Clinical Efficacy and Mechanism of Tai Chi Cardiac Rehabilitation Program（TCCRP） in Patients With Chronic Coronary Syndrome Under Fusion Cardiac Rehabilitation Model: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Change in score of Chinese Perceived Stress Scale (CPSS)
研究概览
简要总结
This study is a prospective, multi-center, randomized controlled clinical study. It developed an innovative Tai Chi Cardiac Rehabilitation Program (TCCRP) for patients with chronic coronary syndrome (CCS) and evaluated the efficacy, acceptability and safety of TCCRP on patients with CCS in order to explore the possible mechanism of its feasibility.
详细描述
This study is a prospective, multi-center, randomized controlled clinical trial of 100 participants with chronic coronary syndrome (CCS) that compares Tai Chi cardiac rehabilitation program (TCCRP) with conventional exercise rehabilitation programs (CERP), with an allocation ratio of 1:1. A total of 6 months study period, including 1 month in-hospital rehabilitation, 2 months home-based rehabilitation and 3 months follow-up. The main outcome indicators were measured at baseline, 1 month, 3 months and 6 months. The secondary outcome measures will be measured at baseline and at 3 months.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant women aged from 18 to 80 years;
- •Patients who met the stable angina pectoris in accordance with coronary heart disease;
- •NYHA class Ι, Π or Ш;
- •Participants were able to understand the purpose of clinical trials and voluntarily participate and sign informed consent.
排除标准
- •Acute myocardial infarction (AMI) within 2 weeks;
- •Severe aortic stenosis;
- •Hypertrophic cardiomyopathy;
- •Severe valvular heart disease;
- •Malignant tachyarrhythmia;
- •The patient compliance was poor and the clinical trial could not be completed according to the requirements.
- •Combined exercise can cause deterioration of the nervous system, motor system disease, or rheumatic disease.
- •In the past 3 months, those who regularly practice Tai Chi;
- •Patients with gastrointestinal diseases, infectious diseases, renal insufficiency, and a history of gastrointestinal surgery within one year
结局指标
主要结局
Change in score of Chinese Perceived Stress Scale (CPSS)
时间窗: baseline, 1 month, 3 months, 6 months
Chinese Perceived Stress Scale is a self-rated questionnaire, which assesses perceived stress. Chinese Perceived Stress Scale is consisted of 14 items, which are divided into two dimensions: sense of tension and loss of control. Higher scores indicate higher levels of stress，lower scores indicate lower levels of stress. Chinese Perceived Stress Scale will be evaluated at baseline, 1 month, 3 months and 6 months.
Change in score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey)
时间窗: baseline,1 month, 3 months, 6 months
SF-36 Health Survey(SF-36) . This is a multi-purpose, short-form health survey with only 36 questions. SF-36 items cover eight domains: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. Higher scores indicate higher levels of health. SF-36 will be evaluated at baseline, 1 month, 3 months and 6 months.
6-minute walk test (6 MWT)
时间窗: baseline, 1 month, 3 months, 6months
6-minute walk test (6 MWT). 6MWT measures the distance a patient can walk quickly on a flat, hard ground in 6 minutes. 6MWT will be evaluated at baseline, 1 month, 3 months and 6 months.
次要结局
- Body fat rate(baseline, 3 months)
- Peak oxygen uptake（VO2Peak）(baseline, 3 months)
- Left ventricular ejection fraction(LVEF)(baseline, 3 months)
- Testing of intestinal flora(baseline, 3 months)
- Low-density lipoprotein(baseline, 3 months)
- Locomotor skills(baseline，3 months)
- Heart rate variability(baseline, 3 months)
研究者
Jing Ma
Clincial professor
Chinese PLA General Hospital