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

July 23, 2017 updated by: Xiyuan Hospital of China Academy of Chinese Medical Sciences

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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Xiyuan Hospital of China Academy of Chinese Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Behavioral: Baduanjin exercise
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:
  • Routine rehabilitation
ACTIVE_COMPARATOR: Routine rehabilitation group
Participants in this group only received routine rehabilitation training
Behavioral: Routine rehabilitation group
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Investigators

  • Study Director: Hao Xu, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2017

Primary Completion (ANTICIPATED)

June 30, 2018

Study Completion (ANTICIPATED)

December 30, 2018

Study Registration Dates

First Submitted

July 23, 2017

First Submitted That Met QC Criteria

July 23, 2017

First Posted (ACTUAL)

July 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 23, 2017

Last Verified

July 1, 2017

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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