Myocardial InfarctionNCT02693795
Baduanjin Exercise Prevents Post-Myocardial Infarction Left Ventricular Remodeling (BE-PREMIER Trial)
A study testing Baduanjin exercise and aerobic exercise in people with Myocardial Infarction, run by Guangdong Provincial Hospital of Traditional Chinese Medicine.
Trial summary
Left ventricular (LV) remodeling following myocardial infarction (MI) is an established prognostic factor for adverse cardiovascular events and the leading cause of heart failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Baduanjin exercise and aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- May 2016to 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of MI who has successful revascularization after the symptom onset;
- Aged 18 years or over and under 80 years;
- Availability to attend sessions twice a week over a 12-week period;
- Physical aptitude to participate in a Baduanjin exercise -based cardiac rehabilitation program.
Who cannot join
- Inability or difficulty to exercise
- Prior history of practicing Qigong (Taiji or Baduanjin exercise, etc);
- Presence of unstable angina, detectable myocardial ischemia (at rest or on exertion), significant valvular disease, and hypertrophic cardiomyopathy;
- Severe symptomatic congestive heart failure (NYHA cardiac function class IV or left ventricular ejection fraction≤35%);
- Severe pulmonary disease, musculoskeletal system diseases, other comorbidities precluding physical activity;
- Life-threatening diseases with limited life expectancy <1 year;
- Pregnant and lactating women;
- Participation in other clinical trials.
Trial locations and contacts
No sites are listed yet.
About this study
Left ventricular (LV) remodeling following myocardial infarction (MI) is an established prognostic factor for adverse cardiovascular events and the leading cause of heart failure. Empirical observations suggests that Baduanjin exercise, an important component of traditional Chinese Qigong, exert potential impacts on cardiopulmonary function. However, the impact of a Baduanjin exercise-based cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed. The aim of this trail is to evaluate whether Baduanjin exercise would prevent the maladaptive progression to adverse LV remodeling in patients following MI.
Read the detailed description
The increasing evidence indicates that exercise after a MI is associated with decreases in LV end-diastolic/ systolic volumes and increases in LV ejection fraction (LVEF), improvement in activity tolerance and quality of life, and reduction in the overall and cardiovascular-related mortality. However, on account of the heterogeneity in exercise intervention, limitation in methodology, and the varied characteristics of study populations, some other trials reported that post-MI exercise does not alter LV remodeling or cardiac function. Thus, more strict randomized controlled studies are needed to evaluate the benefits of exercise after MI and provide more indisputable evidence for guidelines and health professionals.
As an important component of Chinese Qigong exercises, Baduanjin exercise has origins in ancient martial arts that have been practiced for thousands of years. It is a combination of moderate-intensity physical activity, meditation, and body awareness, which designed to improve holistic health. Baduanjin exercise can systematically exert the movable joints and muscle, enhance cardiopulmonary functions, and concurrently modulate mind and spirit, ultimately achieve the integration of mind and body. Many clinical studies have demonstrated the beneficial effects of Baduanjin exercise on decreasing cholesterol and triglyceride concentrations, controlling systemic hypertension, stabilizing glucose and glycosylated hemoglobin levels. Some review articles have described Baduanjin exercise as a therapy with potential to exert positive impacts on cardiopulmonary function. Additionally, several recent studies have proven the benefits of Baduanjin exercise including preventing ischemic stroke, relieving pain and stiffness, and improving sleep quality and psychological well-being. However, it is not known if Baduanjin exercise could be a feasible approach for post-MI individuals because the scientific basis for this intervention is limited. To address a research gap, the BE-PREMIER (Baduanjin Exercise PREvents post-Myocardial Infarction left vEntricular Remodeling) trial is designed and to assess LV remodeling in clinically stable post-MI patients after a 12-week period of Baduanjin exercise-based cardiac rehabilitation.
- Conditions
- Myocardial Infarction
- Being tested
- Baduanjin exercise, aerobic exercise
- Keywords
- myocardial infarction, left ventricular remodeling
- Medical subject headings
- Myocardial Infarction, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin exerciseOther
A detailed description of a standardized Baduanjin exercise protocol complied with the "Health Qigong Baduanjin Standard" enacted by the General Administration of Sports in 2003.
aerobic exerciseOther
Participants allocated to the usual exercise control group receive a closely supervised, group-format aerobic exercise program located on cardiac rehabilitation centre lasting 3 month. The program is consistent with the current recommended guidelines of moderate intensity exercises for MI.
