1  693 139 EFFECT OF CONTROLLED BREATHING EXERCISES ON THE PSYCHOLOGICAL STATUS AND THE CARDIAC AUTONOMIC TONE: SUDARSHAN KRIYA AND PRANA-YOGA. OBJECTIVE: THE OBJECTIVE OF THE STUDY WAS TO OBSERVE THE EFFECT OF CONTROLLED BREATHING EXERCISES INCLUDING SUDARSHAN KRIYA (SK) AND PRANA-YOGA (PY) ON THE PSYCHO-PHYSIOLOGICAL STATUS. METHODS: THE STUDY GROUP INCLUDED 60 HEALTHY VOLUNTEERS (M:30, F:30) IN THE AGE GROUP OF 18 TO 30 YEARS (21.3 +/- 3.2 YRS), RANDOMLY DIVIDED IN TO THREE GROUPS OF 20 SUBJECTS EACH--(1) THE SK GROUP (2) THE PY GROUP AND THE (3) CONTROL GROUP. THE PSYCHO-PHYSIOLOGICAL DATA WAS COLLECTED AT THE FOLLOWING FOUR TIME INTERVENTIONS: BASELINE, 6TH, 60TH AND THE 150TH DAY. PSYCHOLOGICAL ASSESSMENT WAS DONE USING QUESTIONNAIRES AND FOR THE AUTONOMIC TONE QUANTIFICATION HEART RATE VARIABILITY (HRV) ANALYSIS WAS DONE USING THE STANDARD LEAD II ELECTROCARDIOGRAM RECORDINGS. IN A POST-HOC ANALYSIS EACH GROUP WAS FURTHER SUB DIVIDED IN TO THE FOLLOWING TWO PATTERNS, BASED ON THE BASELINE VALUES OF NORMALIZED LOW FREQUENCY (LF) POWER (CUTOFF 64 MS2): (I) PATTERN A-SUBJECTS WITH LOW LEVEL LF POWER, AND (II) PATTERN B- SUBJECTS WITH HIGH LEVEL LF POWER. RESULTS: THE STRESS MANAGEMENT SKILLS HAVE SHOWN SIGNIFICANT INCREASE IN SK GROUP BUT NOT IN PY AND CONTROL GROUP. SUBJECTS OF SK, PY, AND CONTROL GROUP SHOWED SIGNIFICANT INCREASE IN LF VALUE AND LF:HF RATIO FOR PATTERN A AND SIGNIFICANT DECREASE FOR PATTERN B. PLOTTED LF VALUE FOR PATTERN A & B IN SK AND PY PRACTITIONERS SHOWED CONVERGENCE, COMING TO A MEAN VALUE OVER THE PERIOD OF 150 DAYS. THE LF:HF RATIO CURVE PLOTTED OVER TIME FOR PATTERN A & B SHOWED CONVERGENCE IN SK GROUP ONLY. NO SUCH CONVERGENCE IN LF VALUE & LF/HF RATIO FOR PATTERN A & B WAS SEEN IN CONTROL GROUP. CONCLUSION: IN CONCLUSION, SUDARSHAN KRIYA POSITIVELY MODIFIES STRESS COPING BEHAVIOR AND INITIATES APPROPRIATE BALANCE IN CARDIAC AUTONOMIC TONE.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
2  602  25 DEVELOPMENT AND VALIDATION OF A YOGA MODULE FOR PARKINSON DISEASE. BACKGROUND PARKINSON'S DISEASE (PD), A PROGRESSIVE NEURODEGENERATIVE DISEASE, AFFECTS MOTOR AND NONMOTOR FUNCTIONS, LEADING TO SEVERE DEBILITY AND POOR QUALITY OF LIFE. STUDIES HAVE REPORTED THE BENEFICIAL ROLE OF YOGA IN ALLEVIATING THE SYMPTOMS OF PD; HOWEVER, A VALIDATED YOGA MODULE FOR PD IS UNAVAILABLE. THIS STUDY DEVELOPED AND VALIDATED AN INTEGRATED YOGA MODULE(IYM) FOR PD. METHODS THE IYM WAS PREPARED AFTER A THOROUGH REVIEW OF CLASSICAL YOGA TEXTS AND PREVIOUS FINDINGS. TWENTY EXPERIENCED YOGA EXPERTS, WHO FULFILLED THE INCLUSION CRITERIA, WERE SELECTED VALIDATING THE CONTENT OF THE IYM. A TOTAL OF 28 PRACTICES WERE INCLUDED IN THE IYM, AND EACH PRACTICE WAS DISCUSSED AND RATED AS (I) NOT ESSENTIAL, (II) USEFUL BUT NOT ESSENTIAL, AND (III) ESSENTIAL; THE CONTENT VALIDITY RATIO (CVR) WAS CALCULATED USING LAWSHE'S FORMULA. RESULTS DATA ANALYSIS REVEALED THAT OF THE 28 IYM PRACTICES, 21 EXHIBITED SIGNIFICANT CONTENT VALIDITY (CUT-OFF VALUE: 0.42, AS CALCULATED BY APPLYING LAWSHE'S FORMULA FOR THE CVR). CONCLUSIONS THE IYM IS VALID FOR PD, WITH GOOD CONTENT VALIDITY. HOWEVER, FUTURE STUDIES MUST DETERMINE THE FEASIBILITY AND EFFICACY OF THE DEVELOPED MODULE.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
3  622  36 DEVELOPMENT, VALIDATION, AND FEASIBILITY TESTING OF A YOGA MODULE FOR OPIOID USE DISORDER. CONTEXT: OPIOID USE DISORDER (OUD) INVOLVES EXCESSIVE USE OF OPIOIDS-SUCH AS HEROIN, MORPHINE, FENTANYL, CODEINE, OXYCODONE, AND HYDROCODONE-LEADING TO MAJOR HEALTH, SOCIAL, AND ECONOMIC CONSEQUENCES. YOGA LIFESTYLE INTERVENTIONS HAVE BEEN FOUND TO BE USEFUL AS ADJUNCT THERAPIES IN MANAGEMENT OF SUBSTANCE USE DISORDERS AND CHRONIC PAIN CONDITIONS. OBJECTIVE: THE RESEARCH TEAM INTENDED TO DEVELOP, VALIDATE, AND TEST FOR FEASIBILITY A YOGA PROGRAM FOR OUD PATIENTS THAT COULD REDUCE OPIATE WITHDRAWAL SYMPTOMS-SUCH AS PAIN, FATIGUE, LOW MOOD, ANXIETY AND SLEEP DISTURBANCES-AND CRAVINGS ASSOCIATED WITH DRUGS. DESIGN: THE RESEARCH TEAM FIRST PERFORMED A LITERATURE REVIEW OF TRADITIONAL AND CONTEMPORARY YOGA TEXTS, SUCH AS HATHA YOGA PRADIPIKA AND LIGHT ON YOGA, AS WELL AS MODERN SCIENTIFIC LITERATURE IN THE FOLLOWING SEARCH ENGINES-GOOGLE SCHOLAR, PUBMED, AND PSYCHINFO, USING THE KEYWORDS YOGA, PRANAYAMA, HATHA YOGA, RELAXATION. MEDITATION, SUBSTANCE USE, ADDICTION, IMPULSIVITY, CRAVING, SLEEP QUALITY, AND FATIGUE. USING THE INFORMATION OBTAINED, THE TEAM DEVELOPED A YOGA PROGRAM AND DESIGNED A PILOT STUDY THAT USED THE PROGRAM. SETTING: THE STUDY TOOK PLACE IN THE DEPARTMENT OF INTEGRATIVE MEDICINE AT THE NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES (NIMHANS) IN BANGALORE, INDIA. PARTICIPANTS: PARTICIPANTS IN THE PILOT STUDY WERE 8 INPATIENTS, 6 MALES AND 2 FEMALES, WHO WERE ON OPIOID AGONIST TREATMENT (BUPRENORPHINE) FOR OUD. INTERVENTION: THE INTERVENTION WAS THE YOGA PROGRAM PREVIOUSLY VALIDATED BY THE RESEARCH TEAM. IN THE PILOT