1 1345 165 HYPERTENSION ANALYSIS OF STRESS REDUCTION USING MINDFULNESS MEDITATION AND YOGA (THE HARMONY STUDY): STUDY PROTOCOL OF A RANDOMISED CONTROL TRIAL. INTRODUCTION: HYPERTENSION (HTN) IS A LEADING RISK FACTOR FOR PREVENTABLE CARDIOVASCULAR DISEASE, WITH OVER ONE IN FIVE ADULTS AFFECTED WORLDWIDE. LIFESTYLE MODIFICATION IS A KEY STRATEGY FOR THE PREVENTION AND TREATMENT OF HTN. STRESS HAS BEEN ASSOCIATED WITH GREATER CARDIOVASCULAR RISK, AND STRESS MANAGEMENT IS A RECOMMENDED INTERVENTION FOR HYPERTENSIVES. STRESS REDUCTION THROUGH RELAXATION THERAPIES HAS BEEN SHOWN TO HAVE AN EFFECT ON HUMAN PHYSIOLOGY, INCLUDING LOWERING BLOOD PRESSURE (BP). HOWEVER, INDIVIDUALISED BEHAVIOURAL INTERVENTIONS ARE RESOURCE INTENSIVE, AND GROUP STRESS MANAGEMENT APPROACHES HAVE NOT BEEN VALIDATED FOR REDUCING HTN. THE HARMONY STUDY IS A PILOT RANDOMISED CONTROLLED TRIAL DESIGNED TO DETERMINE IF MINDFULNESS-BASED STRESS REDUCTION (MBSR), A STANDARDISED GROUP THERAPY, IS AN EFFECTIVE INTERVENTION FOR LOWERING BP IN STAGE 1 UNMEDICATED HYPERTENSIVES. METHODS AND ANALYSIS: MEN AND WOMEN UNMEDICATED FOR HTN WITH MEAN DAYTIME AMBULATORY BLOOD PRESSURE (ABP) >/=135/85 MM HG OR 24 H ABP >/=130/80 MM HG ARE INCLUDED IN THE STUDY. SUBJECTS ARE RANDOMISED TO RECEIVE MBSR IMMEDIATELY OR AFTER A WAIT-LIST CONTROL PERIOD. THE PRIMARY OUTCOME MEASURE IS MEAN AWAKE AND 24 H ABP. THE PRIMARY OBJECTIVE OF THE HARMONY STUDY IS TO COMPARE ABP BETWEEN THE TREATMENT AND WAIT-LIST CONTROL ARM AT THE 12-WEEK PRIMARY ASSESSMENT PERIOD. RESULTS FROM THIS STUDY WILL DETERMINE IF MBSR IS AN EFFECTIVE INTERVENTION FOR LOWERING BP IN EARLY UNMEDICATED HYPERTENSIVES. ETHICS AND DISSEMINATION: THIS RESEARCH PROJECT WAS APPROVED BY THE SUNNYBROOK RESEARCH ETHICS BOARD AND THE UNIVERSITY HEALTH NETWORK RESEARCH ETHICS BOARD (TORONTO, CANADA). PLANNED ANALYSES ARE IN FULL COMPLIANCE WITH THE PRINCIPLES OF THE DECLARATION OF HELSINKI. DATA COLLECTION WILL BE COMPLETED BY EARLY SPRING 2012. PRIMARY AND SECONDARY ANALYSIS WILL COMMENCE IMMEDIATELY AFTER DATA MONITORING IS COMPLETED; DISSEMINATION PLANS INCLUDE PREPARING PUBLICATIONS FOR SUBMISSION DURING THE SUMMER OF 2012. TRIAL REGISTRATION NUMBER: THIS STUDY IS REGISTERED WITH HTTP://CLINICALTRIALS.GOV (NCT00825526). 2012 2 1552 52 LIFESTYLE MODIFICATION IN BLOOD PRESSURE STUDY II (LIMBS): STUDY PROTOCOL OF A RANDOMIZED CONTROLLED TRIAL ASSESSING THE EFFICACY OF A 24 WEEK STRUCTURED YOGA PROGRAM VERSUS LIFESTYLE MODIFICATION ON BLOOD PRESSURE REDUCTION. HYPERTENSION IS A MAJOR PUBLIC HEALTH ISSUE AFFECTING 68 MILLION ADULTS IN THE UNITED STATES. LIFESTYLE MODIFICATIONS INCLUDING COMPLEMENTARY THERAPIES SUCH AS THE MOVEMENT BASED