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

January 4, 2022 updated by: Ji Huang, Beijing Anzhen Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Beijing Anzhen Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The experimental group
Routine treatment, and tai Chi exercise,5 times a week
Behavioral: Tai Chi Intervention Group
Tai Chi intervention group: routine treatment and tai Chi exercise,5 times a week.
No Intervention: The control group
Routine treatment, and cardiac rehabilitation is not mandatory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nuclein myocardial perfusion Imaging-total scores of stress perfusion（SSS）
Time Frame: 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.
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.
Nuclein myocardial perfusion Imaging-total scores of rest perfusion（SRS）
Time Frame: 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.
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.
Nuclein myocardial perfusion Imaging-Total myocardial ischemia score
Time Frame: 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.
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.
Left ventricular ejection fraction difference（△LVEF）
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiopulmonary exercise test-Peak oxygen uptake (PVO2)
Time Frame: 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.
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.
Cardiopulmonary exercise test-Oxygen uptake to power ratio（ΔVO2/ΔＷＲ）
Time Frame: 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 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.
Cardiopulmonary exercise test-Metabolic equivalents (MET)
Time Frame: 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.
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.
Cardiopulmonary exercise test-Carbon dioxide ventilation equivalent（VE/VCO2）
Time Frame: 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 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.
Total serum cholesterol(TC)
Time Frame: 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 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.
High-density lipoprotein cholesterol (HDL-C)
Time Frame: 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 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.
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: 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 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.
Triglycerides (TG)
Time Frame: 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 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.
Body Mass Index(BMI)
Time Frame: 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 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.
Assess the quality of life
Time Frame: 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.
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.
Self-rating anxiety scale(SAS)
Time Frame: 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 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.
Self-Rating Depression scale(SDS)
Time Frame: 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 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

December 30, 2024

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

November 27, 2021

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TaiChi trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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