NCT02584192

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Status
completed

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

Study Start

First participant enrolled

October 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

10 months

First QC Date

October 16, 2015

Last Update Submit

October 21, 2015

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • myocardial function using the three-dimensional speckle tracking echocardiography (3D-STE)

    Change from baseline strain parameters at four-week follow-up

Study Arms (2)

the rehabilitation group

EXPERIMENTAL

entailing an early home-based CR program

Behavioral: entailing an early home-based CR program

the control group

OTHER

enter the usual care program, including the importance of carrying out physical activity, which was performed during inpatient care.

Other: enter the usual care program

Interventions

entailing an early home-based CR programBEHAVIORAL

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)

the rehabilitation group
enter the usual care programOTHER

enter the usual care program, including the importance of carrying out physical activity, which was performed during inpatient care.

the control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being aged 18-65 years with a confirmed AMI diagnosis
  • Being suitable for the CR program
  • Undergoing PCI at the entry

You may not qualify if:

  • Known ischemic heart disease, heart valvular lesions, intra-ventricular conduction disturbances, malignant arrhythmia, cardiac shock, and poor echocardiographic conditions to take STE examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34741536DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 22, 2015

Study Start

October 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 22, 2015

Record last verified: 2015-10