MIND BODY PRACTICE OF YOGA HAVE BECOME INCREASINGLY POPULAR IN THE UNITED STATES AND HAVE BEEN CONSIDERED AS A POTENTIAL ALTERNATIVE TO MEDICATION IN BLOOD PRESSURE REDUCTION. WE COMPLETED A PILOT STUDY IN 2009 WHICH SHOWED MEANINGFUL DECREASES IN 24-HOUR AMBULATORY BLOOD PRESSURE READINGS AFTER A 12 WEEK PERIOD OF YOGA PARTICIPATION. BASED ON DATA FROM OUR PILOT STUDY WE ARE NOW COMPLETING THE LIFESTYLE MODIFICATION AND BLOOD PRESSURE STUDY (LIMBS II) WHICH IS A PHASE 2 RANDOMIZED CONTROLLED TRIAL DESIGNED TO DETERMINE THE EFFECTS OF YOGA THERAPY AND ENHANCED LIFESTYLE MODIFICATION ON LOWERING BLOOD PRESSURE IN PRE-HYPERTENSIVE AND STAGE 1 HYPERTENSIVE SUBJECTS. USING 24-HOUR AMBULATORY BLOOD PRESSURE MONITORING, LIMBS II AIMS TO COMPARE THE EFFECTS ON BLOOD PRESSURE REDUCTION IN SUBJECTS RANDOMIZED FOR 24 WEEKS TO ONE OF THE THREE FOLLOWING GROUPS: YOGA THERAPY VERSUS BLOOD PRESSURE EDUCATION PROGRAM (SODIUM RESTRICTION AND WALKING PROGRAM) VERSUS A COMBINATION PROGRAM THAT INVOLVES COMPONENTS OF BOTH GROUPS. LIMBS II WILL ALSO EXAMINE THE IMPACT THAT CHANGES IN BLOOD PRESSURE HAVE ON CEREBRAL BLOOD FLOW. IF SUCCESSFUL, THE LIMBS STUDY WILL DETERMINE IF YOGA THERAPY COMBINED WITH ENHANCED LIFESTYLE MODIFICATION WILL RESULT IN CLINICALLY MEANINGFUL DECREASES IN BLOOD PRESSURE AND THUS CAN BE IMPLEMENTED AS AN ALTERNATIVE TO DRUG THERAPY FOR PATIENTS WITH PREHYPERTENSION AND STAGE 1 HYPERTENSION. 2013 3 1346 59 HYPERTENSION ANALYSIS OF STRESS REDUCTION USING MINDFULNESS MEDITATION AND YOGA: RESULTS FROM THE HARMONY RANDOMIZED CONTROLLED TRIAL. BACKGROUND: THE HARMONY STUDY WAS A RANDOMIZED, CONTROLLED TRIAL EXAMINING THE EFFICACY OF AN 8-WEEK MINDFULNESS-BASED STRESS REDUCTION (MBSR) PROGRAM FOR BLOOD PRESSURE (BP) LOWERING AMONG UNMEDICATED STAGE 1 HYPERTENSIVE PARTICIPANTS. METHODS: PARTICIPANTS DIAGNOSED WITH STAGE 1 HYPERTENSION BASED ON AMBULATORY BP WERE RANDOMIZED TO EITHER IMMEDIATE TREATMENT OF MBSR FOR 8 WEEKS OR WAIT-LIST CONTROL. PRIMARY OUTCOME ANALYSIS EVALUATED WHETHER CHANGE IN AWAKE AND 24-HOUR AMBULATORY BP FROM BASELINE TO WEEK 12 WAS SIGNIFICANTLY DIFFERENT BETWEEN THE 2 GROUPS. A WITHIN-GROUP BEFORE AND AFTER MBSR ANALYSIS WAS ALSO PERFORMED. RESULTS: THE STUDY ENROLLED 101 ADULTS (38% MALE) WITH BASELINE AVERAGE 24-HOUR AMBULATORY BP OF 135+/-7.9/82+/-5.8MM HG AND DAYTIME AMBULATORY BP OF 140+/-7.7/87+/-6.3 MMHG. AT WEEK 12, THE CHANGE FROM BASELINE IN 24-HOUR AMBULATORY BP WAS 0.4+/-6.7/0.0+/-4.9MM HG FOR THE IMMEDIATE INTERVENTION AND 0.4+/-7.8/-0.4+/-4.6MM HG FOR THE WAIT-LIST CONTROL. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN INTERVENTION AND WAIT-LIST CONTROL FOR ALL AMBULATORY BP PARAMETERS. THE SECONDARY WITHIN-GROUP ANALYSIS FOUND A SMALL REDUCTION IN BP AFTER MBSR COMPARED WITH BASELINE, A FINDING LIMITED TO FEMALE SUBJECTS IN A SEX ANALYSIS. CONCLUSIONS: MBSR DID NOT LOWER AMBULATORY BP BY A STATISTICALLY OR CLINICALLY SIGNIFICANT AMOUNT IN UNTREATED, STAGE 1 HYPERTENSIVE PATIENTS WHEN COMPARED WITH A WAIT-LIST CONTROL GROUP. IT LEAVES UNTESTED WHETHER MBSR MIGHT BE USEFUL FOR LOWERING BP BY IMPROVING ADHERENCE IN TREATED HYPERTENSIVE PARTICIPANTS. CLINICAL TRIALS REGISTRATION: NCT00825526. 2014 4 1370 55 IMPACT OF A STRUCTURED YOGA PROGRAM ON BLOOD PRESSURE REDUCTION AMONG HYPERTENSIVE PATIENTS: STUDY PROTOCOL FOR A PRAGMATIC RANDOMIZED MULTICENTER TRIAL IN PRIMARY HEALTH CARE SETTINGS IN NEPAL. BACKGROUND: HYPERTENSION CONTROL REMAINS A MAJOR GLOBAL CHALLENGE. THE BEHAVIORAL APPROACHES RECOMMENDED FOR BLOOD PRESSURE REDUCTION ARE STRESS REDUCTION, INCREASED EXERCISE AND HEALTHY DIETARY HABITS. SOME STUDY FINDINGS SUGGEST THAT YOGA HAS A BENEFICIAL EFFECT IN REDUCING BLOOD PRESSURE. HOWEVER, THE ROLE OF YOGA ON BLOOD PRESSURE HAS RECEIVED LITTLE ATTENTION IN EXISTING HEALTH CARE PRACTICES IN DEVELOPING COUNTRIES. THIS STUDY WILL BE CONDUCTED IN PRIMARY HEALTH CARE FACILITIES IN NEPAL TO ASSESS THE EFFECTIVENESS OF A PRAGMATIC YOGA INTERVENTION TO COMPLEMENT STANDARD PRACTICE IN FURTHER REDUCING BLOOD PRESSURE. METHODS: THIS WILL BE MULTICENTRIC, TWO ARMS, RANDOMIZED, NONBLINDED, PRAGMATIC TRIAL. IT WILL BE CONDUCTED IN SEVEN DISTRICT AYURVEDA HEALTH CENTERS (DAHCS) IN NEPAL BETWEEN JULY 2017 AND JUNE 2018. THE STUDY PARTICIPANTS WILL CONSIST OF HYPERTENSIVE PATIENTS WITH OR WITHOUT ANTIHYPERTENSIVE MEDICATION ATTENDING TO THE OUTPATIENT DEPARTMENT (OPD). ONE HUNDRED AND FORTY PARTICIPANTS WILL BE RANDOMIZED TO TREATMENT OR CONTROL GROUPS BY USING A STRATIFIED BLOCK RANDOMIZATION. AT THE STUDY SITE, THE TREATMENT ARM PARTICIPANTS WILL RECEIVE AN INTERVENTION CONSISTING OF FIVE DAYS OF STRUCTURED YOGA TRAINING AND PRACTICE OF THE SAME PACKAGE AT HOME WITH A RECOMMENDATION OF FIVE DAYS A WEEK FOR THE FOLLOWING 90 DAYS. BOTH THE INTERVENTION AND CONTROL GROUPS WILL RECEIVE TWO HOURS OF HEALTH EDUCATION ON LIFESTYLE MODIFICATIONS. THE PRIMARY OUTCOME OF THIS TRIAL WILL BE THE CHANGE IN SYSTOLIC BLOOD PRESSURE AND IT WILL BE ASSESSED AFTER 90 DAYS OF THE INTERVENTION. DISCUSSION: THIS STUDY WILL ESTABLISH THE EXTENT TO WHICH A YOGA INTERVENTION PACKAGE CAN HELP REDUCE BLOOD PRESSURE IN HYPERTENSIVE PATIENTS. IF PROVEN EFFECTIVE, STUDY FINDINGS MAY BE USED TO RECOMMEND THE GOVERNING BODIES AND OTHER STAKEHOLDERS FOR THE INTEGRATION OF YOGA IN THE NATIONAL HEALTHCARE SYSTEM FOR THE TREATMENT AND CONTROL OF HYPERTENSION. TRIAL REGISTRATION: CLINICAL TRIAL REGISTRY- INDIA (CTRI); CTRI REG. NO- CTRI/2017/02/007822 . REGISTERED ON 10/02/2017. 