STUDY, PARTICIPANTS WERE TAUGHT A ONE-HOUR, YOGA-BASED INTERVENTION, WITH SESSIONS OCCURRING ONCE PER DAY, FOR 10 SESSIONS. OUTCOME MEASURES: FOR VALIDATION, 13 EXPERTS SCORED THE YOGA PROGRAM THAT THE RESEARCH TEAM HAD DEVELOPED AND GAVE SUGGESTIONS FOR EACH YOGIC PRACTICE FOR USE DURING THE ACUTE PHASE OF WITHDRAWAL AND THE MAINTENANCE PHASE RESPECTIVELY. A CONTENT VALIDITY RATIO (CVR) WAS CALCULATED FROM THEIR SCORING, AND THE RESEARCH TEAM MADE CHANGES TO THE PROGRAM BASE ON THE SCORING AND SUGGESTIONS. FOR THE PILOT STUDY, ASSESSMENTS OCCURRED AT BASELINE AND POSTINTERVENTION. THE PARTICIPANTS' YOGA PERFORMANCE WAS RATED BY THE YOGA TRAINER ON A YOGA PERFORMANCE ASSESSMENT SCALE (YPA). OTHER MEASUREMENTS INCLUDED: (1) THE CLINICAL OPIATE WITHDRAWAL SCALE (COWS), (2) THE HAMILTON'S ANXIETY RATING SCALE (HAM-A), (3) THE HAMILTON'S DEPRESSION RATING SCALE (HAM-D), (4) BUPRENORPHINE DOSAGE, (5) THE CLINICAL GLOBAL IMPRESSION SEVERITY (CGI-S) SCALE, (6) A VISUAL ANALOG SCALE (VAS) FOR PAIN, (7) SLEEP QUALITY (LATENCY AND DURATION), AND (8) THE MODULE'S SAFETY. RESULTS: FOUR PRACTICES WERE REMOVED FROM THE PROGRAM DUE TO CVR SCORES BELOW THE CUTOFF, AND ONE PRACTICE WAS FOUND NOT TO BE FEASIBLE (KAPALABHATI). TWO CATEGORIES OF YOGA MODULES EMERGED: (1) FOR THE ACUTE SYMPTOMATIC PHASE (40 MINUTES) AND (2) FOR THE MAINTENANCE PHASE (ONE HOUR). PRACTICES WERE ADDED OR EXCLUDED BASED ON THE PHASE. CONCLUSIONS: THE YOGA MODULE THAT WAS DEVELOPED FOR REDUCING WITHDRAWAL SYMPTOMS AND CRAVINGS IN OUD PATIENTS WAS FOUND TO BE SAFE, FEASIBLE, AND POTENTIALLY USEFUL AS AN ADJUNCT THERAPY TO CONVENTIONAL TREATMENT.	2021	
                                                                                                                                                                                                                    
4  603  20 DEVELOPMENT AND VALIDATION OF INTEGRATED YOGA MODULE FOR OBESITY IN ADOLESCENTS. BACKGROUND: OBESITY IS A GROWING GLOBAL EPIDEMIC AND CAUSE OF NONCOMMUNICABLE DISEASES. YOGA IS ONE OF THE EFFECTIVE WAYS TO REDUCE STRESS WHICH IS ONE OF THE CAUSES OF OBESITY. NOWADAYS, CHILDREN IN ADOLESCENT AGE ARE MORE PRONE TO GET OBESE DUE TO LACK OF PHYSICAL ACTIVITY MAKING THEM MORE SEDENTARY. AIM: TO IDENTIFY THE DESIGN AND VALIDATION OF INTEGRATED APPROACH OF YOGA THERAPY MODULE (IAYTM) FOR OBESITY IN ADOLESCENTS. MATERIALS AND METHODS: FIRST PHASE - IAYTM FOR OBESITY WAS DESIGNED BASED ON THE LITERATURE REVIEW OF CLASSICAL TEXTS AND RECENTLY PUBLISHED RESEARCH ARTICLES. SECOND PHASE - DESIGNED IAYTM WAS VALIDATED BY 16 SUBJECT MATTER (YOGA) EXPERTS. CONTENT-VALIDITY RATIO (CVR) WAS ANALYZED USING LAWSHE'S FORMULA. RESULTS: YOGA PRACTICES WERE DESIGNED FOR INTEGRATED YOGA MODULE FOR OBESITY IN ADOLESCENTS. YOGA PRACTICES WITH CVR >/=0.5 AND WHICH WERE VALIDATED BY 16 YOGA EXPERTS AND APPROVED IN FACULTY GROUP DISCUSSION WERE INCLUDED IN FINAL INTEGRATED YOGA THERAPY MODULE. CONCLUSION: THE YOGA PRACTICES WERE DESIGNED AND VALIDATED FOR IAYTM FOR OBESITY IN ADOLESCENTS.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
5 2731  42 YOGA OFFERS CARDIOVASCULAR PROTECTION IN EARLY POSTMENOPAUSAL WOMEN. CONTEXT: POSTMENOPAUSE, AN ESTROGEN DEFICIENT STATE COMES WITH INCREASED INCIDENCE OF CARDIOVASCULAR DISEASES (CVDS). YOGA HAS BEEN DESCRIBED AS HAVING A BENEFICIAL EFFECT ON HEART RATE VARIABILITY (HRV), A MARKER FOR CARDIAC AUTONOMIC ACTIVITY WHICH CAN ASSESS CARDIOVASCULAR RISK, IN VARIOUS POPULATIONS. AIM: THE AIM OF THE STUDY WAS TO STUDY THE EFFECT OF 3-MONTH LONG YOGA PRACTICE ON HRV IN EARLY POSTMENOPAUSAL WOMEN. SETTINGS AND DESIGN: A PROSPECTIVE LONGITUDINAL STUDY OF 67 WOMEN WITHIN 5 YEARS OF MENOPAUSE BETWEEN 45 AND 60 YEARS OF AGE ATTENDING MENOPAUSE CLINIC OF DEPARTMENT OF GYNAECOLOGY, SUCHETA KRIPLANI HOSPITAL FULFILLING INCLUSION AND EXCLUSION CRITERIA AND CONSENTING WERE ENROLLED FOR THE STUDY. SUBJECTS AND METHODS: HRV OF 37 CASES (YOGA GROUP) AND 30 CONTROLS (NON-YOGA GROUP) WAS RECORDED PRE AND 3-MONTH POSTINTERVENTION. STATISTICAL ANALYSIS USED: GRAPHPAD PRISM VERSION 5 SOFTWARE WAS USED. VALUES ARE A MEAN AND STANDARD ERROR OF MEAN. STATISTICAL SIGNIFICANCE WAS SET UP AT P < 0.05. RESULTS: IN HRV, FREQUENCY DOMAIN ANALYSIS SHOWED A SIGNIFICANT FALL IN LOW FREQUENCY (LF) IN NORMALIZED UNITS (NU) AND LF: HIGH FREQUENCY (HF) RATIO AND SIGNIFICANT RISE IN HF IN NU IN THE YOGA GROUP (DEPICTING PARASYMPATHETIC DOMINANCE) AGAINST A SIGNIFICANT RISE IN LF (NU) AND LF: HF RATIO AND SIGNIFICANT FALL IN HF (NU) IN NON-YOGA GROUP (INDICATING SYMPATHETIC DOMINANCE). TIME DOMAIN ANALYSIS SHOWED A SIGNIFICANT DECREASE IN STANDARD DEVIATION OF NN INTERVALS IN NON-YOGA GROUP AGAINST NONSIGNIFICANT CHANGES IN YOGA GROUP INDICATING DETERIORATION IN PARASYMPATHETIC ACTIVITY IN NON-YOGA GROUP. CONCLUSIONS: THREE-MONTH LONG YOGA PRACTICE IMPROVED HRV IN EARLY POSTMENOPAUSAL WOMEN SIGNIFICANTLY AND HAS THE POTENTIAL TO ATTENUATE THE CVD RISK IN POSTMENOPAUSAL WOMEN.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
