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

T

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

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.

Trial contacts and locations

1

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Central trial contact

Yuchun Lee, MD

Data sourced from clinicaltrials.gov

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