The Effect of TaiChi on Ischemic Burden of Patients With Coronary Heart Disease Complicated With Renal Insufficiency
1 other identifier
interventional
142
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedFirst Posted
Study publicly available on registry
January 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedJanuary 5, 2022
January 1, 2022
3 years
November 27, 2021
January 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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.
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 (12)
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.
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.
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.
- +7 more secondary outcomes
Study Arms (2)
The experimental group
EXPERIMENTALRoutine treatment, and tai Chi exercise,5 times a week
The control group
NO INTERVENTIONRoutine treatment, and cardiac rehabilitation is not mandatory
Interventions
Tai Chi intervention group: routine treatment and tai Chi exercise,5 times a week.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 27, 2021
First Posted
January 5, 2022
Study Start
January 1, 2022
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
January 5, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share