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Baduanjin Exercise Prevents Post-Myocardial Infarction Left Ventricular Remodeling (BE-PREMIER Trial)

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ClinicalTrials.gov Identifier: NCT02693795
Recruitment Status : Unknown
Verified August 2016 by shuai Mao, Guangdong Provincial Hospital of Traditional Chinese Medicine.
Recruitment status was:  Not yet recruiting
First Posted : February 29, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
shuai Mao, Guangdong Provincial Hospital of Traditional Chinese Medicine

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Other: Baduanjin exercise Other: aerobic exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Baduanjin Exercise Prevents Post-Myocardial Infarction Left Ventricular Remodeling (BE-PREMIER Trial)
Study Start Date : May 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Baduanjin exercise group
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.
Other: Baduanjin exercise
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.

Active Comparator: usual exercise control group
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.
Other: aerobic exercise
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.




Primary Outcome Measures :
  1. 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 (%)


Secondary Outcome Measures :
  1. the change in echocardiographic measures of ventricular volumes (LV end-systolic/ diastolic volume) [ Time Frame: baseline and 6 months ]
    LV end-systolic/ diastolic volume (mL)

  2. The occurrence and composite of major adverse cardiac events (MACE) [ Time Frame: baseline and 6 months ]
    defined as cardiogenic death, stroke, recurrent myocardial infarction, readmission on account of deterioration of congestive heart failure or unstable angina, target vessel revascularization

  3. MacNew heart disease health-related quality of life questionnaire [ Time Frame: baseline and 6 months ]
    in Units on a Scale

  4. The short form 36 questionnaire [ Time Frame: baseline and 6 months ]
    in Units on a Scale

  5. The 6-minute walk test [ Time Frame: from 3 to 6 months ]
    A 6-minute walk test measures the distance patients can quickly walk in 6 minutes. (in meters)

  6. cardiopulmonary exercise test [ Time Frame: from 3 to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Presence of MI who has successful revascularization after the symptom onset;
  2. Aged 18 years or over and under 80 years;
  3. Availability to attend sessions twice a week over a 12-week period;
  4. Physical aptitude to participate in a Baduanjin exercise -based cardiac rehabilitation program.

Exclusion Criteria:

  1. Inability or difficulty to exercise
  2. Prior history of practicing Qigong (Taiji or Baduanjin exercise, etc);
  3. Presence of unstable angina, detectable myocardial ischemia (at rest or on exertion), significant valvular disease, and hypertrophic cardiomyopathy;
  4. Severe symptomatic congestive heart failure (NYHA cardiac function class IV or left ventricular ejection fraction≤35%);
  5. Severe pulmonary disease, musculoskeletal system diseases, other comorbidities precluding physical activity;
  6. Life-threatening diseases with limited life expectancy <1 year;
  7. Pregnant and lactating women;
  8. Participation in other clinical trials.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693795


Contacts
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Contact: Shuai Mao, M.D. 86-20-81887233 ext 35954 maoshuaitcm@hotmail.com

Sponsors and Collaborators
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
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Study Chair: Minzhou zhang, M.D. 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: shuai Mao, Director, Guangdong Provincial Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02693795    
Other Study ID Numbers: BE-PREMIER trial
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by shuai Mao, Guangdong Provincial Hospital of Traditional Chinese Medicine:
myocardial infarction
left ventricular remodeling
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ventricular Remodeling
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pathological Conditions, Anatomical