NCT02693795

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-07-01
• Completion: 2018-12-01
• First posted: 2016-02-29
• Last updated: 2016-08-09