A Perspective Randomized Controlled Study of the Formulation and Efficacy of Exercise Prescription for Patients With Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Improvement of 6-minute walk test
研究概览
简要总结
The purposes of this study is to standardize the process of formulating exercise prescriptions for coronary heart disease（CHD）, verify the safety and effectiveness of exercise prescriptions, and establish a database of exercise prescriptions for CHD, with a view to providing new solutions for cardiac rehabilitation.
详细描述
This study conducted a comparative study on the therapeutic effect and safety of exercise prescriptions for patients with coronary heart disease with different risk stratifications. The purposes of this study is to standardize the process of formulating exercise prescriptions for coronary heart disease（CHD）, verify the safety and effectiveness of exercise prescriptions, and establish a database of exercise prescriptions for CHD, with a view to providing new solutions for cardiac rehabilitation.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years old with a diagnosis of coronary heart disease，NYHA class I-III HF patients.
排除标准
- •acute myocardial infarction within 2 weeks
- •Uncontrolled tachycardia (heart rate at rest >120bpm
- •Uncontrolled polypnea（breath rate at rest >30 breath per minute
- •Uncontrolled respiratory failure （SPO2 ≤90%）
- •Uncontrolled hyperglycemia (Random blood glucose>18mmol/L)
- •Uncontrolled malignant arrhythmia with hemodynamic instability
- •Uncontrolled septic shock and septicopyemia
- •Uncooperation of the patients
研究组 & 干预措施
Moderate Intensity Group
Group received a moderate exercise prescription of moderate intensity
干预措施: Moderate intensity exercise prescription (Behavioral)
High Intensity Group
Group received a moderate exercise prescription of high intensity
干预措施: High intensity exercise prescription (Behavioral)
结局指标
主要结局
Improvement of 6-minute walk test
时间窗: 6 month
the improvement of 6 minute walking distance
Improvement of Cardiopulmonary exercise test
时间窗: 6 month
the improvement of maximum oxygen uptake
Improvement of grip strength test
时间窗: 6 month
the improvement of grip strength
Incidence of MACE
时间窗: 6 month
any incidence of the following: death, cardiac death, AMI, revascularization, stroke
Routine color Doppler echocardiography changed.
时间窗: 6 month
Routine color Doppler echocardiography changed.
The score of Seattle Angina Questionnaire increased
时间窗: 6 month
The score of Seattle Angina Questionnaire (SAQ, 0-100 each dimension, higher means greater condition）increased.
次要结局
- The score of Patient Health Questionnaire decreased(6 month)
- The score of Generalized Anxiexy Disorde-7 decreased(6 month)
- The score of Pittsburgh Sleep Quality Index Scale decreased.(6 month)
- The score of Fagerstrom Test for Nicotine Dependence decreased.(6 month)
- The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased(6 month)
- The score of Chinese perceived stress scale decreased.(6 month)
研究者
Jing Ma
Clincial professor
Chinese PLA General Hospital