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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.

ABSTRACT: 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.

SUBMITTER: Cohen DL

PROVIDER: S-EPMC4593488 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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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.

Cohen Debbie L DL Bowler Anne A Fisher Stephen A SA Norris Angela A Newberg Andrew A Rao Hengyi H Bhavsar Rupal R Detre John A JA Tenhave Thomas T Townsend Raymond R RR

Contemporary clinical trials 20130527 1

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 ...[more]

PMID: 23721984

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Project description:Background Population-wide reduction in mean blood pressure is proposed as a key strategy for primary prevention of cardiovascular disease. We evaluated the effectiveness of a task-sharing strategy involving frontline health workers in the primary prevention of elevated blood pressure. Methods and Results We conducted DISHA (Diet and lifestyle Interventions for Hypertension Risk reduction through Anganwadi Workers and Accredited Social Health Activists) study, a cluster randomized controlled trial involving 12 villages each from 4 states in India. Frontline health workers delivered a custom-made and structured lifestyle modification intervention in the selected villages. A baseline survey was conducted in 23 and 24 clusters in the control (n=6663) and intervention (n=7150) groups, respectively. The baseline characteristics were similar between control and intervention clusters. In total 5616 participants from 23 clusters in the control area and 5699 participants from 24 clusters in the intervention area participated in a repeat cross-sectional survey conducted immediately after the intervention phase of 18-months. The mean (SD) systolic blood pressure increased from 125.7 (18.1) mm Hg to 126.1 (16.8) mm Hg in the control clusters, and it increased from 124.4 (17.8) mm Hg to 126.7 (17.5) mm Hg in the intervention clusters. The population average adjusted mean difference in difference in systolic blood pressure was 1.75 mm Hg (95% CI, -0.21 to 3.70). Conclusions Task-sharing interventions involving minimally trained nonphysician health workers are not effective in reducing population average blood pressure in India. Expanding the scope of task sharing and intensive training of health workers such as nurses, nutritionists, or health counselors in management of cardiovascular risk at the population level may be more effective in primary prevention of cardiovascular disease. Registration URL: https://www.ctri.nic.in; Unique identifier: CTRI/2013/10/004049.

Project description:ObjectiveAssociation of lifestyle modification and pharmacological adherence among patients with hypertension attending a national referral hospital in Kenya.DesignDescriptive, cross-sectional.SettingMedical wards and outpatient clinic of a national referral hospital.ParticipantsPatients (n=229) diagnosed with primary hypertension for at least 6 months.Primary outcomesClinical makers, cholesterol levels, anthropometrics, lifestyle/dietary habits adjusted for age, gender and education; antihypertensive adherence; views on prevention of hypertension and adequacy of hypertension information.ResultsAgeing was associated with elevated diastolic blood pressure (BP) (p<0.05), heart rate (HR) and cholesterol. Females had higher body mass index (BMI). More males reported drinking alcohol and smoking (p<0.001), especially the highly educated. Higher BPs were observed in smokers and drinkers (p<0.05). Daily vegetables and fruits intake were linked to lower BP, HR and BMI (p<0.05). Intake of foods high in saturated fat and cholesterol were associated with raised HR (p<0.05). Respondents on antihypertensive medication, those engaged in healthy lifestyle and took their prescribed medications had lower mean BPs than those on medication only (138/85 vs 140/90). Few respondents (30.8%) considered hypertension as preventable, mainly the single and highly educated (p<0.05). Respondents (53.6%) believed they should stop taking their antihypertensive medication once hypertension is controlled.ConclusionMissed targets for BP control and hypertension-related risks are associated with ageing, female gender, fast food and animal fat intake. Alcohol and smoking is common in males associated with poor BP control. Daily vegetables and fruits intake are associated with better BP control and overall hypertension risk reduction. Observed suboptimal BP control despite pharmacological adherence suggests lifestyle modification is needed besides antihypertensive medication. Interventions should address modifiable risk factors aggravated by age and adverse lifestyles through adopting combined lifestyle modification, pharmacological adherence and tailored expert delivered hypertension-related information.

Dataset Information

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.

Publications

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.

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