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

Primary Purpose

Coronary Heart Disease, Chronic Coronary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Control Group ：conventional exercise rehabilitation programs (CERP)
Experimental Group ：Tai Chi cardiac rehabilitation program (TCCRP)
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Tai Chi, Cardiac rehabilitation, Chronic coronary syndrome, Safety, Effectiveness, Randomized controlled trial, Fusion cardiac rehabilitation model

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Water Conservancy HospitalRecruiting
  • Chinese PLA General HospitalRecruiting
  • Beijing Chaoyang District Anzhen Community Health Service CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

Group received conventional exercise rehabilitation programs (CERP).

Group received Tai Chi cardiac rehabilitation program(TCCRP).

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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).
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.
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.
Heart rate variability
Heart rate variability will be assessed at baseline and at the end of the 3-month intervention.
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.
Testing of intestinal flora
Intestinal flora tests will be evaluated at baseline and at the end of the 3-month intervention.

Full Information

First Posted
May 1, 2019
Last Updated
December 7, 2020
Sponsor
Chinese PLA General Hospital
Collaborators
Beijing Normal University
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1. Study Identification

Unique Protocol Identification Number
NCT03936504
Brief Title
Efficacy and Mechanism of TCCRP in Patients With Chronic Coronary Syndrome Under Fusion Cardiac Rehabilitation Model
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 17, 2019 (Actual)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
Collaborators
Beijing Normal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Chronic Coronary Syndrome
Keywords
Tai Chi, Cardiac rehabilitation, Chronic coronary syndrome, Safety, Effectiveness, Randomized controlled trial, Fusion cardiac rehabilitation model

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Group received conventional exercise rehabilitation programs (CERP).
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Group received Tai Chi cardiac rehabilitation program(TCCRP).
Intervention Type
Behavioral
Intervention Name(s)
Control Group ：conventional exercise rehabilitation programs (CERP)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Experimental Group ：Tai Chi cardiac rehabilitation program (TCCRP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in score of Chinese Perceived Stress Scale (CPSS)
Description
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.
Time Frame
baseline, 1 month, 3 months, 6 months
Title
Change in score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey)
Description
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.
Time Frame
baseline,1 month, 3 months, 6 months
Title
6-minute walk test (6 MWT)
Description
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.
Time Frame
baseline, 1 month, 3 months, 6months
Secondary Outcome Measure Information:
Title
Body fat rate
Description
Body fat rate will be tested by the Inbody770 at baseline and 3 months (at the end of the intervention) through bioelectrical impedance analysis.
Time Frame
baseline, 3 months
Title
Peak oxygen uptake（VO2Peak）
Description
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).
Time Frame
baseline, 3 months
Title
Locomotor skills
Description
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.
Time Frame
baseline，3 months
Title
Left ventricular ejection fraction(LVEF)
Description
LVED Vi and LVEF are also to be assessed using echocardiography at baseline and at the end of the 12-week intervention.
Time Frame
baseline, 3 months
Title
Heart rate variability
Description
Heart rate variability will be assessed at baseline and at the end of the 3-month intervention.
Time Frame
baseline, 3 months
Title
Low-density lipoprotein
Description
Low-density lipoprotein inspections will be tested at baseline and at the end of the 3-month intervention using an automatic biochemical analyzer.
Time Frame
baseline, 3 months
Title
Testing of intestinal flora
Description
Intestinal flora tests will be evaluated at baseline and at the end of the 3-month intervention.
Time Frame
baseline, 3 months
Other Pre-specified Outcome Measures:
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
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.
Time Frame
baseline, 3 months
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 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. Exclusion criteria 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ma Jing, doctor
Phone
13681257396
Email
crystalma@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Ma, doctor
Organizational Affiliation
Department of Cardiology in Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Water Conservancy Hospital
City
Beijing
ZIP/Postal Code
100036
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianshan Zhao
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Ma
Facility Name
Beijing Chaoyang District Anzhen Community Health Service Center
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Li

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
6 months after republication
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
The IPD of the publication will be shared, including characteristic data,results, clinical follow up data.
Citations:
PubMed Identifier
29354065
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.
Results Reference
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PubMed Identifier
3240110
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. No abstract available. Portuguese.
Results Reference
background
PubMed Identifier
392869
Citation
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.
Results Reference
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PubMed Identifier
2257154
Citation
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.
Results Reference
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PubMed Identifier
6390610
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. doi: 10.2165/00007256-198401060-00001. No abstract available.
Results Reference
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PubMed Identifier
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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.
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Citation
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.
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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.
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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.
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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.
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Results Reference
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Links:
URL
http://www.researcherid.com/rid/C-4027-2012
Description
Wichita State University

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

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