1 908 168 EFFECTIVENESS OF DEEP CERVICAL FASCIAL MANIPULATION AND YOGA POSTURES ON PAIN, FUNCTION, AND OCULOMOTOR CONTROL IN PATIENTS WITH MECHANICAL NECK PAIN: STUDY PROTOCOL OF A PRAGMATIC, PARALLEL-GROUP, RANDOMIZED, CONTROLLED TRIAL. INTRODUCTION: MECHANICAL NECK PAIN (MNP) IS A COMMONLY OCCURRING MUSCULOSKELETAL CONDITION THAT IS USUALLY MANAGED USING ELECTRICAL MODALITIES, JOINT MOBILIZATION TECHNIQUES, AND THERAPEUTIC EXERCISES, BUT HAS LIMITED EVIDENCE OF THEIR EFFICACY. PATHOLOGY (DENSIFICATION) OF THE DEEP CERVICAL FASCIA THAT OCCURS DUE TO THE INCREASED VISCOSITY OF HYALURONIC ACID (HA) MAY INDUCE NECK PAIN AND ASSOCIATED PAINFUL SYMPTOMS OF THE UPPER QUARTER REGION. FASCIAL MANIPULATION (FM) AND YOGA POSES ARE CONSIDERED TO REDUCE THE THIXOTROPY OF THE GROUND SUBSTANCES OF THE DEEP FASCIA AND IMPROVE MUSCLE FUNCTION. THE PURPOSE OF THIS STUDY IS TO INVESTIGATE THE EFFECT OF FM AND SEQUENTIAL YOGA POSES (SYP) WHEN COMPARED TO THE USUAL CARE ON PAIN, FUNCTION, AND OCULOMOTOR CONTROL IN MNP. METHODS: THIS FACE-MAN TRIAL WILL RECRUIT 160 PATIENTS WITH SUBACUTE AND CHRONIC MECHANICAL NECK PAIN DIAGNOSED USING PREDEFINED CRITERIA. PARTICIPANTS WILL BE RANDOMIZED TO EITHER THE INTERVENTION GROUP OR THE USUAL CARE GROUP, USING A RANDOM ALLOCATION RATIO OF 1:1. PATIENTS IN THE INTERVENTION GROUP WILL RECEIVE FM (4 SESSIONS IN 4 WEEKS) AND SYP (12 WEEKS) WHEREAS THE STANDARD CARE GROUP WILL RECEIVE CERVICAL MOBILIZATION/ THORACIC MANIPULATION (4 SESSIONS IN 4 WEEKS) AND THERAPEUTIC EXERCISES (12 WEEKS). THE PRIMARY OUTCOME IS THE CHANGE IN THE NUMERIC PAIN RATING SCALE (NPRS). THE SECONDARY OUTCOMES INCLUDE CHANGES IN THE PATIENT-SPECIFIC FUNCTIONAL SCALE AND OCULOMOTOR CONTROL, MYOFASCIAL STIFFNESS, FEAR-AVOIDANCE BEHAVIOR QUESTIONNAIRE, AND ELBOW EXTENSION RANGE OF MOTION DURING NEURODYNAMICS TEST 1. DISCUSSION: IF FOUND EFFECTIVE, FM ALONG WITH SYP INVESTIGATED IN THIS TRIAL CAN BE CONSIDERED AS A TREATMENT STRATEGY IN THE MANAGEMENT OF MECHANICAL NECK PAIN. CONSIDERING THE MAGNITUDE OF THE PROBLEM, AND THE PRAGMATIC AND PATIENT-CENTERED APPROACH TO BE FOLLOWED, IT IS WORTH INVESTIGATING THIS TRIAL. TRIAL REGISTRATION: CLINICALTRIALS.GOV CTRI/2020/01/022934 . REGISTERED ON JANUARY 24, 2020 WITH CTRI.NIC.IN. CLINICAL TRIALS REGISTRY - INDIA. 2021 2 2662 41 YOGA IN BURN: ROLE OF PRANAYAMA BREATHING EXERCISE ON PULMONARY FUNCTION, RESPIRATORY MUSCLE ACTIVITY AND EXERCISE TOLERANCE IN FULL-THICKNESS CIRCUMFERENTIAL BURNS OF THE CHEST. BACKGROUND: CIRCUMFERENTIAL BURN OF CHEST (CBC) IS A SIGNIFICANT TYPE OF BURN AND CONSIDERS AS A MAJOR CAUSE OF RESTRICTIVE LUNG DISEASE (RLD). PATIENT WHO HAS CBC WITH RLD LEADS TO RESPIRATORY SYMPTOMS SUCH AS BREATHING DIFFICULTY, AIRWAY OBSTRUCTION, REDUCED EXERCISE CAPACITY AND ALTERED PULMONARY FUNCTIONS. HOWEVER, STUDIES EXAMINING THE ROLE OF PRANAYAMA BREATHING EXERCISE ON PULMONARY FUNCTION, RESPIRATORY MUSCLE ACTIVITY AND EXERCISE TOLERANCE IN FULL THICKNESS CIRCUMFERENTIAL BURN OF CHEST ARE LACKING. OBJECTIVE: TO FIND THE SHORT TERM EFFECTS OF PRANAYAMA BREATHING EXERCISE ON PULMONARY FUNCTION, RESPIRATORY MUSCLE ACTIVITY AND EXERCISE TOLERANCE IN FULL THICKNESS CIRCUMFERENTIAL BURNS OF CHEST. METHODS: THROUGH SIMPLE RANDOM SAMPLING METHOD THIRTY SUBJECTS (N = 30) WITH RLD FOLLOWING CBC WERE ALLOCATED TO PRANAYAMA BREATHING EXERCISE GROUP (PBE-G; N = 15) AND CONVENTIONAL BREATHING EXERCISE GROUP (CBE-G; N = 15). THEY RECEIVED PRANAYAMA BREATHING EXERCISE AND CONVENTIONAL BREATHING EXERCISE FOR 4 WEEKS RESPECTIVELY. ALL THE SUBJECTS RECEIVED CHEST MOBILITY EXERCISE AS COMMON TREATMENT. PRIMARY (NUMERIC PAIN RATING SCALE - NPRS, FORCED EXPIRATORY VOLUME (FEV1), FORCED VITAL CAPACITY (FVC) AND MAXIMUM VOLUNTARY VENTILATION (MVV) AND SECONDARY (ELECTROMYOGRAM OF STERNOCLEIDOMASTOID, SCALENE, EXTERNAL INTERCOSTAL AND DIAPHRAGM MUSCLE, 6 MIN WALK TEST & GLOBAL RATING OF CHANGE - GRC) OUTCOME MEASURES WERE MEASURED AT BASELINE, AFTER