Stress Reduction in the Prevention of Left Ventricular Hypertrophy

Overview

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 Title of Study: “Stress Reduction in the Prevention of Left Ventricular Hypertrophy: A Randomized Controlled Trial of Transcendental Meditation and Health Education in Hypertensive African Americans”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 1998

Detailed 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.

Interventions

  • Behavioral: meditation
    • meditation practice 20 minutes twice a day at home and attending classes at the clinic.
  • Behavioral: Health education control
    • didactic based classes in CVD risk factor reduction and prevention

Arms, Groups and Cohorts

  • Experimental: Transcendental Meditation
    • 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).
  • Active Comparator: Health Education
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • left ventricular mass (LVM)
    • Time Frame: 6 months pre to post
    • The primary outcome was change in LVMI. LVM was measured by M-mode echocardiography and indexed by body surface area to generate LVMI. [18] Measurements were obtained at the end-diastole. Interventricular septal thickness, posterior wall thickness, and left ventricle internal dimension were measured.

Secondary Measures

  • blood pressure
    • Time Frame: 0 and 6 months
    • systolic and diastolic blood pressure
  • anger expression
    • Time Frame: 0 and 6 months
    • Speilberger Anger expression scale
  • perceived stress
    • Time Frame: 0 and 6 months
    • Perceived Stress Scale, a 5-item subset of the California Self-Evaluation Scale to measure self-esteem, and a personal efficacy scale

Participating in This Clinical Trial

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) -

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Maharishi International University
  • Collaborator
    • Charles Drew University of Medicine and Science
  • Provider of Information About this Clinical Study
    • Principal Investigator: Robert Schneider, MD, Director and Dean – Maharishi International University
  • Overall Official(s)
    • Robert H Schneider, M.D., Principal Investigator, Maharishi International University

Citations Reporting on Results

Schneider RH, Myers HF, Marwaha K, Rainforth MA, Salerno JW, Nidich SI, Gaylord-King C, Alexander CN, Norris KC. Stress Reduction in the Prevention of Left Ventricular Hypertrophy: A Randomized Controlled Trial of Transcendental Meditation and Health Education in Hypertensive African Americans. Ethn Dis. 2019 Oct 17;29(4):577-586. doi: 10.18865/ed.29.4.577. eCollection 2019 Fall.

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