1 1941 357 SAFETY AND EFFICACY OF AYURVEDIC INTERVENTIONS AND YOGA ON LONG TERM EFFECTS OF COVID-19: A STRUCTURED SUMMARY OF A STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. OBJECTIVES: PRIMARY OBJECTIVE * TO ASSESS THE EFFICACY OF AYURVEDA INTERVENTIONS AND YOGA IN REHABILITATION OF COVID-19 CASES SUFFERING WITH LONG TERM EFFECTS OF COVID 19 AS COMPARED TO WHO REHABILITATION SELF-MANAGEMENT AFTER COVID-19- RELATED ILLNESS. SECONDARY OBJECTIVE * TO ASSESS THE SAFETY OF AYURVEDIC INTERVENTIONS IN CASES SUFFERING WITH LONG TERM EFFECTS OF COVID 19 TRIAL DESIGN: MULTI-CENTRIC, RANDOMIZED, CONTROLLED, PARALLEL GROUP, OPEN-LABEL, EXPLORATORY STUDY. THE STUDY DURATION IS 9 MONTHS AND THE INTERVENTION PERIOD IS 90 DAYS FROM THE DAY OF ENROLMENT OF THE PARTICIPANT. PARTICIPANTS: PATIENTS OF EITHER SEX BETWEEN 18 TO 60 YEARS, AMBULATORY, WILLING TO PARTICIPATE, WITH HISTORY (NOT MORE THAN 4 WEEKS) OF POSITIVE RT-PCR FOR COVID-19 OR IGM ANTIBODIES POSITIVITY FOR SARS COV-2, BUT HAVING NEGATIVE RT-PCR FOR COVID-19 AT THE TIME OF SCREENING WILL BE CONSIDERED ELIGIBLE FOR ENROLMENT IN THE STUDY. CRITICALLY ILL PATIENTS WITH ARDS (ACUTE RESPIRATORY DISTRESS SYNDROME), REQUIRING INVASIVE RESPIRATORY SUPPORT IN THE INTENSIVE CARE UNIT, KNOWN CASE OF ANY MALIGNANCY, IMMUNE-COMPROMISED STATE (E.G. HIV), DIABETES MELLITUS, ACTIVE PULMONARY TUBERCULOSIS, PAST HISTORY OF ANY CHRONIC RESPIRATORY DISEASE, MOTOR NEURON DISEASE, MULTIPLE SCLEROSIS, STROKE, IMPAIRED COGNITION, ATRIAL FIBRILLATION, ACUTE CORONARY SYNDROME, MYOCARDIAL INFARCTION, SEVERE ARRHYTHMIA, CONCURRENT SERIOUS HEPATIC DISEASE OR RENAL DISEASE, PREGNANT OR LACTATING WOMEN, PATIENTS ON IMMUNOSUPPRESSIVE MEDICATIONS, HISTORY OF HYPERSENSITIVITY TO THE TRIAL DRUGS OR THEIR INGREDIENTS, DEPRESSIVE ILLNESS (BEFORE COVID-19), DIAGNOSED PSYCHOTIC ILLNESSES, SUBSTANCE DEPENDENCE OR ALCOHOLISM WILL BE EXCLUDED. THE TRIAL WILL BE CONDUCTED AT TWO MEDICAL COLLEGES IN MAHARASHTRA, INDIA. INTERVENTION AND COMPARATOR: INTERVENTION ARM (GROUP-I): AYURVEDA INTERVENTIONS INCLUDING AGASTYA HARITAKI SIX GRAM AND ASHWAGANDHA TABLET 500 MG TWICE DAILY ORALLY AFTER MEALS WITH WARM WATER AND TWO SESSIONS OF YOGA (MORNING 30 MINUTES AND EVENING 15 MINUTES) DAILY FOR 90 DAYS, AS PER THE POST-COVID-19 CARE PROTOCOL PROVIDED IN NATIONAL CLINICAL MANAGEMENT PROTOCOL BASED ON AYURVEDA AND YOGA FOR MANAGEMENT OF COVID-19 PUBLISHED BY MINISTRY OF AYUSH, GOVERNMENT OF INDIA. COMPARATOR ARM (GROUP-II): WHO REHABILITATION SELF-MANAGEMENT AFTER COVID-19 RELATED ILLNESS FOR 90 DAYS. THE TRIAL DRUGS ARE BEING PROCURED FROM A GMP CERTIFIED PHARMACEUTICAL COMPANY. MAIN OUTCOMES: PRIMARY OUTCOME: CHANGE IN RESPIRATORY FUNCTION TO BE ASSESSED BY SAN DIEGO SHORTNESS OF BREATH QUESTIONNAIRE, 6-MINUTES WALK TEST AND PULMONARY FUNCTION TEST. SECONDARY OUTCOMES: CHANGE IN HIGH-RESOLUTION COMPUTED TOMOGRAPHY (HRCT) CHEST CHANGE IN FATIGUE SCORE ASSESSED BY MODIFIED FATIGUE IMPACT SCALE CHANGE IN ANXIETY SCORE ASSESSED BY HOSPITAL ANXIETY AND DEPRESSION SCALE SCORE CHANGE IN SLEEP QUALITY ASSESSED BY PITTSBURGH SLEEP QUALITY INDEX CHANGE IN THE QUALITY OF LIFE ASSESSED BY COV19-QOL SCALE SAFETY OF THE INTERVENTIONS WILL BE ASSESSED BY COMPARING HEMATOLOGICAL AND BIOCHEMICAL INVESTIGATIONS BEFORE AND AFTER THE INTERVENTION PERIOD AND ADVERSE EVENT/ ADVERSE DRUG REACTION TIMELINES FOR OUTCOME ASSESSMENT: SUBJECTIVE PARAMETERS AND CLINICAL ASSESSMENT WILL BE ASSESSED AT BASELINE, 15(TH) DAY, 30(TH) DAY, 60(TH) DAY AND 90(TH) DAY. LABORATORY PARAMETERS (CBC, LFT, KFT, HBA1C, HS-CRP, D-DIMER), PULMONARY FUNCTION TEST AND HRCT CHEST WILL BE DONE AT BASELINE AND AFTER COMPLETION OF STUDY PERIOD I.E. 90(TH) DAY. RANDOMISATION: STATISTICAL PACKAGE FOR SOCIAL SCIENCES (SPSS) VERSION 15.0 IS USED TO GENERATE THE RANDOM NUMBER SEQUENCES. THE PARTICIPANTS WILL BE RANDOMIZED TO TWO STUDY GROUPS IN THE RATIO OF 1:1. BLINDING (MASKING): THE STUDY IS OPEN-LABEL DESIGN. HOWEVER, THE OUTCOME ASSESSOR WILL BE KEPT BLINDED REGARDING THE STUDY GROUP ALLOCATION OF THE PARTICIPANTS. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) SAMPLE SIZE: THE SAMPLE SIZE FOR THE STUDY IS CALCULATED ASSUMING IMPROVEMENT IN 6-MINUTES WALK TEST BY 40 METER IN GROUP I AND A CHANGE OF 10 METER IN GROUP II WITH A STANDARD DEVIATION OF 50 METER BASED ON THE RESULTS OF THE PREVIOUS STUDIES, WITH 95% CONFIDENCE LEVEL (ALPHA = 0.05) AND 80% POWER AND EXPECTING A DROPOUT RATE OF 20%. THE NUMBER OF PARTICIPANTS TO BE ENROLLED IN THE STUDY SHOULD BE APPROXIMATELY 55 IN EACH GROUP. HENCE, A TOTAL OF 110 PARTICIPANTS WILL BE ENROLLED IN THE TRIAL AT EACH STUDY SITE. TRIAL STATUS: PARTICIPANTS' RECRUITMENT STARTED ON 1(ST) MAY 2021. ANTICIPATED END OF RECRUITMENT IS AUGUST 2021. PROTOCOL NUMBER: CCRAS-01 PROTOCOL VERSION NUMBER: 1.1, 13TH JANUARY 2021. TRIAL REGISTRATION: THE TRIAL IS PROSPECTIVELY REGISTERED WITH THE CLINICAL TRIAL REGISTRY OF INDIA (CTRI) ON 03(RD) MARCH 2021 [ CTRI/2021/03/031686 ]. FULL PROTOCOL: THE FULL PROTOCOL IS ATTACHED AS AN ADDITIONAL FILE, ACCESSIBLE FROM THE JOURNAL WEBSITE (ADDITIONAL FILE 1). THIS COMMUNICATION SERVES AS A SUMMARY OF THE KEY ELEMENTS OF THE FULL PROTOCOL. 2021
2 1461 41 INFLUENCE OF YOGA ON MOOD STATES, DISTRESS, QUALITY OF LIFE AND IMMUNE OUTCOMES IN EARLY STAGE BREAST CANCER PATIENTS UNDERGOING SURGERY. CONTEXT: BREAST CANCER PATIENTS AWAITING SURGERY EXPERIENCE HEIGHTENED DISTRESS THAT COULD AFFECT POSTOPERATIVE OUTCOMES. AIMS: THE AIM OF OUR STUDY WAS TO EVALUATE THE EFFECTS OF YOGA INTERVENTION ON MOOD STATES, TREATMENT-RELATED SYMPTOMS, QUALITY OF LIFE AND IMMUNE OUTCOMES IN BREAST CANCER PATIENTS UNDERGOING SURGERY. SETTINGS AND DESIGN: NINETY-EIGHT RECENTLY DIAGNOSED STAGE II AND III BREAST CANCER PATIENTS WERE RECRUITED FOR A RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFECTS OF A YOGA PROGRAM WITH SUPPORTIVE THERAPY PLUS EXERCISE REHABILITATION ON POSTOPERATIVE OUTCOMES FOLLOWING SURGERY. MATERIALS AND METHODS: SUBJECTS WERE ASSESSED PRIOR TO SURGERY AND FOUR WEEKS THEREAFTER. PSYCHOMETRIC INSTRUMENTS WERE USED TO ASSESS SELF-REPORTED ANXIETY, DEPRESSION, TREATMENT-RELATED DISTRESS AND QUALITY OF LIFE. BLOOD SAMPLES WERE COLLECTED FOR ENUMERATION OF T LYMPHOCYTE SUBSETS (CD4 %, CD8 % AND NATURAL KILLER (NK) CELL % COUNTS) AND SERUM IMMUNOGLOBULINS (IGG, IGA AND IGM). STATISTICAL ANALYSIS USED: WE USED ANALYSIS OF COVARIANCE TO COMPARE INTERVENTIONS POSTOPERATIVELY. RESULTS: SIXTY-NINE PATIENTS CONTRIBUTED DATA TO THE CURRENT ANALYSIS (YOGA N = 33, CONTROL N = 36). THE RESULTS SUGGEST A SIGNIFICANT DECREASE IN THE STATE (P = 0.04) AND TRAIT (P = 0.004) OF ANXIETY, DEPRESSION (P = 0.01), SYMPTOM SEVERITY (P = 0.01), DISTRESS (P < 0.01) AND IMPROVEMENT IN QUALITY OF LIFE (P = 0.01) IN THE YOGA GROUP AS COMPARED TO THE CONTROLS. THERE WAS ALSO A SIGNIFICANTLY LESSER DECREASE IN CD 56% (P = 0.02) AND LOWER LEVELS OF SERUM IGA (P = 0.001) IN THE YOGA GROUP AS COMPARED TO CONTROLS FOLLOWING SURGERY. CONCLUSIONS: THE RESULTS SUGGEST POSSIBLE BENEFITS FOR YOGA IN REDUCING POSTOPERATIVE DISTRESS AND PREVENTING IMMUNE SUPPRESSION FOLLOWING SURGERY. 2008
3 945 60 EFFECTS OF A 12-WEEK YOGA VERSUS A 12-WEEK EDUCATIONAL FILM INTERVENTION ON SYMPTOMS OF RESTLESS LEGS SYNDROME AND RELATED OUTCOMES: AN EXPLORATORY RANDOMIZED CONTROLLED TRIAL. STUDY OBJECTIVES: TO ASSESS THE EFFECTS OF A YOGA VERSUS EDUCATIONAL FILM (EF) PROGRAM ON RESTLESS LEGS SYNDROME (RLS) SYMPTOMS AND RELATED OUTCOMES IN ADULTS WITH RLS. METHODS: FORTY-ONE COMMUNITY-DWELLING, AMBULATORY NONPREGNANT ADULTS WITH MODERATE TO SEVERE RLS WERE RANDOMIZED TO A 12-WEEK YOGA (N = 19) OR EF PROGRAM (N = 22). IN ADDITION TO ATTENDING CLASSES, ALL PARTICIPANTS COMPLETED PRACTICE/TREATMENT LOGS. YOGA GROUP PARTICIPANTS WERE ASKED TO PRACTICE AT HOME 30 MINUTES PER DAY ON NONCLASS DAYS; EF PARTICIPANTS WERE INSTRUCTED TO RECORD ANY RLS TREATMENTS USED ON THEIR DAILY LOGS. CORE OUTCOMES ASSESSED PRETREATMENT AND POSTTREATMENT WERE RLS SYMPTOMS AND SYMPTOM SEVERITY (INTERNATIONAL RLS STUDY GROUP SCALE (IRLS) AND RLS ORDINAL SCALE), SLEEP QUALITY, MOOD, PERCEIVED STRESS, AND QUALITY OF LIFE (QOL). RESULTS: THIRTY ADULTS (13 YOGA, 17 EF), AGED 24 TO 73 (MEAN = 50.4 +/- 2.4 YEARS), COMPLETED THE 12-WEEK STUDY (78% FEMALE, 80.5% WHITE). POST-INTERVENTION, BOTH GROUPS SHOWED SIGNIFICANT IMPROVEMENT IN RLS SYMPTOMS AND SEVERITY, PERCEIVED STRESS, MOOD, AND QOL-MENTAL HEALTH (P </= .04). RELATIVE TO THE EF GROUP, YOGA PARTICIPANTS DEMONSTRATED SIGNIFICANTLY GREATER REDUCTIONS IN RLS SYMPTOMS AND SYMPTOM SEVERITY (P </= .01), AND GREATER IMPROVEMENTS IN PERCEIVED STRESS AND MOOD (P </= .04), AS WELL AS SLEEP QUALITY (P = .09); RLS SYMPTOMS DECREASED TO MINIMAL/MILD IN 77% OF YOGA GROUP PARTICIPANTS, WITH NONE SCORING IN THE SEVERE RANGE BY WEEK 12, VERSUS 24% AND 12%, RESPECTIVELY, IN EF PARTICIPANTS. IN THE YOGA GROUP, IRLS AND RLS SEVERITY SCORES DECLINED WITH INCREASING MINUTES OF HOMEWORK PRACTICE (R = .7, P = .009 AND R = .6, P = .03, RESPECTIVELY), SUGGESTING A POSSIBLE DOSE-RESPONSE RELATIONSHIP. CONCLUSIONS: FINDINGS OF THIS EXPLORATORY RCT SUGGEST THAT YOGA MAY BE EFFECTIVE IN REDUCING RLS SYMPTOMS AND SYMPTOM SEVERITY, DECREASING PERCEIVED STRESS, AND IMPROVING MOOD AND SLEEP IN ADULTS WITH RLS. CLINICAL TRIAL REGISTRATION: REGISTRY: CLINICALTRIALS.GOV; TITLE: YOGA VS. EDUCATION FOR RESTLESS LEGS: A FEASIBILITY STUDY; IDENTIFIER: NCT03570515; URL: HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT03570515. 2020
4 2821 87 YOGA TREATMENT FOR CHRONIC NON-SPECIFIC LOW BACK PAIN. BACKGROUND: NON-SPECIFIC LOW BACK PAIN IS A COMMON, POTENTIALLY DISABLING CONDITION USUALLY TREATED WITH SELF-CARE AND NON-PRESCRIPTION MEDICATION. FOR CHRONIC LOW BACK PAIN, CURRENT GUIDELINES STATE THAT EXERCISE THERAPY MAY BE BENEFICIAL. YOGA IS A MIND-BODY EXERCISE SOMETIMES USED FOR NON-SPECIFIC LOW BACK PAIN. OBJECTIVES: TO ASSESS THE EFFECTS OF YOGA FOR TREATING CHRONIC NON-SPECIFIC LOW BACK PAIN, COMPARED TO NO SPECIFIC TREATMENT, A MINIMAL INTERVENTION (E.G. EDUCATION), OR ANOTHER ACTIVE TREATMENT, WITH A FOCUS ON PAIN, FUNCTION, AND ADVERSE EVENTS. SEARCH METHODS: WE SEARCHED CENTRAL, MEDLINE, EMBASE, FIVE OTHER DATABASES AND FOUR TRIALS REGISTERS TO 11 MARCH 2016 WITHOUT RESTRICTION OF LANGUAGE OR PUBLICATION STATUS. WE SCREENED REFERENCE LISTS AND CONTACTED EXPERTS IN THE FIELD TO IDENTIFY ADDITIONAL STUDIES. SELECTION CRITERIA: WE INCLUDED RANDOMIZED CONTROLLED TRIALS OF YOGA TREATMENT IN PEOPLE WITH CHRONIC NON-SPECIFIC LOW BACK PAIN. WE INCLUDED STUDIES COMPARING YOGA TO ANY OTHER INTERVENTION OR TO NO INTERVENTION. WE ALSO INCLUDED STUDIES COMPARING YOGA AS AN ADJUNCT TO OTHER THERAPIES, VERSUS THOSE OTHER THERAPIES ALONE. DATA COLLECTION AND ANALYSIS: TWO AUTHORS INDEPENDENTLY SCREENED AND SELECTED STUDIES, EXTRACTED OUTCOME DATA, AND ASSESSED RISK OF BIAS. WE CONTACTED STUDY AUTHORS TO OBTAIN MISSING OR UNCLEAR INFORMATION. WE EVALUATED THE OVERALL CERTAINTY OF EVIDENCE USING THE GRADE APPROACH. MAIN RESULTS: WE INCLUDED 12 TRIALS (1080 PARTICIPANTS) CARRIED OUT IN THE USA (SEVEN TRIALS), INDIA (THREE TRIALS), AND THE UK (TWO TRIALS). STUDIES WERE UNFUNDED (ONE TRIAL), FUNDED BY A YOGA INSTITUTION (ONE TRIAL), FUNDED BY NON-PROFIT OR GOVERNMENT SOURCES (SEVEN TRIALS), OR DID NOT REPORT ON FUNDING (THREE TRIALS). MOST TRIALS USED IYENGAR, HATHA, OR VINIYOGA FORMS OF YOGA. THE TRIALS COMPARED YOGA TO NO INTERVENTION OR A NON-EXERCISE INTERVENTION SUCH AS EDUCATION (SEVEN TRIALS), AN EXERCISE INTERVENTION (THREE TRIALS), OR BOTH EXERCISE AND NON-EXERCISE INTERVENTIONS (TWO TRIALS). ALL TRIALS WERE AT HIGH RISK OF PERFORMANCE AND DETECTION BIAS BECAUSE PARTICIPANTS AND PROVIDERS WERE NOT BLINDED TO TREATMENT ASSIGNMENT, AND OUTCOMES WERE SELF-ASSESSED. THEREFORE, WE DOWNGRADED ALL OUTCOMES TO 'MODERATE' CERTAINTY EVIDENCE BECAUSE OF RISK OF BIAS, AND WHEN THERE WAS ADDITIONAL SERIOUS RISK OF BIAS, UNEXPLAINED HETEROGENEITY BETWEEN STUDIES, OR THE ANALYSES WERE IMPRECISE, WE DOWNGRADED THE CERTAINTY OF THE EVIDENCE FURTHER.FOR YOGA COMPARED TO NON-EXERCISE CONTROLS (9 TRIALS; 810 PARTICIPANTS), THERE WAS LOW-CERTAINTY EVIDENCE THAT YOGA PRODUCED SMALL TO MODERATE IMPROVEMENTS IN BACK-RELATED FUNCTION AT THREE TO FOUR MONTHS (STANDARDIZED MEAN DIFFERENCE (SMD) -0.40, 95% CONFIDENCE INTERVAL (CI) -0.66 TO -0.14; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MEAN DIFFERENCE (MD) -2.18, 95% -3.60 TO -0.76), MODERATE-CERTAINTY EVIDENCE FOR SMALL TO MODERATE IMPROVEMENTS AT SIX MONTHS (SMD -0.44, 95% CI -0.66 TO -0.22; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD -2.15, 95% -3.23 TO -1.08), AND LOW-CERTAINTY EVIDENCE FOR SMALL IMPROVEMENTS AT 12 MONTHS (SMD -0.26, 95% CI -0.46 TO -0.05; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD -1.36, 95% -2.41 TO -0.26). ON A 0-100 SCALE THERE WAS VERY LOW- TO MODERATE-CERTAINTY EVIDENCE THAT YOGA WAS SLIGHTLY BETTER FOR PAIN AT THREE TO FOUR MONTHS (MD -4.55, 95% CI -7.04 TO -2.06), SIX MONTHS (MD -7.81, 95% CI -13.37 TO -2.25), AND 12 MONTHS (MD -5.40, 95% CI -14.50 TO -3.70), HOWEVER WE PRE-DEFINED CLINICALLY SIGNIFICANT CHANGES IN PAIN AS 15 POINTS OR GREATER AND THIS THRESHOLD WAS NOT MET. BASED ON INFORMATION FROM SIX TRIALS, THERE WAS MODERATE-CERTAINTY EVIDENCE THAT THE RISK OF ADVERSE EVENTS, PRIMARILY INCREASED BACK PAIN, WAS HIGHER IN YOGA THAN IN NON-EXERCISE CONTROLS (RISK DIFFERENCE (RD) 5%, 95% CI 2% TO 8%).FOR YOGA COMPARED TO NON-YOGA EXERCISE CONTROLS (4 TRIALS; 394 PARTICIPANTS), THERE WAS VERY-LOW-CERTAINTY EVIDENCE FOR LITTLE OR NO DIFFERENCE IN BACK-RELATED FUNCTION AT THREE MONTHS (SMD -0.22, 95% CI -0.65 TO 0.20; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD -0.99, 95% -2.87 TO 0.90) AND SIX MONTHS (SMD -0.20, 95% CI -0.59 TO 0.19; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD -0.90, 95% -2.61 TO 0.81), AND NO INFORMATION ON BACK-RELATED FUNCTION AFTER SIX MONTHS. THERE WAS VERY LOW-CERTAINTY EVIDENCE FOR LOWER PAIN ON A 0-100 SCALE AT SEVEN MONTHS (MD -20.40, 95% CI -25.48 TO -15.32), AND NO INFORMATION ON PAIN AT THREE MONTHS OR AFTER SEVEN MONTHS. BASED ON INFORMATION FROM THREE TRIALS, THERE WAS LOW-CERTAINTY EVIDENCE FOR NO DIFFERENCE IN THE RISK OF ADVERSE EVENTS BETWEEN YOGA AND NON-YOGA EXERCISE CONTROLS (RD 1%, 95% CI -4% TO 6%).FOR YOGA ADDED TO EXERCISE COMPARED TO EXERCISE ALONE (1 TRIAL; 24 PARTICIPANTS), THERE WAS VERY-LOW-CERTAINTY EVIDENCE FOR LITTLE OR NO DIFFERENCE AT 10 WEEKS IN BACK-RELATED FUNCTION (SMD -0.60, 95% CI -1.42 TO 0.22; CORRESPONDING TO A CHANGE IN THE OSWESTRY DISABILITY INDEX OF MD -17.05, 95% -22.96 TO 11.14) OR PAIN ON A 0-100 SCALE (MD -3.20, 95% CI -13.76 TO 7.36). THERE WAS NO INFORMATION ON OUTCOMES AT OTHER TIME POINTS. THERE WAS NO INFORMATION ON ADVERSE EVENTS.STUDIES PROVIDED LIMITED EVIDENCE ON RISK OF CLINICAL IMPROVEMENT, MEASURES OF QUALITY OF LIFE, AND DEPRESSION. THERE WAS NO EVIDENCE ON WORK-RELATED DISABILITY. AUTHORS' CONCLUSIONS: THERE IS LOW- TO MODERATE-CERTAINTY EVIDENCE THAT YOGA COMPARED TO NON-EXERCISE CONTROLS RESULTS IN SMALL TO MODERATE IMPROVEMENTS IN BACK-RELATED FUNCTION AT THREE AND SIX MONTHS. YOGA MAY ALSO BE SLIGHTLY MORE EFFECTIVE FOR PAIN AT THREE AND SIX MONTHS, HOWEVER THE EFFECT SIZE DID NOT MEET PREDEFINED LEVELS OF MINIMUM CLINICAL IMPORTANCE. IT IS UNCERTAIN WHETHER THERE IS ANY DIFFERENCE BETWEEN YOGA AND OTHER EXERCISE FOR BACK-RELATED FUNCTION OR PAIN, OR WHETHER YOGA ADDED TO EXERCISE IS MORE EFFECTIVE THAN EXERCISE ALONE. YOGA IS ASSOCIATED WITH MORE ADVERSE EVENTS THAN NON-EXERCISE CONTROLS, BUT MAY HAVE THE SAME RISK OF ADVERSE EVENTS AS OTHER BACK-FOCUSED EXERCISE. YOGA IS NOT ASSOCIATED WITH SERIOUS ADVERSE EVENTS. THERE IS A NEED FOR ADDITIONAL HIGH-QUALITY RESEARCH TO IMPROVE CONFIDENCE IN ESTIMATES OF EFFECT, TO EVALUATE LONG-TERM OUTCOMES, AND TO PROVIDE ADDITIONAL INFORMATION ON COMPARISONS BETWEEN YOGA AND OTHER EXERCISE FOR CHRONIC NON-SPECIFIC LOW BACK PAIN. 2017
5 258 62 ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME (RLS): STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: RESTLESS LEGS SYNDROME (RLS) IS A COMMON AND BURDENSOME SLEEP DISORDER ASSOCIATED WITH PROFOUND IMPAIRMENT OF HEALTH, WELL-BEING, AND QUALITY OF LIFE. UNFORTUNATELY, THE MEDICATIONS USED FOR RLS MANAGEMENT CARRY RISK OF SERIOUS SIDE EFFECTS, INCLUDING AUGMENTATION OF SYMPTOMS. YOGA, AN ANCIENT MIND-BODY DISCIPLINE DESIGNED TO PROMOTE PHYSICAL, EMOTIONAL, AND MENTAL WELL-BEING, MAY OFFER A VIABLE, LOW-RISK NEW TREATMENT. THE PRIMARY OBJECTIVES OF THIS PILOT, PARALLEL-ARM, RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO ASSESS THE ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RLS. METHODS: FORTY-FOUR ADULTS WITH CONFIRMED MODERATE TO SEVERE RLS WILL BE RECRUITED AND RANDOMIZED TO A 12-WEEK YOGA (N = 22) OR STANDARDIZED EDUCATIONAL FILM PROGRAM (N = 22). YOGA GROUP PARTICIPANTS WILL ATTEND TWO 75-MIN IYENGAR YOGA CLASSES PER WEEK FOR THE FIRST 4 WEEKS, THEN ONE 75-MIN CLASS PER WEEK FOR THE REMAINING 8 WEEKS, AND WILL COMPLETE A 30-MIN HOMEWORK ROUTINE ON NON-CLASS DAYS. EDUCATIONAL FILM GROUP PARTICIPANTS WILL ATTEND ONE 75-MIN CLASS PER WEEK FOR 12 WEEKS AND COMPLETE A DAILY RLS TREATMENT LOG; CLASSES WILL INCLUDE INFORMATION ON: RLS MANAGEMENT, INCLUDING SLEEP HYGIENE PRACTICES; OTHER SLEEP DISORDERS; AND COMPLEMENTARY THERAPIES LIKELY TO BE OF INTEREST TO THOSE PARTICIPATING IN A YOGA AND SLEEP EDUCATION STUDY. YOGA AND TREATMENT LOGS WILL BE COLLECTED WEEKLY. FEASIBILITY OUTCOMES WILL INCLUDE RECRUITMENT, ENROLLMENT, AND RANDOMIZATION RATES, RETENTION, ADHERENCE, AND PROGRAM SATISFACTION. PROGRAM EVALUATION AND YOGA-DOSING QUESTIONNAIRES WILL BE COLLECTED AT WEEK 12; DATA ON EXPLORATORY OUTCOMES (E.G., RLS SYMPTOM SEVERITY (IRLS), SLEEP QUALITY (PSQI), MOOD (POMS, PSS), AND HEALTH-RELATED QUALITY OF LIFE (SF-36)) WILL BE GATHERED AT BASELINE AND WEEK 12. DISCUSSION: THIS STUDY WILL LAY THE ESSENTIAL GROUNDWORK FOR A PLANNED LARGER RCT TO DETERMINE THE EFFICACY OF A YOGA PROGRAM FOR REDUCING SYMPTOMS AND ASSOCIATED BURDEN OF RLS. IF THE FINDINGS OF THE CURRENT TRIAL AND THE SUBSEQUENT LARGER RCTS ARE POSITIVE, THIS STUDY WILL ALSO HELP SUPPORT A NEW APPROACH TO CLINICAL TREATMENT OF THIS CHALLENGING DISORDER, HELP FOSTER IMPROVED UNDERSTANDING OF RLS ETIOLOGY, AND ULTIMATELY CONTRIBUTE TO REDUCING THE INDIVIDUAL, SOCIETAL, AND ECONOMIC BURDEN ASSOCIATED WITH THIS CONDITION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, ID: NCT03570515 . RETROSPECTIVELY REGISTERED ON 1 FEBRUARY 2017. 2019
6 2820 83 YOGA TREATMENT FOR CHRONIC NON-SPECIFIC LOW BACK PAIN (2017). WIELAND LS, SKOETZ N, PILKINGTON K, VEMPATI R, DADAMO CR, BERMAN BM. YOGA TREATMENT FOR CHRONIC NON-SPECIFIC LOW BACK PAIN.COCHRANE DATABASE SYST REV2017, ISSUE 1. ART. NO.: CD010671. DOI: 10.1002/14651858.CD010671.PUB2. BACKGROUND: NON-SPECIFIC LOW BACK PAIN IS A COMMON, POTENTIALLY DISABLING CONDITION USUALLY TREATED WITH SELF-CARE AND NON-PRESCRIPTION MEDICATION. FOR CHRONIC LOW BACK PAIN, CURRENT GUIDELINES STATE THAT EXERCISE THERAPY MAY BE BENEFICIAL. YOGA IS A MIND-BODY EXERCISE SOMETIMES USED FOR NON-SPECIFIC LOW BACK PAIN. OBJECTIVES: TO ASSESS THE EFFECTS OF YOGA FOR TREATING CHRONIC NON-SPECIFIC LOW BACK PAIN, COMPARED TO NO SPECIFIC TREATMENT, A MINIMAL INTERVENTION (E.G., EDUCATION), OR ANOTHER ACTIVE TREATMENT, WITH A FOCUS ON PAIN, FUNCTION, AND ADVERSE EVENTS. SEARCH METHODS: WE SEARCHED CENTRAL, MEDLINE, EMBASE, FIVE OTHER DATABASES, AND FOUR TRIALS REGISTERS TO 11 MARCH 2016 WITHOUT RESTRICTION OF LANGUAGE OR PUBLICATION STATUS. WE SCREENED REFERENCE LISTS AND CONTACTED EXPERTS IN THE FIELD TO IDENTIFY ADDITIONAL STUDIES. SELECTION CRITERIA: WE INCLUDED RANDOMIZED CONTROLLED TRIALS OF YOGA TREATMENT IN PEOPLE WITH CHRONIC NON-SPECIFIC LOW BACK PAIN. WE INCLUDED STUDIES COMPARING YOGA TO ANY OTHER INTERVENTION OR TO NO INTERVENTION. WE ALSO INCLUDED STUDIES COMPARING YOGA AS AN ADJUNCT TO OTHER THERAPIES, VERSUS THOSE OTHER THERAPIES ALONE. DATA COLLECTION AND ANALYSIS: TWO AUTHORS INDEPENDENTLY SCREENED AND SELECTED STUDIES, EXTRACTED OUTCOME DATA, AND ASSESSED RISK OF BIAS. WE CONTACTED STUDY AUTHORS TO OBTAIN MISSING OR UNCLEAR INFORMATION. WE EVALUATED THE OVERALL CERTAINTY OF EVIDENCE USING THE GRADE APPROACH. MAIN RESULTS: WE INCLUDED 12 TRIALS (1080 PARTICIPANTS) CARRIED OUT IN THE USA (SEVEN TRIALS), INDIA (THREE TRIALS), AND THE UK (TWO TRIALS). STUDIES WERE UNFUNDED (ONE TRIAL), FUNDED BY A YOGA INSTITUTION (ONE TRIAL), FUNDED BY NON-PROFIT OR GOVERNMENT SOURCES (SEVEN TRIALS), OR DID NOT REPORT ON FUNDING (THREE TRIALS). MOST TRIALS USED IYENGAR, HATHA, OR VINIYOGA FORMS OF YOGA. THE TRIALS COMPARED YOGA TO NO INTERVENTION OR A NON-EXERCISE INTERVENTION SUCH AS EDUCATION (SEVEN TRIALS), AN EXERCISE INTERVENTION (THREE TRIALS), OR BOTH EXERCISE AND NON-EXERCISE INTERVENTIONS (TWO TRIALS). ALL TRIALS WERE AT HIGH RISK OF PERFORMANCE AND DETECTION BIAS BECAUSE PARTICIPANTS AND PROVIDERS WERE NOT BLINDED TO TREATMENT ASSIGNMENT, AND OUTCOMES WERE SELF-ASSESSED. THEREFORE, WE DOWNGRADED ALL OUTCOMES TO "MODERATE" CERTAINTY EVIDENCE BECAUSE OF RISK OF BIAS, AND WHEN THERE WAS ADDITIONAL SERIOUS RISK OF BIAS, UNEXPLAINED HETEROGENEITY BETWEEN STUDIES, OR THE ANALYSES WERE IMPRECISE, WE DOWNGRADED THE CERTAINTY OF THE EVIDENCE FURTHER. FOR YOGA COMPARED TO NON-EXERCISE CONTROLS (9 TRIALS; 810 PARTICIPANTS), THERE WAS LOW-CERTAINTY EVIDENCE THAT YOGA PRODUCED SMALL TO MODERATE IMPROVEMENTS IN BACK-RELATED FUNCTION AT THREE TO FOUR MONTHS [STANDARDIZED MEAN DIFFERENCE (SMD) = -0.40, 95% CI: -0.66 TO -0.14; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MEAN DIFFERENCE (MD) = -2.18, 95% CI: -3.60 TO -0.76], MODERATE-CERTAINTY EVIDENCE FOR SMALL TO MODERATE IMPROVEMENTS AT SIX MONTHS (SMD = -0.44, 95% CI: -0.66 TO -0.22; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD = -2.15, 95% CI: -3.23 TO -1.08), AND LOW-CERTAINTY EVIDENCE FOR SMALL IMPROVEMENTS AT 12 MONTHS (SMD = -0.26, 95% CI: -0.46 TO -0.05; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD = -1.36, 95% CI: -2.41 TO -0.26). ON A 0-100 SCALE THERE WAS VERY LOW- TO MODERATE-CERTAINTY EVIDENCE THAT YOGA WAS SLIGHTLY BETTER FOR PAIN AT THREE TO FOUR MONTHS (MD = -4.55, 95% CI: -7.04 TO -2.06), SIX MONTHS (MD = -7.81, 95% CI: -13.37 TO -2.25), AND 12 MONTHS (MD = -5.40, 95% CI: -14.50 TO -3.70); HOWEVER, WE PRE-DEFINED CLINICALLY SIGNIFICANT CHANGES IN PAIN AS 15 POINTS OR GREATER AND THIS THRESHOLD WAS NOT MET. BASED ON INFORMATION FROM SIX TRIALS, THERE WAS MODERATE-CERTAINTY EVIDENCE THAT THE RISK OF ADVERSE EVENTS, PRIMARILY INCREASED BACK PAIN, WAS HIGHER IN YOGA THAN IN NON-EXERCISE CONTROLS [RISK DIFFERENCE (RD) = 5%, 95% CI: 2-8%]. FOR YOGA COMPARED TO NON-YOGA EXERCISE CONTROLS (4 TRIALS; 394 PARTICIPANTS), THERE WAS VERY-LOW-CERTAINTY EVIDENCE FOR LITTLE OR NO DIFFERENCE IN BACK-RELATED FUNCTION AT THREE MONTHS (SMD = -0.22, 95% CI: -0.65 TO 0.20; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD = -0.99, 95% CI: -2.87 TO 0.90) AND SIX MONTHS (SMD = -0.20, 95% CI: -0.59 TO 0.19; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD = -0.90, 95% CI: -2.61 TO 0.81), AND NO INFORMATION ON BACK-RELATED FUNCTION AFTER SIX MONTHS. THERE WAS VERY LOW-CERTAINTY EVIDENCE FOR LOWER PAIN ON A 0-100 SCALE AT SEVEN MONTHS (MD = -20.40, 95% CI: -25.48 TO -15.32), AND NO INFORMATION ON PAIN AT THREE MONTHS OR AFTER SEVEN MONTHS. BASED ON INFORMATION FROM THREE TRIALS, THERE WAS LOW-CERTAINTY EVIDENCE FOR NO DIFFERENCE IN THE RISK OF ADVERSE EVENTS BETWEEN YOGA AND NON-YOGA EXERCISE CONTROLS (RD = 1%, 95% CI: -4% TO 6%). FOR YOGA ADDED TO EXERCISE COMPARED TO EXERCISE ALONE (1 TRIAL; 24 PARTICIPANTS), THERE WAS VERY-LOW-CERTAINTY EVIDENCE FOR LITTLE OR NO DIFFERENCE AT 10 WEEKS IN BACK-RELATED FUNCTION (SMD = -0.60, 95% CI: -1.42 TO 0.22; CORRESPONDING TO A CHANGE IN THE OSWESTRY DISABILITY INDEX OF MD = -17.05, 95% CI: -22.96 TO 11.14) OR PAIN ON A 0-100 SCALE (MD = -3.20, 95% CI: -13.76 TO 7.36). THERE WAS NO INFORMATION ON OUTCOMES AT OTHER TIME POINTS. THERE WAS NO INFORMATION ON ADVERSE EVENTS. STUDIES PROVIDED LIMITED EVIDENCE ON RISK OF CLINICAL IMPROVEMENT, MEASURES OF QUALITY OF LIFE, AND DEPRESSION. THERE WAS NO EVIDENCE ON WORK-RELATED DISABILITY. 2017
7 1748 52 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
8 518 49 COMPARING ONCE- VERSUS TWICE-WEEKLY YOGA CLASSES FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY LOW INCOME MINORITIES: A RANDOMIZED DOSING TRIAL. BACKGROUND. PREVIOUS STUDIES HAVE DEMONSTRATED THAT ONCE-WEEKLY YOGA CLASSES ARE EFFECTIVE FOR CHRONIC LOW BACK PAIN (CLBP) IN WHITE ADULTS WITH HIGH SOCIOECONOMIC STATUS. THE COMPARATIVE EFFECTIVENESS OF TWICE-WEEKLY CLASSES AND GENERALIZABILITY TO RACIALLY DIVERSE LOW INCOME POPULATIONS ARE UNKNOWN. METHODS. WE CONDUCTED A 12-WEEK RANDOMIZED, PARALLEL-GROUP, DOSING TRIAL FOR 95 ADULTS RECRUITED FROM AN URBAN SAFETY-NET HOSPITAL AND FIVE COMMUNITY HEALTH CENTERS COMPARING ONCE-WEEKLY (N = 49) VERSUS TWICE-WEEKLY (N = 46) STANDARDIZED YOGA CLASSES SUPPLEMENTED BY HOME PRACTICE. PRIMARY OUTCOMES WERE CHANGE FROM BASELINE TO 12 WEEKS IN PAIN (11-POINT SCALE) AND BACK-RELATED FUNCTION (23-POINT MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE). RESULTS. 82% OF PARTICIPANTS WERE NONWHITE; 77% HAD ANNUAL HOUSEHOLD INCOMES <$40,000. THE SAMPLE'S BASELINE MEAN PAIN INTENSITY [6.9 (SD 1.6)] AND FUNCTION [13.7 (SD 5.0)] REFLECTED MODERATE TO SEVERE BACK PAIN AND IMPAIRMENT. PAIN AND BACK-RELATED FUNCTION IMPROVED WITHIN BOTH GROUPS (P < 0.001). HOWEVER, THERE WERE NO DIFFERENCES BETWEEN ONCE-WEEKLY AND TWICE-WEEKLY GROUPS FOR PAIN REDUCTION [-2.1 (95% CI -2.9, -1.3) VERSUS -2.4 (95% CI -3.1, -1.8), P = 0.62] OR BACK-RELATED FUNCTION [-5.1 (95% CI -7.0, -3.2) VERSUS -4.9 (95% CI -6.5, -3.3), P = 0.83]. CONCLUSIONS. TWELVE WEEKS OF ONCE-WEEKLY OR TWICE-WEEKLY YOGA CLASSES WERE SIMILARLY EFFECTIVE FOR PREDOMINANTLY LOW INCOME MINORITY ADULTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN. THIS TRIAL IS REGISTERED WITH CLINICALTRIALS.GOV NCT01761617. 2013
