19 71 35 A FEASIBILITY STUDY OF RESTORATIVE YOGA VERSUS VIGOROUS YOGA INTERVENTION FOR SEDENTARY BREAST AND OVARIAN CANCER SURVIVORS. YOGA HAS BEEN SHOWN TO IMPROVE CANCER SURVIVORS' QUALITY OF LIFE, YET REGULAR YOGA PRACTICE IS A CHALLENGE FOR THOSE WHO ARE SEDENTARY. WE CONDUCTED A PILOT RANDOMIZED CONTROLLED STUDY TO ASSESS FEASIBILITY AND ADHERENCE OF TWO TYPES OF YOGA INTERVENTION AMONG SEDENTARY CANCER SURVIVORS. SEDENTARY BREAST AND OVARIAN CANCER SURVIVORS WERE RANDOMIZED TO PRACTICE EITHER RESTORATIVE YOGA (MINIMAL PHYSICAL EXERTION, GROUP R) OR VIGOROUS YOGA (CONSIDERABLE PHYSICAL EXERTION, GROUP V) IN THREE 60-MINUTE SUPERVISED SESSIONS A WEEK FOR 12 WEEKS, FOLLOWED BY 12 WEEKS OF HOME PRACTICE. ACCRUAL, ADHERENCE, AND ATTENDANCE RATES WERE ASSESSED. OF THE 226 ELIGIBLE PATIENTS, 175 (77%) DECLINED TO PARTICIPATE IN THE STUDY, CITING TIME COMMITMENT AND TRAVEL AS THE MOST COMMON BARRIERS. FORTY-TWO SUBJECTS CONSENTED TO PARTICIPATE IN THE STUDY. OF THE 35 PARTICIPANTS WHO BEGAN THE INTERVENTION (20 IN GROUP R AND 15 IN GROUP V), ADHERENCE RATE (PERCENTAGE REMAINING IN THE STUDY AT WEEK 12) WAS 100% AND 87%, RESPECTIVELY. RATE OF ADEQUATE ATTENDANCE (MORE THAN 66% OF THE SCHEDULED SUPERVISED SESSIONS) WAS 85% AND 73%, RESPECTIVELY. RATE OF COMPLETION OF THE HOME PRACTICE PERIOD WAS 85% AND 77%, RESPECTIVELY. IN THIS STUDY, SEDENTARY CANCER SURVIVORS WERE ABLE TO ADHERE TO A LONG-TERM, REGULAR YOGA REGIMEN. THE RATE OF ADEQUATE ATTENDANCE WAS HIGHER FOR RESTORATIVE YOGA. FUTURE STUDIES FOR SEDENTARY PATIENTS SHOULD FOCUS ON REDUCING TIME COMMITMENT AND TRAVEL REQUIREMENTS TO IMPROVE RECRUITMENT, AND ON USING RESTORATIVE YOGA AS A MORE FEASIBLE INTERVENTION FOR THIS POPULATION. 2018
20 1240 45 FEASIBILITY OF A MINDFUL YOGA PROGRAM FOR WOMEN WITH METASTATIC BREAST CANCER: RESULTS OF A RANDOMIZED PILOT STUDY. PURPOSE: PATIENTS WITH METASTATIC BREAST CANCER (MBC) EXPERIENCE HIGH LEVELS OF SYMPTOMS. YOGA INTERVENTIONS HAVE SHOWN PROMISE FOR IMPROVING CANCER SYMPTOMS BUT HAVE RARELY BEEN TESTED IN PATIENTS WITH ADVANCED DISEASE. THIS STUDY EXAMINED THE ACCEPTABILITY OF A COMPREHENSIVE YOGA PROGRAM FOR MBC AND THE FEASIBILITY OF CONDUCTING A RANDOMIZED TRIAL TESTING THE INTERVENTION. METHODS: SIXTY-THREE WOMEN WITH MBC WERE RANDOMIZED WITH A 2:1 ALLOCATION TO YOGA OR A SUPPORT GROUP COMPARISON CONDITION. BOTH INTERVENTIONS INVOLVED EIGHT WEEKLY GROUP SESSIONS. FEASIBILITY WAS QUANTIFIED USING RATES OF ACCRUAL, ATTRITION, AND SESSION ATTENDANCE. ACCEPTABILITY WAS ASSESSED WITH A STANDARDIZED SELF-REPORT MEASURE. PAIN, FATIGUE, SLEEP QUALITY, PSYCHOLOGICAL DISTRESS, MINDFULNESS, AND FUNCTIONAL CAPACITY WERE ASSESSED AT BASELINE, POST-INTERVENTION, AND 3 AND 6 MONTHS POST-INTERVENTION. RESULTS: WE MET GOALS FOR ACCRUAL AND RETENTION, WITH 50% OF ELIGIBLE PATIENTS ENROLLED AND 87% OF RANDOMIZED PARTICIPANTS COMPLETING POST-INTERVENTION SURVEYS. SIXTY-FIVE PERCENT OF WOMEN IN THE YOGA CONDITION AND 90% IN THE SUPPORT GROUP ATTENDED >/= 4 SESSIONS. EIGHTY PERCENT OF PARTICIPANTS IN THE YOGA CONDITION AND 65% IN THE SUPPORT GROUP INDICATED THAT THEY WERE HIGHLY SATISFIED WITH THE INTERVENTION. FOLLOWING TREATMENT, WOMEN IN THE YOGA INTERVENTION HAD MODEST IMPROVEMENTS IN SOME OUTCOMES; HOWEVER, OVERALL SYMPTOM LEVELS WERE LOW FOR WOMEN IN BOTH CONDITIONS. CONCLUSIONS: FINDINGS SUGGEST THAT THE YOGA INTERVENTION CONTENT WAS HIGHLY ACCEPTABLE TO PATIENTS WITH MBC, BUT THAT THERE ARE CHALLENGES TO IMPLEMENTING AN INTERVENTION INVOLVING EIGHT GROUP-BASED IN-PERSON SESSIONS. ALTERNATIVE MODES OF DELIVERY MAY BE NECESSARY TO REACH PATIENTS MOST IN NEED OF INTERVENTION. 2019