FOUR WEEKS AND AFTER THREE MONTHS FOLLOW UP. RESULTS: BASELINE DEMOGRAPHIC AND CLINICAL VARIABLES SHOW HOMOGENOUS DISTRIBUTION BETWEEN THE GROUPS (P > 0.05). FOUR WEEKS FOLLOWING DIFFERENT BREATHING EXERCISES, PBE-G GROUP SHOWS MORE SIGNIFICANT CHANGES IN PAIN INTENSITY, PULMONARY FUNCTION, RESPIRATORY MUSCLE ACTIVITY, EXERCISE TOLERANCE AND GLOBAL RATING OF CHANGE THAN CBE-G GROUP (P /=3/10 ON THE NUMERIC PAIN RATING SCALE FOR >3 MONTHS (CONTROLS N=17, PILATES N=20, YOGA N=19). INTERVENTIONS: EXERCISE PARTICIPANTS COMPLETED 12 SMALL-GROUP SESSIONS WITH MODIFICATIONS AND PROGRESSIONS SUPERVISED BY A PHYSIOTHERAPIST. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME MEASURE WAS THE NECK DISABILITY INDEX (NDI). SECONDARY OUTCOMES WERE PAIN RATINGS, RANGE OF MOVEMENT AND POSTURAL MEASUREMENTS COLLECTED AT BASELINE, 6 WEEKS AND 12 WEEKS. FOLLOW-UP WAS PERFORMED 6 WEEKS AFTER COMPLETION OF THE EXERCISE CLASSES (WEEK 18). RESULTS: NDI DECREASED SIGNIFICANTLY IN THE PILATES {BASELINE: 11.1 [STANDARD DEVIATION (SD) 4.3] VS WEEK 12: 6.8 (SD 4.3); MEAN DIFFERENCE -4.3 (95% CONFIDENCE INTERVAL -1.64 TO -6.7); P<0.001} AND YOGA GROUPS [BASELINE: 12.8 (SD 7.4) VS WEEK 12: 8.1 (SD 5.6); MEAN DIFFERENCE -4.7 (95% CONFIDENCE INTERVAL -2.1 TO -7.4); P<0.00], WITH NO CHANGE IN THE CONTROL GROUP. PAIN RATINGS ALSO IMPROVED SIGNIFICANTLY. MODERATE-TO-LARGE EFFECT SIZES (0.7 TO 1.8) AND LOW NUMBERS NEEDED TO TREAT WERE FOUND. THERE WERE NO DIFFERENCES IN OUTCOMES BETWEEN THE EXERCISE GROUPS OR ASSOCIATED ADVERSE EFFECTS. NO IMPROVEMENTS IN RANGE OF MOVEMENT OR POSTURE WERE FOUND. CONCLUSIONS: PILATES AND YOGA GROUP EXERCISE INTERVENTIONS WITH APPROPRIATE MODIFICATIONS AND SUPERVISION WERE SAFE AND EQUALLY EFFECTIVE FOR DECREASING DISABILITY AND PAIN COMPARED WITH THE CONTROL GROUP FOR INDIVIDUALS WITH MILD-TO-MODERATE CNP. PHYSIOTHERAPISTS MAY CONSIDER INCLUDING THESE APPROACHES IN A PLAN OF CARE. CLINICAL TRIAL REGISTRATION NUMBER: CLINICALTRIALS.GOV NCT01999283. 2016 4 521 44 COMPARING YOGA, EXERCISE, AND A SELF-CARE BOOK FOR CHRONIC LOW BACK PAIN: A RANDOMIZED, CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN IS A COMMON PROBLEM THAT HAS ONLY MODESTLY EFFECTIVE TREATMENT OPTIONS. OBJECTIVE: TO DETERMINE WHETHER YOGA IS MORE EFFECTIVE THAN CONVENTIONAL THERAPEUTIC EXERCISE OR A SELF-CARE BOOK FOR PATIENTS WITH CHRONIC LOW BACK PAIN. DESIGN: RANDOMIZED, CONTROLLED TRIAL. SETTING: A NONPROFIT, INTEGRATED HEALTH CARE SYSTEM. PATIENTS: 101 ADULTS WITH CHRONIC LOW BACK PAIN. INTERVENTION: 12-WEEK SESSIONS OF YOGA OR CONVENTIONAL THERAPEUTIC EXERCISE CLASSES OR A SELF-CARE BOOK. MEASUREMENTS: PRIMARY OUTCOMES WERE BACK-RELATED FUNCTIONAL STATUS (MODIFIED 24-POINT ROLAND DISABILITY SCALE) AND "BOTHERSOMENESS" OF PAIN (11-POINT NUMERICAL SCALE). THE PRIMARY TIME POINT WAS 12 WEEKS. CLINICALLY SIGNIFICANT CHANGE WAS CONSIDERED TO BE 2.5 POINTS ON THE FUNCTIONAL STATUS SCALE AND 1.5 POINTS ON THE BOTHERSOMENESS SCALE. SECONDARY OUTCOMES WERE DAYS OF RESTRICTED ACTIVITY, GENERAL HEALTH STATUS, AND MEDICATION USE. RESULTS: AFTER ADJUSTMENT FOR BASELINE VALUES, BACK-RELATED FUNCTION IN THE YOGA GROUP WAS SUPERIOR TO THE BOOK AND EXERCISE GROUPS AT 12 WEEKS (YOGA VS. BOOK: MEAN DIFFERENCE, -3.4 [95% CI, -5.1 TO - 1.6] [P < 0.001]; YOGA VS. EXERCISE: MEAN DIFFERENCE, -1.8 [CI, -3.5 TO - 0.1] [P = 0.034]). NO SIGNIFICANT DIFFERENCES IN SYMPTOM BOTHERSOMENESS WERE FOUND BETWEEN ANY 2 GROUPS AT 12 WEEKS; AT 26 WEEKS, THE YOGA GROUP WAS SUPERIOR TO THE BOOK GROUP WITH RESPECT TO THIS MEASURE (MEAN DIFFERENCE, -2.2 [CI, -3.2 TO - 1.2]; P < 0.001). AT 26 WEEKS, BACK-RELATED FUNCTION IN THE YOGA GROUP WAS SUPERIOR TO THE BOOK GROUP (MEAN DIFFERENCE, -3.6 [CI, -5.4 TO - 1.8]; P < 0.001). LIMITATIONS: PARTICIPANTS IN THIS STUDY WERE FOLLOWED FOR ONLY 26 WEEKS AFTER RANDOMIZATION. ONLY 1 INSTRUCTOR DELIVERED EACH INTERVENTION. CONCLUSIONS: YOGA WAS MORE EFFECTIVE THAN A SELF-CARE BOOK FOR IMPROVING FUNCTION AND REDUCING CHRONIC LOW BACK PAIN, AND THE BENEFITS PERSISTED FOR AT LEAST SEVERAL MONTHS. 