Stress Reduction in the Prevention of Left Ventricular Hypertrophy

Maharishi International University

Status: Completed

Conditions: High Blood Pressure; Left Ventricular Hypertrophy

Treatments: Behavioral: Health education control; Behavioral: meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT05373732

2100mdmvc

Details and patient eligibility

About

This study evaluated the effect of stress reduction by Transcendental Meditation (TM) on left ventricular mass compared to a health education control group in pre-hypertensive or hypertensive African-American adults over a six-month intervention period.

Full description

Left ventricular hypertrophy (LVH) is an independent risk factor for cardiovascular disease (CVD). African Americans have higher rates of LVH and CVD than whites. Substantial evidence indicates that psychological stress contributes to LVH. This randomized controlled trial evaluated the effect of stress reduction with the Transcendental Meditation (TM) technique on left ventricular mass (LVM) in hypertensive African-Americans.

Hypertensive African American men and women were tested at baseline for left ventricular mass index (LVMI) by M-mode echocardiography, blood pressure, lifestyle and behavioral factors. Subjects were randomly assigned to either TM or health education (HE) control. After six months intervention, 86 subjects were posttested on all outcomes. Data were analyzed for between-group and within-group differences.

Enrollment: 171 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: self-identified African-American men and women ages, 20-75 years old, with either prehypertension (systolic blood pressure (SBP) of 120-139 mm Hg and/or diastolic blood pressure (DBP) of 80-89 mm Hg), Stage-1 hypertension (SBP of 140-159 mm Hg and/or DBP of 90-99 mm Hg) or Stage-2 hypertension (SBP of 160-179 and/or DBP of 100-109 mm of Hg), with or without antihypertensive medications -

Exclusion Criteria: Patients with a history of stroke, transient cerebral ischemic attack, congestive heart failure, myocardial infarction, angina pectoris or with significant ECG abnormalities, major psychiatric or behavioral disorder such as alcoholism (> 28 drinks per week)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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171 participants in 2 patient groups

Transcendental Meditation

Experimental group

Description:

The Transcendental Meditation (TM) technique is described as a simple, natural technique that is practiced twice a day for 20 minutes while sitting comfortably with eyes closed. There are no required changes in lifestyle, beliefs or philosophy. Instruction in the TM technique involves a seven-step course over five sessions (90-minute meetings).

Treatment:

Behavioral: meditation

Health Education

Active Comparator group

Description:

The health education (HE) intervention provided behavioral instructions for CVD risk factor prevention . This group received written materials, structured presentations, didactic instructions and group support for modifying the major cardiovascular risk factors including salt restriction, weight reduction, aerobic exercise, alcohol and smoking cessation.

Treatment:

Behavioral: Health education control