- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03229681
Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation (BEPCR)
Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation: A Prospective, Randomized, Controlled Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Meili Yu
- Phone Number: +86(010)62835341
- Email: woshananyang@163.com
Study Locations
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Beijing, China
- Recruiting
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
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Contact:
- Meili Yu
- Phone Number: +86(010)62835341
- Email: woshananyang@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Baduanjin exercise group
Participants in this group received routine rehabilitation training and Baduanjin exercise
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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.
Other Names:
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ACTIVE_COMPARATOR: Routine rehabilitation group
Participants in this group only received routine rehabilitation training
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six-minute walk test(6MWT)
Time Frame: Baseline, 3 months
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Testing patients changes on walking distance and accompanies symptoms in 6 minutes
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Baseline, 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiopulmonary exercise test (CPET)
Time Frame: Baseline, 3 months
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CPET including peak VO2 (ml/kg/min), AT,VE/VCO2, et,al.
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Baseline, 3 months
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Left ventricular ejection fraction(LVEF)
Time Frame: Baseline, 3 months
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Baseline, 3 months
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Left ventricular end-diastolic diameter (LVDD)
Time Frame: Baseline, 3 months
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Baseline, 3 months
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Minnesota living with heart failure questionnaire (MLHFQ)
Time Frame: Baseline, 3 months
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Record the quality of life of patients with heart failure
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Baseline, 3 months
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NT-proBNP
Time Frame: Baseline, 3 months
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Baseline, 3 months
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hs-CRP
Time Frame: Baseline, 3 months
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Baseline, 3 months
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HRV
Time Frame: Baseline, 3 months
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Mainly includes SDANN Index, SDNN Index
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Baseline, 3 months
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Major adverse cardiovascular events (MACE)
Time Frame: Baseline, 3 months, 6months
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Defined as death, myocardial infarction (MI), stroke and re-hospitalization related to cardiovascular disease
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Baseline, 3 months, 6months
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NYHA classification
Time Frame: Baseline, 3 months, 6months
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The changes of heart function were compared after treatment
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Baseline, 3 months, 6months
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The Main TCM symptoms
Time Frame: Baseline, 3 months
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The changes of scores of TCM syndromes
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Baseline, 3 months
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Collaborators and Investigators
Investigators
- Study Director: Hao Xu, Xiyuan Hospital of China Academy of Chinese Medical Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20170506
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rehabilitation With CHF; NYHA Class I or II
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Vanderbilt University Medical CenterWithdrawnHeart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure NYHA Class IUnited States
-
Massachusetts General HospitalRecruitingHeart Failure | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure NYHA Class IUnited States
-
Indiana UniversityCompletedHeart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure NYHA Class IUnited States
-
John ParissisCompletedHeart Failure | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure NYHA Class IV | Heart Failure NYHA Class IGreece
-
Riphah International UniversityCompletedHeart Failure NYHA Class II | Heart Failure NYHA Class IPakistan
-
Alexandria UniversityCompletedHeart Failure | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IVEgypt
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Aalborg UniversityOdense University Hospital; University of Aarhus; Regionshospitalet Viborg, Skive and other collaboratorsCompletedAcute Decompensated Heart Failure | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure NYHA Class IV | Heart Failure NYHA Class IDenmark
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Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
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Ivoclar Vivadent AGNot yet recruitingClass I or II Cavities in Premolars or Molars
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University of LeipzigActive, not recruitingHeart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Preserved Ejection Fraction | Hypertrophy, Left Ventricular | Heart Failure NYHA Class IV | Cardiac Amyloidosis | Heart Failure With Mid Range Ejection FractionGermany
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Guangdong Provincial Hospital of Traditional Chinese...Unknown
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The Hong Kong Polytechnic UniversityRecruiting
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Shenyang Northern HospitalRecruiting
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Children's Hospital of Fudan UniversityShanghai Municipal Science and Technology CommissionCompletedAttention Deficit Hyperactivity DisorderChina
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