2005 5 777 39 EFFECT OF YOGA AND PHYSIOTHERAPY ON PULMONARY FUNCTIONS IN CHILDREN WITH DUCHENNE MUSCULAR DYSTROPHY - A COMPARATIVE STUDY. CONTEXT: ABNORMAL RESPIRATORY FUNCTION IS KNOWN TO BE DETECTABLE ALMOST AS SOON AS IT CAN BE MEASURED RELIABLY. STUDIES HAVE IDENTIFIED THE EFFECT OF RESPIRATORY MUSCLE TRAINING AS WELL AS BREATHING EXERCISES IN IMPROVING PULMONARY FUNCTIONS IN CHILDREN WITH DUCHENNE MUSCULAR DYSTROPHY (DMD). AIMS: THIS STUDY AIMS TO IDENTIFY THE ADD-ON EFFECT OF YOGA OVER PHYSIOTHERAPY ON PULMONARY FUNCTIONS IN CHILDREN WITH DMD. SETTINGS AND DESIGN: ONE HUNDRED AND TWENTY-FOUR PATIENTS WITH DMD WERE RANDOMIZED TO TWO GROUPS. GROUP I RECEIVED HOME-BASED PHYSIOTHERAPY AND GROUP II RECEIVED PHYSIOTHERAPY ALONG WITH YOGA INTERVENTION. MATERIALS AND METHODS: PULMONARY FUNCTION TEST (PFT) WAS ASSESSED BEFORE THE INTERVENTION (BASELINE DATA) AND AT REGULAR INTERVALS OF 3 MONTHS FOR A PERIOD OF 1 YEAR. STATISTICAL ANALYSIS USED: NORMALITY WAS ASSESSED USING SHAPIRO-WILK NORMALITY TEST. THE BASELINE DATA WERE ANALYZED USING MANN-WHITNEY U-TEST TO IDENTIFY THE HOMOGENEITY. REPEATED MEASURES ANALYSIS OF VARIANCE WAS USED TO ASSESS SIGNIFICANT CHANGES IN STUDY PARAMETERS DURING THE ASSESSMENT OF EVERY 3 MONTHS, BOTH WITHIN AND BETWEEN THE TWO GROUPS OF PATIENTS. RESULTS: A TOTAL OF 88 PARTICIPANTS COMPLETED ALL THE 5 ASSESSMENTS, WITH A MEAN AGE OF 7.9 +/- 1.5 YEARS. PFT PARAMETERS SUCH AS FORCED VITAL CAPACITY (FVC), PEAK EXPIRATORY FLOW RATE, MAXIMUM VOLUNTARY VENTILATION (MVV), AND TIDAL VOLUME DURING MAXIMUM VOLUNTARY VENTILATION (MVT) DEMONSTRATED SIGNIFICANT IMPROVEMENTS IN GROUP I. IN GROUP II, FVC AND MVT SIGNIFICANTLY IMPROVED FROM BASELINE UP TO 1 YEAR, WHEREAS MVV IMPROVED FROM BASELINE UP TO 9 MONTHS. TIDAL VOLUME DID NOT SHOW ANY CHANGES IN BOTH THE GROUPS. CONCLUSIONS: THE FINDINGS SUGGEST THAT INTRODUCTION OF YOGA WITH PHYSIOTHERAPY INTERVENTION AT AN EARLY AGE CAN BE CONSIDERED AS ONE OF THE THERAPEUTIC STRATEGIES IN IMPROVING PULMONARY FUNCTIONS IN PATIENTS WITH DMD. 2021 6 1748 34 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 7 199 37 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 8 214 27 A STUDY OF THE EFFECT OF YOGA TRAINING ON PULMONARY FUNCTIONS IN PATIENTS WITH BRONCHIAL ASTHMA. THE ROLE OF YOGA BREATHING EXERCISES, AS AN ADJUNCT TREATMENT FOR BRONCHIAL ASTHMA IS WELL RECOGNIZED. ONE HUNDRED TWENTY PATIENTS OF ASTHMA WERE RANDOMIZED INTO TWO GROUPS I.E GROUP A (YOGA TRAINING GROUP) AND GROUP B (CONTROL GROUP). EACH GROUP INCLUDED SIXTY PATIENTS. PULMONARY FUNCTION TESTS WERE PERFORMED ON ALL THE PATIENTS AT BASELINE, AFTER 4 WEEKS AND THEN AFTER 8 WEEKS. MAJORITY OF THE SUBJECTS IN THE TWO GROUPS HAD MILD DISEASE (34 PATIENTS IN GROUP A AND 32 IN GROUP B). GROUP A SUBJECTS SHOWED A STATISTICALLY SIGNIFICANT INCREASING TREND (P < 0.01) IN % PREDICTED PEAK EXPIRATORY FLOW RATE (PEFR), FORCED EXPIRATORY VOLUME IN THE FIRST SECOND (FEV1), FORCED VITAL CAPACITY (FVC), FORCED MID EXPIRATORY FLOW IN 0.25-0.75 SECONDS (FEF25-75) AND FEV1/FVC% RATIO AT 4 WEEKS AND 8 WEEKS AS COMPARED TO GROUP B. THUS, YOGA BREATHING EXERCISES USED ADJUNCTIVELY WITH STANDARD PHARMACOLOGICAL TREATMENT SIGNIFICANTLY IMPROVES PULMONARY FUNCTIONS IN PATIENTS WITH BRONCHIAL ASTHMA. 