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

Taichung Veterans General Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Acute Coronary Syndrome

Treatments: Behavioral: information reveal

Study type: Interventional

Funder types: Other

Identifiers

NCT05401240

CE22225A

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• acute coronary patients

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

CEPT informed

Experimental group

Description:

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.

Treatment:

Behavioral: information reveal

CPET not informed

No Intervention group

Description:

the patient is asked to returned to the outpatient department (OPD) in order to received cardiac rehabilitation, but not informed about the cardiopulmonary exercise testing.