跳至主要内容
临床试验/NCT00010608
NCT00010608已完成2 期

Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

National Center for Complementary and Integrative Health (NCCIH)4 个研究点 分布在 1 个国家目标入组 196 人开始时间: 1999年10月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
196
试验地点
4
主要终点
Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: one year

次要结局

未报告次要终点

研究者

研究点 (4)

Loading locations...

相似试验