Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation

Study Overview
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Brief Summary
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Chronic heart failure (CHF) is the end stage of various kinds of cardiovascular diseases with high mortality. After a long period of medical treatment or surgical treatment, patients suffered great pain physically and mentally. How to improve the quality of life and prognosis in patients with CHF, which is a hot topic in the field of cardiac rehabilitation now. Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for CHF patients. To investigate the efficacy and safety of Baduanjin exercise for patients with coronary heart disease complicated with chronic heart failure (CHF). A randomized, controlled and prospective clinical trial was designed.

Official Title
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Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation: A Prospective, Randomized, Controlled Clinical Trial

Conditions
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Rehabilitation With CHF; NYHA Class I or II

Intervention / Treatment
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* Behavioral: Baduanjin exercise
* Behavioral: Routine rehabilitation group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 40 to 75 years; Diagnosed with chronic heart failure caused by coronary heart disease; NYHA class I or II; Patients with an ejection fraction (LVEF) more than 40%; Participants in accordance with the guidelines define as stage II cardiac rehabilitation; Participants signed the informed consent freely and voluntarily. Exclusion Criteria: The condition was serious or movement restrained by other diseases; In the acute stage of chronic heart failure; Participants with poorly control of blood pressure (SBP≥180mmHg or DBP≥100mmHg); Resting heart rate is beating over 120 beats a minute, or merged with malignant arrhythmia; Participants who have contraindications to cardiopulmonary test or exercise training; Patients who have other serious acute， chronic organic disease or mental disorders; Participants practiced in any kinds of traditional Chinese medicine exercises in last three months.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baduanjin exercise group<br>Participants in this group received routine rehabilitation training and Baduanjin exercise | Behavioral: Baduanjin exercise<br>* Participants in this groups received routine rehabilitation training and Baduanjin exercise. During the period of rehabilitation, physicians provides a wide range of medical, nutrition and mental health counseling, as well as rational drug-treatment. Baduanjin exercise protocol according to the Health Qigong Baduanjin Standard enacted by the General Administration of Sports in 2003. Due to the low-activity tolerance of CHF patients, we performed with a refined version of Baduanjin. Each Baduanjin exercise session lasts 45 minutes and continues twice per week for 12 weeks.<br>* Other names: Routine rehabilitation;|
| Active Comparator: Routine rehabilitation group<br>Participants in this group only received routine rehabilitation training | Behavioral: Routine rehabilitation group<br>* Participants in this qroup only received the routine rehabilitation training. During the period of rehabilitation, physicians provides a wide range of medical, nutrition and mental health counseling, as well as rational drug-treatment. They should also come to rehabilitation center for physical exercise,45 minutes per day，twice per week, lasts 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walk test（6MWT） | Testing patients changes on walking distance and accompanies symptoms in 6 minutes | Baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary exercise test (CPET) | CPET including peak VO2 (ml/kg/min)， AT，VE/VCO2, et,al. | Baseline, 3 months | 
| Left ventricular ejection fraction（LVEF） |  | Baseline, 3 months | 
| Left ventricular end-diastolic diameter (LVDD) |  | Baseline, 3 months | 
| Minnesota living with heart failure questionnaire (MLHFQ) | Record the quality of life of patients with heart failure | Baseline, 3 months | 
| NT-proBNP |  | Baseline, 3 months | 
| hs-CRP |  | Baseline, 3 months | 
| HRV | Mainly includes SDANN Index, SDNN Index | Baseline, 3 months | 
| Major adverse cardiovascular events (MACE) | Defined as death, myocardial infarction (MI), stroke and re-hospitalization related to cardiovascular disease | Baseline, 3 months, 6months | 
| NYHA classification | The changes of heart function were compared after treatment | Baseline, 3 months, 6months | 
| The Main TCM symptoms | The changes of scores of TCM syndromes | Baseline, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Baduanjin; CHF; 6MWT; CPET