9 1462 45 INFLUENCE OF YOGA ON POSTOPERATIVE OUTCOMES AND WOUND HEALING IN EARLY OPERABLE BREAST CANCER PATIENTS UNDERGOING SURGERY. CONTEXT: PRE- AND POSTOPERATIVE DISTRESS IN BREAST CANCER PATIENTS CAN CAUSE COMPLICATIONS AND DELAY RECOVERY FROM SURGERY. OBJECTIVE: THE AIM OF OUR STUDY WAS TO EVALUATE THE EFFECTS OF YOGA INTERVENTION ON POSTOPERATIVE OUTCOMES AND WOUND HEALING IN EARLY OPERABLE BREAST CANCER PATIENTS UNDERGOING SURGERY. METHODS: NINETY-EIGHT RECENTLY DIAGNOSED STAGE II AND III BREAST CANCER PATIENTS WERE RECRUITED IN A RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFECTS OF A YOGA PROGRAM WITH SUPPORTIVE THERAPY AND EXERCISE REHABILITATION ON POSTOPERATIVE OUTCOMES AND WOUND HEALING FOLLOWING SURGERY. SUBJECTS WERE ASSESSED AT THE BASELINE PRIOR TO SURGERY AND FOUR WEEKS LATER. SOCIODEMOGRAPHIC, CLINICAL AND INVESTIGATIVE NOTES WERE ASCERTAINED IN THE BEGINNING OF THE STUDY. BLOOD SAMPLES WERE COLLECTED FOR ESTIMATION OF PLASMA CYTOKINES-SOLUBLE INTERLEUKIN (IL)-2 RECEPTOR (IL-2R), TUMOR NECROSIS FACTOR (TNF)-ALPHA AND INTERFERON (IFN)-GAMMA. POSTOPERATIVE OUTCOMES SUCH AS THE DURATION OF HOSPITAL STAY AND DRAIN RETENTION, TIME OF SUTURE REMOVAL AND POSTOPERATIVE COMPLICATIONS WERE ASCERTAINED. WE USED INDEPENDENT SAMPLES T TEST AND NONPARAMETRIC MANN WHITNEY U TESTS TO COMPARE GROUPS FOR POSTOPERATIVE OUTCOMES AND PLASMA CYTOKINES. REGRESSION ANALYSIS WAS DONE TO DETERMINE PREDICTORS FOR POSTOPERATIVE OUTCOMES. RESULTS: SIXTY-NINE PATIENTS CONTRIBUTED DATA TO THE CURRENT ANALYSIS (YOGA: N = 33, CONTROL: N = 36). THE RESULTS SUGGEST A SIGNIFICANT DECREASE IN THE DURATION OF HOSPITAL STAY (P = 0.003), DAYS OF DRAIN RETENTION (P = 0.001) AND DAYS FOR SUTURE REMOVAL (P = 0.03) IN THE YOGA GROUP AS COMPARED TO THE CONTROLS. THERE WAS ALSO A SIGNIFICANT DECREASE IN PLASMA TNF ALPHA LEVELS FOLLOWING SURGERY IN THE YOGA GROUP (P < 0.001), AS COMPARED TO THE CONTROLS. REGRESSION ANALYSIS ON POSTOPERATIVE OUTCOMES SHOWED THAT THE YOGA INTERVENTION AFFECTED THE DURATION OF DRAIN RETENTION AND HOSPITAL STAY AS WELL AS TNF ALPHA LEVELS. CONCLUSION: THE RESULTS SUGGEST POSSIBLE BENEFITS OF YOGA IN REDUCING POSTOPERATIVE COMPLICATIONS IN BREAST CANCER PATIENTS. 2008
10 2316 67 TRAUMA-SENSITIVE YOGA FOR POST-TRAUMATIC STRESS DISORDER IN WOMEN VETERANS WHO EXPERIENCED MILITARY SEXUAL TRAUMA: INTERIM RESULTS FROM A RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TO CONDUCT AN INTERIM ANALYSIS OF DATA COLLECTED FROM AN ONGOING MULTISITE RANDOMIZED CLINICAL TRIAL (RCT) ASSESSING THE EFFECTIVENESS OF TRAUMA CENTER TRAUMA-SENSITIVE YOGA (TCTSY) FOR POST-TRAUMATIC STRESS DISORDER (PTSD) AMONG WOMEN VETERANS WITH PTSD RELATED TO MILITARY SEXUAL TRAUMA (MST). THE PURPOSE OF THE INTERIM ANALYSIS WAS TO ASSESS OUTCOMES FROM THE PRIMARY SITE, WHICH IS GEOGRAPHICALLY, DEMOGRAPHICALLY, CULTURALLY, AND PROCEDURALLY DISTINCT FROM THE SECOND SITE. DESIGN: RCT WAS CONDUCTED WITHIN A VETERANS ADMINISTRATION HEALTH CARE SYSTEM. DATA COLLECTION INCLUDED PREINTERVENTION THROUGH 3 MONTHS POSTINTERVENTION. PARTICIPANTS: ENROLLMENT FOR THE MAIN SITE WAS 152 WOMEN. THE SAMPLE SIZE FOR THE INTENT-TO-TREAT ANALYSIS WAS 104. THE MAJORITY WERE AFRICAN AMERICAN (91.3%) WITH A MEAN AGE OF 48.46 YEARS. INTERVENTION: THE TCTSY INTERVENTION (N = 58) WAS CONDUCTED BY TCTSY-CERTIFIED YOGA FACILITATORS AND CONSISTED OF 10 WEEKLY 60-MIN GROUP SESSIONS. THE CONTROL INTERVENTION, COGNITIVE PROCESSING THERAPY (CPT; N = 46), CONSISTED OF 12 90-MIN WEEKLY GROUP SESSIONS CONDUCTED PER VETERANS ADMINISTRATION PROTOCOL BY CLINICIANS IN THE PTSD CLINIC. OUTCOME MEASURES: THE CLINICIAN ADMINISTERED PTSD SCALE FOR DSM-5 (CAPS-5) WAS USED TO ASSESS CURRENT PTSD DIAGNOSIS AND SYMPTOM SEVERITY, INCLUDING OVERALL PTSD AND FOUR SYMPTOM CLUSTERS. THE PTSD CHECKLIST FOR DSM-5 (PCL-5) WAS USED TO OBTAIN SELF-REPORT OF PTSD SYMPTOM SEVERITY, INCLUDING TOTAL SCORE AND FOUR SYMPTOM CLUSTERS. RESULTS: THE FINDINGS REPORTED HERE ARE INTERIM RESULTS FROM ONE CLINICAL SITE. FOR BOTH THE CAPS-5 AND PCL-5, TOTAL SCORES AND ALL FOUR CRITERION SCORES DECREASED SIGNIFICANTLY (P < 0.01) OVER TIME IN ALL FIVE MULTILEVEL LINEAR MODELS WITHIN BOTH TCTSY AND CPT GROUPS, WITHOUT SIGNIFICANT DIFFERENCES BETWEEN GROUPS. THERE WERE CLINICALLY MEANINGFUL IMPROVEMENTS SEEN FOR BOTH TCTSY AND CPT WITH 51.1%-64.3% OF TCTSY SUBJECTS AND 43.5%-73.7% OF CPT DECREASING THEIR CAPS-5 SCORES BY 10 POINTS OR MORE. EFFECT SIZES FOR TOTAL SYMPTOM SEVERITY WERE LARGE FOR TCTSY (COHEN'S D = 1.10-1.18) AND CPT (COHEN'S D = 0.90-1.40). INTERVENTION COMPLETION WAS HIGHER IN TCTSY (60.3%) THAN IN CPT (34.8%). SYMPTOM IMPROVEMENT OCCURRED EARLIER FOR TCTSY (MIDINTERVENTION) THAN FOR CPT (2 WEEKS POSTINTERVENTION). SAFETY: THERE WERE NO UNANTICIPATED ADVERSE EVENTS IN THIS STUDY. CONCLUSION: THE RESULTS OF THIS STUDY DEMONSTRATE THAT TCTSY MAY BE AN EFFECTIVE TREATMENT FOR PTSD THAT YIELDS SYMPTOM IMPROVEMENT MORE QUICKLY, HAS HIGHER RETENTION THAN CPT, AND HAS A SUSTAINED EFFECT. TCTSY MAY BE AN EFFECTIVE ALTERNATIVE TO TRAUMA-FOCUSED THERAPY FOR WOMEN VETERANS WITH PTSD RELATED TO MST. THE STUDY IS REGISTERED IN CLINICALTRIALS.GOV (CTR NO.: NCT02640690). 2021
11 2657 82 YOGA IN ADDITION TO STANDARD CARE FOR PATIENTS WITH HAEMATOLOGICAL MALIGNANCIES. BACKGROUND: HAEMATOLOGICAL MALIGNANCIES ARE MALIGNANT NEOPLASMS OF THE MYELOID OR LYMPHATIC CELL LINES INCLUDING LEUKAEMIA, LYMPHOMA AND MYELOMA. IN ORDER TO MANAGE PHYSICAL AND PSYCHOLOGICAL ASPECTS OF THE DISEASE AND ITS TREATMENT, COMPLEMENTARY THERAPIES LIKE YOGA ARE COMING INCREASINGLY INTO FOCUS. HOWEVER, THE EFFECTIVENESS OF YOGA PRACTICE FOR PEOPLE SUFFERING FROM HAEMATOLOGICAL MALIGNANCIES REMAINS UNCLEAR. OBJECTIVES: TO ASSESS THE EFFECTS OF YOGA PRACTICE IN ADDITION TO STANDARD CANCER TREATMENT FOR PEOPLE WITH HAEMATOLOGICAL MALIGNANCIES. SEARCH METHODS: OUR SEARCH STRATEGY INCLUDED THE COCHRANE CENTRAL REGISTER OF CONTROLLED TRIALS (CENTRAL), MEDLINE (1950 TO 4TH FEBRUARY 2014), DATABASES OF ONGOING TRIALS (CONTROLLED-TRIALS.COM; CLINICALTRIALS.GOV), CONFERENCE PROCEEDINGS OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY, THE AMERICAN SOCIETY OF HEMATOLOGY, THE EUROPEAN HAEMATOLOGY ASSOCIATION, THE EUROPEAN CONGRESS FOR INTEGRATIVE MEDICINE, AND GLOBAL ADVANCES IN HEALTH AND MEDICINE. WE HANDSEARCHED REFERENCES OF THESE STUDIES FROM IDENTIFIED TRIALS AND RELEVANT REVIEW ARTICLES. TWO REVIEW AUTHORS INDEPENDENTLY SCREENED THE SEARCH RESULTS. SELECTION CRITERIA: WE INCLUDED RANDOMISED CONTROLLED TRIALS (RCTS) OF YOGA IN ADDITION TO STANDARD CARE FOR HAEMATOLOGICAL MALIGNANCIES COMPARED WITH STANDARD CARE ONLY. WE DID NOT RESTRICT THIS TO ANY SPECIFIC STYLE OF YOGA. DATA COLLECTION AND ANALYSIS: TWO REVIEW AUTHORS INDEPENDENTLY EXTRACTED DATA FOR ELIGIBLE STUDIES AND ASSESSED THE RISK OF BIAS ACCORDING TO PREDEFINED CRITERIA. WE EVALUATED DISTRESS, FATIGUE, ANXIETY, DEPRESSION AND QUALITY OF SLEEP. FURTHER OUTCOMES WE PLANNED TO ASSESS WERE HEALTH-RELATED QUALITY OF LIFE (HRQOL), OVERALL SURVIVAL (OS) AND ADVERSE EVENTS (AE), BUT DATA ON THESE WERE NOT AVAILABLE. MAIN RESULTS: OUR SEARCH STRATEGIES LED TO 149 POTENTIALLY RELEVANT REFERENCES, BUT ONLY A SINGLE SMALL STUDY MET OUR INCLUSION CRITERIA. THE INCLUDED STUDY WAS PUBLISHED AS A FULL TEXT ARTICLE AND INVESTIGATED THE FEASIBILITY AND EFFECT OF TIBETAN YOGA ADDITIONAL TO STANDARD CARE (N = 20; 1 PERSON DROPPED OUT BEFORE ATTENDING ANY CLASSES AND NO DATA WERE COLLECTED) COMPARED TO STANDARD CARE ONLY (N = 19). THE STUDY INCLUDED PEOPLE WITH ALL STAGES OF HODGKIN AND NON-HODGKIN'S LYMPHOMA, WITH AND WITHOUT CURRENT CANCER TREATMENT. THE MEAN AGE WAS 51 YEARS.WE JUDGED THE OVERALL RISK OF BIAS AS HIGH AS WE FOUND A HIGH RISK FOR PERFORMANCE, DETECTION AND ATTRITION BIAS. ADDITIONALLY, POTENTIAL OUTCOME REPORTING BIAS COULD NOT BE COMPLETELY RULED OUT. FOLLOWING THE RECOMMENDATIONS OF GRADE, WE JUDGED THE OVERALL QUALITY OF THE BODY OF EVIDENCE FOR ALL PREDEFINED OUTCOMES AS 'VERY LOW', DUE TO THE METHODICAL LIMITATIONS AND THE VERY SMALL SAMPLE SIZE.THE INFLUENCE OF YOGA ON HRQOL AND OS WAS NOT REPORTED. THERE IS NO EVIDENCE THAT YOGA IN ADDITION TO STANDARD CARE COMPARED WITH STANDARD CARE ONLY CAN IMPROVE DISTRESS IN PEOPLE WITH HAEMATOLOGICAL MALIGNANCIES (MEAN DIFFERENCE (MD) -0.30, 95% CONFIDENCE INTERVAL (CI) -5.55 TO 4.95; P = 0.91). SIMILARLY, THERE IS NO EVIDENCE OF A DIFFERENCE BETWEEN EITHER GROUP FOR FATIGUE (MD 0.00, 95% CI -0.94 TO 0.94; P = 1.00), ANXIETY (MD 0.30, 95% CI -5.01 TO 5.61; P = 0.91) OR DEPRESSION (MD -0.70, 95% CI -3.21 TO 1.81; P = 0.58).THERE IS VERY LOW QUALITY EVIDENCE THAT YOGA IMPROVES THE OVERALL QUALITY OF SLEEP (MD -2.30, 95% CI -3.78 TO -0.82; P = 0.002). THE YOGA GROUPS' TOTAL SCORE FOR THE PITTSBURGH SLEEP QUALITY INDEX (PSQI) WAS 5.8 (+/- 2.3 SD) AND BETTER THAN THE TOTAL SCORE (8.1 (+/- 2.4 SD)) OF THE CONTROL GROUP. A PSQI TOTAL SCORE OF 0 TO 5 INDICATES GOOD SLEEP WHEREAS PSQI TOTAL SCORE 6 TO 21 POINTS TOWARDS SIGNIFICANT SLEEP DISTURBANCES. THE OCCURRENCE OF AES WAS NOT REPORTED. AUTHORS' CONCLUSIONS: THE CURRENTLY AVAILABLE DATA PROVIDE LITTLE INFORMATION ABOUT THE EFFECTIVENESS OF YOGA INTERVENTIONS FOR PEOPLE SUFFERING FROM HAEMATOLOGICAL MALIGNANCIES. THE FINDING THAT YOGA MAY BE BENEFICIAL FOR THE PATIENTS' QUALITY OF SLEEP IS BASED ON A VERY SMALL BODY OF EVIDENCE. THEREFORE, THE ROLE OF YOGA AS AN ADDITIONAL THERAPY FOR HAEMATOLOGICAL MALIGNANCIES REMAINS UNCLEAR. FURTHER HIGH-QUALITY RANDOMISED CONTROLLED TRIALS WITH LARGER NUMBERS OF PARTICIPANTS ARE NEEDED TO MAKE A DEFINITIVE STATEMENT. 2014
12 851 43 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 2587 83 YOGA FOR IMPROVING HEALTH-RELATED QUALITY OF LIFE, MENTAL HEALTH AND CANCER-RELATED SYMPTOMS IN WOMEN DIAGNOSED WITH BREAST CANCER. BACKGROUND: BREAST CANCER IS THE CANCER MOST FREQUENTLY DIAGNOSED IN WOMEN WORLDWIDE. EVEN THOUGH SURVIVAL RATES ARE CONTINUALLY INCREASING, BREAST CANCER IS OFTEN ASSOCIATED WITH LONG-TERM PSYCHOLOGICAL DISTRESS, CHRONIC PAIN, FATIGUE AND IMPAIRED QUALITY OF LIFE. YOGA COMPRISES ADVICE FOR AN ETHICAL LIFESTYLE, SPIRITUAL PRACTICE, PHYSICAL ACTIVITY, BREATHING EXERCISES AND MEDITATION. IT IS A COMPLEMENTARY THERAPY THAT IS COMMONLY RECOMMENDED FOR BREAST CANCER-RELATED IMPAIRMENTS AND HAS BEEN SHOWN TO IMPROVE PHYSICAL AND MENTAL HEALTH IN PEOPLE WITH DIFFERENT CANCER TYPES. OBJECTIVES: TO ASSESS EFFECTS OF YOGA ON HEALTH-RELATED QUALITY OF LIFE, MENTAL HEALTH AND CANCER-RELATED SYMPTOMS AMONG WOMEN WITH A DIAGNOSIS OF BREAST CANCER WHO ARE RECEIVING ACTIVE TREATMENT OR HAVE COMPLETED TREATMENT. SEARCH METHODS: WE SEARCHED THE COCHRANE BREAST CANCER SPECIALISED REGISTER, MEDLINE (VIA PUBMED), EMBASE, THE COCHRANE CENTRAL REGISTER OF CONTROLLED TRIALS (CENTRAL; 2016, ISSUE 1), INDEXING OF INDIAN MEDICAL JOURNALS (INDMED), THE WORLD HEALTH ORGANIZATION (WHO) INTERNATIONAL CLINICAL TRIALS REGISTRY PLATFORM (ICTRP) SEARCH PORTAL AND CLINICALTRIALS.GOV ON 29 JANUARY 2016. WE ALSO SEARCHED REFERENCE LISTS OF IDENTIFIED RELEVANT TRIALS OR REVIEWS, AS WELL AS CONFERENCE PROCEEDINGS OF THE INTERNATIONAL CONGRESS ON COMPLEMENTARY MEDICINE RESEARCH (ICCMR), THE EUROPEAN CONGRESS FOR INTEGRATIVE MEDICINE (ECIM) AND THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO). WE APPLIED NO LANGUAGE RESTRICTIONS. SELECTION CRITERIA: RANDOMISED CONTROLLED TRIALS WERE ELIGIBLE WHEN THEY (1) COMPARED YOGA INTERVENTIONS VERSUS NO THERAPY OR VERSUS ANY OTHER ACTIVE THERAPY IN WOMEN WITH A DIAGNOSIS OF NON-METASTATIC OR METASTATIC BREAST CANCER, AND (2) ASSESSED AT LEAST ONE OF THE PRIMARY OUTCOMES ON PATIENT-REPORTED INSTRUMENTS, INCLUDING HEALTH-RELATED QUALITY OF LIFE, DEPRESSION, ANXIETY, FATIGUE OR SLEEP DISTURBANCES. DATA COLLECTION AND ANALYSIS: TWO REVIEW AUTHORS INDEPENDENTLY COLLECTED DATA ON METHODS AND RESULTS. WE EXPRESSED OUTCOMES AS STANDARDISED MEAN DIFFERENCES (SMDS) WITH 95% CONFIDENCE INTERVALS (CIS) AND CONDUCTED RANDOM-EFFECTS MODEL META-ANALYSES. WE ASSESSED POTENTIAL RISK OF PUBLICATION BIAS THROUGH VISUAL ANALYSIS OF FUNNEL PLOT SYMMETRY AND HETEROGENEITY BETWEEN STUDIES BY USING THE CHI(2) TEST AND THE I(2) STATISTIC. WE CONDUCTED SUBGROUP ANALYSES FOR CURRENT TREATMENT STATUS, TIME SINCE DIAGNOSIS, STAGE OF CANCER AND TYPE OF YOGA INTERVENTION. MAIN RESULTS: WE INCLUDED 24 STUDIES WITH A TOTAL OF 2166 PARTICIPANTS, 23 OF WHICH PROVIDED DATA FOR META-ANALYSIS. THIRTEEN STUDIES HAD LOW RISK OF SELECTION BIAS, FIVE STUDIES REPORTED ADEQUATE BLINDING OF OUTCOME ASSESSMENT AND 15 STUDIES HAD LOW RISK OF ATTRITION BIAS.SEVENTEEN STUDIES THAT COMPARED YOGA VERSUS NO THERAPY PROVIDED MODERATE-QUALITY EVIDENCE SHOWING THAT YOGA IMPROVED HEALTH-RELATED QUALITY OF LIFE (POOLED SMD 0.22, 95% CI 0.04 TO 0.40; 10 STUDIES, 675 PARTICIPANTS), REDUCED FATIGUE (POOLED SMD -0.48, 95% CI -0.75 TO -0.20; 11 STUDIES, 883 PARTICIPANTS) AND REDUCED SLEEP DISTURBANCES IN THE SHORT TERM (POOLED SMD -0.25, 95% CI -0.40 TO -0.09; SIX STUDIES, 657 PARTICIPANTS). THE FUNNEL PLOT FOR HEALTH-RELATED QUALITY OF LIFE WAS ASYMMETRICAL, FAVOURING NO THERAPY, AND THE FUNNEL PLOT FOR FATIGUE WAS ROUGHLY SYMMETRICAL. THIS HINTS AT OVERALL LOW RISK OF PUBLICATION BIAS. YOGA DID NOT APPEAR TO REDUCE DEPRESSION (POOLED SMD -0.13, 95% CI -0.31 TO 0.05; SEVEN STUDIES, 496 PARTICIPANTS; LOW-QUALITY EVIDENCE) OR ANXIETY (POOLED SMD -0.53, 95% CI -1.10 TO 0.04; SIX STUDIES, 346 PARTICIPANTS; VERY LOW-QUALITY EVIDENCE) IN THE SHORT TERM AND HAD NO MEDIUM-TERM EFFECTS ON HEALTH-RELATED QUALITY OF LIFE (POOLED SMD 0.10, 95% CI -0.23 TO 0.42; TWO STUDIES, 146 PARTICIPANTS; LOW-QUALITY EVIDENCE) OR FATIGUE (POOLED SMD -0.04, 95% CI -0.36 TO 0.29; TWO STUDIES, 146 PARTICIPANTS; LOW-QUALITY EVIDENCE). INVESTIGATORS REPORTED NO SERIOUS ADVERSE EVENTS.FOUR STUDIES THAT COMPARED YOGA VERSUS PSYCHOSOCIAL/EDUCATIONAL INTERVENTIONS PROVIDED MODERATE-QUALITY EVIDENCE INDICATING THAT YOGA CAN REDUCE DEPRESSION (POOLED SMD -2.29, 95% CI -3.97 TO -0.61; FOUR STUDIES, 226 PARTICIPANTS), ANXIETY (POOLED SMD -2.21, 95% CI -3.90 TO -0.52; THREE STUDIES, 195 PARTICIPANTS) AND FATIGUE (POOLED SMD -0.90, 95% CI -1.31 TO -0.50; TWO STUDIES, 106 PARTICIPANTS) IN THE SHORT TERM. VERY LOW-QUALITY EVIDENCE SHOWED NO SHORT-TERM EFFECTS ON HEALTH-RELATED QUALITY OF LIFE (POOLED SMD 0.81, 95% CI -0.50 TO 2.12; TWO