search
Back to results

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

Primary Purpose

Rehabilitation With CHF; NYHA Class I or II

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Baduanjin exercise
Routine rehabilitation group
Sponsored by
Xiyuan Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rehabilitation With CHF; NYHA Class I or II focused on measuring Baduanjin; CHF; 6MWT; CPET

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiyuan Hospital of China Academy of Chinese Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Baduanjin exercise group

Routine rehabilitation group

Arm Description

Participants in this group received routine rehabilitation training and Baduanjin exercise

Participants in this group only received routine rehabilitation training

Outcomes

Primary Outcome Measures

Six-minute walk test（6MWT）
Testing patients changes on walking distance and accompanies symptoms in 6 minutes

Secondary Outcome Measures

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

Full Information

First Posted
July 23, 2017
Last Updated
July 23, 2017
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT03229681
Brief Title
Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation
Acronym
BEPCR
Official Title
Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation: A Prospective, Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
December 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation With CHF; NYHA Class I or II
Keywords
Baduanjin; CHF; 6MWT; CPET

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baduanjin exercise group
Arm Type
Experimental
Arm Description
Participants in this group received routine rehabilitation training and Baduanjin exercise
Arm Title
Routine rehabilitation group
Arm Type
Active Comparator
Arm Description
Participants in this group only received routine rehabilitation training
Intervention Type
Behavioral
Intervention Name(s)
Baduanjin exercise
Other Intervention Name(s)
Routine rehabilitation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Routine rehabilitation group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Six-minute walk test（6MWT）
Description
Testing patients changes on walking distance and accompanies symptoms in 6 minutes
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Cardiopulmonary exercise test (CPET)
Description
CPET including peak VO2 (ml/kg/min)， AT，VE/VCO2, et,al.
Time Frame
Baseline, 3 months
Title
Left ventricular ejection fraction（LVEF）
Time Frame
Baseline, 3 months
Title
Left ventricular end-diastolic diameter (LVDD)
Time Frame
Baseline, 3 months
Title
Minnesota living with heart failure questionnaire (MLHFQ)
Description
Record the quality of life of patients with heart failure
Time Frame
Baseline, 3 months
Title
NT-proBNP
Time Frame
Baseline, 3 months
Title
hs-CRP
Time Frame
Baseline, 3 months
Title
HRV
Description
Mainly includes SDANN Index, SDNN Index
Time Frame
Baseline, 3 months
Title
Major adverse cardiovascular events (MACE)
Description
Defined as death, myocardial infarction (MI), stroke and re-hospitalization related to cardiovascular disease
Time Frame
Baseline, 3 months, 6months
Title
NYHA classification
Description
The changes of heart function were compared after treatment
Time Frame
Baseline, 3 months, 6months
Title
The Main TCM symptoms
Description
The changes of scores of TCM syndromes
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meili Yu
Phone
+86(010)62835341
Email
woshananyang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Xu
Organizational Affiliation
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Xiyuan Hospital of China Academy of Chinese Medical Sciences
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meili Yu
Phone
+86(010)62835341
Email
woshananyang@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30012193
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs