Baduanjin Exercise Prevents post-Myocardial Infarction Left Ventricular Remodeling (BE-PREMIER trial): Design and Rationale of a Pragmatic Randomized Controlled Trial.
BACKGROUND
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 have suggested that Baduanjin exercise, an important component of traditional Chinese Qigong, may exert potential benefits on cardiopulmonary function. However, the impact of a Baduanjin exercise-based cardiac rehabilitation program for patients recovering from a recent MI has yet to be assessed. The aim of this trial is to evaluate the potential role of Baduanjin exercise in preventing the maladaptive progression to adverse LV remodeling in patients post-MI.


METHODS
A total of 110 clinically stable patients following an MI after undergoing successful infarct-related artery reperfusion will be randomly assigned to the Baduanjin exercise group or usual exercise control group. In addition to usual physical activity, participants in the Baduanjin exercise group will participate in a 45 min Baduanjin exercise training session twice a week, for a total of 12 weeks. The primary endpoint will be the percentage change in LV end-diastolic volume index (LVEDVi) assessed using echocardiography from baseline to 6 months.


CONCLUSIONS
The results of this study may provide novel evidence on the efficacy of Baduanjin exercise therapy in post-MI patients in reversing adverse LV remodeling and improving clinical outcome.


BACKGROUND
Clinical Trials.gov: NCT02693795.
Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.|Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.|Physiology & Experimental Medicine, Hospital for Sick Children, University Ave, Toronto, M5G 0A4, Canada.
Shuai
S
Mao
Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.|Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Xiaoxuan
X
Zhang
Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.
Biying
B
Shao
Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Xiyan
X
Hu
Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Yanan
Y
Hu
Faculty of Medicine, University of Toronto, University Ave., Toronto, M5G 0A4, Canada.
Winny
W
Li
Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.|Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Liheng
L
Guo
Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. minzhouzhang@yeah.net.|Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. minzhouzhang@yeah.net.
Minzhou
M
Zhang
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004452:Echocardiography; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000534:rehabilitation*; D064906:Qigong; D012107:Research Design; D016277:Ventricular Function, Left / Q000502:physiology*; D020257:Ventricular Remodeling; D055815:Young Adult
Baduanjin exercise; Cardiac rehabilitation; Left ventricular remodeling; Myocardial infarction