Clinical trial NCT03229681: Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation
Official title: Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation: A Prospective, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rehabilitation With CHF; NYHA Class I or II
Keywords: Baduanjin; CHF; 6MWT; CPET
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Six-minute walk test（6MWT）
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Cardiopulmonary exercise test (CPET)
timeFrame: Baseline, 3 months
measure: Left ventricular ejection fraction（LVEF）
timeFrame: Baseline, 3 months
measure: Left ventricular end-diastolic diameter (LVDD)
timeFrame: Baseline, 3 months
measure: Minnesota living with heart failure questionnaire (MLHFQ)
timeFrame: Baseline, 3 months
measure: NT-proBNP
timeFrame: Baseline, 3 months
measure: hs-CRP
timeFrame: Baseline, 3 months
measure: HRV
timeFrame: Baseline, 3 months
measure: Major adverse cardiovascular events (MACE)
timeFrame: Baseline, 3 months, 6months
measure: NYHA classification
timeFrame: Baseline, 3 months, 6months
measure: The Main TCM symptoms
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study officials:
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Hao Xu
role: STUDY_DIRECTOR
References:
citation: Yu M, Li S, Li S, Li J, Xu H, Chen K. Baduanjin exercise for patients with ischemic heart failure on phase-II cardiac rehabilitation (BEAR trial): study protocol for a prospective randomized controlled trial. Trials. 2018 Jul 16;19(1):381. doi: 10.1186/s13063-018-2759-4.