2018 5 1854 52 RANDOMISED CONTROLLED TRIAL OF A 12 WEEK YOGA INTERVENTION ON NEGATIVE AFFECTIVE STATES, CARDIOVASCULAR AND COGNITIVE FUNCTION IN POST-CARDIAC REHABILITATION PATIENTS. BACKGROUND: NEGATIVE AFFECTIVE STATES SUCH AS ANXIETY, DEPRESSION AND STRESS ARE SIGNIFICANT RISK FACTORS FOR CARDIOVASCULAR DISEASE, PARTICULARLY IN CARDIAC AND POST-CARDIAC REHABILITATION POPULATIONS.YOGA IS A BALANCED PRACTICE OF PHYSICAL EXERCISE, BREATHING CONTROL AND MEDITATION THAT CAN REDUCE PSYCHOSOCIAL SYMPTOMS AS WELL AS IMPROVE CARDIOVASCULAR AND COGNITIVE FUNCTION. IT HAS THE POTENTIAL TO POSITIVELY AFFECT MULTIPLE DISEASE PATHWAYS AND MAY PROVE TO BE A PRACTICAL ADJUNCT TO CARDIAC REHABILITATION IN FURTHER REDUCING CARDIAC RISK FACTORS AS WELL AS IMPROVING SELF-EFFICACY AND POST-CARDIAC REHABILITATION ADHERENCE TO HEALTHY LIFESTYLE BEHAVIOURS. METHOD AND DESIGN: THIS IS A PARALLEL ARM, MULTI-CENTRE, RANDOMISED CONTROLLED TRIAL THAT WILL ASSESS THE OUTCOMES OF POST- PHASE 2 CARDIAC REHABILITATION PATIENTS ASSIGNED TO A YOGA INTERVENTION IN COMPARISON TO A NO-TREATMENT WAIT-LIST CONTROL GROUP. PARTICIPANTS RANDOMISED TO THE YOGA GROUP WILL ENGAGE IN A 12 WEEK YOGA PROGRAM COMPRISING OF TWO GROUP BASED SESSIONS AND ONE SELF-ADMINISTERED HOME SESSION EACH WEEK. GROUP BASED SESSIONS WILL BE LED BY AN EXPERIENCED YOGA INSTRUCTOR. THIS WILL INVOLVE TEACHING BEGINNER STUDENTS A HATHA YOGA SEQUENCE THAT INCORPORATES ASANA (POSES AND POSTURES), PRANAYAMA (BREATHING CONTROL) AND MEDITATION. THE PRIMARY OUTCOMES OF THIS STUDY ARE NEGATIVE AFFECTIVE STATES OF ANXIETY, DEPRESSION AND STRESS ASSESSED USING THE DEPRESSION ANXIETY STRESS SCALE. SECONDARY OUTCOMES INCLUDE MEASURES OF QUALITY OF LIFE, AND CARDIOVASCULAR AND COGNITIVE FUNCTION. THE CARDIOVASCULAR OUTCOMES WILL INCLUDE BLOOD PRESSURE, HEART RATE, HEART RATE VARIABILITY, PULSE WAVE VELOCITY, CAROTID INTIMA MEDIA THICKNESS MEASUREMENTS, LIPID/GLUCOSE PROFILES AND C-REACTIVE PROTEIN ASSAYS. ASSESSMENTS WILL BE CONDUCTED PRIOR TO (WEEK 0), MID-WAY THROUGH (WEEK 6) AND FOLLOWING THE INTERVENTION PERIOD (WEEK 12) AS WELL AS AT A FOUR WEEK FOLLOW-UP (WEEK 16). DISCUSSION: THIS STUDY WILL DETERMINE THE EFFECT OF YOGA PRACTICE ON NEGATIVE AFFECTIVE STATES, CARDIOVASCULAR AND COGNITIVE FUNCTION IN POST-PHASE 2 CARDIAC REHABILITATION PATIENTS. THE FINDINGS MAY PROVIDE EVIDENCE TO INCORPORATE YOGA INTO STANDARDISED CARDIAC REHABILITATION PROGRAMS AS A PRACTICAL ADJUNCT TO IMPROVE THE MANAGEMENT OF PSYCHOSOCIAL SYMPTOMS ASSOCIATED WITH CARDIOVASCULAR EVENTS IN ADDITION TO IMPROVING PATIENTS' COGNITIVE AND CARDIOVASCULAR FUNCTIONS. TRIAL REGISTRATION: ACTRN12612000358842. 