Baduanjin Exercise Prevents Post-Myocardial Infarction Left Ventricular Remodeling (BE-PREMIER Trial)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 主要终点
- the percentage change from baseline to 6 months (%Δ) in echocardiographic LV end-diastolic volume index (LVEDVi)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
the percentage change from baseline to 6 months (%Δ) in echocardiographic LV end-diastolic volume index (LVEDVi)
时间窗: baseline and 6 months
the percentage change end-diastolic volume index (%)
次要结局
- the change in echocardiographic measures of ventricular volumes (LV end-systolic/ diastolic volume)(baseline and 6 months)
- The occurrence and composite of major adverse cardiac events (MACE)(baseline and 6 months)
- MacNew heart disease health-related quality of life questionnaire(baseline and 6 months)
- The short form 36 questionnaire(baseline and 6 months)
- The 6-minute walk test(from 3 to 6 months)
- cardiopulmonary exercise test(from 3 to 6 months)
研究者
shuai Mao
Director
Guangdong Provincial Hospital of Traditional Chinese Medicine