6  350  55 ASSESSMENT OF CARDIAC AUTONOMIC TONE FOLLOWING LONG SUDARSHAN KRIYA YOGA IN ART OF LIVING PRACTITIONERS. OBJECTIVE: THE BREATHING PROCESSES ARE KNOWN TO MODULATE CARDIAC AUTONOMIC TONE AND IMPROVE PSYCHOLOGICAL STATUS. WE INVESTIGATED CARDIAC AUTONOMIC TONE FOLLOWING LONG SUDARSHAN KRIYA YOGA (SKY) USING HEART RATE VARIABILITY (HRV) AND SKIN CONDUCTANCE LEVEL (SCL). METHODS: THIRTY HEALTHY VOLUNTEERS (AGE 28.3 +/- 8.4 YEARS; 23 M: 7 F) PARTICIPATED IN THE STUDY. ELECTROCARDIOGRAM (ECG) AND SCL WERE RECORDED FOR 5 MIN EACH, BEFORE AND AFTER LONG SKY. LONG SKY IS A COMBINATION OF PRANAYAMA AND CYCLIC RHYTHMIC BREATHING AND IS PERFORMED BY FOLLOWING THE GUIDED AUDIO INSTRUCTIONS. HRV ANALYSIS WAS USED FOR THE ASSESSMENT OF CARDIAC AUTONOMIC TONE. TIME AND FREQUENCY DOMAIN PARAMETERS OF HRV WERE CALCULATED BY USING RR INTERVAL OF ECG. SCL WAS ACQUIRED USING GALVANIC SKIN RESPONSE (GSR) AMPLIFIER OF POWERLAB IN MICROSEIMENS (MUS). RESULTS: TIME DOMAIN PARAMETERS OF HRV, INCLUDING MEAN RR INTERVAL (P = 0.000), RESPIRATORY SINUS ARRHYTHMIA (RSA) (P = 0.037), STANDARD DEVIATION OF ALL NN INTERVALS (SDNN) (P = 0.013), NN50 COUNT DIVIDED BY THE TOTAL NUMBER OF ALL NN INTERVALS (PNN50) (P = 0.004), AND SQUARE ROOT OF THE MEAN OF THE SUM OF THE SQUARES OF DIFFERENCES BETWEEN ADJACENT NN INTERVALS (RMSSD) (P = 0.002) INCREASED, AND MEAN HEART RATE DECREASED (P = 0.000) FOLLOWING LONG SKY. IN FREQUENCY DOMAIN ANALYSIS, POWER OF LOW-FREQUENCY (LF) COMPONENT (P = 0.010) AND LF/HF RATIO (P = 0.008) DECREASED SIGNIFICANTLY, WHEREAS POWER OF HIGH FREQUENCY (HF) SIGNIFICANTLY INCREASED (P = 0.010). SCL DECREASED FOLLOWING LONG SKY, ALTHOUGH IT DID NOT ATTAIN STATISTICAL SIGNIFICANCE. CONCLUSIONS: THE RESULTS SUGGEST THAT LONG SKY INDUCES SIGNIFICANT OSCILLATIONS IN CARDIAC AUTONOMIC TONE. PARASYMPATHETIC ACTIVITY INCREASES AND SYMPATHETIC ACTIVITY DECREASES AND SYMPATHOVAGAL BALANCE IMPROVES FOLLOWING LONG SKY. DECREASE IN SYMPATHETIC ACTIVITY IS ALSO DEMONSTRATED BY DECREASE IN CONDUCTANCE ALTHOUGH IT DID NOT REACH STATISTICAL SIGNIFICANCE. FROM THIS STUDY IT CAN BE CONCLUDED THAT LONG SKY HAS A BENEFICIAL EFFECT ON CARDIAC AUTONOMIC TONE, AND PSYCHOPHYSIOLOGICAL RELAXATION. IT MAY SERVE AS A TOOL TO IMPROVE HRV, WHICH IS THE MARKER OF CARDIOVASCULAR HEALTH.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
7  903  37 EFFECTIVENESS OF A YOGA-BASED LIFESTYLE PROTOCOL (YLP) IN PREVENTING DIABETES IN A HIGH-RISK INDIAN COHORT: A MULTICENTER CLUSTER-RANDOMIZED CONTROLLED TRIAL (NMB-TRIAL). INTRODUCTION: THOUGH SEVERAL LINES OF EVIDENCE SUPPORT THE UTILITY OF YOGA-BASED INTERVENTIONS IN DIABETES PREVENTION, MOST OF THESE STUDIES HAVE BEEN LIMITED BY METHODOLOGICAL ISSUES, PRIMARILY SAMPLE SIZE INADEQUACY. HENCE, WE TESTED THE EFFECTIVENESS OF YOGA-BASED LIFESTYLE INTERVENTION AGAINST DIABETES RISK REDUCTION IN MULTICENTRE, LARGE COMMUNITY SETTINGS OF INDIA, THROUGH A SINGLE-BLIND CLUSTER-RANDOMIZED CONTROLLED TRIAL, NIYANTRITA MADHUMEHA BHARAT ABHIYAN (NMB). RESEARCH DESIGN AND METHODS: NMB-TRIAL IS A MULTICENTRE CLUSTER-RANDOMIZED TRIAL CONDUCTED IN 80 CLUSTERS [COMPOSED OF RURAL UNITS (VILLAGES) AND URBAN UNITS (CENSUS ENUMERATION BLOCKS)] RANDOMLY ASSIGNED IN A 1:1 RATIO TO INTERVENTION AND CONTROL GROUPS. PARTICIPANTS WERE INDIVIDUALS (AGE, 20-70 YEARS) WITH PREDIABETES (BLOOD HBA1C VALUES IN THE RANGE OF 5.7-6.4%) AND IDRS >/= 60. THE INTERVENTION INCLUDED THE PRACTICE OF YOGA-BASED LIFESTYLE MODIFICATION PROTOCOL (YLP) FOR 9 CONSECUTIVE DAYS, FOLLOWED BY DAILY HOME AND WEEKLY SUPERVISED PRACTICES FOR 3 MONTHS. THE CONTROL CLUSTER RECEIVED STANDARD OF CARE ADVICE FOR DIABETES PREVENTION. STATISTICAL ANALYSES WERE PERFORMED ON AN INTENTION-TO-TREAT BASIS, USING AVAILABLE AND IMPUTED DATASETS. THE PRIMARY OUTCOME WAS THE CONVERSION FROM PREDIABETES TO DIABETES AFTER THE YLP INTERVENTION OF 3 MONTHS (DIAGNOSED BASED UPON HBA1C CUTOFF >6.5%). SECONDARY OUTCOME INCLUDED REGRESSION TO NORMOGLYCEMIA WITH HBA1C <5.7%. RESULTS: A TOTAL OF 3380 (75.96%) PARTICIPANTS WERE FOLLOWED UP AT 3 MONTHS. AT 3 MONTHS POST-INTERVENTION, OVERALL, DIABETES DEVELOPED IN 726 (21.44%) PARTICIPANTS. YLP WAS FOUND TO BE SIGNIFICANTLY EFFECTIVE IN HALTING PROGRESSION TO DIABETES AS COMPARED TO STANDARD OF CARE; ADJUSTED RRR WAS 63.81(95% CI = 56.55-69.85). THE YLP ALSO ACCELERATED REGRESSION TO NORMOGLYCEMIA [ADJUSTED ODDS RATIO (ADJOR) = 1.20 (95% CI, 1.02-1.43)]. IMPORTANTLY, YOUNGER PARTICIPANTS (</=40 YEARS) WERE FOUND TO REGRESS TO NORMOGLYCEMIA MORE EFFECTIVELY THAN THE OLDER PARTICIPANTS PINTERACTION<0.001. CONCLUSION: BASED ON THE SIGNIFICANT RISK REDUCTION DERIVED FROM THE LARGE SAMPLE SIZE, AND THE CAREFULLY DESIGNED RANDOMIZED YOGA-BASED INTERVENTION ON HIGH-RISK POPULATIONS, THE STUDY IS A PRELIMINARY BUT STRONG PROOF-OF-CONCEPT FOR YOGA AS A POTENTIAL LIFESTYLE-BASED TREATMENT TO CURB THE EPIDEMIC OF DIABETES. THE OBSERVED FINDINGS ALSO INDICATE A POTENTIAL OF YLP FOR DIABETES PREVENTION IN LOW/MODERATE RISK PROFILE INDIVIDUALS THAT NEEDS LARGE-SCALE VALIDATION. TRIAL REGISTRATION: CLINICAL TRIAL REGISTRATION NUMBER: CTRI/2018/03/012804.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
8  582  22 DESIGNING AND VALIDATION OF A YOGA-BASED MODULE FOR OBESITY WITH METABOLIC COMORBIDITIES. OBJECTIVES: OBESITY IS A CONDITION OF INCREASED ADIPOSE TISSUE IN THE BODY, WHICH IS COMMONLY ASSOCIATED WITH VARIOUS COMORBIDITIES LIKE DIABETES, HYPERTENSION, ARTHRITIS, BACK PAIN, AND MANY OTHERS. YOGA MODULES HAVE BEEN DESIGNED AND VALIDATED FOR OBESITY; HOWEVER, WE COULDN'T FIND ANY SPECIFIC MODULE FOR METABOLIC SYNDROME, A CONDITION WHICH INCLUDES OBESITY, DIABETES MELLITUS TYPE 2 AND/OR HYPERTENSION TOGETHER. KEEPING THIS IN VIEW, OUR STUDY AIMED TO DEVELOP AND VALIDATE A SPECIFIC GENERIC YOGA-BASED INTERVENTION MODULE FOR METABOLIC SYNDROME PATIENTS. MATERIALS AND METHODS: A YOGA MODULE WAS DESIGNED BASED ON TRADITIONAL AND CONTEMPORARY YOGA LITERATURE AS WELL AS PUBLISHED STUDIES. WE DERIVED THE YOGA PRACTICES FOR THE MODULE, FROM THESE YOGA TEXTS AND RESEARCH EVIDENCE WERE ALREADY AVAILABLE. THE YOGA MODULE WAS SENT TO 40 YOGA EXPERTS FOR THEIR VALIDATION. RESULTS: TWENTY-TWO EXPERTS GAVE THEIR OPINION ON THE USEFULNESS OF A YOGA MODULE FOR PATIENTS WITH METABOLIC SYNDROME WITH SOME SUGGESTIONS. OF THESE EXPERTS, 73% WERE MALES, AND 27% WERE FEMALES. YOGA THERAPY PRACTICES WITH CONTENT VALIDITY RATIO (CVR) >0.08 WERE INCLUDED IN THE FINAL MODULE. IN TOTAL, 86% (31 OF 36 ITEMS) OF THE ITEMS IN THE INITIAL MODULE WERE RETAINED. CONCLUSION: A SPECIFIC YOGA-BASED MODULE FOR METABOLIC SYNDROME WAS DESIGNED AND VALIDATED BY EXPERTS. FURTHER STUDIES ARE NEEDED TO CONFIRM THE EFFICACY AND CLINICAL UTILITY OF THE MODULE.ADDITIONAL CLINICAL VALIDATION IS SUGGESTED.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
9  625  31 DIABETIC YOGA PROTOCOL IMPROVES GLYCEMIC, ANTHROPOMETRIC AND LIPID LEVELS IN HIGH RISK INDIVIDUALS FOR DIABETES: A RANDOMIZED CONTROLLED TRIAL FROM NORTHERN INDIA. PURPOSE: TO STUDY THE EFFECTIVENESS OF DIABETIC YOGA PROTOCOL (DYP) AGAINST MANAGEMENT OF CARDIOVASCULAR RISK PROFILE IN A HIGH-RISK COMMUNITY FOR DIABETES, FROM CHANDIGARH, INDIA. METHODS: THE STUDY WAS A RANDOMIZED CONTROLLED TRIAL, CONDUCTED AS A SUB STUDY OF THE PAN INDIA TRIAL NIYANTRITA MADHUMEHA BHARATH (NMB). THE COHORT WAS IDENTIFIED THROUGH THE INDIAN DIABETES RISK SCORING (IDRS) (>/= 60) AND A TOTAL OF 184 INDIVIDUALS WERE RANDOMIZED INTO INTERVENTION (N = 91) AND CONTROL GROUPS (N = 93). THE DYP GROUP UNDERWENT THE SPECIFIC DYP TRAINING WHEREAS THE CONTROL GROUP FOLLOWED THEIR DAILY REGIMEN. THE STUDY OUTCOMES INCLUDED CHANGES IN GLYCEMIC AND LIPID PROFILE. ANALYSIS WAS DONE UNDER INTENT-TO-TREAT PRINCIPLE. RESULTS: THE 3 MONTHS DYP PRACTICE SHOWED DIVERSE RESULTS SHOWING GLYCEMIC AND LIPID PROFILE OF THE HIGH RISK INDIVIDUALS. THREE MONTHS OF DYP INTERVENTION WAS FOUND TO SIGNIFICANTLY REDUCE THE LEVELS OF POST-PRANDIAL GLUCOSE LEVELS (P = 0.035) AND LDL-C LEVELS (P = 0.014) AND WAIST CIRCUMFERENCE (P = 0.001). CONCLUSION: THE FINDINGS INDICATE THAT THE DYP INTERVENTION COULD IMPROVE THE METABOLIC STATUS OF THE HIGH-DIABETES-RISK INDIVIDUALS WITH RESPECT TO THEIR GLUCOSE TOLERANCE AND LIPID LEVELS, PARTIALLY EXPLAINED BY THE REDUCTION IN ABDOMINAL OBESITY. THE STUDY HIGHLIGHTS THE POTENTIAL ROLE OF YOGA INTERVENTION IN REAL TIME IMPROVEMENT OF CARDIOVASCULAR PROFILE IN A HIGH DIABETES RISK COHORT. TRIAL REGISTRATION: CTRI, CTRI/2018/03/012804. REGISTERED 01 MARCH 2018-RETROSPECTIVELY REGISTERED, HTTP://WWW.CTRI.NIC.IN/ CTRI/2018/03/012804.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
10 1578  47 MEASUREMENT OF THE EFFECT OF ISHA YOGA ON CARDIAC AUTONOMIC NERVOUS SYSTEM USING SHORT-TERM HEART RATE VARIABILITY. BACKGROUND: BENEFICIAL EFFECTS OF YOGA HAVE BEEN POSTULATED TO BE DUE TO MODULATION OF THE AUTONOMIC NERVOUS SYSTEM. OBJECTIVE: TO ASSESS THE EFFECT OF ISHA YOGA PRACTICES ON CARDIOVASCULAR AUTONOMIC NERVOUS SYSTEM THROUGH SHORT-TERM HEART RATE VARIABILITY (HRV). DESIGN OF THE STUDY: SHORT-TERM HRV OF LONG-TERM REGULAR HEALTHY 14 (12 MALES AND 2 FEMALES) ISHA YOGA PRACTITIONERS WAS COMPARED WITH THAT OF AGE- AND GENDER-MATCHED 14 (12 MALES AND 2 FEMALES) NON-YOGA PRACTITIONERS. METHODS AND MATERIALS: ECG LEAD II AND RESPIRATORY MOVEMENTS WERE RECORDED IN BOTH GROUPS USING POLYRITE DURING SUPINE REST FOR 5 MIN AND CONTROLLED DEEP BREATHING FOR 1 MINUTE. FREQUENCY DOMAIN ANALYSIS [RR INTERVAL IS THE MEAN OF DISTANCE BETWEEN SUBSEQUENT R WAVE PEAKS IN ECG], LOW FREQUENCY (LF) POWER, HIGH FREQUENCY (HF) POWER, LF NORMALIZED UNITS (NU), HF NU, LF/HF RATIO] AND TIME DOMAIN ANALYSIS [STANDARD DEVIATION OF NORMAL TO NORMAL INTERVAL (SDNN), SQUARE OF MEAN SQUARED DIFFERENCE OF SUCCESSIVE NORMAL TO NORMAL INTERVALS (RMSSD), NORMAL TO NORMAL INTERVALS WHICH ARE DIFFERING BY 50 MS (NN50), AND PERCENTAGE OF NN50 (PNN50)] OF HRV VARIABLES WERE ANALYZED FOR SUPINE REST. TIME DOMAIN ANALYSIS WAS RECORDED FOR DEEP BREATHING. RESULTS: RESULTS SHOWED STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN ISHA YOGA PRACTITIONERS AND CONTROLS IN BOTH FREQUENCY AND TIME DOMAIN ANALYSES OF HRV INDICES, WITH NO DIFFERENCE IN RESTING HEART RATE BETWEEN THE GROUPS. CONCLUSIONS: PRACTITIONERS OF ISHA YOGA SHOWED WELL-BALANCED BENEFICIAL ACTIVITY OF VAGAL EFFERENTS, AN OVERALL INCREASED HRV, AND SYMPATHOVAGAL BALANCE, COMPARED TO NON-YOGA PRACTITIONERS DURING SUPINE REST AND DEEP BREATHING.	2012	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
11 1803  31 PREVALENCE OF DIABETES AND ITS DETERMINANTS IN THE YOUNG ADULTS INDIAN POPULATION-CALL FOR YOGA INTERVENTION. BACKGROUND: THE YOUNG INDIAN POPULATION, WHICH CONSTITUTES 65% OF THE COUNTRY, IS FAST ADAPTING TO A NEW LIFESTYLE, WHICH WAS NOT KNOWN EARLIER. THEY ARE AT A HIGH RISK OF THE INCREASING BURDEN OF DIABETES AND ASSOCIATED COMPLICATIONS. THE NEW EVOLVING LIFESTYLE IS NOT ONLY AFFECTING PEOPLE'S HEALTH BUT ALSO MOUNTING THE MONETARY BURDEN ON A DEVELOPING COUNTRY SUCH AS INDIA. AIM: WE AIMED TO COLLECT INFORMATION REGARDING THE PREVALENCE OF RISK OF DIABETES IN YOUNG ADULTS (<35 YEARS) IN THE 29 MOST POPULOUS STATES AND UNION TERRITORIES (7 ZONES) OF INDIA, USING A VALIDATED QUESTIONNAIRE. METHODS: A USER-FRIENDLY QUESTIONNAIRE-BASED SURVEY USING A MOBILE APPLICATION WAS CONDUCTED ON ALL ADULTS IN THE 29 MOST POPULOUS STATES/UNION TERRITORIES OF INDIA, AFTER OBTAINING ETHICAL CLEARANCE FOR THE STUDY. HERE, WE REPORT THE ESTIMATION OF THE PREVALENCE OF THE RISK OF DIABETES AND SELF-REPORTED DIABETES ON 58,821 YOUNG INDIVIDUALS BELOW THE AGE OF 35 YEARS. RISK FOR DIABETES WAS ASSESSED USING A STANDARDIZED INSTRUMENT, THE INDIAN DIABETES RISK SCORE (IDRS), THAT HAS 4 FACTORS (AGE, FAMILY HISTORY OF DIABETES, WAIST CIRCUMFERENCE, AND PHYSICAL ACTIVITY). SPEARMAN'S CORRELATION COEFFICIENT WAS USED TO CHECK THE CORRELATIONS. RESULTS: THE PREVALENCE OF HIGH (IDRS SCORE > 60), MODERATE (IDRS SCORE 30-50), AND LOW (IDRS < 30) DIABETES RISK IN YOUNG ADULTS (<35 YEARS) WAS 10.2%, 33.1%, AND 56.7%, RESPECTIVELY. THOSE WITH HIGH-RISK SCORES WERE HIGHEST (14.4%) IN THE JAMMU ZONE AND LOWEST (4.1%) IN THE CENTRAL ZONE. THE PREVALENCE OF SELF-REPORTED DIABETES WAS 1.8% WITH A SMALL DIFFERENCE BETWEEN MEN (1.7%) AND WOMEN (1.9%), AND THE HIGHEST (8.4%) IN THOSE WITH A PARENTAL HISTORY OF DIABETES. THE SOUTH ZONE HAD THE HIGHEST (2.5%), AND THE NORTH WEST ZONE HAD THE LOWEST (4.4%) PREVALENCE. CONCLUSIONS: INDIAN YOUTH ARE AT HIGH RISK FOR DIABETES, WHICH CALLS FOR AN URGENT ACTION PLAN THROUGH INTENSIVE EFFORTS TO PROMOTE LIFESTYLE BEHAVIOR MODIFICATIONS DURING THE PANDEMICS OF BOTH COMMUNICABLE AND NONCOMMUNICABLE DISEASES.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
12  613  29 DEVELOPMENT OF A YOGA PROGRAM FOR TYPE-2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE IN INDIA. INTRODUCTION: MANY INDIANS ARE AT HIGH-RISK OF TYPE-2 DIABETES MELLITUS (T2DM). YOGA IS AN ANCIENT INDIAN MIND-BODY DISCIPLINE, THAT HAS BEEN ASSOCIATED WITH IMPROVED GLUCOSE LEVELS AND CAN HELP TO PREVENT T2DM. THE STUDY AIMED TO SYSTEMATICALLY DEVELOP A YOGA PROGRAM FOR T2DM PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE IN INDIA USING A COMPLEX INTERVENTION DEVELOPMENT APPROACH. MATERIALS AND METHODS: AS PART OF THE INTERVENTION, WE DEVELOPED A BOOKLET AND A HIGH-DEFINITION VIDEO FOR PARTICIPANTS AND A MANUAL FOR YOGA-DP INSTRUCTORS. A SYSTEMATIC ITERATIVE PROCESS WAS FOLLOWED TO DEVELOP THE INTERVENTION AND INCLUDED FIVE STEPS: (I) A SYSTEMATIC REVIEW OF THE LITERATURE TO GENERATE A LIST OF YOGIC PRACTICES THAT IMPROVES BLOOD GLUCOSE LEVELS AMONG ADULTS AT HIGH-RISK OF OR WITH T2DM, (II) VALIDATION OF IDENTIFIED YOGIC PRACTICES BY YOGA EXPERTS, (III) DEVELOPMENT OF THE INTERVENTION, (IV) CONSULTATION WITH YOGA, EXERCISE, PHYSICAL ACTIVITY, DIET, BEHAVIOR CHANGE, AND/OR DIABETES EXPERTS ABOUT THE INTERVENTION, AND (V) PRETEST THE INTERVENTION AMONG YOGA PRACTITIONERS AND LAY PEOPLE (THOSE AT RISK OF T2DM AND HAD NOT PRACTICED YOGA BEFORE) IN INDIA. RESULTS: YOGA-DP IS A STRUCTURED LIFESTYLE EDUCATION AND EXERCISE PROGRAM, PROVIDED OVER A PERIOD OF 24 WEEKS. THE EXERCISE PART IS BASED ON YOGA AND INCLUDES SHITHILIKARANA VYAYAMA (LOOSENING EXERCISES), SURYA NAMASKAR (SUN SALUTATION EXERCISES), ASANA (YOGIC POSES), PRANAYAMA (BREATHING PRACTICES), AND DHYANA (MEDITATION) AND RELAXATION PRACTICES. ONCE PARTICIPANTS COMPLETE THE PROGRAM, THEY ARE STRONGLY ENCOURAGED TO MAINTAIN A HEALTHY LIFESTYLE IN THE LONG-TERM. CONCLUSIONS: WE SYSTEMATICALLY DEVELOPED A NOVEL YOGA PROGRAM FOR T2DM PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE IN INDIA. A MULTI-CENTER FEASIBILITY RANDOMIZED CONTROLLED TRIAL IS IN PROGRESS IN INDIA.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
