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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
Lin Xu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 16, 2015
    Last Updated
    October 21, 2015
    Sponsor
    Lin Xu
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    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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