STUDIES, 153 PARTICIPANTS) OR SLEEP DISTURBANCES (POOLED SMD -0.21, 95% CI -0.76 TO 0.34; TWO STUDIES, 119 PARTICIPANTS). NO TRIAL ADEQUATELY REPORTED SAFETY-RELATED DATA.THREE STUDIES THAT COMPARED YOGA VERSUS EXERCISE PRESENTED VERY LOW-QUALITY EVIDENCE SHOWING NO SHORT-TERM EFFECTS ON HEALTH-RELATED QUALITY OF LIFE (POOLED SMD -0.04, 95% CI -0.30 TO 0.23; THREE STUDIES, 233 PARTICIPANTS) OR FATIGUE (POOLED SMD -0.21, 95% CI -0.66 TO 0.25; THREE STUDIES, 233 PARTICIPANTS); NO TRIAL PROVIDED SAFETY-RELATED DATA. AUTHORS' CONCLUSIONS: MODERATE-QUALITY EVIDENCE SUPPORTS THE RECOMMENDATION OF YOGA AS A SUPPORTIVE INTERVENTION FOR IMPROVING HEALTH-RELATED QUALITY OF LIFE AND REDUCING FATIGUE AND SLEEP DISTURBANCES WHEN COMPARED WITH NO THERAPY, AS WELL AS FOR REDUCING DEPRESSION, ANXIETY AND FATIGUE, WHEN COMPARED WITH PSYCHOSOCIAL/EDUCATIONAL INTERVENTIONS. VERY LOW-QUALITY EVIDENCE SUGGESTS THAT YOGA MIGHT BE AS EFFECTIVE AS OTHER EXERCISE INTERVENTIONS AND MIGHT BE USED AS AN ALTERNATIVE TO OTHER EXERCISE PROGRAMMES. 2017
14 2852 58 YOGA, PHYSICAL THERAPY, OR EDUCATION FOR CHRONIC LOW BACK PAIN: A RANDOMIZED NONINFERIORITY TRIAL. BACKGROUND: YOGA IS EFFECTIVE FOR MILD TO MODERATE CHRONIC LOW BACK PAIN (CLBP), BUT ITS COMPARATIVE EFFECTIVENESS WITH PHYSICAL THERAPY (PT) IS UNKNOWN. MOREOVER, LITTLE IS KNOWN ABOUT YOGA'S EFFECTIVENESS IN UNDERSERVED PATIENTS WITH MORE SEVERE FUNCTIONAL DISABILITY AND PAIN. OBJECTIVE: TO DETERMINE WHETHER YOGA IS NONINFERIOR TO PT FOR CLBP. DESIGN: 12-WEEK, SINGLE-BLIND, 3-GROUP RANDOMIZED NONINFERIORITY TRIAL AND SUBSEQUENT 40-WEEK MAINTENANCE PHASE. (CLINICALTRIALS.GOV: NCT01343927). SETTING: ACADEMIC SAFETY-NET HOSPITAL AND 7 AFFILIATED COMMUNITY HEALTH CENTERS. PARTICIPANTS: 320 PREDOMINANTLY LOW-INCOME, RACIALLY DIVERSE ADULTS WITH NONSPECIFIC CLBP. INTERVENTION: PARTICIPANTS RECEIVED 12 WEEKLY YOGA CLASSES, 15 PT VISITS, OR AN EDUCATIONAL BOOK AND NEWSLETTERS. THE MAINTENANCE PHASE COMPARED YOGA DROP-IN CLASSES VERSUS HOME PRACTICE AND PT BOOSTER SESSIONS VERSUS HOME PRACTICE. MEASUREMENTS: PRIMARY OUTCOMES WERE BACK-RELATED FUNCTION, MEASURED BY THE ROLAND MORRIS DISABILITY QUESTIONNAIRE (RMDQ), AND PAIN, MEASURED BY AN 11-POINT SCALE, AT 12 WEEKS. PRESPECIFIED NONINFERIORITY MARGINS WERE 1.5 (RMDQ) AND 1.0 (PAIN). SECONDARY OUTCOMES INCLUDED PAIN MEDICATION USE, GLOBAL IMPROVEMENT, SATISFACTION WITH INTERVENTION, AND HEALTH-RELATED QUALITY OF LIFE. RESULTS: ONE-SIDED 95% LOWER CONFIDENCE LIMITS WERE 0.83 (RMDQ) AND 0.97 (PAIN), DEMONSTRATING NONINFERIORITY OF YOGA TO PT. HOWEVER, YOGA WAS NOT SUPERIOR TO EDUCATION FOR EITHER OUTCOME. YOGA AND PT WERE SIMILAR FOR MOST SECONDARY OUTCOMES. YOGA AND PT PARTICIPANTS WERE 21 AND 22 PERCENTAGE POINTS LESS LIKELY, RESPECTIVELY, THAN EDUCATION PARTICIPANTS TO USE PAIN MEDICATION AT 12 WEEKS. IMPROVEMENTS IN YOGA AND PT GROUPS WERE MAINTAINED AT 1 YEAR WITH NO DIFFERENCES BETWEEN MAINTENANCE STRATEGIES. FREQUENCY OF ADVERSE EVENTS, MOSTLY MILD SELF-LIMITED JOINT AND BACK PAIN, DID NOT DIFFER BETWEEN THE YOGA AND PT GROUPS. LIMITATIONS: PARTICIPANTS WERE NOT BLINDED TO TREATMENT ASSIGNMENT. THE PT GROUP HAD DISPROPORTIONATE LOSS TO FOLLOW-UP. CONCLUSION: A MANUALIZED YOGA PROGRAM FOR NONSPECIFIC CLBP WAS NONINFERIOR TO PT FOR FUNCTION AND PAIN. PRIMARY FUNDING SOURCE: NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH OF THE NATIONAL INSTITUTES OF HEALTH. 2017
15 2132 51 THE EFFECTS OF A GENTLE YOGA PROGRAM ON SLEEP, MOOD, AND BLOOD PRESSURE IN OLDER WOMEN WITH RESTLESS LEGS SYNDROME (RLS): A PRELIMINARY RANDOMIZED CONTROLLED TRIAL. OBJECTIVE. TO EXAMINE THE EFFECTS OF YOGA VERSUS AN EDUCATIONAL FILM PROGRAM ON SLEEP, MOOD, PERCEIVED STRESS, AND SYMPATHETIC ACTIVATION IN OLDER WOMEN WITH RLS. METHODS. PARTICIPANTS WERE DRAWN FROM A LARGER TRIAL REGARDING THE EFFECTS OF YOGA ON CARDIOVASCULAR DISEASE RISK PROFILES IN OVERWEIGHT, SEDENTARY POSTMENOPAUSAL WOMEN. SEVENTY-FIVE WOMEN WERE RANDOMIZED TO RECEIVE EITHER AN 8-WEEK YOGA (N = 38) OR EDUCATIONAL FILM (N = 37) PROGRAM. ALL 75 PARTICIPANTS COMPLETED AN RLS SCREENING QUESTIONNAIRE. THE 20 WOMEN WHO MET ALL FOUR DIAGNOSTIC CRITERIA FOR RLS (N = 10 YOGA, 10 FILM GROUP) COMPRISED THE POPULATION FOR THIS NESTED STUDY. MAIN OUTCOMES ASSESSED PRE- AND POST-TREATMENT INCLUDED: SLEEP (PITTSBURGH SLEEP QUALITY INDEX), STRESS (PERCEIVED STRESS SCALE), MOOD (PROFILE OF MOOD STATES, STATE-TRAIT ANXIETY INVENTORY), BLOOD PRESSURE, AND HEART RATE. RESULTS. THE YOGA GROUP DEMONSTRATED SIGNIFICANTLY GREATER IMPROVEMENTS THAN CONTROLS IN MULTIPLE DOMAINS OF SLEEP QUALITY AND MOOD, AND SIGNIFICANTLY GREATER REDUCTIONS IN INSOMNIA PREVALENCE, ANXIETY, PERCEIVED STRESS, AND BLOOD PRESSURE (ALL P'S</=0.05). ADJUSTED INTERGROUP EFFECT SIZES FOR PSYCHOSOCIAL VARIABLES WERE LARGE, RANGING FROM 1.9 FOR STATE ANXIETY TO 2.6 FOR SLEEP QUALITY. CONCLUSIONS. THESE PRELIMINARY FINDINGS SUGGEST YOGA MAY OFFER AN EFFECTIVE INTERVENTION FOR IMPROVING SLEEP, MOOD, PERCEIVED STRESS, AND BLOOD PRESSURE IN OLDER WOMEN WITH RLS. 2012
16 2831 57 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN CAUSES SUBSTANTIAL MORBIDITY AND COST TO SOCIETY WHILE DISPROPORTIONATELY IMPACTING LOW-INCOME AND MINORITY ADULTS. SEVERAL RANDOMIZED CONTROLLED TRIALS SHOW YOGA IS AN EFFECTIVE TREATMENT. HOWEVER, THE COMPARATIVE EFFECTIVENESS OF YOGA AND PHYSICAL THERAPY, A COMMON MAINSTREAM TREATMENT FOR CHRONIC LOW BACK PAIN, IS UNKNOWN. METHODS/DESIGN: THIS IS A RANDOMIZED CONTROLLED TRIAL FOR 320 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN, COMPARING YOGA, PHYSICAL THERAPY, AND EDUCATION. INCLUSION CRITERIA ARE ADULTS 18-64 YEARS OLD WITH NON-SPECIFIC LOW BACK PAIN LASTING >/= 12 WEEKS AND A SELF-REPORTED AVERAGE PAIN INTENSITY OF >/= 4 ON A 0-10 SCALE. RECRUITMENT TAKES PLACE AT BOSTON MEDICAL CENTER, AN URBAN ACADEMIC SAFETY-NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS LOCATED IN DIVERSE NEIGHBORHOODS. THE 52-WEEK STUDY HAS AN INITIAL 12-WEEK TREATMENT PHASE WHERE PARTICIPANTS ARE RANDOMIZED IN A 2:2:1 RATIO INTO I) A STANDARDIZED WEEKLY HATHA YOGA CLASS SUPPLEMENTED BY HOME PRACTICE; II) A STANDARDIZED EVIDENCE-BASED EXERCISE THERAPY PROTOCOL ADAPTED FROM THE TREATMENT BASED CLASSIFICATION METHOD, INDIVIDUALLY DELIVERED BY A PHYSICAL THERAPIST AND SUPPLEMENTED BY HOME PRACTICE; AND III) EDUCATION DELIVERED THROUGH A SELF-CARE BOOK. CO-PRIMARY OUTCOME MEASURES ARE 12-WEEK PAIN INTENSITY MEASURED ON AN 11-POINT NUMERICAL RATING SCALE AND BACK-SPECIFIC FUNCTION MEASURED USING THE MODIFIED ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 40-WEEK MAINTENANCE PHASE, YOGA PARTICIPANTS ARE RE-RANDOMIZED IN A 1:1 RATIO TO EITHER STRUCTURED MAINTENANCE YOGA CLASSES OR HOME PRACTICE ONLY. PHYSICAL THERAPY PARTICIPANTS ARE SIMILARLY RE-RANDOMIZED TO EITHER FIVE BOOSTER SESSIONS OR HOME PRACTICE ONLY. EDUCATION PARTICIPANTS CONTINUE TO FOLLOW RECOMMENDATIONS OF EDUCATIONAL MATERIALS. WE WILL ALSO ASSESS COST EFFECTIVENESS FROM THE PERSPECTIVES OF THE INDIVIDUAL, INSURERS, AND SOCIETY USING CLAIMS DATABASES, ELECTRONIC MEDICAL RECORDS, SELF-REPORT COST DATA, AND STUDY RECORDS. QUALITATIVE DATA FROM INTERVIEWS WILL ADD SUBJECTIVE DETAIL TO COMPLEMENT QUANTITATIVE DATA. TRIAL REGISTRATION: THIS TRIAL IS REGISTERED IN CLINICALTRIALS.GOV, WITH THE ID NUMBER: NCT01343927. 2014
