NCT02693795

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

February 14, 2016

Last Update Submit

August 6, 2016

Conditions

Myocardial Infarction

Keywords

myocardial infarctionleft ventricular remodeling

Outcome Measures

Primary Outcomes (1)

  • the percentage change from baseline to 6 months (%Δ) in echocardiographic LV end-diastolic volume index (LVEDVi)

    the percentage change end-diastolic volume index (%)

    baseline and 6 months

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Baduanjin exercise group

EXPERIMENTAL

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

usual exercise control group

ACTIVE COMPARATOR

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

Interventions

Baduanjin exerciseOTHER

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.

Baduanjin exercise group
aerobic exerciseOTHER

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.

usual exercise control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Chen MG, Liang X, Kong L, Wang J, Wang F, Hu X, He J, Zeng RX, Mao S, Guo L, Zhang MZ, Zhang X. Effect of Baduanjin Sequential Therapy on the Quality of Life and Cardiac Function in Patients with AMI After PCI: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2020 Jul 4;2020:8171549. doi: 10.1155/2020/8171549. eCollection 2020.

    PMID: 32714423DERIVED

  • Mao S, Zhang X, Shao B, Hu X, Hu Y, Li W, Guo L, Zhang M. Baduanjin Exercise Prevents post-Myocardial Infarction Left Ventricular Remodeling (BE-PREMIER trial): Design and Rationale of a Pragmatic Randomized Controlled Trial. Cardiovasc Drugs Ther. 2016 Jun;30(3):315-22. doi: 10.1007/s10557-016-6660-7.

    PMID: 27106833DERIVED

MeSH Terms

Conditions

Myocardial InfarctionVentricular Remodeling

Interventions

Exercise

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Minzhou zhang, M.D.

    2nd Affiliated Hospital of Guangzhou University of Chinese Medicine

    STUDY CHAIR

Central Study Contacts

Shuai Mao, M.D.

CONTACT

86-20-81887233maoshuaitcm@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 14, 2016

First Posted

February 29, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2018

Last Updated

August 9, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share