Stress Reduction in the Prevention of Left Ventricular Hypertrophy

Sponsor

Maharishi International University (Other)

Overall Status

Completed

CT.gov ID

NCT05373732

Collaborator

Charles Drew University of Medicine and Science (Other)

171

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Left Ventricular Hypertrophy High Blood Pressure	Behavioral: meditation Behavioral: Health education control	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

171 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A randomized, controlled, single-blinded, clinical trial was conducted to compare the effect of Transcendental Meditation (TM) and health education (HE) on left ventricular mass in adult hypertensive African-AmericansA randomized, controlled, single-blinded, clinical trial was conducted to compare the effect of Transcendental Meditation (TM) and health education (HE) on left ventricular mass in adult hypertensive African-Americans

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Randomization was stratified by age, gender, mean arterial pressure, left ventricular mass index (LVMI), and antihypertensive medication. Investigators, data collectors and data management staff were blinded to group assignment. The biostatistician concealed the allocation by conveying the group assignment to the project manager who then informed each participant and instructed them not to reveal it to the research and data collection staff during the course of the study.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 1996

Actual Primary Completion Date :

Oct 1, 1998

Actual Study Completion Date :

Dec 1, 1998

Arms and Interventions

Arm	Intervention/Treatment
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).	Behavioral: meditation meditation practice 20 minutes twice a day at home and attending classes at the clinic. Other Names: stress reduction
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.	Behavioral: Health education control didactic based classes in CVD risk factor reduction and prevention

Arm

Intervention/Treatment

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).

Behavioral: meditation

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

Other Names:

stress reduction

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.

Behavioral: Health education control

didactic based classes in CVD risk factor reduction and prevention

Outcome Measures

Primary Outcome Measures

left ventricular mass (LVM) [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 Outcome Measures

blood pressure [0 and 6 months]
systolic and diastolic blood pressure
anger expression [0 and 6 months]
Speilberger Anger expression scale
perceived stress [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Maharishi International University
Charles Drew University of Medicine and Science

Investigators

Principal Investigator: Robert H Schneider, M.D., Maharishi International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Schneider, MD, Director and Dean, Maharishi International University

ClinicalTrials.gov Identifier:

NCT05373732

Other Study ID Numbers:

2100mdmvc

First Posted:

May 13, 2022

Last Update Posted:

May 13, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Robert Schneider, MD, Director and Dean, Maharishi International University

left ventricular mass

meditation

stress reduction

Additional relevant MeSH terms:

Hypertension

Hypertrophy, Left Ventricular

Hypertrophy

Study Results

No Results Posted as of May 13, 2022