Efficacy and Mechanism of TCCRP in Patients With Chronic Coronary Syndrome Under Fusion Cardiac Rehabilitation Model

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Coronary Heart Disease; Chronic Coronary Syndrome

Treatments: Behavioral: Control Group ：conventional exercise rehabilitation programs (CERP); Behavioral: Experimental Group ：Tai Chi cardiac rehabilitation program (TCCRP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03936504

S2019-060-03

Details and patient eligibility

About

This study is a prospective, multi-center, randomized controlled clinical study. It developed an innovative Tai Chi Cardiac Rehabilitation Program (TCCRP) for patients with chronic coronary syndrome (CCS) and evaluated the efficacy, acceptability and safety of TCCRP on patients with CCS in order to explore the possible mechanism of its feasibility.

Full description

This study is a prospective, multi-center, randomized controlled clinical trial of 100 participants with chronic coronary syndrome (CCS) that compares Tai Chi cardiac rehabilitation program (TCCRP) with conventional exercise rehabilitation programs (CERP), with an allocation ratio of 1:1. A total of 6 months study period, including 1 month in-hospital rehabilitation, 2 months home-based rehabilitation and 3 months follow-up. The main outcome indicators were measured at baseline, 1 month, 3 months and 6 months. The secondary outcome measures will be measured at baseline and at 3 months.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Male or non-pregnant women aged from 18 to 80 years;
2. Patients who met the stable angina pectoris in accordance with coronary heart disease;
3. NYHA class Ι, Π or Ш;
4. Participants were able to understand the purpose of clinical trials and voluntarily participate and sign informed consent.

Exclusion criteria

1. Acute myocardial infarction (AMI) within 2 weeks;
2. Severe aortic stenosis;
3. Hypertrophic cardiomyopathy;
4. Severe valvular heart disease;
5. Malignant tachyarrhythmia;
6. The patient compliance was poor and the clinical trial could not be completed according to the requirements.
7. Combined exercise can cause deterioration of the nervous system, motor system disease, or rheumatic disease.
8. In the past 3 months, those who regularly practice Tai Chi;
9. Patients with gastrointestinal diseases, infectious diseases, renal insufficiency, and a history of gastrointestinal surgery within one year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Group received conventional exercise rehabilitation programs (CERP).

Treatment:

Behavioral: Control Group ：conventional exercise rehabilitation programs (CERP)

Experimental Group

Experimental group

Description:

Group received Tai Chi cardiac rehabilitation program(TCCRP).

Treatment:

Behavioral: Experimental Group ：Tai Chi cardiac rehabilitation program (TCCRP)