2009 9 2855 40 YOGA-AN ALTERNATIVE FORM OF THERAPY IN PATIENTS WITH BLUNT CHEST TRAUMA: A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: YOGA AS ALTERNATIVE FORM OF THERAPY HAS SHOWN POSITIVE IMPACT ON PULMONARY FUNCTIONS, EXERCISE CAPACITY, BEHAVIORAL CHANGES, AND INFLAMMATION IN NON-TRAUMA PATIENTS. HOWEVER, THE EFFICACY OF YOGA HAS NOT BEEN STUDIED IN CHEST TRAUMA PATIENTS. METHODS: THIS RANDOMIZED CONTROLLED TRIAL WAS CONDUCTED AT LEVEL-1 TRAUMA CENTRE. ISOLATED CHEST INJURY PATIENTS WERE RANDOMIZED INTO EITHER STANDARD PHYSIOTHERAPY OR YOGATHERAPY GROUPS. PATIENTS IN PHYSIOTHERAPY GROUP RECEIVED CONVENTIONAL CHEST PHYSIOTHERAPY AND YOGATHERAPY GROUP RECEIVED A SET OF YOGIC EXERCISES IN ADDITION TO CONVENTIONAL CHEST PHYSIOTHERAPY. PRIMARY OUTCOME MEASURE WAS CHANGES IN PULMONARY FUNCTION TESTS (PFT) AT 4 WEEKS OF DISCHARGE. SECONDARY OUTCOMES WERE CHANGES IN QUALITY OF LIFE (QOL), RESPIRATORY MUSCLE STRENGTH AND ENDURANCE, CHEST WALL MOBILITY, AND LEVELS OF CYTOKINES AT 4 WEEKS. DATA WERE ANALYZED USING STATA V14.0. RESULTS: A TOTAL OF 89 ELIGIBLE PATIENTS WERE RANDOMIZED TO PHYSIOTHERAPY (N = 46) AND YOGA THERAPY (N = 43) GROUPS. DEMOGRAPHIC CHARACTERISTICS WERE COMPARABLE IN BOTH THE GROUPS. THERE WERE STATISTICALLY SIGNIFICANT IMPROVEMENTS IN PFT IN THE YOGATHERAPY GROUP COMPARED WITH PHYSIOTHERAPY WITH AN INCREASE IN FORCED VITAL CAPACITY (P = 0.02) AND FORCED EXPIRATORY VOLUME (P = 0.01) AT 4 WEEKS. IN ADDITION, THERE WERE SIGNIFICANT IMPROVEMENT IN PHYSICAL COMPONENT OF QOL, RESPIRATORY MUSCLE ENDURANCE (P = 0.003) AND AXILLARY CIRTOMETRY (P = 0.009) IN THE YOGATHERAPY GROUP. HOWEVER, NO STATISTICALLY SIGNIFICANT DIFFERENCE IN THE TRENDS OF CYTOKINE MARKERS SEEN BETWEEN THE GROUPS. CONCLUSION: YOGA WAS FOUND TO BE EFFECTIVE IN IMPROVING PULMONARY FUNCTIONS AND QOL IN PATIENTS WITH CHEST TRAUMA. (TRIAL REGISTERED AT CTRI.NIC.IN/CLINICALTRIALS/LOGIN.PHP, NUMBERREF/2016/05/011,287). 2021 10 193 40 A RANDOMIZED TRIAL COMPARING YOGA, STRETCHING, AND A SELF-CARE BOOK FOR CHRONIC LOW BACK PAIN. BACKGROUND: CHRONIC LOW BACK PAIN IS A COMMON PROBLEM LACKING HIGHLY EFFECTIVE TREATMENT OPTIONS. SMALL TRIALS SUGGEST THAT YOGA MAY HAVE BENEFITS FOR THIS CONDITION. THIS TRIAL WAS DESIGNED TO DETERMINE WHETHER YOGA IS MORE EFFECTIVE THAN CONVENTIONAL STRETCHING EXERCISES OR A SELF-CARE BOOK FOR PRIMARY CARE PATIENTS WITH CHRONIC LOW BACK PAIN. METHODS: A TOTAL OF 228 ADULTS WITH CHRONIC LOW BACK PAIN WERE RANDOMIZED TO 12 WEEKLY CLASSES OF YOGA (92 PATIENTS) OR CONVENTIONAL STRETCHING EXERCISES (91 PATIENTS) OR A SELF-CARE BOOK (45 PATIENTS). BACK-RELATED FUNCTIONAL STATUS (MODIFIED ROLAND DISABILITY QUESTIONNAIRE, A 23-POINT SCALE) AND BOTHERSOMENESS OF PAIN (AN 11-POINT NUMERICAL SCALE) AT 12 WEEKS WERE THE PRIMARY OUTCOMES. OUTCOMES WERE ASSESSED AT BASELINE, 6, 12, AND 26 WEEKS BY INTERVIEWERS UNAWARE OF TREATMENT GROUP. RESULTS: AFTER ADJUSTMENT FOR BASELINE VALUES, 12-WEEK OUTCOMES FOR THE YOGA GROUP WERE SUPERIOR TO THOSE FOR THE SELF-CARE GROUP (MEAN DIFFERENCE FOR FUNCTION, -2.5 [95% CI, -3.7 TO -1.3]; P < .001; MEAN DIFFERENCE FOR SYMPTOMS, -1.1 [95% CI, -1.7 TO -0.4]; P < .001). AT 26 WEEKS, FUNCTION FOR THE YOGA GROUP REMAINED SUPERIOR (MEAN DIFFERENCE, -1.8 [95% CI, -3.1 TO -0.5]; P < .001). YOGA WAS NOT SUPERIOR TO CONVENTIONAL STRETCHING EXERCISES AT ANY TIME POINT. CONCLUSION: YOGA CLASSES WERE MORE EFFECTIVE THAN A SELF-CARE BOOK, BUT NOT MORE EFFECTIVE THAN STRETCHING CLASSES, IN IMPROVING FUNCTION AND REDUCING SYMPTOMS DUE TO CHRONIC LOW BACK PAIN, WITH BENEFITS LASTING AT LEAST SEVERAL MONTHS. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT00447668. 2011 11 388 43 BENEFITS OF THE RESTORATIVE EXERCISE AND STRENGTH TRAINING FOR OPERATIONAL RESILIENCE AND EXCELLENCE YOGA PROGRAM FOR CHRONIC LOW BACK PAIN IN SERVICE MEMBERS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TO EXAMINE THE FEASIBILITY AND PRELIMINARY EFFECTIVENESS OF AN INDIVIDUALIZED YOGA PROGRAM. DESIGN: PILOT RANDOMIZED CONTROLLED TRIAL. SETTING: MILITARY MEDICAL CENTER. PARTICIPANTS: PATIENTS (N=68) WITH CHRONIC LOW BACK PAIN. INTERVENTIONS: RESTORATIVE EXERCISE AND STRENGTH TRAINING FOR OPERATIONAL RESILIENCE AND EXCELLENCE (RESTORE) PROGRAM (9-12 INDIVIDUAL YOGA SESSIONS) OR TREATMENT AS USUAL (CONTROL) FOR AN 8-WEEK PERIOD. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS PAST 24-HOUR PAIN (DEFENSE & VETERANS PAIN RATING SCALE 2.0). SECONDARY OUTCOMES INCLUDED DISABILITY (ROLAND-MORRIS DISABILITY QUESTIONNAIRE) AND PHYSICAL FUNCTIONING AND SYMPTOM BURDEN (PATIENT-REPORTED OUTCOMES MEASUREMENT INFORMATION SYSTEM-29 SUBSCALES). ASSESSMENT OCCURRED AT BASELINE, WEEK 4, WEEK 8, 3-MONTH FOLLOW-UP, AND 6-MONTH FOLLOW-UP. EXPLORATORY OUTCOMES INCLUDED THE PROPORTION OF PARTICIPANTS IN EACH GROUP REPORTING CLINICALLY MEANINGFUL CHANGES AT 3- AND 6-MONTH FOLLOW-UPS. RESULTS: GENERALIZED LINEAR MIXED MODELS WITH SEQUENTIAL BONFERRONI-ADJUSTED PAIRWISE SIGNIFICANCE TESTS AND CHI-SQUARE ANALYSES EXAMINED LONGITUDINAL OUTCOMES. SECONDARY OUTCOME SIGNIFICANCE TESTS WERE BONFERRONI ADJUSTED FOR MULTIPLE OUTCOMES. THE RESTORE GROUP REPORTED IMPROVED PAIN COMPARED WITH THE CONTROL GROUP. SECONDARY OUTCOMES DID NOT RETAIN SIGNIFICANCE AFTER BONFERRONI ADJUSTMENTS FOR MULTIPLE OUTCOMES, ALTHOUGH A HIGHER PROPORTION OF RESTORE PARTICIPANTS REPORTED CLINICALLY MEANINGFULLY CHANGES IN ALL OUTCOMES AT 3-MONTH FOLLOW-UP AND IN SYMPTOM BURDEN AT 6-MONTH FOLLOW-UP. CONCLUSIONS: RESTORE MAY BE A VIABLE NONPHARMACOLOGICAL TREATMENT FOR LOW BACK PAIN WITH MINIMAL SIDE EFFECTS, AND RESEARCH EFFORTS ARE NEEDED TO COMPARE THE EFFECTIVENESS OF RESTORE DELIVERY FORMATS (EG, GROUP VS INDIVIDUAL) WITH THAT OF OTHER TREATMENT MODALITIES. 2018 12 1941 62 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 13 2441 46 YOGA AND SCHIZOPHRENIA-A COMPREHENSIVE ASSESSMENT OF NEUROPLASTICITY: PROTOCOL FOR A SINGLE BLIND RANDOMIZED CONTROLLED STUDY OF YOGA IN SCHIZOPHRENIA. INTRODUCTION: SCHIZOPHRENIA IS ONE OF THE MOST SEVERE MENTAL DISORDERS WITH A PREVALENCE OF ABOUT 1% AND A LEADING CAUSE OF DISABILITY AMONG YOUNG ADULTS. PHARMACOTHERAPY IS THE MAINSTAY IN THE MANAGEMENT OF SCHIZOPHRENIA. HOWEVER, EVEN WITH THE BEST OF MEDICATION, SEVERAL PROBLEMS LIKE REFRACTORINESS, NEGATIVE SYMPTOMS, FREQUENT RELAPSES, AND COGNITIVE IMPAIRMENTS PERSIST. METHODS: THIS IS A RANDOMIZED-CONTROLLED CLINICAL STUDY INCLUDING PATIENTS FROM AN URBAN TERTIARY HOSPITAL AND A SEMI-URBAN COMMUNITY CENTER, WITH A BETWEEN-GROUP, REPEATED-MEASURES, LONGITUDINAL DESIGN. THIS STUDY WILL RECRUIT 160 PATIENTS WITH DSM 5 DIAGNOSIS OF SCHIZOPHRENIA WHO ARE ON STABLE MEDICATION FOR A MINIMUM OF 6 WEEKS; THEY WILL BE RANDOMLY ASSIGNED INTO 2 ARMS VIZ., YOGA THERAPY (YT), AND TREATMENT-AS-USUAL (TAU) WITH 80 PATIENTS IN EACH ARM. PARTICIPANTS WILL UNDERGO CLINICAL, LABORATORY, AND RADIOLOGICAL ASSESSMENTS AT BASELINE AND AT INTERVALS OF 1 MONTH, 3 MONTHS, AND 6 MONTHS FROM THE BASELINE. IT IS HYPOTHESIZED THAT YOGA WILL IMPROVE PSYCHOPATHOLOGY AND EMOTION PROCESSING, INCREASE SERUM BRAIN DERIVED NEUROTROPHIC FACTOR (BDNF) AND PLASMA OXYTOCIN LEVELS AND EFFECT CHANGES IN CEREBRAL ACTIVATION IN AREAS OF THE BRAIN ASSOCIATED WITH SCHIZOPHRENIA. DISCUSSION: THIS STUDY AIMS TO MEASURE THE EFFICACY OF A YOGA-BASED INTERVENTION AS AN ADJUNCT IN PATIENTS WITH SCHIZOPHRENIA AS WELL AS THE MECHANISMS OF THESE EFFECTS. TRIAL REGISTRATION: REGISTERED RETROSPECTIVELY WITH CLINICAL TRIAL REGISTRY - INDIA (CTRI) WITH REGISTRATION NUMBER CTRI/2017/08/009219. 2019 14 891 39 EFFECT OF YOGA-BASED INTERVENTION IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE. BACKGROUND: INFLAMMATORY BOWEL DISEASE (IBD) IS A CHRONIC ILLNESS CHARACTERIZED BY GROSS INFLAMMATION IN THE GASTROINTESTINAL TRACT THAT CAN RESULT IN SYMPTOMS SUCH AS ABDOMINAL PAIN, CRAMPING, DIARRHEA, AND BLOODY STOOLS. IBD IS BELIEVED TO BE INFLUENCED BY PSYCHOLOGICAL FACTORS SUCH AS STRESS AND ANXIETY. THEREFORE, A YOGA INTERVENTION THAT REDUCES STRESS AND ANXIETY MAY BE AN EFFECTIVE COMPLEMENTARY TREATMENT FOR THESE DISORDERS. MATERIAL AND METHODS: A TOTAL OF 100 IBD PATIENTS [ULCERATIVE COLITIS (UC) N = 60 AND CROHN'S DISEASE (CD) N = 40] DURING THE CLINICAL REMISSION PHASE OF DISEASE WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE ALLOCATED RANDOMLY TO EITHER THE YOGA GROUP THAT UNDERWENT AN 8-WEEK YOGA INTERVENTION (PHYSICAL POSTURES, PRANAYAMA, AND MEDITATION) 1- HOUR/DAY IN ADDITION TO STANDARD