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

Primary Purpose

Coronary Heart Disease (CHD), Renal Insufficiency

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tai Chi Intervention Group
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease (CHD) focused on measuring CHD, PCI, Tai Chi, Renal Insufficiency, Cardiac rehabilitation

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Anzhen Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The experimental group

The control group

Arm Description

Routine treatment, and tai Chi exercise,5 times a week

Routine treatment, and cardiac rehabilitation is not mandatory

Outcomes

Primary Outcome Measures

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.
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.
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.
Left ventricular ejection fraction difference（△LVEF）
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.

Secondary Outcome Measures

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).
Cardiopulmonary exercise test-Oxygen uptake to power ratio（ΔVO2/ΔＷＲ）
The lower the oxygen uptake to power ratio, the worse the cardiorespiratory function.The unit is mL/(min·W) .
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.
Cardiopulmonary exercise test-Carbon dioxide ventilation equivalent（VE/VCO2）
The higher the ratio of VE/VCO2, the lower the ventilation efficiency
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.
High-density lipoprotein cholesterol (HDL-C)
The higher the HDL cholesterol in the blood, the better it is for the cardiovascular system.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 27, 2021
Last Updated
January 4, 2022
Sponsor
Beijing Anzhen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05178602
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease (CHD), Renal Insufficiency
Keywords
CHD, PCI, Tai Chi, Renal Insufficiency, Cardiac rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The experimental group
Arm Type
Experimental
Arm Description
Routine treatment, and tai Chi exercise,5 times a week
Arm Title
The control group
Arm Type
No Intervention
Arm Description
Routine treatment, and cardiac rehabilitation is not mandatory
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi Intervention Group
Intervention Description
Tai Chi intervention group: routine treatment and tai Chi exercise,5 times a week.
Primary Outcome Measure Information:
Title
Nuclein myocardial perfusion Imaging-total scores of stress perfusion（SSS）
Description
The total load perfusion score indicates the extent and severity of abnormal exercise perfusion. Higher scores indicate more severe myocardial ischemia.
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.
Title
Nuclein myocardial perfusion Imaging-total scores of rest perfusion（SRS）
Description
The total resting perfusion score (SRS) refers to the degree of myocardial ischemia at rest, with higher scores indicating more severe myocardial ischemia.
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.
Title
Nuclein myocardial perfusion Imaging-Total myocardial ischemia score
Description
The total myocardial ischemia score reflects the extent and severity of exercise-induced ischemia, with higher scores indicating more severe myocardial ischemia.
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.
Title
Left ventricular ejection fraction difference（△LVEF）
Description
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.
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.
Secondary Outcome Measure Information:
Title
Cardiopulmonary exercise test-Peak oxygen uptake (PVO2)
Description
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).
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.
Title
Cardiopulmonary exercise test-Oxygen uptake to power ratio（ΔVO2/ΔＷＲ）
Description
The lower the oxygen uptake to power ratio, the worse the cardiorespiratory function.The unit is mL/(min·W) .
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.
Title
Cardiopulmonary exercise test-Metabolic equivalents (MET)
Description
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.
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.
Title
Cardiopulmonary exercise test-Carbon dioxide ventilation equivalent（VE/VCO2）
Description
The higher the ratio of VE/VCO2, the lower the ventilation efficiency
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.
Title
Total serum cholesterol(TC)
Description
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.
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.
Title
High-density lipoprotein cholesterol (HDL-C)
Description
The higher the HDL cholesterol in the blood, the better it is for the cardiovascular system.
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.
Title
Low-density lipoprotein cholesterol (LDL-C)
Description
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.
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.
Title
Triglycerides (TG)
Description
Triglycerides is one of the risk factors for coronary heart disease, and the higher the triglycerides level, the worse it is for cardiovascular.
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.
Title
Body Mass Index(BMI)
Description
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.
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.
Title
Assess the quality of life
Description
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.
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.
Title
Self-rating anxiety scale(SAS)
Description
The higher the score on the self-rating scale of anxiety, the more likely it is that anxiety is present.
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.
Title
Self-Rating Depression scale(SDS)
Description
The higher the score on the self-rating scale of anxiety, the more likely it is that depression is present.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JI Huang, Doctor
Phone
15810291548
Email
drjihuang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chu Fan, Postgraduate
Phone
+8618832070253
Email
fc19970915@Foxmail.com
Facility Information:
Facility Name
Beijing Anzhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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