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Completed

NCT Number: NCT05373732

Stress Reduction in the Prevention of Left Ventricular Hypertrophy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

-

Treatment and study plan

Meditation

Behavioral

meditation practice 20 minutes twice a day at home and attending classes at the clinic.

Other names: stress reduction

Health Education Control

Behavioral

didactic based classes in CVD risk factor reduction and prevention

Primary outcomes

  1. 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 outcomes

  1. blood pressure

    Time frame: 0 and 6 months

    systolic and diastolic blood pressure

  2. anger expression

    Time frame: 0 and 6 months

    Speilberger Anger expression scale

  3. 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

Sponsors and collaborators

Lead sponsor

Maharishi International University

Other

Collaborators

  • Charles Drew University of Medicine and Science

Registry information

Official study title

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

Important dates

Study start
1996
Primary completion
1998
Study completion
1998
First posted
May 13, 2022
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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