Efficacy and Mechanism of TCCRP in Patients With Chronic Coronary Syndrome Under Fusion Cardiac Rehabilitation Model
- Conditions
- Coronary Heart DiseaseChronic Coronary Syndrome
- Interventions
- Behavioral: Control Group ：conventional exercise rehabilitation programs (CERP)Behavioral: Experimental Group ：Tai Chi cardiac rehabilitation program (TCCRP)
- Registration Number
- NCT03936504
- Lead Sponsor
- Chinese PLA General Hospital
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Control Group ：conventional exercise rehabilitation programs (CERP) Group received conventional exercise rehabilitation programs (CERP). Experimental Group Experimental Group ：Tai Chi cardiac rehabilitation program (TCCRP) Group received Tai Chi cardiac rehabilitation program(TCCRP).
- Primary Outcome Measures
Name Time Method Change in score of Chinese Perceived Stress Scale (CPSS) baseline, 1 month, 3 months, 6 months Chinese Perceived Stress Scale is a self-rated questionnaire, which assesses perceived stress. Chinese Perceived Stress Scale is consisted of 14 items, which are divided into two dimensions: sense of tension and loss of control. Higher scores indicate higher levels of stress，lower scores indicate lower levels of stress. Chinese Perceived Stress Scale will be evaluated at baseline, 1 month, 3 months and 6 months.
Change in score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) baseline,1 month, 3 months, 6 months SF-36 Health Survey(SF-36) . This is a multi-purpose, short-form health survey with only 36 questions. SF-36 items cover eight domains: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. Higher scores indicate higher levels of health. SF-36 will be evaluated at baseline, 1 month, 3 months and 6 months.
6-minute walk test (6 MWT) baseline, 1 month, 3 months, 6months 6-minute walk test (6 MWT). 6MWT measures the distance a patient can walk quickly on a flat, hard ground in 6 minutes. 6MWT will be evaluated at baseline, 1 month, 3 months and 6 months.
- Secondary Outcome Measures
Name Time Method Body fat rate baseline, 3 months Body fat rate will be tested by the Inbody770 at baseline and 3 months (at the end of the intervention) through bioelectrical impedance analysis.
Peak oxygen uptake（VO2Peak） baseline, 3 months Cardiopulmonary exercise test (CPET) is an objective method being increasingly used in a wide spectrum of clinical practice for assessing the functional capacity of patient with coronary heart disease. Peak oxygen uptake（VO2Peak）will be tested by CPET at baseline and 3 months (at the end of the intervention).
Left ventricular ejection fraction(LVEF) baseline, 3 months LVED Vi and LVEF are also to be assessed using echocardiography at baseline and at the end of the 12-week intervention.
Testing of intestinal flora baseline, 3 months Intestinal flora tests will be evaluated at baseline and at the end of the 3-month intervention.
Low-density lipoprotein baseline, 3 months Low-density lipoprotein inspections will be tested at baseline and at the end of the 3-month intervention using an automatic biochemical analyzer.
Locomotor skills baseline，3 months Locomotor skills includes handgrip strength, balance and flexibility. Handgrip strength, which is used to determine the maximum isometric strength of the hand and forearm muscles, will be measured using the handgrip strength dynamometer produced by CAMRY (product type EH101). The best result from repeated tests of each hand will be recorded. The balance test mainly includes standing on one foot with eyes closed, standing on one foot with eyes open, standing in situ with closed eyes and so on. Flexibility will be measured by seated forward flexion test. Locomotor skills will be evaluated at baseline and at the end of the 3-month intervention.
Heart rate variability baseline, 3 months Heart rate variability will be assessed at baseline and at the end of the 3-month intervention.
Trial Locations
- Locations (3)
Chinese PLA General Hospital
🇨🇳Beijing, China
Beijing Chaoyang District Anzhen Community Health Service Center
🇨🇳Beijing, China
Beijing Water Conservancy Hospital
🇨🇳Beijing, China