Tai Chi Mind-Body Therapy for Chronic Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- HF-specific quality of life
研究概览
简要总结
The purpose of this study is to determine the effects of a tai chi exercise program on functional capacity and health-related quality of life in patients with chronic heart failure (HF). This study will also examine the way tai chi influences mental, physical, and social functioning.
详细描述
HF is a major public health problem in the United States, affecting approximately 5 million adults. Despite recent advances in pharmacologic therapy and technologic devices, HF is the most common reason for hospitalization among Medicare patients and is reaching epidemic proportions as the population ages. New and inexpensive interventions that can improve functional capacity and quality of life and can delay disease progression are needed. Tai chi is a popular mind-body exercise that is a potential treatment for heart disease. This exercise incorporates both gentle physical activity and meditation, and it may be particularly suited to frail patients with HF. This study will examine the effects of a tailored tai chi program on functional capacity and quality of life in patients with HF.
Participants will be randomly assigned to either a tai chi program or heart health education for 12 weeks. Participants in both groups will undergo a bicycle stress test at study entry and will receive weekly training sessions of their assigned intervention. Self-report scales and questionnaires will be used to assess participants at study start and at the end of 12 weeks.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic HF
- •Percentage of blood pumped from the left ventricle (ventricular ejection fraction) less than 40% for at least 1 year prior to study entry
- •Stable medical regimen, defined as no major changes in medication, in the 3 months prior to study entry
- •New York Heart Association Classification of Class I (no activity limitations), Class II (slight activity limitations), or Class III (marked activity limitations)
- •English-speaking
排除标准
- •Unstable angina, myocardial infarction, cardiac resynchronization, or major cardiac surgery within 3 months prior to study entry
- •History of cardiac arrest or diagnosis of peripartum cardiomyopathy within 6 months prior to study entry
- •Unstable ventricular arrhythmias or structural valvular disease
- •Current participation in a conventional cardiac rehabilitation program
- •Inability to perform a bicycle stress test at study entry
- •Lower extremity amputation or other inability to walk due to conditions other than HF
- •Severe cognitive dysfunction preventing informed consent and understanding of tai chi concept
- •Current regular practice of tai chi
- •Current participation in a tai chi pilot study or other studies
结局指标
主要结局
HF-specific quality of life
时间窗: baseline, midpoint, endpoint, 6mo
functional capacity
时间窗: baseline and endpoint
Walking Test
时间窗: baseline, midpoint, endpoint
次要结局
- echocardiography(baseline and endpoint)
- General quality of life(baseline, midpoint, endpoint, 6mo)
- mood and emotional status(baseline, midpoint, endpoint, 6mo)
- exercise self-efficacy(baseline, midpoint, endpoint, 6mo)
- sense of coherence(baseline, midpoint, endpoint, 6mo)
- utility assessment(baseline, midpoint, endpoint, 6mo)
- beliefs, attitudes, and expectations(baseline, midpoint, endpoint)
- physical activity level(baseline, midpoint, endpoint)
- perceived social support(baseline, midpoint, endpoint)
- neurohormonal status(baseline, midpoint, endpoint)
- autonomic tone, heart rate variability(baseline and endpoint)
- costs and use of HF services(baseline and endpoint)
研究者
Gloria Y. Yeh
Associate Professor of Medicine
Beth Israel Deaconess Medical Center