MEDICAL THERAPY (UC, N = 30; CD, N = 20) OR THE CONTROL GROUP (UC, N = 30; CD N = 20), WHICH CONTINUED WITH STANDARD MEDICAL THERAPY ALONE. THE MAIN OUTCOME MEASURES WERE CARDIOVASCULAR AUTONOMIC FUNCTIONS, SERUM EOSINOPHILIC CATIONIC PROTEIN, INTERLEUKIN- 2 SOLUBLE RECEPTORS, SPEILBERGER'S STATE TRAIT ANXIETY INVENTORY (STAI) SCORES, AND CLINICAL SYMPTOMS. RESULTS: BEFORE THE INTERVENTION, ALL THE OUTCOME MEASURES WERE COMPARABLE IN THE TWO GROUPS. AFTER THE 8-WEEK YOGA INTERVENTION, FEWER UC PATIENTS REPORTED ARTHRALGIA. THE NUMBER OF PATIENTS REPORTING INTESTINAL COLIC PAIN IN THE CONTROL GROUP WAS HIGHER. STATE AND TRAIT ANXIETY LEVELS WERE SIGNIFICANTLY REDUCED IN PATIENTS WITH UC. HOWEVER, NO SIGNIFICANT CHANGES WERE OBSERVED IN CARDIOVASCULAR AUTONOMIC FUNCTIONS, EOSINOPHILIC CATIONIC PROTEINS, OR INTERLEUKIN-2 SOLUBLE RECEPTORS. CONCLUSIONS: A SIMPLIFIED YOGA-BASED REGIMEN IS A SAFE AND EFFECTIVE COMPLEMENTARY CLINICAL TREATMENT MODALITY FOR PATIENTS WITH INFLAMMATORY BOWEL DISEASE DURING THE CLINICAL REMISSION PHASE. 2015 15 786 42 EFFECT OF YOGA BREATHING (PRANAYAMA) ON EXERCISE TOLERANCE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE: A RANDOMIZED, CONTROLLED TRIAL. OBJECTIVE: PULMONARY REHABILITATION IMPROVES EXERCISE TOLERANCE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). HOWEVER, MANY PATIENTS DO NOT HAVE ACCESS TO PULMONARY REHABILITATION PROGRAMS. WE HYPOTHESIZED THAT AN ALTERNATIVE TO PULMONARY REHABILITATION TO IMPROVE EXERCISE TOLERANCE IS THE PRACTICE OF PRANAYAMA, OR YOGA BREATHING, WHICH COULD BE DONE INDEPENDENTLY AT HOME. WE ALSO SOUGHT TO DETERMINE WHETHER YOGA NONPROFESSIONALS COULD ADEQUATELY TEACH PRANAYAMA TO PATIENTS. DESIGN: PROOF-OF-CONCEPT, RANDOMIZED, DOUBLE-BLIND, CONTROLLED PILOT TRIAL. SETTINGS/LOCATION: TWO ACADEMIC PULMONARY PRACTICES. SUBJECTS: FORTY-THREE PATIENTS WITH SYMPTOMATIC, MODERATE-TO-SEVERE COPD. INTERVENTIONS: TWELVE WEEKS OF PRANAYAMA PLUS EDUCATION VERSUS EDUCATION ALONE. TWO YOGA PROFESSIONALS TRAINED THE RESEARCH COORDINATORS TO CONDUCT ALL PRANAYAMA TEACHING AND MONITORED THE QUALITY OF THE TEACHING AND THE PRACTICE OF PRANAYAMA BY STUDY PARTICIPANTS. OUTCOME MEASURES: THE PRIMARY OUTCOME WAS A CHANGE IN THE 6-MIN WALK DISTANCE (6MWD). SECONDARY OUTCOMES INCLUDED CHANGES IN LUNG FUNCTION, MARKERS OF OXIDATIVE STRESS AND SYSTEMIC INFLAMMATION, AND MEASURES OF DYSPNEA AND QUALITY OF LIFE. RESULTS: THE 6MWD INCREASED IN THE PRANAYAMA GROUP (LEAST SQUARE MEAN [95% CONFIDENCE INTERVAL] = 28 M [-5 TO 61]) AND DECREASED IN THE CONTROL GROUP (-15 M [-47 TO 16]), WITH A NEARLY SIGNIFICANT TREATMENT EFFECT (P = 0.06) IN FAVOR OF PRANAYAMA. PRANAYAMA ALSO RESULTED IN SMALL IMPROVEMENTS IN INSPIRATORY CAPACITY AND AIR TRAPPING. BOTH GROUPS HAD SIGNIFICANT IMPROVEMENTS IN VARIOUS MEASURES OF SYMPTOMS, BUT NO OVERALL DIFFERENCES IN RESPIRATORY SYSTEM IMPEDANCE OR MARKERS OF OXIDATIVE STRESS OR SYSTEMIC INFLAMMATION. CONCLUSION: THIS PILOT STUDY SUCCESSFULLY DEMONSTRATED THAT PRANAYAMA WAS ASSOCIATED WITH IMPROVED EXERCISE TOLERANCE IN PATIENTS WITH COPD. LAY PERSONNEL WERE ABLE TO ADEQUATELY TEACH PATIENTS TO PRACTICE PRANAYAMA. THESE RESULTS SUGGEST THAT PRANAYAMA MAY HAVE SIGNIFICANT CLINICAL BENEFITS FOR SYMPTOMATIC PATIENTS WITH COPD, A CONCEPT THAT NEEDS TO BE CONFIRMED IN FUTURE, LARGER CLINICAL TRIALS. 2017 16 867 41 EFFECT OF YOGA REGIMEN ON LUNG FUNCTIONS INCLUDING DIFFUSION CAPACITY IN CORONARY ARTERY DISEASE PATIENTS: A RANDOMIZED CONTROLLED STUDY. BACKGROUND: LUNG FUNCTIONS ARE FOUND TO BE IMPAIRED IN CORONARY ARTERY DISEASE (CAD), CONGESTIVE HEART FAILURE, LEFT VENTRICULAR DYSFUNCTION, AND AFTER CARDIAC SURGERY. DIFFUSION CAPACITY PROGRESSIVELY WORSENS AS THE SEVERITY OF CAD INCREASES DUE TO REDUCTION IN LUNG TISSUE PARTICIPATING IN GAS EXCHANGE. AIMS AND OBJECTIVES: PRANAYAMA BREATHING EXERCISES AND YOGIC POSTURES MAY PLAY AN IMPRESSIVE ROLE IN IMPROVING CARDIO-RESPIRATORY EFFICIENCY AND