Rehabilitation With CHF; NYHA Class I or IIBEPCRNCT03229681
Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation
A study testing Baduanjin exercise and Routine rehabilitation group in people with Rehabilitation With CHF; NYHA Class I or II, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Rehabilitation With CHF; NYHA Class I or II
- What is being tested?
- Baduanjin exercise and Routine rehabilitation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 2 May 2017to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing
Meili Yu, +86(010)62835341, woshananyang@163.com
About this study
Official title: 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.
- Being tested
- Baduanjin exercise, Routine rehabilitation group
- Keywords
- Baduanjin; CHF; 6MWT; CPET
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin exerciseBehavioural
Also called Routine rehabilitation
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.
Routine rehabilitation groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin exercise group | Experimental | Participants in this group received routine rehabilitation training and Baduanjin exercise Receives: Behavioral: Baduanjin exercise |
| Routine rehabilitation group | Active comparator | Participants in this group only received routine rehabilitation training Receives: Behavioral: Routine rehabilitation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test（6MWT）
Testing patients changes on walking distance and accompanies symptoms in 6 minutes
Measured: Baseline, 3 months
Secondary outcomes (10)
Cardiopulmonary exercise test (CPET)
CPET including peak VO2 (ml/kg/min)， AT，VE/VCO2, et,al.
Measured: Baseline, 3 months
Left ventricular ejection fraction（LVEF）
Measured: Baseline, 3 months
Left ventricular end-diastolic diameter (LVDD)
Measured: Baseline, 3 months
Minnesota living with heart failure questionnaire (MLHFQ)
Record the quality of life of patients with heart failure
Measured: Baseline, 3 months
NT-proBNP
Measured: Baseline, 3 months
hs-CRP
Measured: Baseline, 3 months
HRV
Mainly includes SDANN Index, SDNN Index
Measured: Baseline, 3 months
Major adverse cardiovascular events (MACE)
Defined as death, myocardial infarction (MI), stroke and re-hospitalization related to cardiovascular disease
Measured: Baseline, 3 months, 6months
NYHA classification
The changes of heart function were compared after treatment
Measured: Baseline, 3 months, 6months
The Main TCM symptoms
The changes of scores of TCM syndromes
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start2 May 2017
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rehabilitation With CHF; NYHA Class I or IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Xu, Study director, Xiyuan Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229681
- Sponsor's protocol ID
- 20170506
- Acronym
- BEPCR
- Status last verified
- Jul 2017
- First submitted
- 23 Jul 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30012193
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation: A Prospective, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03229681
- Acronym / sponsor ID
- BEPCR / 20170506
- Keywords
- Baduanjin; CHF; 6MWT; CPET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baduanjin exercise group | Experimental | Behavioral: Baduanjin exerciseParticipants in this group received routine rehabilitation training and Baduanjin exercise |
| Routine rehabilitation group | Active comparator | Behavioral: Routine rehabilitation groupParticipants in this group only received routine rehabilitation training |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baduanjin exerciseAlso: Routine rehabilitationParticipants 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. | Behavioural | Baduanjin exercise group |
| Routine rehabilitation groupParticipants 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. | Behavioural | Routine rehabilitation group |
Primary outcome
Six-minute walk test（6MWT）
Time frame: Baseline, 3 months
Testing patients changes on walking distance and accompanies symptoms in 6 minutes
10 secondary outcomes
Cardiopulmonary exercise test (CPET)
Time frame: Baseline, 3 months
Left ventricular ejection fraction（LVEF）
Time frame: Baseline, 3 months
Left ventricular end-diastolic diameter (LVDD)
Time frame: Baseline, 3 months
Minnesota living with heart failure questionnaire (MLHFQ)
Time frame: Baseline, 3 months
NT-proBNP
Time frame: Baseline, 3 months
hs-CRP
Time frame: Baseline, 3 months
HRV
Time frame: Baseline, 3 months
Major adverse cardiovascular events (MACE)
Time frame: Baseline, 3 months, 6months
NYHA classification
Time frame: Baseline, 3 months, 6months
The Main TCM symptoms
Time frame: Baseline, 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Derived from this study: PubMed 30012193Yu 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Xu study director
Xiyuan Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin exercise and Routine rehabilitation group in people with Rehabilitation With CHF; NYHA Class I or II, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meili Yu (+86(010)62835341, woshananyang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walk test（6MWT） (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03229681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.