Clinical trial NCT05401240: Using Cardiopulmonary Exercise Test as an Incentive to Outpatient Cardiac Rehabilitation for Acute Coronary Syndrome Survivors.
Official title: Cardiopulmonary Exercise Test as an Incentive to Outpatient Cardiac Rehabilitation for Acute Coronary Syndrome Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: cardiac rehabilitation
cardiopulmonary exercise testing
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: the return rate
timeFrame: scheduled appointment time, about 2 to 4 weeks after discharge
Secondary outcomes:
measure: the adherence
timeFrame: 6 months after discharge
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Yuchun Lee, MD
role: STUDY_DIRECTOR
References: