Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation: A Prospective, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Six-minute walk test（6MWT）
研究概览
简要总结
Chronic heart failure (CHF) is the end stage of various kinds of cardiovascular diseases with high mortality. After a long period of medical treatment or surgical treatment, patients suffered great pain physically and mentally. How to improve the quality of life and prognosis in patients with CHF, which is a hot topic in the field of cardiac rehabilitation now. Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for CHF patients.
To investigate the efficacy and safety of Baduanjin exercise for patients with coronary heart disease complicated with chronic heart failure (CHF). A randomized, controlled and prospective clinical trial was designed.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 40 to 75 years;
- •Diagnosed with chronic heart failure caused by coronary heart disease;
- •NYHA class I or II;
- •Patients with an ejection fraction (LVEF) more than 40%;
- •Participants in accordance with the guidelines define as stage II cardiac rehabilitation;
- •Participants signed the informed consent freely and voluntarily.
排除标准
- •The condition was serious or movement restrained by other diseases;
- •In the acute stage of chronic heart failure;
- •Participants with poorly control of blood pressure (SBP≥180mmHg or DBP≥100mmHg);
- •Resting heart rate is beating over 120 beats a minute, or merged with malignant arrhythmia;
- •Participants who have contraindications to cardiopulmonary test or exercise training;
- •Patients who have other serious acute， chronic organic disease or mental disorders;
- •Participants practiced in any kinds of traditional Chinese medicine exercises in last three months.
研究组 & 干预措施
Baduanjin exercise group
Participants in this group received routine rehabilitation training and Baduanjin exercise
干预措施: Baduanjin exercise (Behavioral)
Routine rehabilitation group
Participants in this group only received routine rehabilitation training
干预措施: Routine rehabilitation group (Behavioral)
结局指标
主要结局
Six-minute walk test（6MWT）
时间窗: Baseline, 3 months
Testing patients changes on walking distance and accompanies symptoms in 6 minutes
次要结局
- NT-proBNP(Baseline, 3 months)
- Cardiopulmonary exercise test (CPET)(Baseline, 3 months)
- Left ventricular end-diastolic diameter (LVDD)(Baseline, 3 months)
- hs-CRP(Baseline, 3 months)
- Left ventricular ejection fraction（LVEF）(Baseline, 3 months)
- HRV(Baseline, 3 months)
- Minnesota living with heart failure questionnaire (MLHFQ)(Baseline, 3 months)
- Major adverse cardiovascular events (MACE)(Baseline, 3 months, 6months)
- NYHA classification(Baseline, 3 months, 6months)
- The Main TCM symptoms(Baseline, 3 months)