The Effect of TaiChi on Ischemic Burden of Patients With Coronary Heart Disease Complicated With Renal Insufficiency

Renal Insufficiency Clinical Trial

Official title:

The Effect of TaiChi on Ischemic Burden of Patients With Coronary Heart Disease Complicated With Renal Insufficiency

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05178602
• Other study ID #: TaiChi trial
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2022
• Source: Beijing Anzhen Hospital
• Contact: JI Huang, Doctor
• Phone: 15810291548
• Email: drjihuang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 142
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease (CHD)
• Heart Diseases
• Myocardial Ischemia
• Renal Insufficiency

Intervention

Behavioral:
• Tai Chi Intervention Group
Tai Chi intervention group: routine treatment and tai Chi exercise,5 times a week.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nuclein myocardial perfusion Imaging-total scores of stress perfusion(SSS)	The total load perfusion score indicates the extent and severity of abnormal exercise perfusion. Higher scores indicate more severe myocardial ischemia.	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.
Primary	Nuclein myocardial perfusion Imaging-total scores of rest perfusion(SRS)	The total resting perfusion score (SRS) refers to the degree of myocardial ischemia at rest, with higher scores indicating more severe myocardial ischemia.	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.
Primary	Nuclein myocardial perfusion Imaging-Total myocardial ischemia score	The total myocardial ischemia score reflects the extent and severity of exercise-induced ischemia, with higher scores indicating more severe myocardial ischemia.	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.
Primary	Left ventricular ejection fraction difference(?LVEF)	?LVEF 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.	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	Cardiopulmonary exercise test-Peak oxygen uptake (PVO2)	Peak oxygen uptake is an important indicator of cardiopulmonary exercise function, it is the golden indicator to assess aerobic exercise capacity, the greater the peak oxygen uptake, the better the cardiopulmonary function. The unit is mL/(min-kg).	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	Cardiopulmonary exercise test-Oxygen uptake to power ratio(?VO2/?WR)	The lower the oxygen uptake to power ratio, the worse the cardiorespiratory function.The unit is mL/(min·W) .	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	Cardiopulmonary exercise test-Metabolic equivalents (MET)	Metabolic equivalent is an important indicator in cardiac rehabilitation, which is used to quantify various activities and to determine the intensity of exercise. The higher the metabolic equivalent, the better the cardiopulmonary function.	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	Cardiopulmonary exercise test-Carbon dioxide ventilation equivalent(VE/VCO2)	The higher the ratio of VE/VCO2, the lower the ventilation efficiency	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	Total serum cholesterol(TC)	Total serum cholesterol level is one of the risk factors for coronary heart disease, and the higher the total serum cholesterol level, the worse it is for cardiovascular.	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	High-density lipoprotein cholesterol (HDL-C)	The higher the HDL cholesterol in the blood, the better it is for the cardiovascular system.	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	Low-density lipoprotein cholesterol (LDL-C)	Low-density lipoprotein cholesterol is one of the risk factors for coronary heart disease, and the higher the Low-density lipoprotein cholesterol level, the worse it is for cardiovascular.	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	Triglycerides (TG)	Triglycerides is one of the risk factors for coronary heart disease, and the higher the triglycerides level, the worse it is for cardiovascular.	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	Body Mass Index(BMI)	The normal value of BMI is between 20kg/m^2 and 25kg/m^2, more than 25kg/m^2 is overweight and more than 30kg/m^2 is obese.	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	Assess the quality of life	In this study, the Seattle Angina Questionnaire (SAQ) was used to measure the quality of life. The higher the patient's score on this questionnaire, the better 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.
Secondary	Self-rating anxiety scale(SAS)	The higher the score on the self-rating scale of anxiety, the more likely it is that anxiety is present.	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	Self-Rating Depression scale(SDS)	The higher the score on the self-rating scale of anxiety, the more likely it is that depression is present.	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.