Stress Reduction in the Prevention of Left Ventricular Hypertrophy

NCT05373732 | Completed DMC

• 1 other identifier: 2100mdmvc
• Study Type: interventional
• Target: 171
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Left Ventricular Hypertrophy; High Blood Pressure

Keywords

left ventricular mass; meditation; stress reduction

Outcome Measures

Primary Outcomes (1)

• left ventricular mass (LVM)

  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.

  6 months pre to post

Secondary Outcomes (3)

• blood pressure

  0 and 6 months

• anger expression

  0 and 6 months

• perceived stress

  0 and 6 months

Study Arms (2)

Transcendental Meditation

EXPERIMENTAL

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

Health Education

ACTIVE COMPARATOR

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

Interventions

meditation BEHAVIORAL

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

Also known as: stress reduction

Transcendental Meditation

Health education control BEHAVIORAL

didactic based classes in CVD risk factor reduction and prevention

Health Education

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Maharishi International University: lead
• Charles Drew University of Medicine and Science: collaborator

Related Publications (1)

• 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.

  PMID: 31641325 RESULT

MeSH Terms

Conditions

Hypertrophy, Left Ventricular; Hypertension

Interventions

Meditation; Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mindfulness; Cognitive Behavioral Therapy

Study Officials

• Robert H Schneider, M.D.

  Maharishi International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Dean

Model Details: 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

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: May 13, 2022
• Study Start: April 1, 1996
• Primary Completion: October 1, 1998
• Study Completion: December 1, 1998
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: currently available
• Access Criteria: contact investigators and request access to database and submit short study proposal