Myocardial Infarction Clinical Trial
Official title:
Baduanjin Exercise Prevents Post-Myocardial Infarction Left Ventricular Remodeling (BE-PREMIER Trial)
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
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