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

August 6, 2016 updated by: shuai Mao, Guangdong Provincial Hospital of Traditional Chinese Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Baduanjin exercise group
The participants randomized to Baduanjin exercise will collectively practice at cardiac rehabilitation centre in Guangdong Provincial Hospital of Chinese Medicine. 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. Each Baduanjin exercise session lasts 45 minutes and continues twice per week for 12 weeks.
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.
Active Comparator: usual exercise control group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the percentage change from baseline to 6 months (%Δ) in echocardiographic LV end-diastolic volume index (LVEDVi)
Time Frame: baseline and 6 months
the percentage change end-diastolic volume index (%)
baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change in echocardiographic measures of ventricular volumes (LV end-systolic/ diastolic volume)
Time Frame: baseline and 6 months
LV end-systolic/ diastolic volume (mL)
baseline and 6 months
The occurrence and composite of major adverse cardiac events (MACE)
Time Frame: baseline and 6 months
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
MacNew heart disease health-related quality of life questionnaire
Time Frame: baseline and 6 months
in Units on a Scale
baseline and 6 months
The short form 36 questionnaire
Time Frame: baseline and 6 months
in Units on a Scale
baseline and 6 months
The 6-minute walk test
Time Frame: from 3 to 6 months
A 6-minute walk test measures the distance patients can quickly walk in 6 minutes. (in meters)
from 3 to 6 months
cardiopulmonary exercise test
Time Frame: from 3 to 6 months
from 3 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Investigators

  • Study Chair: Minzhou zhang, M.D., 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 14, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 29, 2016

Study Record Updates

Last Update Posted (Estimate)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 6, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE-PREMIER trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Baduanjin exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe