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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02584192
Other study ID # CR2014
Secondary ID
Status Completed
Phase N/A
First received October 16, 2015
Last updated October 21, 2015
Start date October 2014
Est. completion date August 2015

Study information

Verified date October 2015
Source Guangzhou General Hospital of Guangzhou Military Command
Contact n/a
Is FDA regulated No
Health authority China: Health and Family Planning Commission of Changzhou
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
entailing an early home-based CR program
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)
Other:
enter the usual care program
enter the usual care program, including the importance of carrying out physical activity, which was performed during inpatient care.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Lin Xu

Outcome

Type Measure Description Time frame Safety issue
Primary myocardial function using the three-dimensional speckle tracking echocardiography (3D-STE) Change from baseline strain parameters at four-week follow-up Yes
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