FACILITATING GAS DIFFUSION AT THE ALVEOLO-CAPILLARY MEMBRANE. THIS STUDY WAS DONE TO SEE THE EFFECT OF YOGA REGIMEN ON LUNG FUNCTIONS PARTICULARLY DIFFUSION CAPACITY IN CAD PATIENTS. MATERIALS AND METHODS: A TOTAL OF 80 STABLE CAD PATIENTS BELOW 65 YEARS OF AGE OF BOTH SEXES WERE SELECTED AND RANDOMIZED INTO TWO GROUPS OF 40 EACH. GROUP I CAD PATIENTS WERE GIVEN YOGA REGIMEN FOR 3 MONTHS WHICH CONSISTED OF YOGIC POSTURES, PRANAYAMA BREATHING EXERCISES, DIETARY MODIFICATION, AND HOLISTIC TEACHING ALONG WITH THEIR CONVENTIONAL MEDICINE WHILE GROUP II CAD PATIENTS WERE PUT ONLY ON CONVENTIONAL MEDICINE. LUNG FUNCTIONS INCLUDING DIFFUSION CAPACITY WERE RECORDED THRICE IN BOTH THE GROUPS: 0 DAY AS BASELINE, 22(ND) DAY AND ON 90(TH) DAY BY USING COMPUTERIZED MS MEDISOFT CARDIO-RESPIRATORY INSTRUMENT, HYP'AIR COMPACT MODEL OF CARDIO-RESPIRATORY TESTING MACHINE WAS MANUFACTURED BY P K MORGAN, INDIA. THE RECORDED PARAMETERS WERE STATISTICALLY ANALYZED BY REPEATED MEASURES ANOVA FOLLOWED BY TUKEY'S TEST IN BOTH THE GROUPS. CARDIOVASCULAR PARAMETERS WERE ALSO COMPARED BEFORE AND AFTER INTERVENTION IN BOTH THE GROUPS. RESULTS: STATISTICALLY SIGNIFICANT IMPROVEMENTS WERE SEEN IN SLOW VITAL CAPACITY, FORCED VITAL CAPACITY, PEAK EXPIRATORY FLOW RATE, MAXIMUM VOLUNTARY VENTILATION, AND DIFFUSION FACTOR/ TRANSFER FACTOR OF LUNG FOR CARBON MONOXIDE AFTER 3 MONTHS OF YOGA REGIMEN IN GROUP I. FORCED EXPIRATORY VOLUME IN 1(ST) SEC (FEV1), AND FEV1 % ALSO SHOWED A TREND TOWARD IMPROVEMENT ALTHOUGH NOT STATISTICALLY SIGNIFICANT. HR, SBP AND DBP ALSO SHOWED SIGNIFICANT IMPROVEMENT IN GROUP-I PATIENTS WHO FOLLOWED YOGA REGIMEN. CONCLUSIONS: YOGA REGIMEN WAS FOUND TO IMPROVE LUNG FUNCTIONS AND DIFFUSION CAPACITY IN CAD PATIENTS BESIDES IMPROVING CARDIOVASCULAR FUNCTIONS. THUS, IT CAN BE USED AS A COMPLIMENTARY OR ADJUNCT THERAPY ALONG WITH THE CONVENTIONAL MEDICINE FOR THEIR TREATMENT AND REHABILITATION. 2015 17 2831 48 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 18 2638 46 YOGA FOR VETERANS WITH CHRONIC LOW BACK PAIN: DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL. CHRONIC LOW BACK PAIN (CLBP) AFFLICTS MILLIONS OF PEOPLE WORLDWIDE, WITH PARTICULARLY HIGH PREVALENCE IN MILITARY VETERANS. MANY TREATMENT OPTIONS EXIST FOR CLBP, BUT MOST HAVE LIMITED EFFECTIVENESS AND SOME HAVE SIGNIFICANT SIDE EFFECTS. IN GENERAL POPULATIONS WITH CLBP, YOGA HAS BEEN SHOWN TO IMPROVE HEALTH OUTCOMES WITH FEW SIDE EFFECTS. HOWEVER, YOGA HAS NOT BEEN ADEQUATELY STUDIED IN MILITARY VETERAN POPULATIONS. IN THE CURRENT PAPER WE WILL DESCRIBE THE DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL AIMED AT EXAMINING WHETHER YOGA CAN EFFECTIVELY REDUCE DISABILITY AND PAIN IN US MILITARY VETERANS WITH CLBP. A TOTAL OF 144 US MILITARY VETERANS WITH CLBP WILL BE RANDOMIZED TO EITHER YOGA OR A DELAYED TREATMENT COMPARISON GROUP. THE YOGA INTERVENTION WILL CONSIST OF 2X WEEKLY YOGA CLASSES FOR 12WEEKS, COMPLEMENTED BY REGULAR HOME PRACTICE GUIDED BY A MANUAL. THE DELAYED TREATMENT GROUP WILL RECEIVE THE SAME INTERVENTION AFTER SIX MONTHS. THE PRIMARY OUTCOME IS THE CHANGE IN BACK PAIN-RELATED DISABILITY MEASURED WITH THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE AT BASELINE AND 12-WEEKS. SECONDARY OUTCOMES INCLUDE PAIN INTENSITY, PAIN INTERFERENCE, DEPRESSION, ANXIETY, FATIGUE/ENERGY, QUALITY OF LIFE, SELF-EFFICACY, SLEEP QUALITY, AND MEDICATION USAGE. ADDITIONAL PROCESS AND/OR MEDIATIONAL FACTORS WILL BE MEASURED TO EXAMINE DOSE RESPONSE AND EFFECT MECHANISMS. ASSESSMENTS WILL BE CONDUCTED AT BASELINE, 6-WEEKS, 12-WEEKS, AND 6-MONTHS. ALL RANDOMIZED PARTICIPANTS WILL BE INCLUDED IN INTENTION-TO-TREAT ANALYSES. STUDY RESULTS WILL PROVIDE MUCH NEEDED EVIDENCE ON THE FEASIBILITY AND EFFECTIVENESS OF YOGA AS A THERAPEUTIC MODALITY FOR THE TREATMENT OF CLBP IN US MILITARY VETERANS. 2016 19 2596 50 YOGA FOR MILITARY VETERANS WITH CHRONIC LOW BACK PAIN: A RANDOMIZED CLINICAL TRIAL. INTRODUCTION: CHRONIC LOW BACK PAIN (CLBP) IS PREVALENT, ESPECIALLY AMONG MILITARY VETERANS. MANY CLBP TREATMENT OPTIONS HAVE LIMITED BENEFITS AND ARE ACCOMPANIED BY SIDE EFFECTS. MAJOR EFFORTS TO REDUCE OPIOID USE AND EMBRACE NONPHARMACOLOGICAL PAIN TREATMENTS HAVE RESULTED. RESEARCH WITH COMMUNITY CLBP PATIENTS INDICATES THAT YOGA CAN IMPROVE HEALTH OUTCOMES AND HAS FEW SIDE EFFECTS. THE BENEFITS OF YOGA AMONG MILITARY VETERANS WERE EXAMINED. DESIGN: PARTICIPANTS WERE RANDOMIZED TO EITHER YOGA OR DELAYED YOGA TREATMENT IN 2013-2015. OUTCOMES WERE ASSESSED AT BASELINE, 6 WEEKS, 12 WEEKS, AND 6 MONTHS. INTENTION-TO-TREAT ANALYSES OCCURRED IN 2016. SETTING/PARTICIPANTS: ONE HUNDRED AND FIFTY MILITARY VETERANS WITH CLBP WERE RECRUITED FROM A MAJOR VETERANS AFFAIRS MEDICAL CENTER IN CALIFORNIA. INTERVENTION: YOGA CLASSES (WITH HOME PRACTICE) WERE LED BY A CERTIFIED INSTRUCTOR TWICE WEEKLY FOR 12 WEEKS, AND CONSISTED PRIMARILY OF PHYSICAL POSTURES, MOVEMENT, AND BREATHING TECHNIQUES. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES AFTER 12 WEEKS. PAIN INTENSITY WAS IDENTIFIED AS AN IMPORTANT SECONDARY OUTCOME. RESULTS: PARTICIPANT CHARACTERISTICS WERE MEAN AGE 53 YEARS, 26% WERE FEMALE, 35% WERE UNEMPLOYED OR DISABLED, AND MEAN BACK PAIN DURATION WAS 15 YEARS. IMPROVEMENTS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES DID NOT DIFFER BETWEEN THE TWO GROUPS AT 12 WEEKS, BUT YOGA PARTICIPANTS HAD GREATER REDUCTIONS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES THAN DELAYED TREATMENT PARTICIPANTS AT 6 MONTHS -2.48 (95% CI= -4.08, -0.87). YOGA PARTICIPANTS IMPROVED MORE ON PAIN INTENSITY AT 12 WEEKS AND AT 6 MONTHS. OPIOID MEDICATION USE DECLINED AMONG ALL PARTICIPANTS, BUT GROUP DIFFERENCES WERE NOT FOUND. CONCLUSIONS: YOGA IMPROVED HEALTH OUTCOMES AMONG VETERANS DESPITE EVIDENCE THEY HAD FEWER RESOURCES, WORSE HEALTH, AND MORE CHALLENGES ATTENDING YOGA SESSIONS THAN COMMUNITY SAMPLES STUDIED PREVIOUSLY. THE MAGNITUDE OF PAIN INTENSITY DECLINE WAS SMALL, BUT OCCURRED IN THE CONTEXT OF REDUCED OPIOID USE. THE FINDINGS SUPPORT WIDER IMPLEMENTATION OF YOGA PROGRAMS FOR VETERANS. TRIAL REGISTRATION: THIS STUDY IS REGISTERED AT WWW.CLINICALTRIALS.GOV NCT02524158. 2017 20 2698 49 YOGA INTERVENTION AND REMINDER E-MAILS FOR REDUCING CANCER-RELATED FATIGUE - A STUDY PROTOCOL OF A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: ALMOST 90% OF CANCER PATIENTS SUFFER FROM SYMPTOMS OF FATIGUE DURING TREATMENT. SUPPORTING TREATMENTS ARE INCREASINGLY USED TO ALLEVIATE THE BURDEN OF FATIGUE. THIS STUDY EXAMINES THE SHORT-TERM AND LONG-TERM EFFECTS OF YOGA ON FATIGUE AND THE EFFECT OF WEEKLY REMINDER E-MAILS ON EXERCISE FREQUENCY AND FATIGUE SYMPTOMS. METHODS: THE AIM OF THE FIRST PART OF THE STUDY WILL EVALUATE THE EFFECTIVENESS OF YOGA FOR CANCER PATIENTS WITH MIXED DIAGNOSES REPORTING FATIGUE. WE WILL RANDOMLY ALLOCATE 128 PATIENTS TO AN INTERVENTION GROUP (N = 64) RECEIVING YOGA AND A WAIT-LIST CONTROL GROUP (N = 64) RECEIVING YOGA 9 WEEKS LATER. THE YOGA THERAPY WILL BE PERFORMED IN WEEKLY SESSIONS OF 60 MIN EACH FOR 8 WEEKS. THE PRIMARY OUTCOME WILL BE SELF-REPORTED FATIGUE SYMPTOMS. IN THE SECOND PART OF THE STUDY, THE EFFECTIVENESS OF REMINDER E-MAILS WITH REGARD TO THE EXERCISE FREQUENCY AND SELF-REPORTED FATIGUE SYMPTOMS WILL BE EVALUATED. A RANDOMIZED ALLOCATED GROUP OF THE PARTICIPANTS ("EMAIL") RECEIVES WEEKLY REMINDER E-MAILS, THE OTHER GROUP DOES NOT. DATA WILL BE ASSESSED USING QUESTIONNAIRES THE BEGINNING AND AFTER YOGA THERAPY AS WELL AS AFTER 6 MONTHS. DISCUSSION: SUPPORT OF PATIENTS SUFFERING FROM FATIGUE IS AN IMPORTANT GOAL IN CANCER PATIENTS CARE. IF YOGA THERAPY WILL REDUCE FATIGUE, THIS TYPE OF THERAPY MAY BE INTRODUCED INTO ROUTINE PRACTICE. IF THE REMINDER E-MAILS PROVE TO BE HELPFUL, NEW OFFERS FOR PATIENTS MAY ALSO DEVELOP FROM THIS. TRIAL REGISTRATION: GERMAN CLINCIAL TRIALS REGISTER ( DRKS00016034 , 12/2018), RETROSPECTIVELY REGISTERED. 2019