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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02693795
• Other study ID #: BE-PREMIER trial
• Status: Not yet recruiting
• Phase: N/A
• First received: February 14, 2016
• Last updated: August 6, 2016
• Start date: May 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: Shuai Mao, M.D.
• Phone: 86-20-81887233
• Email: maoshuaitcm[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: December 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Presence of MI who has successful revascularization after the symptom onset;

2. Aged 18 years or over and under 80 years;

3. Availability to attend sessions twice a week over a 12-week period;

4. Physical aptitude to participate in a Baduanjin exercise -based cardiac rehabilitation program.

Exclusion Criteria:

1. Inability or difficulty to exercise

2. Prior history of practicing Qigong (Taiji or Baduanjin exercise, etc);

3. Presence of unstable angina, detectable myocardial ischemia (at rest or on exertion), significant valvular disease, and hypertrophic cardiomyopathy;

4. Severe symptomatic congestive heart failure (NYHA cardiac function class IV or left ventricular ejection fraction=35%);

5. Severe pulmonary disease, musculoskeletal system diseases, other comorbidities precluding physical activity;

6. Life-threatening diseases with limited life expectancy <1 year;

7. Pregnant and lactating women;

8. Participation in other clinical trials.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Ventricular Remodeling

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage change from baseline to 6 months (%?) in echocardiographic LV end-diastolic volume index (LVEDVi)	the percentage change end-diastolic volume index (%)	baseline and 6 months	No
Secondary	the change in echocardiographic measures of ventricular volumes (LV end-systolic/ diastolic volume)	LV end-systolic/ diastolic volume (mL)	baseline and 6 months	No
Secondary	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	baseline and 6 months	No
Secondary	MacNew heart disease health-related quality of life questionnaire	in Units on a Scale	baseline and 6 months	No
Secondary	The short form 36 questionnaire	in Units on a Scale	baseline and 6 months	No
Secondary	The 6-minute walk test	A 6-minute walk test measures the distance patients can quickly walk in 6 minutes. (in meters)	from 3 to 6 months	No
Secondary	cardiopulmonary exercise test		from 3 to 6 months	Yes