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin exercise group | Experimental | The participants randomized to Baduanjin exercise will collectively practice at cardiac rehabilitation centre in Guangdong Provincial Hospital of Chinese Medicine. A detailed description of a standardized Baduanjin exercise protocol complied with the "Health Qigong Baduanjin Standard" enacted by the General Administration of Sports in 2003. Each Baduanjin exercise session lasts 45 minutes and continues twice per week for 12 weeks. Receives: Other: Baduanjin exercise |
| usual exercise control group | Active comparator | Participants allocated to the usual exercise control group receive a closely supervised, group-format aerobic exercise program located on cardiac rehabilitation centre lasting 3 month. The program is consistent with the current recommended guidelines of moderate intensity exercises for MI. Receives: Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage change from baseline to 6 months (%Δ) in echocardiographic LV end-diastolic volume index (LVEDVi)
the percentage change end-diastolic volume index (%)
Measured: baseline and 6 months
Secondary outcomes (6)
the change in echocardiographic measures of ventricular volumes (LV end-systolic/ diastolic volume)
LV end-systolic/ diastolic volume (mL)
Measured: baseline and 6 months
The occurrence and composite of major adverse cardiac events (MACE)
defined as cardiogenic death, stroke, recurrent myocardial infarction, readmission on account of deterioration of congestive heart failure or unstable angina, target vessel revascularization
Measured: baseline and 6 months
MacNew heart disease health-related quality of life questionnaire
in Units on a Scale
Measured: baseline and 6 months
The short form 36 questionnaire
in Units on a Scale
Measured: baseline and 6 months
The 6-minute walk test
A 6-minute walk test measures the distance patients can quickly walk in 6 minutes. (in meters)
Measured: from 3 to 6 months
cardiopulmonary exercise test
Measured: from 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shuai Mao, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Minzhou zhang, M.D., Study chair, 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693795
- Sponsor's protocol ID
- BE-PREMIER trial
- Status last verified
- Aug 2016
- First submitted
- 14 Feb 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Chen MG, Liang X, Kong L, Wang J, Wang F, Hu X, He J, Zeng RX, Mao S, Guo L, Zhang MZ, Zhang X. Effect of Baduanjin Sequential Therapy on the Quality of Life and Cardiac Function in Patients with AMI After PCI: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2020 Jul 4;2020:8171549. doi: 10.1155/2020/8171549. eCollection 2020.
PubMed 32714423Mao S, Zhang X, Shao B, Hu X, Hu Y, Li W, Guo L, Zhang M. Baduanjin Exercise Prevents post-Myocardial Infarction Left Ventricular Remodeling (BE-PREMIER trial): Design and Rationale of a Pragmatic Randomized Controlled Trial. Cardiovasc Drugs Ther. 2016 Jun;30(3):315-22. doi: 10.1007/s10557-016-6660-7.
PubMed 27106833
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baduanjin Exercise Prevents Post-Myocardial Infarction Left Ventricular Remodeling (BE-PREMIER Trial)
- ClinicalTrials.gov ID
- NCT02693795
- Acronym / sponsor ID
- BE-PREMIER trial
- Conditions
- Myocardial Infarction
- Keywords
- myocardial infarction, left ventricular remodeling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Feb 2016 (estimated)
- 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.
Left ventricular (LV) remodeling following myocardial infarction (MI) is an established prognostic factor for adverse cardiovascular events and the leading cause of heart failure. Empirical observations suggests that Baduanjin exercise, an important component of traditional Chinese Qigong, exert potential impacts on cardiopulmonary function. However, the impact of a Baduanjin exercise-based cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed. The aim of this trail is to evaluate whether Baduanjin exercise would prevent the maladaptive progression to adverse LV remodeling in patients following MI.
Detailed description
The increasing evidence indicates that exercise after a MI is associated with decreases in LV end-diastolic/ systolic volumes and increases in LV ejection fraction (LVEF), improvement in activity tolerance and quality of life, and reduction in the overall and cardiovascular-related mortality. However, on account of the heterogeneity in exercise intervention, limitation in methodology, and the varied characteristics of study populations, some other trials reported that post-MI exercise does not alter LV remodeling or cardiac function. Thus, more strict randomized controlled studies are needed to evaluate the benefits of exercise after MI and provide more indisputable evidence for guidelines and health professionals.
