Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05373732
Other study ID # 2100mdmvc
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1996
Est. completion date December 1998

Study information

Verified date May 2022
Source Maharishi International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 171
Est. completion date December 1998
Est. primary completion date October 1998
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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) -

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Maharishi International University Charles Drew University of Medicine and Science

References & 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 Educ — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 blood pressure systolic and diastolic blood pressure 0 and 6 months
Secondary anger expression Speilberger Anger expression scale 0 and 6 months
Secondary perceived stress Perceived Stress Scale, a 5-item subset of the California Self-Evaluation Scale to measure self-esteem, and a personal efficacy scale 0 and 6 months
See also
  Status Clinical Trial Phase
Completed NCT03812614 - Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support N/A
Completed NCT03650166 - High BP and Home Monitoring Experience (HoME) Study N/A
Recruiting NCT02908139 - Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients N/A
Completed NCT01622400 - Efficacy of a Dedicated Therapeutic Education Program in Patients at High Cardiovascular Risk N/A
Completed NCT00659672 - Effect of Whey Protein on Blood Pressure N/A
Completed NCT00473681 - Intervention Study to Control High Blood Pressure for Korean American N/A
Completed NCT03542240 - Effects of Curcumin Supplementation on Gut Barrier Function in Patients With Metabolic Syndrome N/A
Active, not recruiting NCT05526092 - OAT-GUT-BRAIN: Effects of Oats and Rice on Comprehensive Health of Metabolically Challenged Individuals N/A
Completed NCT02218931 - ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes N/A
Recruiting NCT03753204 - Salt-Sensitivity and Immunity Cell Activation Phase 1/Phase 2
Completed NCT04479384 - The Immediate Effect of an Osteopathic Manual Treatment on Blood Pressure in Adults With Hypertension - a Pilot Study. N/A
Not yet recruiting NCT04064281 - The Healthy Cantonese Diet on Cardiometabolic Syndrome N/A
Completed NCT04082819 - MediBeat - HeartBeat Observation Trial N/A
Completed NCT03555344 - Effect of Mantra on Hypertensive Patients N/A
Withdrawn NCT03319823 - Treating Nocturnal Hypertension and Nocturia in African American Men Phase 4
Completed NCT00689819 - Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients N/A
Completed NCT00417170 - Comparison of Aliskiren and Amlodipine on Insulin Resistance and Endothelial Dysfunction in Patients With Hypertension and Metabolic Syndrome Phase 2
Completed NCT00130156 - Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension Phase 4
Completed NCT05808556 - Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure N/A
Recruiting NCT05321368 - A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities N/A