17 199 51 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
18 2857 60 YOGA-BASED CARDIAC REHABILITATION AFTER ACUTE MYOCARDIAL INFARCTION: A RANDOMIZED TRIAL. BACKGROUND: GIVEN THE SHORTAGE OF CARDIAC REHABILITATION (CR) PROGRAMS IN INDIA AND POOR UPTAKE WORLDWIDE, THERE IS AN URGENT NEED TO FIND ALTERNATIVE MODELS OF CR THAT ARE INEXPENSIVE AND MAY OFFER CHOICE TO SUBGROUPS WITH POOR UPTAKE (E.G., WOMEN AND ELDERLY). OBJECTIVES: THIS STUDY SOUGHT TO EVALUATE THE EFFECTS OF YOGA-BASED CR (YOGA-CARE) ON MAJOR CARDIOVASCULAR EVENTS AND SELF-RATED HEALTH IN A MULTICENTER RANDOMIZED CONTROLLED TRIAL. METHODS: THE TRIAL WAS CONDUCTED IN 24 MEDICAL CENTERS ACROSS INDIA. THIS STUDY RECRUITED 3,959 PATIENTS WITH ACUTE MYOCARDIAL INFARCTION WITH A MEDIAN AND MINIMUM FOLLOW-UP OF 22 AND 6 MONTHS. PATIENTS WERE INDIVIDUALLY RANDOMIZED TO RECEIVE EITHER A YOGA-CARE PROGRAM (N = 1,970) OR ENHANCED STANDARD CARE INVOLVING EDUCATIONAL ADVICE (N = 1,989). THE CO-PRIMARY OUTCOMES WERE: 1) FIRST OCCURRENCE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) (COMPOSITE OF ALL-CAUSE MORTALITY, MYOCARDIAL INFARCTION, STROKE, OR EMERGENCY CARDIOVASCULAR HOSPITALIZATION); AND 2) SELF-RATED HEALTH ON THE EUROPEAN QUALITY OF LIFE-5 DIMENSIONS-5 LEVEL VISUAL ANALOGUE SCALE AT 12 WEEKS. RESULTS: MACE OCCURRED IN 131 (6.7%) PATIENTS IN THE YOGA-CARE GROUP AND 146 (7.4%) PATIENTS IN THE ENHANCED STANDARD CARE GROUP (HAZARD RATIO WITH YOGA-CARE: 0.90; 95% CONFIDENCE INTERVAL [CI]: 0.71 TO 1.15; P = 0.41). SELF-RATED HEALTH WAS 77 IN YOGA-CARE AND 75.7 IN THE ENHANCED STANDARD CARE GROUP (BASELINE-ADJUSTED MEAN DIFFERENCE IN FAVOR OF YOGA-CARE: 1.5; 95% CI: 0.5 TO 2.5; P = 0.002). THE YOGA-CARE GROUP HAD GREATER RETURN TO PRE-INFARCT ACTIVITIES, BUT THERE WAS NO DIFFERENCE IN TOBACCO CESSATION OR MEDICATION ADHERENCE BETWEEN THE TREATMENT GROUPS (SECONDARY OUTCOMES). CONCLUSIONS: YOGA-CARE IMPROVED SELF-RATED HEALTH AND RETURN TO PRE-INFARCT ACTIVITIES AFTER ACUTE MYOCARDIAL INFARCTION, BUT THE TRIAL LACKED STATISTICAL POWER TO SHOW A DIFFERENCE IN MACE. YOGA-CARE MAY BE AN OPTION WHEN CONVENTIONAL CR IS UNAVAILABLE OR UNACCEPTABLE TO INDIVIDUALS. (A STUDY ON EFFECTIVENESS OF YOGA BASED CARDIAC REHABILITATION PROGRAMME IN INDIA AND UNITED KINGDOM; CTRI/2012/02/002408). 2020
19 2507 57 YOGA BASED CARDIAC REHABILITATION AFTER CORONARY ARTERY BYPASS SURGERY: ONE-YEAR RESULTS ON LVEF, LIPID PROFILE AND PSYCHOLOGICAL STATES--A RANDOMIZED CONTROLLED STUDY. OBJECTIVE: TO COMPARE THE LONG TERM EFFECTS OF YOGA BASED CARDIAC REHABILITATION PROGRAM WITH ONLY PHYSIOTHERAPY BASED PROGRAM AS AN ADD-ON TO CONVENTIONAL REHABILITATION AFTER CORONARY ARTERY BYPASS GRAFTING (CABG) ON RISK FACTORS. METHODS: IN THIS SINGLE BLIND PROSPECTIVE RANDOMIZED PARALLEL TWO ARMED ACTIVE CONTROL STUDY, 1026 PATIENTS POSTED FOR CABG AT NARAYANA HRUDAYALAYA INSTITUTE OF CARDIAC SCIENCES, BENGALURU (INDIA) WERE SCREENED. OF THESE, 250 MALE PARTICIPANTS (35-65 YEARS) WHO SATISFIED THE SELECTION CRITERIA AND CONSENTED WERE RANDOMIZED INTO TWO GROUPS. WITHIN AND BETWEEN GROUP COMPARISONS WERE DONE AT THREE POINTS OF FOLLOW UP (I.E. 6TH WEEK, 6TH MONTH, AND 12TH MONTH) BY USING WILCOXON'S SIGNED RANKS TEST AND MANN WHITNEY U TEST RESPECTIVELY. RESULTS: YOGA GROUP HAD SIGNIFICANTLY (P = 0.001, MANN WHITNEY) BETTER IMPROVEMENT IN LVEF THAN CONTROL GROUP IN THOSE WITH ABNORMAL BASELINE EF (<53%) AFTER 1 YEAR. THERE WAS A BETTER REDUCTION IN BMI IN THE YOGA GROUP (P = 0.038, BETWEEN GROUPS) IN THOSE WITH HIGH BASELINE BMI (>/=23) AFTER 12 MONTHS. YOGA GROUP SHOWED SIGNIFICANT (P = 0.008, WILCOXON'S) REDUCTION IN BLOOD GLUCOSE AT ONE YEAR IN THOSE WITH HIGH BASELINE FBS >/=110 MG/DL. THERE WAS SIGNIFICANTLY BETTER IMPROVEMENT IN YOGA THAN THE CONTROL GROUP IN HDL (P = 0.003), LDL (P = 0.01) AND VLDL (P = 0.03) IN THOSE WITH ABNORMAL BASELINE VALUES. THERE WAS SIGNIFICANTLY BETTER IMPROVEMENT (P = 0.02, BETWEEN GROUPS) IN POSITIVE AFFECT IN YOGA GROUP. WITHIN YOGA GROUP, THERE WAS SIGNIFICANT DECREASE IN PERCEIVED STRESS (P = 0.001), ANXIETY (P = 0.001), DEPRESSION (P = 0.001), AND NEGATIVE AFFECT (P = 0.03) WHILE IN THE CONTROL GROUP THERE WAS REDUCTION (P = 0.003) ONLY IN SCORES ON ANXIETY. CONCLUSION: ADDITION OF YOGA BASED RELAXATION TO CONVENTIONAL POST-CABG CARDIAC REHABILITATION HELPS IN BETTER MANAGEMENT OF RISK FACTORS IN THOSE WITH ABNORMAL BASELINE VALUES AND MAY HELP IN PREVENTING RECURRENCE. 2014
20 881 41 EFFECT OF YOGA TRAINING ON INFLAMMATORY CYTOKINES AND C-REACTIVE PROTEIN IN EMPLOYEES OF SMALL-SCALE INDUSTRIES. OBJECTIVE: THE PRESENT STUDY INTENDS TO SEE THE EFFECT OF YOGA PRACTICES ON LIPID PROFILE, INTERLEUKIN (IL)-6, TUMOR NECROSIS FACTOR (TNF)-ALPHA, AND HIGH-SENSITIVITY-C-REACTIVE PROTEIN (HS-CRP) AMONG APPARENTLY HEALTHY ADULTS EXPOSED TO OCCUPATIONAL HAZARDS. MATERIALS AND METHODS: IN THE PRESENT STUDY, 48 PARTICIPANTS AGED 30-58 YEARS (41.5 +/- 5.2) WHO WERE EXPOSED TO OCCUPATIONAL HAZARDS WERE RANDOMIZED INTO TWO GROUPS, THAT IS, EXPERIMENTAL AND WAIT-LIST CONTROL. ALL THE PARTICIPANTS WERE ASSESSED FOR LIPID PROFILE, IL-6, TNF-ALPHA, AND HS-CRP AT THE BASELINE AND AFTER COMPLETION OF 3 MONTHS OF YOGA TRAINING INTERVENTION. THE EXPERIMENTAL GROUP UNDERWENT YOGA TRAINING INTERVENTION FOR 1 H FOR 6 DAYS A WEEK FOR 3 MONTHS, WHEREAS CONTROL GROUP CONTINUED WITH THEIR DAILY ACTIVITIES EXCEPT YOGA TRAINING. DATA ANALYSIS WAS DONE USING STATISTICAL SOFTWARE SPSS VERSION 20.0. DATA WERE ANALYZED USING PAIRED T-TESTS AND INDEPENDENT T-TEST. RESULTS: THE RESULTS OF WITHIN GROUP COMPARISON REVEALED HIGHLY SIGNIFICANT CHANGES IN CHOLESTEROL (P < 0.001), HIGH-DENSITY LIPOPROTEIN (P < 0.001), LOW-DENSITY LIPOPROTEIN (LDL)(P < 0.01), HS-CRP (P < 0.01), IL-6 (P < 0.001), AND TNF-ALPHA (P < 0.001) IN EXPERIMENTAL GROUP. COMPARISON BETWEEN EXPERIMENTAL AND CONTROL GROUP REVEALED SIGNIFICANT CHANGES IN CHOLESTEROL (P < 0.01), LDL (P < 0.05), IL-6 (P < 0.01), TNF-ALPHA (P < 0.01), AND HS-CRP (P < 0.01). CONCLUSION: A YOGA-BASED LIFESTYLE INTERVENTION SEEMS TO BE A HIGHLY PROMISING ALTERNATIVE THERAPY WHICH FAVORABLY ALTERS INFLAMMATORY MARKERS AND METABOLIC RISK FACTORS. 2017