Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

The purpose of this study is to evaluate the effectiveness of meditation in preventing of atherosclerotic cardiovascular disease (CVD) in postmenopausal, older African American women.

Completed

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Key information

Conditions

Cardiovascular Diseases

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Howard University Medical Center, Washington D.C., District of Columbia, United States

About this study

Older African American women suffer from disproportionately high rates of cardiovascular (CVD) morbidity and mortality compared to white Americans. Numerous controlled studies suggest that this disparity is associated with chronic psychosocial and environmental stress. Research indicates that Transcendental Meditation (TM) may result in significant improvements in CVD risk factors in this high risk population.

Participants in this study will be randomly assigned to either active stress reduction with TM or health education control, both in addition to usual medical care, for 12 months. The primary outcome will be carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography. Secondary measures will include traditional CVD risk factors (blood pressure, serum glucose and insulin levels, obesity, and sedentary lifestyle), stress-related neurohormones (catecholamine metabolite and cortisol), psychosocial stress, and quality of life. The results of this trial will yield valuable new knowledge for the prevention of CVD through a CAM intervention in high risk older African American women.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

African American, self-identified
Coronary artery disease (CAD/CHD) defined by laboratory examination or documented clinical history of: a)myocardial infarction; b) coronary revascularization procedure--CABG, PTCA; c) coronary angiography--at least one coronary artery with >50% stenosis
Informed consent
Written Permission of participant's referring physician

Treatment and study plan

Transcendental Meditation

Behavioral

a mantra meditation technique which originated from the Vedic tradition of India. It is practiced from 20 minutes twice a day sitting comfortably in a chair with eyes closed.

Health Education

Behavioral

didactic education classes for lifestyle modification through diet, exercise, substance use control, and salt intake

Primary outcomes

Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography

Time frame: one year

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Collaborators

Howard University
Morehouse College of Medicine

Registry information

Important dates

Study start: 1999
Primary completion: 2006
Study completion: 2006
First posted: Feb 5, 2001
Registry last updated: Dec 7, 2009

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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Completed