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

Coronary Heart Disease Clinical Trial

Official title:

Clinical Efficacy and Mechanism of Tai Chi Cardiac Rehabilitation Program（TCCRP） in Patients With Chronic Coronary Syndrome Under Fusion Cardiac Rehabilitation Model: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03936504
• Other study ID #: S2019-060-03
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: December 2020
• Source: Chinese PLA General Hospital
• Contact: Ma Jing, doctor
• Phone: 13681257396
• Email: crystalma[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ?, ? or ?;

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

Related Conditions & MeSH terms

• Chronic Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Syndrome

Intervention

Behavioral:
• Control Group :conventional exercise rehabilitation programs (CERP)
The participants in the control group will receive a conventional exercise rehabilitation programs (CERP) thrice a week for 12 weeks. Each training session lasts for 60 minutes, including ordinary warm-up exercises (10 minutes), aerobic activity (30 minutes), resistive exercise (10 minutes), and cool-down exercises(10 minutes). Each training session includes:(1) an active warm-up including arm-swinging, gentle stretches of the neck, shoulders, spine, arms, legs and so on;(2) aerobic activity mainly including aerobic radio exercise;(3) resistive exercise mainly including elastic belt exercise;(4) cool-down session involving active and static stretching exercises with primary body movements.
• Experimental Group :Tai Chi cardiac rehabilitation program (TCCRP)
Participants perform Tai Chi cardiac rehabilitation program(TCCRP) thrice a week for 12 weeks. Each training session lasts for 60 minutes, including Tai Chi warm-up exercises(10 minutes), Bafa Wubu of Tai Chi(30 minutes), Tai-Chi in conjunction with X-light-band resistance exercise(10 minutes), and Tai Chi cool-down exercises(10 minutes). All participants are encouraged to practice Tai Chi followed the instructional video until finishing 12-week exercise.

Locations

Country	Name	City	State
China	Beijing Chaoyang District Anzhen Community Health Service Center	Beijing
China	Beijing Water Conservancy Hospital	Beijing
China	Chinese PLA General Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Beijing Normal University

Country where clinical trial is conducted

China, 

References & Publications (11)

Caruso FR, Junior JC, Mendes RG, Sperling MP, Arakelian VM, Bassi D, Arena R, Borghi-Silva A. Hemodynamic and metabolic response during dynamic and resistance exercise in different intensities: a cross-sectional study on implications of intensity on safety and symptoms in patients with coronary disease. Am J Cardiovasc Dis. 2016 May 18;6(2):36-45. eCollection 2016. — View Citation

Chow CK, Redfern J, Thiagalingam A, Jan S, Whittaker R, Hackett M, Graves N, Mooney J, Hillis GS. Design and rationale of the tobacco, exercise and diet messages (TEXT ME) trial of a text message-based intervention for ongoing prevention of cardiovascular disease in people with coronary disease: a randomised controlled trial protocol. BMJ Open. 2012 Jan 19;2(1):e000606. doi: 10.1136/bmjopen-2011-000606. Print 2012. — View Citation

Dominguez-Rodriguez A, Abreu-Gonzalez P. Microvascular coronary disease in women: role of the cardiopulmonary exercise testing. Int J Cardiol. 2013 Oct 3;168(3):3012-3. doi: 10.1016/j.ijcard.2013.04.055. Epub 2013 May 7. — View Citation

Ferguson RJ, Bourassa MG, Côté P, Chaitman BR. [Cardiovascular effects of exercise and physical training in coronary disease]. Union Med Can. 1979 Oct;108(10):1187-94. Review. French. — View Citation

Ferguson RJ, Petitclerc R, Choquette G, Chaniotis L, Gauthier P, Huot R, Allard C, Jankowski L, Campeau L. Effect of physical training on treadmill exercise capacity, collateral circulation and progression of coronary disease. Am J Cardiol. 1974 Dec;34(7):764-9. — View Citation

Fernandes F, Morais C, Esteves M, Camilo V, Nazaré J, da Cunha JC, Amram SS. [Atrial pacing and the exercise test in the evaluation of coronary disease. A comparative study]. Rev Port Cardiol. 1990 Sep;9(9):675-9. Portuguese. — View Citation

