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

NCT03936504 | Unknown DMC

• 1 other identifier: S2019-060-03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Coronary Heart Disease; Chronic Coronary Syndrome

Keywords

Tai Chi; Cardiac rehabilitation; Chronic coronary syndrome; Safety; Effectiveness; Randomized controlled trial; Fusion cardiac rehabilitation model

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (7)

• Body fat rate

  baseline, 3 months

• Peak oxygen uptake（VO2Peak）

  baseline, 3 months

• Locomotor skills

  baseline，3 months

• Left ventricular ejection fraction(LVEF)

  baseline, 3 months

• Heart rate variability

  baseline, 3 months

Other Outcomes (2)

• Generalized Anxiety Disorder-7 (GAD-7)

  baseline, 3 months

• Patient Health Questionnaire-9 (PHQ-9)

  baseline, 3 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Group received conventional exercise rehabilitation programs (CERP).

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

Experimental Group

EXPERIMENTAL

Group received Tai Chi cardiac rehabilitation program(TCCRP).

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

Interventions

Control Group ：conventional exercise rehabilitation programs (CERP) BEHAVIORAL

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.

Control Group

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

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Beijing Normal University: collaborator

Study Sites (3)

Beijing Water Conservancy Hospital

Beijing, 100036, China

RECRUITING

Chinese PLA General Hospital

Beijing, 100853, China

RECRUITING

Beijing Chaoyang District Anzhen Community Health Service Center

Beijing, China

RECRUITING

Related Publications (13)

• 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.

  PMID: 29354065 BACKGROUND

• 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. No abstract available. Portuguese.

  PMID: 3240110 BACKGROUND

• Ferguson RJ, Bourassa MG, Cote P, Chaitman BR. [Cardiovascular effects of exercise and physical training in coronary disease]. Union Med Can. 1979 Oct;108(10):1187-94. No abstract available. French.

  PMID: 392869 BACKGROUND

• Fernandes F, Morais C, Esteves M, Camilo V, Nazare 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.

  PMID: 2257154 BACKGROUND

• 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. doi: 10.2165/00007256-198401060-00001. No abstract available.

  PMID: 6390610 BACKGROUND

• 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. doi: 10.1016/0002-9149(74)90693-6. No abstract available.

  PMID: 4432806 BACKGROUND

• Lepretre 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. doi: 10.1055/s-0042-112591. Epub 2016 Nov 10.

  PMID: 27832671 BACKGROUND

• 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. No abstract available.

  PMID: 30496563 BACKGROUND

• 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.

  PMID: 27335689 BACKGROUND

• 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.

  PMID: 22267690 BACKGROUND

• 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. No abstract available.

  PMID: 23664441 BACKGROUND

• Li Y, Li C, Wen J, Cui M, Wei Q, Liu M, Chen Z, Fang H, Liu L, Fu J, Zhang J, Lyu S. Tai Chi as a mind-body exercise modulates endothelial function in coronary artery disease: A randomized clinical trial. Complement Ther Med. 2025 Sep;92:103201. doi: 10.1016/j.ctim.2025.103201. Epub 2025 Jun 18.

  PMID: 40553955 DERIVED

• Ma J, Zhang JW, Li H, Zhao LS, Guo AY, Chen ZH, Yuan W, Gao TM, Li YM, Li CH, Wang HW, Song B, Lu YL, Cui MZ, Wei QY, Lyu SJ, Yin HC. Safety and effectiveness of a Tai Chi-based cardiac rehabilitation programme for chronic coronary syndrom patients: study protocol for a randomised controlled trial. BMJ Open. 2020 Jul 5;10(7):e036061. doi: 10.1136/bmjopen-2019-036061.

  PMID: 32624473 DERIVED

Related Links

• Wichita State University

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jing Ma, doctor

  Department of Cardiology in Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ma Jing, doctor

CONTACT

13681257396; crystalma@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clincial professor

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 3, 2019
• Study Start: October 17, 2019
• Primary Completion: July 30, 2021
• Study Completion: October 30, 2021
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: The IPD of the publication will be shared, including characteristic data,results, clinical follow up data.

Locations

CN (3)