Using Cardiopulmonary Exercise Test as an Incentive to Outpatient Cardiac Rehabilitation for Acute Coronary Syndrome Survivors.

Phase 4

Not yet recruiting

• Conditions: Acute Coronary Syndrome
• Interventions: Behavioral: information reveal

• Registration Number: NCT05401240
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

Exercise-based cardiac rehabilitation is a class I recommendation for acute coronary syndrome (ACS) patients. However, participate rate of outpatient rehabilitation is quite low and remains a global issue. The study is to propose a strategy in order to encourage post-ACS patients to participate in the outpatient cardiac rehabilitation.

Detailed Description

Background: exercise-based cardiac rehabilitation is a class I recommendation for acute coronary syndrome (ACS) patients. However, participate rate of outpatient rehabilitation is quite low and remains a global issue. The study is to propose a strategy in order to encourage post-ACS patients to participate in the outpatient cardiac rehabilitation.

Hypothesis: cardiopulmonary exercise test (CPET) incentives ACS survivors to participate in outpatient cardiac rehabilitation.

Objectives: 200 ACS survivors who are eligible for cardiac rehabilitation will be allocated randomly into control and experimental groups.

Method: before discharge, both control and experimental groups will be informed of the importance of cardiac rehabilitation and invited to participate the outpatient rehabilitation. The experimental group will also be told that an important examination, i.e. the CPET, will be performed in order to evaluate their heart function at the outpatient department (OPD).

Primary outcome: the presence of ACS survivors at the OPD of rehabilitation in order to receive the rehabilitation/CPET.

Secondary outcomes: the adherence to cardiac rehabilitation, defined as completing a full course of cardiac rehabilitation (6 sessions) or home-based exercise.

Factors that might influence the presence of ACS survivors at OPD of rehabilitation will also be recorded and analyzed, including:

* Patient characteristics: age, sex, body mass index (BMI), cardiovascular disease (CVD) risk factors

* Electrocardiography (ECG): ST elevation myocardial infarction (STEMI) or non ST elevation myocardial infarction (NSTEMI)

* Lab data: peak troponin level.

* Days of hospitalization. Statistics: t-test, ANOVA

Study Timeline

• Study First Submitted: 2022-05-29
• Study First Submitted QC: 2022-05-29
• Study First Posted: 2022-06-02
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-15
• Study Start: 2022-09-01
• Primary Completion: 2024-05-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• acute coronary patients

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Exclusion Criteria

• acute illness that stayed in hospital for more than 2 weeks.
• patients who received surgical intervention
• severe complications (ex. respiratory failure, stroke, acute renal failure)
• contraindications of cardiopulmonary exercise testing
• patients who cannot perform the cardiopulmonary exercise testing

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CEPT informed	information reveal	the patient is informed and asked to returned to the outpatient department (OPD) in order to received cardiac rehabilitation, as well as to take an important examination (cardiopulmonary exercise testing) for his/her cardiorespiratory fitness.

Primary Outcome Measures

Name	Time	Method
the return rate	scheduled appointment time, about 2 to 4 weeks after discharge	patient that did return to the OPD for examination and cardiac rehabilitation

Secondary Outcome Measures

Name	Time	Method
the adherence	6 months after discharge	the percentage of patients that keep taking cardiac rehabilitation for more than one session

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan