Stress Reduction in the Prevention of Left Ventricular Hypertrophy

NCT ID: NCT05373732

Last Updated: 2022-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-04-30

Study Completion Date

1998-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Left Ventricular Hypertrophy High Blood Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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-Americans
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

meditation

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Health education control

Intervention Type BEHAVIORAL

didactic based classes in CVD risk factor reduction and prevention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

meditation

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

Intervention Type BEHAVIORAL

Health education control

didactic based classes in CVD risk factor reduction and prevention

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

stress reduction

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Charles Drew University of Medicine and Science

OTHER

Sponsor Role collaborator

Maharishi International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Robert Schneider, MD

Director and Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert H Schneider, M.D.

Role: PRINCIPAL_INVESTIGATOR

Maharishi International University

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 31641325 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2100mdmvc

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Expecting Study
NCT02125149 ACTIVE_NOT_RECRUITING NA