Efficacy of Early Home-based Cardiac Rehabilitation Program for Patients After Acute Myocardial Infarction
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
entailing an early home-based CR program
enter the usual care program
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- Being aged 18-65 years with a confirmed AMI diagnosis
- Being suitable for the CR program
- Undergoing PCI at the entry
Exclusion Criteria:
- Known ischemic heart disease, heart valvular lesions, intra-ventricular conduction disturbances, malignant arrhythmia, cardiac shock, and poor echocardiographic conditions to take STE examination
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
the rehabilitation group
the control group
Arm Description
entailing an early home-based CR program
enter the usual care program, including the importance of carrying out physical activity, which was performed during inpatient care.
Outcomes
Primary Outcome Measures
myocardial function using the three-dimensional speckle tracking echocardiography (3D-STE)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02584192
Brief Title
Efficacy of Early Home-based Cardiac Rehabilitation Program for Patients After Acute Myocardial Infarction
Official Title
Efficacy of Early Home-based Cardiac Rehabilitation Program for Patients After Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lin Xu
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to evaluate the effect of this CR program on the improvement of myocardial function using the three-dimensional speckle tracking echocardiography (3D-STE) in AMI patients.
Detailed Description
The effect of early short-term home-based cardiac rehabilitation (CR) program on left ventricular function in acute myocardial infarction (AMI) patients is not clear yet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the rehabilitation group
Arm Type
Experimental
Arm Description
entailing an early home-based CR program
Arm Title
the control group
Arm Type
Other
Arm Description
enter the usual care program, including the importance of carrying out physical activity, which was performed during inpatient care.
Intervention Type
Behavioral
Intervention Name(s)
entailing an early home-based CR program
Intervention Description
enter the early outpatient phase of CR program. The progressive exercise training of this phase was performed without supervision after their discharge. The CR program consisted of a five-minute warm-up period (stretching), a twenty-minute aerobic exercise (walking or trotting, gymnastics), and a five-minute cooling-down period (stretching)
Intervention Type
Other
Intervention Name(s)
enter the usual care program
Intervention Description
enter the usual care program, including the importance of carrying out physical activity, which was performed during inpatient care.
Primary Outcome Measure Information:
Title
myocardial function using the three-dimensional speckle tracking echocardiography (3D-STE)
Time Frame
Change from baseline strain parameters at four-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being aged 18-65 years with a confirmed AMI diagnosis
Being suitable for the CR program
Undergoing PCI at the entry
Exclusion Criteria:
Known ischemic heart disease, heart valvular lesions, intra-ventricular conduction disturbances, malignant arrhythmia, cardiac shock, and poor echocardiographic conditions to take STE examination
12. IPD Sharing Statement
Citations:
PubMed Identifier
34741536
Citation
Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
Results Reference
derived
Learn more about this trial
Efficacy of Early Home-based Cardiac Rehabilitation Program for Patients After Acute Myocardial Infarction
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