13  581  21 DESIGNING AND VALIDATION OF A YOGA-BASED INTERVENTION FOR SCHIZOPHRENIA. CONTEXT: SCHIZOPHRENIA IS A CHRONIC MENTAL ILLNESS WHICH CAUSES SIGNIFICANT DISTRESS AND DYSFUNCTION. YOGA HAS BEEN FOUND TO BE EFFECTIVE AS AN ADD-ON THERAPY IN SCHIZOPHRENIA. MODULES OF YOGA USED IN PREVIOUS STUDIES WERE BASED ON INDIVIDUAL RESEARCHER'S EXPERIENCE. AIM: THIS STUDY AIMED TO DEVELOP AND VALIDATE A SPECIFIC GENERIC YOGA-BASED INTERVENTION MODULE FOR PATIENTS WITH SCHIZOPHRENIA. THE STUDY WAS CONDUCTED AT NIMHANS INTEGRATED CENTRE FOR YOGA (NICY). MATERIALS AND METHODS: A YOGA MODULE WAS DESIGNED BASED ON TRADITIONAL AND CONTEMPORARY YOGA LITERATURE AS WELL AS PUBLISHED STUDIES. THE YOGA MODULE ALONG WITH THREE CASE VIGNETTES OF ADULT PATIENTS WITH SCHIZOPHRENIA WAS SENT TO 10 YOGA EXPERTS FOR THEIR VALIDATION. RESULTS: EXPERTS (N = 10) GAVE THEIR OPINION ON THE USEFULNESS OF A YOGA MODULE FOR PATIENTS WITH SCHIZOPHRENIA WITH SOME MODIFICATIONS. IN TOTAL, 87% (13 OF 15 ITEMS) OF THE ITEMS IN THE INITIAL MODULE WERE RETAINED, WITH MODIFICATION IN THE REMAINDER AS SUGGESTED BY THE EXPERTS. CONCLUSION: A SPECIFIC YOGA-BASED MODULE FOR SCHIZOPHRENIA WAS DESIGNED AND VALIDATED BY EXPERTS. FURTHER STUDIES ARE NEEDED TO CONFIRM EFFICACY AND CLINICAL UTILITY OF THE MODULE. ADDITIONAL CLINICAL VALIDATION IS SUGGESTED.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
14 2629  39 YOGA FOR THE PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE. BACKGROUND: A SEDENTARY LIFESTYLE AND STRESS ARE MAJOR RISK FACTORS FOR CARDIOVASCULAR DISEASE (CVD). SINCE YOGA INVOLVES EXERCISE AND IS THOUGHT TO HELP IN STRESS REDUCTION IT MAY BE AN EFFECTIVE STRATEGY IN THE PRIMARY PREVENTION OF CVD. OBJECTIVES: TO DETERMINE THE EFFECT OF ANY TYPE OF YOGA ON THE PRIMARY PREVENTION OF CVD. SEARCH METHODS: WE SEARCHED THE FOLLOWING ELECTRONIC DATABASES: THE COCHRANE CENTRAL REGISTER OF CONTROLLED TRIALS (CENTRAL) (2013, ISSUE 11) IN THE COCHRANE LIBRARY; MEDLINE (OVID) (1946 TO NOVEMBER WEEK 3 2013); EMBASE CLASSIC + EMBASE (OVID) (1947 TO 2013 WEEK 48); WEB OF SCIENCE (THOMSON REUTERS) (1970 TO 4 DECEMBER 2013); DATABASE OF ABSTRACTS OF REVIEWS OF EFFECTS (DARE), HEALTH TECHNOLOGY ASSESSMENT DATABASE AND HEALTH ECONOMICS EVALUATIONS DATABASE (ISSUE 4 OF 4, 2013) IN THE COCHRANE LIBRARY. WE ALSO SEARCHED A NUMBER OF ASIAN DATABASES AND THE ALLIED AND COMPLEMENTARY MEDICINE DATABASE (AMED) (INCEPTION TO DECEMBER 2012). WE SEARCHED TRIAL REGISTERS AND REFERENCE LISTS OF REVIEWS AND ARTICLES, AND APPROACHED EXPERTS IN THE FIELD. WE APPLIED NO LANGUAGE RESTRICTIONS. SELECTION CRITERIA: RANDOMISED CONTROLLED TRIALS LASTING AT LEAST THREE MONTHS INVOLVING HEALTHY ADULTS OR THOSE AT HIGH RISK OF CVD. TRIALS EXAMINED ANY TYPE OF YOGA AND THE COMPARISON GROUP WAS NO INTERVENTION OR MINIMAL INTERVENTION. OUTCOMES OF INTEREST WERE CLINICAL CVD EVENTS AND MAJOR CVD RISK FACTORS. WE DID NOT INCLUDE ANY TRIALS THAT INVOLVED MULTIFACTORIAL LIFESTYLE INTERVENTIONS OR WEIGHT LOSS. DATA COLLECTION AND ANALYSIS: TWO AUTHORS INDEPENDENTLY SELECTED TRIALS FOR INCLUSION, EXTRACTED DATA AND ASSESSED THE RISK OF BIAS. MAIN RESULTS: WE IDENTIFIED 11 TRIALS (800 PARTICIPANTS) AND TWO ONGOING STUDIES. STYLE AND DURATION OF YOGA DIFFERED BETWEEN TRIALS. HALF OF THE PARTICIPANTS RECRUITED TO THE STUDIES WERE AT HIGH RISK OF CVD. MOST OF STUDIES WERE AT RISK OF PERFORMANCE BIAS, WITH INADEQUATE DETAILS REPORTED IN MANY OF THEM TO JUDGE THE RISK OF SELECTION BIAS.NO STUDY REPORTED CARDIOVASCULAR MORTALITY, ALL-CAUSE MORTALITY OR NON-FATAL EVENTS, AND MOST STUDIES WERE SMALL AND SHORT-TERM. THERE WAS SUBSTANTIAL HETEROGENEITY BETWEEN STUDIES MAKING IT IMPOSSIBLE TO COMBINE STUDIES STATISTICALLY FOR SYSTOLIC BLOOD PRESSURE AND TOTAL CHOLESTEROL. YOGA WAS FOUND TO PRODUCE REDUCTIONS IN DIASTOLIC BLOOD PRESSURE (MEAN DIFFERENCE (MD) -2.90 MMHG, 95% CONFIDENCE INTERVAL (CI) -4.52 TO -1.28), WHICH WAS STABLE ON SENSITIVITY ANALYSIS, TRIGLYCERIDES (MD -0.27 MMOL/L, 95% CI -0.44 TO -0.11) AND HIGH-DENSITY LIPOPROTEIN (HDL) CHOLESTEROL (MD 0.08 MMOL/L, 95% CI 0.02 TO 0.14). HOWEVER, THE CONTRIBUTING STUDIES WERE SMALL, SHORT-TERM AND AT UNCLEAR OR HIGH RISK OF BIAS. THERE WAS NO CLEAR EVIDENCE OF A DIFFERENCE BETWEEN GROUPS FOR LOW-DENSITY LIPOPROTEIN (LDL) CHOLESTEROL (MD -0.09 MMOL/L, 95% CI -0.48 TO 0.30), ALTHOUGH THERE WAS MODERATE STATISTICAL HETEROGENEITY. ADVERSE EVENTS, OCCURRENCE OF TYPE 2 DIABETES AND COSTS WERE NOT REPORTED IN ANY OF THE INCLUDED STUDIES. QUALITY OF LIFE WAS MEASURED IN THREE TRIALS BUT THE RESULTS WERE INCONCLUSIVE. AUTHORS' CONCLUSIONS: THE LIMITED EVIDENCE COMES FROM SMALL, SHORT-TERM, LOW-QUALITY STUDIES. THERE IS SOME EVIDENCE THAT YOGA HAS FAVOURABLE EFFECTS ON DIASTOLIC BLOOD PRESSURE, HDL CHOLESTEROL AND TRIGLYCERIDES, AND UNCERTAIN EFFECTS ON LDL CHOLESTEROL. THESE RESULTS SHOULD BE CONSIDERED AS EXPLORATORY AND INTERPRETED WITH CAUTION.	2014	

15 1318  44 HEART RATE VARIABILITY IN CHRONIC LOW BACK PAIN PATIENTS RANDOMIZED TO YOGA OR STANDARD CARE. BACKGROUND: CHRONIC PAIN CAN ALTER THE AUTONOMIC BALANCE WITH INCREASED SYMPATHETIC ACTIVITY REFLECTED IN ALTERED HEART RATE VARIABILITY (HRV). IT HAS BEEN PROPOSED THAT YOGA CAN BE USEFUL TO CORRECT THE AUTONOMIC IMBALANCE IN PATIENTS WITH CHRONIC PAIN WHO HAVE REDUCED HRV. METHODS AND DESIGNS: IN THE PRESENT RANDOMIZED CONTROLLED TRIAL 62 PATIENTS WITH CHRONIC LOW BACK PAIN ASSOCIATED WITH ALTERED ALIGNMENT OF INTERVERTEBRAL DISCS (AGED BETWEEN 20 AND 45 YEARS, 32 MALES) WERE RANDOMIZED TO 2 GROUPS. ONE GROUP RECEIVED YOGA FOR 3 MONTHS WHILE THE OTHER GROUP CARRIED OUT STANDARD MEDICAL CARE BASED ON THE PHYSICIAN'S ADVICE. THE DURATION WAS THE SAME, I.E., 3 MONTHS. THE HEART RATE VARIABILITY AND RATE OF RESPIRATION WERE ASSESSED AT BASELINE AND AT THE END OF 3 MONTHS. RESULTS: THERE WAS A SIGNIFICANT DIFFERENCE IN THE BASELINE (PRE) VALUES BETWEEN GROUPS (P = 0.008) FOR RESPIRATION RATE WHICH WAS HIGHER IN THE YOGA GROUP. THE CHANGES REPORTED BELOW ARE PRE-POST COMPARISONS WITHIN EACH GROUP. THE YOGA GROUP SHOWED A SIGNIFICANT (P < 0.05; REPEATED MEASURES ANOVA, POST-HOC ANALYSES) DECREASE IN THE LF POWER OF HRV, RATE OF RESPIRATION AND A SIGNIFICANT INCREASE IN THE HF POWER OF HRV AND IN THE PNN50. CONCLUSION: THE RESULTS SUGGEST THAT YOGA PRACTICE CAN SHIFT THE AUTONOMIC BALANCE TOWARDS VAGAL DOMINANCE IN PATIENTS WITH CHRONIC LOW BACK PAIN ASSOCIATED WITH ALTERED ALIGNMENT OF INTERVERTEBRAL DISCS. TRIAL REGISTRATION: THE STUDY IS REGISTERED WITH THE CLINICAL TRIALS REGISTRY OF INDIA ( CTRI/2012/11/003094 ) AND CAN BE ACCESSED AT.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
16  584  37 DESIGNING, VALIDATION, AND FEASIBILITY OF A YOGA MODULE FOR PATIENTS WITH ANKYLOSING SPONDYLITIS. BACKGROUND: ANKYLOSING SPONDYLITIS (AS) IS A CHRONIC INFLAMMATORY DISEASE THAT CAUSES SIGNIFICANT DISABILITY AND REDUCED QUALITY OF LIFE. SCIENTIFIC STUDIES ON YOGA HAVE REVEALED ITS VARIOUS HEALTH BENEFITS IN CHRONIC CONDITIONS, INCLUDING AUTOIMMUNE DISEASES. HOWEVER, WHETHER YOGA IS FEASIBLE FOR AS PATIENTS OR NOT IS NOT STUDIED. FURTHER, NO VALIDATED YOGA MODULE IS AVAILABLE FOR AS PATIENTS. OBJECTIVE(S): THIS STUDY INTENDED TO DEVELOP A YOGA MODULE FOR AS PATIENTS AND INVESTIGATED ITS FEASIBILITY OF USE. MATERIALS AND METHODS: THE STUDY WAS COMPLETED IN THREE STAGES. IN STAGE I, SIX YOGA EXPERTS PREPARED A LIST OF 64 YOGA PRACTICES BASED ON THE CLASSICAL AND CONTEMPORARY YOGIC LITERATURE REVIEW. OF THESE PRACTICES, 41 WERE INCLUDED IN THE DESIGNED YOGA MODULE. IN STAGE II, 41 EXPERTS WITH A MINIMUM OF FIVE YEARS OF EXPERIENCE IN YOGA THERAPY WERE INVITED FOR YOGA MODULE VALIDATION. THE USEFULNESS OF THE PRACTICES WAS RATED BY EXPERTS ON A 3-POINT SCALE (1: NOT AT ALL USEFUL, 2: MODERATELY USEFUL, AND 3: VERY MUCH USEFUL). THE LAWSHE CONTENT VALIDITY RATIO (CVR) METHOD WAS USED FOR THE CONTENT VALIDITY OF THE YOGA MODULE. PRACTICES WITH A CVR SCORE OF > 0.3 WERE RETAINED IN THE FINAL YOGA MODULE. IN STAGE III, A CERTIFIED YOGA INSTRUCTOR ADMINISTERED THE VALIDATED YOGA MODULE TO 19 AS PATIENTS (AVERAGE AGE: 35.5 +/- 10.7 YEARS) THRICE WEEKLY FOR A MONTH. FEASIBILITY WAS ASSESSED ON THE BASIS OF THE ATTRITION RATE, RETENTION RATE, ATTENDANCE OF THE PARTICIPANTS, AND THE SUBJECTIVE RESPONSE ON PRACTICAL SESSIONS USING A STRUCTURED CHECKLIST. RESULTS: OF THE 41 PRACTICES IN THE MODULE, 31 HAD A CVR SCORE OF > 0.3 AND WERE INCLUDED IN THE FINAL YOGA MODULE. OF THE 25 PARTICIPANTS, 19 (76%) COMPLETED THE STUDY WHILE SIX DROPPED OUT (24%). NINETEEN PATIENTS REPORTED GREATER IMPROVEMENT IN PAIN AND FLEXIBILITY. THEY FOUND YOGA RELAXING AND EASY TO PRACTICE. MOST PARTICIPANTS (65%) WERE ABLE TO PRACTICE A MINIMUM OF 30 MIN/DAY. CONCLUSION: THE PRESENT STUDY OFFERS A VALIDATED YOGA MODULE CONSISTING OF 31 PRACTICES FOR AS PATIENTS. THE RESULTS OF THE PILOT SUGGESTED THAT THE MODULE IS FEASIBLE, ACCEPTABLE, AND EASY TO PRACTICE FOR AS PATIENTS. WE RECOMMEND THAT AS PATIENTS SHOULD PRACTICE THIS YOGA MODULE FOR A MINIMUM OF 30 MIN EVERY DAY UNDER THE SUPERVISION OF A YOGA EXPERT.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
17 2857  28 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
18 2829  41 YOGA VERSUS STANDARD CARE FOR SCHIZOPHRENIA. BACKGROUND: YOGA IS AN ANCIENT SPIRITUAL PRACTICE THAT ORIGINATED IN INDIA AND IS CURRENTLY ACCEPTED IN THE WESTERN WORLD AS A FORM OF RELAXATION AND EXERCISE. IT HAS BEEN OF INTEREST FOR PEOPLE WITH SCHIZOPHRENIA TO DETERMINE ITS EFFICACY AS AN ADJUNCT TO STANDARD-CARE TREATMENT. OBJECTIVES: TO EXAMINE THE EFFECTS OF YOGA VERSUS STANDARD CARE FOR PEOPLE WITH SCHIZOPHRENIA. SEARCH METHODS: WE SEARCHED THE COCHRANE SCHIZOPHRENIA GROUP TRIALS REGISTER (NOVEMBER 2012 AND JANUARY 29, 2015), WHICH IS BASED ON REGULAR SEARCHES OF MEDLINE, PUBMED, EMBASE, CINAHL, BIOSIS, AMED, PSYCINFO, AND REGISTRIES OF CLINICAL TRIALS. WE SEARCHED THE REFERENCES OF ALL INCLUDED STUDIES. THERE WERE NO LANGUAGE, DATE, DOCUMENT TYPE, OR PUBLICATION STATUS LIMITATIONS FOR INCLUSION OF RECORDS IN THE REGISTER. SELECTION CRITERIA: ALL RANDOMISED CONTROLLED TRIALS (RCTS) INCLUDING PEOPLE WITH SCHIZOPHRENIA COMPARING YOGA TO STANDARD-CARE CONTROL. DATA COLLECTION AND ANALYSIS: THE REVIEW TEAM INDEPENDENTLY SELECTED STUDIES, QUALITY RATED THESE, AND EXTRACTED DATA. FOR BINARY OUTCOMES, WE CALCULATED RISK RATIO (RR) AND ITS 95% CONFIDENCE INTERVAL (CI), ON AN INTENTION-TO-TREAT BASIS. FOR CONTINUOUS DATA, WE ESTIMATED THE MEAN DIFFERENCE (MD) BETWEEN GROUPS AND ITS 95% CI. WE EMPLOYED MIXED-EFFECT AND FIXED-EFFECT MODELS FOR ANALYSES. WE EXAMINED DATA FOR HETEROGENEITY (I(2) TECHNIQUE), ASSESSED RISK OF BIAS FOR INCLUDED STUDIES, AND CREATED 'SUMMARY OF FINDINGS' TABLES USING GRADE (GRADING OF RECOMMENDATIONS ASSESSMENT, DEVELOPMENT AND EVALUATION). MAIN RESULTS: WE INCLUDED EIGHT STUDIES IN THE REVIEW. ALL OUTCOMES WERE SHORT TERM (LESS THAN SIX MONTHS). THERE WERE CLEAR DIFFERENCES IN A NUMBER OF OUTCOMES IN FAVOUR OF THE YOGA GROUP, ALTHOUGH THESE WERE BASED ON ONE STUDY EACH, WITH THE EXCEPTION OF LEAVING THE STUDY EARLY. THESE INCLUDED MENTAL STATE (IMPROVEMENT IN POSITIVE AND NEGATIVE SYNDROME SCALE, 1 RCT, N = 83, RR 0.70 CI 0.55 TO 0.88, MEDIUM-QUALITY EVIDENCE), SOCIAL FUNCTIONING (IMPROVEMENT IN SOCIAL OCCUPATIONAL FUNCTIONING SCALE, 1 RCT, N = 83, RR 0.88 CI 0.77 TO 1, MEDIUM-QUALITY EVIDENCE), QUALITY OF LIFE (AVERAGE CHANGE 36-ITEM SHORT FORM SURVEY (SF-36) QUALITY-OF-LIFE SUBSCALE, 1 RCT, N = 60, MD 15.50, 95% CI 4.27 TO 26.73, LOW-QUALITY EVIDENCE), AND LEAVING THE STUDY EARLY (8 RCTS, N = 457, RR 0.91 CI 0.6 TO 1.37, MEDIUM-QUALITY EVIDENCE). FOR THE OUTCOME OF PHYSICAL HEALTH, THERE WAS NOT A CLEAR DIFFERENCE BETWEEN GROUPS (AVERAGE CHANGE SF-36 PHYSICAL-HEALTH SUBSCALE, 1 RCT, N = 60, MD 6.60, 95% CI -2.44 TO 15.64, LOW-QUALITY EVIDENCE). ONLY ONE STUDY REPORTED ADVERSE EFFECTS, FINDING NO INCIDENCE OF ADVERSE EVENTS IN EITHER TREATMENT GROUP. THIS REVIEW WAS SUBJECT TO A CONSIDERABLE NUMBER OF MISSING OUTCOMES, WHICH INCLUDED GLOBAL STATE, CHANGE IN COGNITION, COSTS OF CARE, EFFECT ON STANDARD CARE, SERVICE INTERVENTION, DISABILITY, AND ACTIVITIES OF DAILY LIVING. AUTHORS' CONCLUSIONS: EVEN THOUGH WE FOUND SOME POSITIVE EVIDENCE IN FAVOUR OF YOGA OVER STANDARD-CARE CONTROL, THIS SHOULD BE INTERPRETED CAUTIOUSLY IN VIEW OF OUTCOMES LARGELY BASED EACH ON ONE STUDY WITH LIMITED SAMPLE SIZES AND SHORT-TERM FOLLOW-UP. OVERALL, MANY OUTCOMES WERE NOT REPORTED AND EVIDENCE PRESENTED IN THIS REVIEW IS OF LOW TO MODERATE QUALITY - -TOO WEAK TO INDICATE THAT YOGA IS SUPERIOR TO STANDARD-CARE CONTROL FOR THE MANAGEMENT OF SCHIZOPHRENIA.	2015	
                                                                           
19  614  29 DEVELOPMENT OF A YOGA-BASED CARDIAC REHABILITATION (YOGA-CARE) PROGRAMME FOR SECONDARY PREVENTION OF MYOCARDIAL INFARCTION. CARDIAC REHABILITATION (CR) AFTER MYOCARDIAL INFARCTION IS HIGHLY EFFECTIVE. IT IS UNAVAILABLE IN PUBLIC HOSPITALS IN INDIA DUE TO LIMITED RESOURCES. OUR OBJECTIVE WAS TO DEVELOP A SCALABLE MODEL OF CR FOR INDIA BASED ON YOGA, WHICH COULD ALSO APPEAL TO SOME GROUPS WITH LOW UPTAKE OF CR (E.G., ETHNIC MINORITIES, WOMEN, AND OLDER PEOPLE) GLOBALLY. THE INTERVENTION WAS DEVELOPED USING A STRUCTURED PROCESS. A LITERATURE REVIEW AND CONSULTATIONS WITH YOGA EXPERTS, CR EXPERTS, AND POSTMYOCARDIAL INFARCTION PATIENTS WERE CONDUCTED TO SYSTEMATICALLY IDENTIFY AND SHORTLIST APPROPRIATE YOGA EXERCISES AND POSTURES, BREATHING EXERCISES, MEDITATION AND RELAXATION PRACTICES, AND LIFESTYLE CHANGES, WHICH WERE INCORPORATED INTO A CONVENTIONAL CR FRAMEWORK. THE DRAFT INTERVENTION WAS FURTHER REFINED BASED ON THE FEEDBACK FROM AN INTERNAL STAKEHOLDER GROUP AND AN EXTERNAL PANEL OF INTERNATIONAL EXPERTS, BEFORE BEING PILOTED WITH YOGA INSTRUCTORS AND PATIENTS WITH MYOCARDIAL INFARCTION. A FOUR-PHASE YOGA-BASED CR (YOGA-CARE) PROGRAMME WAS DEVELOPED FOR DELIVERY BY A SINGLE YOGA INSTRUCTOR WITH BASIC TRAINING. THE PROGRAMME CONSISTS OF A TOTAL OF 13 INSTRUCTOR-LED SESSIONS (2 INDIVIDUAL AND 11 GROUP) OVER A 3-MONTH PERIOD. GROUP SESSIONS INCLUDE GUIDED PRACTICE OF YOGA EXERCISES AND POSTURES, BREATHING EXERCISES, AND MEDITATION AND RELAXATION PRACTICES, AND SUPPORT FOR THE LIFESTYLE CHANGE AND COPING THROUGH A MODERATED DISCUSSION. PATIENTS ARE ENCOURAGED TO SELF-PRACTICE DAILY AT HOME AND CONTINUE LONG-TERM WITH THE HELP OF A BOOKLET AND DIGITAL VIDEO DISC (DVD). FAMILY MEMBERS/CARERS ARE ENCOURAGED TO JOIN THROUGHOUT. IN CONCLUSION, A NOVEL YOGA-BASED CR PROGRAMME HAS BEEN DEVELOPED, WHICH PROMISES TO PROVIDE A SCALABLE CR SOLUTION FOR INDIA AND AN ALTERNATIVE CHOICE FOR CR GLOBALLY. IT IS CURRENTLY BEING EVALUATED IN A LARGE MULTICENTRE RANDOMISED CONTROLLED TRIAL ACROSS INDIA.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
20 2831  24 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