Brief Summary

Acute myocardial infarction (AMI) is one of the leading causes of death around the world, with the potential for substantial morbidity and mortality. The increasing evidence indicates that exercise training has beneficial effects on LV remodelling in post-MI patients with greater benefits occurring when training earlier following MI, among which the earliest time for rehabilitation is one week after myocardial infarction. However, the effect of Baduanjin sequential therapy for patients after one week of AMI has yet to be assessed. Therefore, the aim of this study is to assess the impact of Baduanjin sequential therapy on cardiac and physical function in patients with AMI and reduced ejection fraction after primary PCI.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

140

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Nov 2021

Geographic Reach

1 country

1 active site

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

1.3 years study duration

Study Start

First participant enrolled

November 11, 2021

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2021

Completed

25 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2023

Completed

Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

1.3 years

First QC Date

December 27, 2021

Last Update Submit

January 9, 2022

Conditions

AMI

Keywords

Acute myocardial infarctionBaduanjinPercutaneous coronary interventionCardiac functionPhysical function

Outcome Measures

Primary Outcomes (1)

Left ventricular ejection fraction (LVEF)
The change in echocardiographic measures of left ventricular ejection fraction，(LVEF). LVEF in %.
baseline and 3 months

Secondary Outcomes (15)

SF-36
baseline and 3 months
Generalized Anxiety Disorder 7-item (GAD-7)
baseline and 3 months
Patient Health Questionnaire (PHQ-9)
baseline and 3 months
Seattle Angina Questionnaire (SAQ)
baseline and 3 months
Minnesota Satisfaction Questionnaire (MSQ)
baseline and 3 months
+10 more secondary outcomes

Other Outcomes (2)

The occurrence and composite of major adverse cardiac and cerebrovascular event (MACCE)
baseline and 3 months
Adverse events related to exercise rehabilitation
baseline and 3 months

Study Arms (2)

Baduanjin sequential therapy

EXPERIMENTAL

Behavioral: Baduanjin sequential therapy

Aerobic exercise

ACTIVE COMPARATOR

Behavioral: Aerobic exercise

Interventions

Baduanjin sequential therapyBEHAVIORAL

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 sequential therapy

Aerobic exerciseBEHAVIORAL

Participants allocated to the usual exercise control group receive a closely supervised, group-format aerobic exercise program located at home or cardiac rehabilitation centre lasting 3 months. The program is consistent with the current recommended guidelines of moderate-intensity exercises for MI.

Aerobic exercise

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Acute myocardial infarction undergoing primary percutaneous coronary intervention;
Aged 18 years or over and under 80 years;
% \< LVEF \< 50% and LV \< 65mm;
With informed consents

You may not qualify if:

Severe symptomatic congestive heart failure (KILLIP cardiac function class III-IV);
Malignant arrhythmias (ventricular fibrillation, ventricular tachycardia, frequent multiple source ventricular premature);
Uncontrolled hypertension (systolic blood pressure greater than 160mmhg, diastolic blood pressure greater than 100mmhg);
Life-threatening diseases with limited life expectancy \<6 months;
Inability or difficulty to exercise;
Participation in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Shenyang Northern Hospitallead

Study Sites (1)

General Hospital of Shenyang Military Region

Shenyang, Liaoning, 110016, China

RECRUITING

Related Publications (4)

Perelshtein Brezinov O, Klempfner R, Zekry SB, Goldenberg I, Kuperstein R. Prognostic value of ejection fraction in patients admitted with acute coronary syndrome: A real world study. Medicine (Baltimore). 2017 Mar;96(9):e6226. doi: 10.1097/MD.0000000000006226.
PMID: 28248882RESULT
Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
PMID: 28886621RESULT
Yeh RW, Sidney S, Chandra M, Sorel M, Selby JV, Go AS. Population trends in the incidence and outcomes of acute myocardial infarction. N Engl J Med. 2010 Jun 10;362(23):2155-65. doi: 10.1056/NEJMoa0908610.
PMID: 20558366RESULT
Haykowsky M, Scott J, Esch B, Schopflocher D, Myers J, Paterson I, Warburton D, Jones L, Clark AM. A meta-analysis of the effects of exercise training on left ventricular remodeling following myocardial infarction: start early and go longer for greatest exercise benefits on remodeling. Trials. 2011 Apr 4;12:92. doi: 10.1186/1745-6215-12-92.
PMID: 21463531RESULT

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

Meili Liu, MD
General Hospital of Shenyang Military Region
PRINCIPAL INVESTIGATOR

Central Study Contacts

Meili Liu, MD

CONTACT

86-18940193302 liumeili1983bl@163.com

Yaling Han, MD

CONTACT

86-24-23922184 hanyaling@163.net

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 of cardiology, General Hospital of Northern Theater Command

Study Record Dates

First Submitted

December 27, 2021

First Posted

January 21, 2022

Study Start

November 11, 2021

Primary Completion

February 11, 2023

Study Completion

February 11, 2023

Last Updated

January 21, 2022

Record last verified: 2022-01

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Other Outcomes (2)

Study Arms (2)

Baduanjin sequential therapy

Aerobic exercise

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations