An interventional study of Baduanjin exercise and aerobic exercise in Myocardial Infarction, sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-08-09.
Sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine · Not applicable, Interventional, and Prevention
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.
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's planned enrollment of 110 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
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Exclusion Criteria:
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
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
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.
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.
the percentage change from baseline to 6 months (%Δ) in echocardiographic LV end-diastolic volume index (LVEDVi)
the percentage change end-diastolic volume index (%)
Time frame: baseline and 6 months
the change in echocardiographic measures of ventricular volumes (LV end-systolic/ diastolic volume)
LV end-systolic/ diastolic volume (mL)
Time frame: 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
Time frame: baseline and 6 months
MacNew heart disease health-related quality of life questionnaire
in Units on a Scale
Time frame: baseline and 6 months
The short form 36 questionnaire
in Units on a Scale
Time frame: 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)
Time frame: from 3 to 6 months
cardiopulmonary exercise test
Time frame: from 3 to 6 months
No study locations are listed for this record.
Plan to share: Yes
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Guangdong Provincial Hospital of Traditional Chinese Medicine