Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation
BEPCR
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2017
CompletedFirst Submitted
Initial submission to the registry
July 23, 2017
CompletedFirst Posted
Study publicly available on registry
July 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedJuly 25, 2017
July 1, 2017
1.2 years
July 23, 2017
July 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Six-minute walk test（6MWT）
Testing patients changes on walking distance and accompanies symptoms in 6 minutes
Baseline, 3 months
Secondary Outcomes (10)
Cardiopulmonary exercise test (CPET)
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)
Baseline, 3 months
NT-proBNP
Baseline, 3 months
- +5 more secondary outcomes
Study Arms (2)
Baduanjin exercise group
EXPERIMENTALParticipants in this group received routine rehabilitation training and Baduanjin exercise
Routine rehabilitation group
ACTIVE COMPARATORParticipants in this group only received routine rehabilitation training
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, China
Related Publications (1)
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.
PMID: 30012193DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hao Xu
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2017
First Posted
July 25, 2017
Study Start
May 2, 2017
Primary Completion
June 30, 2018
Study Completion
December 30, 2018
Last Updated
July 25, 2017
Record last verified: 2017-07