As an important component of Chinese Qigong exercises, Baduanjin exercise has origins in ancient martial arts that have been practiced for thousands of years. It is a combination of moderate-intensity physical activity, meditation, and body awareness, which designed to improve holistic health. Baduanjin exercise can systematically exert the movable joints and muscle, enhance cardiopulmonary functions, and concurrently modulate mind and spirit, ultimately achieve the integration of mind and body. Many clinical studies have demonstrated the beneficial effects of Baduanjin exercise on decreasing cholesterol and triglyceride concentrations, controlling systemic hypertension, stabilizing glucose and glycosylated hemoglobin levels. Some review articles have described Baduanjin exercise as a therapy with potential to exert positive impacts on cardiopulmonary function. Additionally, several recent studies have proven the benefits of Baduanjin exercise including preventing ischemic stroke, relieving pain and stiffness, and improving sleep quality and psychological well-being. However, it is not known if Baduanjin exercise could be a feasible approach for post-MI individuals because the scientific basis for this intervention is limited. To address a research gap, the BE-PREMIER (Baduanjin Exercise PREvents post-Myocardial Infarction left vEntricular Remodeling) trial is designed and to assess LV remodeling in clinically stable post-MI patients after a 12-week period of Baduanjin exercise-based cardiac rehabilitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baduanjin exercise group | Experimental | Other: Baduanjin exerciseThe participants randomized to Baduanjin exercise will collectively practice at cardiac rehabilitation centre in Guangdong Provincial Hospital of Chinese Medicine. A detailed description of a standardized Baduanjin exercise protocol complied with the "Health Qigong Baduanjin Standard" enacted by the General Administration of Sports in 2003. Each Baduanjin exercise session lasts 45 minutes and continues twice per week for 12 weeks. |
| usual exercise control group | Active comparator | Other: aerobic exerciseParticipants allocated to the usual exercise control group receive a closely supervised, group-format aerobic exercise program located on cardiac rehabilitation centre lasting 3 month. The program is consistent with the current recommended guidelines of moderate intensity exercises for MI. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of MI who has successful revascularization after the symptom onset;
- Aged 18 years or over and under 80 years;
- Availability to attend sessions twice a week over a 12-week period;
- Physical aptitude to participate in a Baduanjin exercise -based cardiac rehabilitation program.
Key exclusion criteria (8 listed)
- Inability or difficulty to exercise
- Prior history of practicing Qigong (Taiji or Baduanjin exercise, etc);
- Presence of unstable angina, detectable myocardial ischemia (at rest or on exertion), significant valvular disease, and hypertrophic cardiomyopathy;
- Severe symptomatic congestive heart failure (NYHA cardiac function class IV or left ventricular ejection fraction≤35%);
- Severe pulmonary disease, musculoskeletal system diseases, other comorbidities precluding physical activity;
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 exerciseA detailed description of a standardized Baduanjin exercise protocol complied with the "Health Qigong Baduanjin Standard" enacted by the General Administration of Sports in 2003. | Other | Baduanjin exercise group |
| aerobic exerciseParticipants allocated to the usual exercise control group receive a closely supervised, group-format aerobic exercise program located on cardiac rehabilitation centre lasting 3 month. The program is consistent with the current recommended guidelines of moderate intensity exercises for MI. | Other | usual exercise control group |
Primary outcome
the percentage change from baseline to 6 months (%Δ) in echocardiographic LV end-diastolic volume index (LVEDVi)
Time frame: baseline and 6 months
the percentage change end-diastolic volume index (%)
6 secondary outcomes
the change in echocardiographic measures of ventricular volumes (LV end-systolic/ diastolic volume)
Time frame: baseline and 6 months
The occurrence and composite of major adverse cardiac events (MACE)
Time frame: baseline and 6 months
MacNew heart disease health-related quality of life questionnaire
Time frame: baseline and 6 months
The short form 36 questionnaire
Time frame: baseline and 6 months
The 6-minute walk test
Time frame: from 3 to 6 months
cardiopulmonary exercise test
Time frame: from 3 to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Derived from this study: PubMed 32714423Chen MG, Liang X, Kong L, Wang J, Wang F, Hu X, He J, Zeng RX, Mao S, Guo L, Zhang MZ, Zhang X. Effect of Baduanjin Sequential Therapy on the Quality of Life and Cardiac Function in Patients with AMI After PCI: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2020 Jul 4;2020:8171549. doi: 10.1155/2020/8171549. eCollection 2020.
- Derived from this study: PubMed 27106833Mao S, Zhang X, Shao B, Hu X, Hu Y, Li W, Guo L, Zhang M. Baduanjin Exercise Prevents post-Myocardial Infarction Left Ventricular Remodeling (BE-PREMIER trial): Design and Rationale of a Pragmatic Randomized Controlled Trial. Cardiovasc Drugs Ther. 2016 Jun;30(3):315-22. doi: 10.1007/s10557-016-6660-7.
- Individual participant dataSharing planned: Yes
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
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.
Minzhou zhang, M.D. study chair
2nd Affiliated Hospital of Guangzhou University of Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin exercise and aerobic exercise in people with Myocardial Infarction, run by Guangdong Provincial Hospital of Traditional Chinese Medicine.
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 4 inclusion and 8 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 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Shuai Mao, M.D. (86-20-81887233 ext. 35954, maoshuaitcm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage change from baseline to 6 months (%Δ) in echocardiographic LV end-diastolic volume index (LVEDVi) (time frame: baseline and 6 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 NCT02693795, which also lists 2 linked publications.
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 9 Aug 2016.