2014 6 2834 43 YOGA'S EFFECT ON INFLAMMATORY BIOMARKERS AND METABOLIC RISK FACTORS IN A HIGH RISK POPULATION - A CONTROLLED TRIAL IN PRIMARY CARE. BACKGROUND: YOGA CAN REDUCE BLOOD PRESSURE AND HAS ALSO BEEN SUGGESTED TO REDUCE INFLAMMATORY BIOMARKERS AND METABOLIC RISK FACTORS FOR CARDIOVASCULAR DISEASES (CVDS). WE AIMED TO ASSESS THE BENEFIT OF TWO YOGA INTERVENTIONS ON INFLAMMATORY BIOMARKERS AND METABOLIC RISK FACTORS IN A HIGH RISK POPULATION IN PRIMARY CARE. METHODS: ADULT PATIENTS FROM A HEALTH CARE CENTER IN SWEDEN, WITH DIAGNOSED HYPERTENSION, WERE INVITED TO UNDERGO A BASELINE CHECK AT THE HEALTH CARE CENTER. BASELINE CHECK INCLUDED STANDARDIZED BLOOD PRESSURE MEASUREMENT, BMI AND WEIGHT CIRCUMFERENCE MEASUREMENTS, BLOOD SAMPLING (HS-CRP, IL-6, FP-GLUCOSE, HBA1C, CHOLESTEROL, TG, LDL AND HDL) AND A QUESTIONNAIRE ON SELF-RATED QUALITY OF LIFE (WHOQOL-BREF). THERE WERE THREE GROUPS: 1) YOGA CLASS WITH YOGA INSTRUCTOR; 2) YOGA AT HOME; AND 3) A CONTROL GROUP. IN TOTAL, 83 PATIENTS WERE INCLUDED AND MATCHED AT THE GROUP LEVEL FOR SYSTOLIC BLOOD PRESSURE. A MAJORITY OF THE PATIENTS (92 %) WERE ON ANTIHYPERTENSIVE MEDICATION, WHICH THEY WERE REQUESTED NOT TO CHANGE DURING THE STUDY. AFTER 12 WEEKS OF INTERVENTION, THE ASSESSMENTS WERE PERFORMED AGAIN. RESULTS: WE RECORDED NO EVIDENCE THAT YOGA ALTERED INFLAMMATORY BIOMARKERS OR METABOLIC RISK FACTORS IN OUR STUDY POPULATION. A TOTAL OF 49 PARTICIPANTS (59 %) MET THE CRITERIA FOR METABOLIC SYNDROME. CONCLUSION: THE YOGA INTERVENTIONS PERFORMED IN OUR STUDY DID NOT AFFECT INFLAMMATORY BIOMARKERS OR METABOLIC RISK FACTORS ASSOCIATED WITH CVD IN THE STUDY POPULATION OF PRIMARY CARE PATIENTS WITH HYPERTENSION. FURTHER RANDOMIZED TRIALS ARE NEEDED TO ELUCIDATE THE EFFECTS OF YOGA ON CVD RISK FACTORS IN THIS PARTICULAR GROUP. TRAIL REGISTRATION: NCT01302535 , FEBRUARY 22, 2011. 2015 7 1402 45 IMPACT OF YOGA ON BLOOD PRESSURE AND QUALITY OF LIFE IN PATIENTS WITH HYPERTENSION - A CONTROLLED TRIAL IN PRIMARY CARE, MATCHED FOR SYSTOLIC BLOOD PRESSURE. BACKGROUND: MEDICAL TREATMENT OF HYPERTENSION IS NOT ALWAYS SUFFICIENT TO ACHIEVE BLOOD PRESSURE CONTROL. DESPITE THIS, PREVIOUS STUDIES ON SUPPLEMENTARY THERAPIES, SUCH AS YOGA, ARE RELATIVELY FEW. WE INVESTIGATED THE EFFECTS OF TWO YOGA INTERVENTIONS ON BLOOD PRESSURE AND QUALITY OF LIFE IN PATIENTS IN PRIMARY HEALTH CARE DIAGNOSED WITH HYPERTENSION. METHODS: ADULT PATIENTS (AGE 20-80 YEARS) WITH DIAGNOSED HYPERTENSION WERE IDENTIFIED BY AN ELECTRONIC CHART SEARCH AT A PRIMARY HEALTH CARE CENTER IN SOUTHERN SWEDEN. IN TOTAL, 83 SUBJECTS WITH BLOOD PRESSURE VALUES OF 120-179/