Clinical trial NCT05178602: The Effect of TaiChi on Ischemic Burden of Patients With Coronary Heart Disease Complicated With Renal Insufficiency
Official title: The Effect of TaiChi on Ischemic Burden of Patients With Coronary Heart Disease Complicated With Renal Insufficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease (CHD)
Renal Insufficiency
Keywords: CHD
PCI
Tai Chi
Renal Insufficiency
Cardiac rehabilitation
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 142
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 30-75 years old, all genders;
2. At least two main vessels or their main branch vessels have obvious stenosis (≥50%) according to the coronary angiography;
3. 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);
4. eGFR\<60ml/min·1.73m2;
5. Willing to be treated and followed-up during the specified time of the study;
6. Signed the informed consent approved by the Ethics Committee

Exclusion Criteria:

1. Patients with high-risks according to the exercise rehabilitation risks of patients with heart disease by AACVPR;
2. Severe cardiac insufficiency or cardiogenic shock;
3. Combined with severe ventricular arrhythmia, ICD is required;
4. Combined with severe pulmonary hypertension, chronic obstructive pulmonary disease, severe infectious disease, blood system disease, malignant tumor, severe liver damage, etc.;
5. Nervous, mental and motor system diseases;
6. Unwilling to be followed-up.

Primary outcomes:
measure: Nuclein myocardial perfusion Imaging-total scores of stress perfusion（SSS）
timeFrame: 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.
measure: Nuclein myocardial perfusion Imaging-total scores of rest perfusion（SRS）
timeFrame: 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.
measure: Nuclein myocardial perfusion Imaging-Total myocardial ischemia score
timeFrame: 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.
measure: Left ventricular ejection fraction difference（△LVEF）
timeFrame: 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.
Secondary outcomes:
measure: Cardiopulmonary exercise test-Peak oxygen uptake (PVO2)
timeFrame: 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.
measure: Cardiopulmonary exercise test-Oxygen uptake to power ratio（ΔVO2/ΔＷＲ）
timeFrame: 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.
measure: Cardiopulmonary exercise test-Metabolic equivalents (MET)
timeFrame: 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.
measure: Cardiopulmonary exercise test-Carbon dioxide ventilation equivalent（VE/VCO2）
timeFrame: 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.
measure: Total serum cholesterol(TC)
timeFrame: 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.
measure: High-density lipoprotein cholesterol (HDL-C)
timeFrame: 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.
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: 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.
measure: Triglycerides (TG)
timeFrame: 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.
measure: Body Mass Index(BMI)
timeFrame: 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.
measure: Assess the quality of life
timeFrame: 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.
measure: Self-rating anxiety scale(SAS)
timeFrame: 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.
measure: Self-Rating Depression scale(SDS)
timeFrame: 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.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
References: