The Effect of TaiChi on Ischemic Burden of Patients With Coronary Heart Disease Complicated With Renal Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Left ventricular ejection fraction difference（△LVEF）
研究概览
简要总结
This study focuses on patients with incomplete revascularization combined with renal insufficiency. And since heart and kidney are two organs influence each other, the study take the mechanism of heart and kidney comorbidity and the risk factors of the two organs.As one of the traditional Chinese sports, Tai Chi is an aerobic exercise combineing movements with static postures, which can significantly improve the aerobic endurance of patients with coronary heart disease. In this study, a parallel, randomized controlled study method is used to quantitatively evaluate the myocardial ischemia condition by myocardial perfusion imaging indicators. This study aims to figure out whether the cardiac rehabilitation training program based on Tai Chi has a positive effect on the patients' myocardial ischemic.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30-75 years old, all genders;
- •At least two main vessels or their main branch vessels have obvious stenosis (≥50%) according to the coronary angiography;
- •Received stent implantation and incomplete revascularization (incomplete revascularization: at least one vessel whose a diameter> 2.0 mm and at least one lesion with a stenosis> 50%, after PCI);
- •eGFR<60ml/min·1.73m2;
- •Willing to be treated and followed-up during the specified time of the study;
- •Signed the informed consent approved by the Ethics Committee
排除标准
- •Patients with high-risks according to the exercise rehabilitation risks of patients with heart disease by AACVPR;
- •Severe cardiac insufficiency or cardiogenic shock;
- •Combined with severe ventricular arrhythmia, ICD is required;
- •Combined with severe pulmonary hypertension, chronic obstructive pulmonary disease, severe infectious disease, blood system disease, malignant tumor, severe liver damage, etc.;
- •Nervous, mental and motor system diseases;
- •Unwilling to be followed-up.
研究组 & 干预措施
The experimental group
Routine treatment, and tai Chi exercise,5 times a week
干预措施: Tai Chi Intervention Group (Behavioral)
The control group
Routine treatment, and cardiac rehabilitation is not mandatory
结局指标
主要结局
Left ventricular ejection fraction difference（△LVEF）
时间窗: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
ΔLVEF refers to the difference between the subject's post-test ejection fraction and the pre-test ejection fraction, with a larger difference indicating better improvement in cardiac function.
Nuclein myocardial perfusion Imaging-total scores of stress perfusion（SSS）
时间窗: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
The total load perfusion score indicates the extent and severity of abnormal exercise perfusion. Higher scores indicate more severe myocardial ischemia.
Nuclein myocardial perfusion Imaging-total scores of rest perfusion（SRS）
时间窗: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
The total resting perfusion score (SRS) refers to the degree of myocardial ischemia at rest, with higher scores indicating more severe myocardial ischemia.
Nuclein myocardial perfusion Imaging-Total myocardial ischemia score
时间窗: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
The total myocardial ischemia score reflects the extent and severity of exercise-induced ischemia, with higher scores indicating more severe myocardial ischemia.
次要结局
- Assess the quality of life(The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.)
- High-density lipoprotein cholesterol (HDL-C)(The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.)
- Body Mass Index(BMI)(The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.)
- Cardiopulmonary exercise test-Peak oxygen uptake (PVO2)(The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.)
- Cardiopulmonary exercise test-Oxygen uptake to power ratio（ΔVO2/ΔＷＲ）(The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.)
- Total serum cholesterol(TC)(The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.)
- Self-Rating Depression scale(SDS)(The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.)
- Cardiopulmonary exercise test-Metabolic equivalents (MET)(The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.)
- Cardiopulmonary exercise test-Carbon dioxide ventilation equivalent（VE/VCO2）(The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.)
- Low-density lipoprotein cholesterol (LDL-C)(The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.)
- Self-rating anxiety scale(SAS)(The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.)
- Triglycerides (TG)(The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.)
研究者
Ji Huang
Professor
Beijing Anzhen Hospital