Hartung GH. Diet and exercise in the regulation of plasma lipids and lipoproteins in patients at risk of coronary disease. Sports Med. 1984 Nov-Dec;1(6):413-8. Review. — View Citation

Leprêtre PM, Ghannem M, Bulvestre M, Ahmaidi S, Delanaud S, Weissland T, Lopes P. Exercise-based Cardiac Rehabilitation in Coronary Disease: Training Impulse or Modalities? Int J Sports Med. 2016 Dec;37(14):1144-1149. Epub 2016 Nov 10. — View Citation

Pozzan R, Da Cruz P di M, Castier MB, Barbosa EC, Barbosa JS, Da Rocha PJ, Albanesi Filho FM, Ginefra P, Gomes Filho JB. [Cardiac rehabilitation of patients with coronary disease. Evaluation after 3 and 6 months of aerobic training at the community level]. Arq Bras Cardiol. 1988 May;50(5):305-10. Portuguese. — View Citation

Sharma S, Malhotra A. Exercise testing and coronary disease: pushing fitness to higher peaks. Eur Heart J. 2019 May 21;40(20):1640-1642. doi: 10.1093/eurheartj/ehy777. — View Citation

Yang YL, Wang YH, Wang SR, Shi PS, Wang C. The Effect of Tai Chi on Cardiorespiratory Fitness for Coronary Disease Rehabilitation: A Systematic Review and Meta-Analysis. Front Physiol. 2018 Jan 4;8:1091. doi: 10.3389/fphys.2017.01091. eCollection 2017. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Generalized Anxiety Disorder-7 (GAD-7)	Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure. The GAD-7 asks how often participants have been bothered by anxiety symptoms in the past 2 weeks. Items are rated on a 4-point Likert scale indicating symptom frequency, ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, with higher scores indicating GAD. According to the original authors, the total score can then be interpreted as indicating no/minimal anxiety (0-4), mild (5-9), moderate (10-14), or severe (15-21), with a reasonable cut-off value for identifying cases of GAD at 10 points. GAD-7 will be evaluated at baseline and at the end of the 3-month intervention.	baseline, 3 months
Other	Patient Health Questionnaire-9 (PHQ-9)	The Patient Health Questionnaire-9 (PHQ-9) is designed for use with adults in assessing and monitoring depression severity based on Diagnostic and Statistical Manual of Mental Disorders (4th ed.;DSM-IV); The PHQ-9 asks clients to check off the number of days they have been bothered by each of the PHQ-9 symptoms over the"last two weeks." The nine items, based on DSM criteria for diagnosis of depression, are used to generate scores of 0, 1, 2, or 3 to the response categories of "not at all," "several days," "more than half the days," and "nearly every day,". The higher the score, the more serious the depression. PHQ-9 will be evaluated at baseline and at the end of the 3-month intervention.	baseline, 3 months
Primary	Change in score of Chinese Perceived Stress Scale (CPSS)	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.	baseline, 1 month, 3 months, 6 months
Primary	Change in score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey)	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.	baseline,1 month, 3 months, 6 months
Primary	6-minute walk test (6 MWT)	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.	baseline, 1 month, 3 months, 6months
Secondary	Body fat rate	Body fat rate will be tested by the Inbody770 at baseline and 3 months (at the end of the intervention) through bioelectrical impedance analysis.	baseline, 3 months
Secondary	Peak oxygen uptake(VO2Peak)	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).	baseline, 3 months
Secondary	Locomotor skills	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.	baseline,3 months
Secondary	Left ventricular ejection fraction(LVEF)	LVED Vi and LVEF are also to be assessed using echocardiography at baseline and at the end of the 12-week intervention.	baseline, 3 months
Secondary	Heart rate variability	Heart rate variability will be assessed at baseline and at the end of the 3-month intervention.	baseline, 3 months
Secondary	Low-density lipoprotein	Low-density lipoprotein inspections will be tested at baseline and at the end of the 3-month intervention using an automatic biochemical analyzer.	baseline, 3 months
Secondary	Testing of intestinal flora	Intestinal flora tests will be evaluated at baseline and at the end of the 3-month intervention.	baseline, 3 months

External Links

•   Wichita State University