Clinical trial NCT06473441: Telehealth and Home-based Exercise and Rehabilitation Therapy for Acute Coronary Syndrome
Official title: Comparative Effectiveness of Three Home-Based Rehabilitation Programs in Patients With Acute Coronary Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
Coronary Artery Disease
Keywords: Acute coronary syndrome
Coronary artery disease
Cardiac rehabilitation
Telerehabilitation
Home-based training
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the effectiveness of three different home-based rehabilitation programs for patients with acute coronary syndrome (ACS). This randomized controlled trial will recruit 60 ACS patients, divided into three groups: a 12-week home rehabilitation group, a 6-week tele-rehabilitation followed by 6-week home rehabilitation group, and a 12-week tele-rehabilitation combined with home rehabilitation group. Patients will be assessed at baseline, and at 3, 6, and 12 months on physical health, cardiopulmonary function, and psychological well-being. The hypothesis is that home-based CR, particularly with tele-rehabilitation, will improve recovery and quality of life more effectively. The study aims to identify the most beneficial home rehabilitation strategy for ACS patients.

Detailed description: This study is designed to evaluate the benefits of three different home-based cardiac rehabilitation (CR) models on the recovery of patients with acute coronary syndrome (ACS). Cardiovascular diseases are a major cause of mortality worldwide, but advancements in CR have significantly improved patient outcomes. Despite the proven benefits of CR in enhancing quality of life and reducing hospital readmission rates, participation in traditional CR programs remains low. Home-based CR, especially using tele-rehabilitation technologies, offers a promising alternative. This randomized controlled trial will recruit 60 ACS patients, divided into three groups: a 12-week home rehabilitation group, a 6-week tele-rehabilitation followed by a 6-week home rehabilitation group, and a 12-week tele-rehabilitation combined with home rehabilitation group. All patients will undergo evaluations at baseline, and at 3, 6, and 12 months to assess physical health, cardiopulmonary function, and psychological well-being. The hypothesis is that home-based CR, particularly with tele-rehabilitation support, will enhance recovery and quality of life more effectively than traditional methods. The findings aim to identify the most effective home rehabilitation strategy for ACS patients, providing insights into improving their cardiopulmonary function and overall well-being.

Eligibility criteria: Inclusion Criteria:

* Hospitalized for acute coronary syndrome (ACS) and have undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) surgery.
* Aged 18 years or older.
* Regular adherence to prescribed medication regimen.
* Stable medical condition and vital signs.
* Conscious and able to follow instructions.
* Able to provide informed consent.

Exclusion Criteria:

* Unable to comply with rehabilitation or assessment procedures.
* Inability to walk independently.
* Dependent in daily living activities prior to hospitalization (Barthel Index score less than 80).
* Terminal illness with an expected life span of less than one year. Contraindications to cardiac rehabilitation as per the American College of Sports Medicine guidelines, such as unstable angina, uncontrolled severe hypertension (resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg), postural hypotension (blood pressure drop of more than 20 mmHg upon standing), severe aortic stenosis, uncontrolled severe arrhythmias, decompensated heart failure, third-degree atrioventricular block, acute pericarditis or myocarditis, aortic dissection, acute pulmonary embolism, and other acute medical conditions like infections and fever.

Primary outcomes:
measure: Maximal Oxygen Uptake (VO2 max)
timeFrame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
measure: Anaerobic Threshold
timeFrame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
measure: Oxygen Pulse
timeFrame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Secondary outcomes:
measure: Muscle strength
timeFrame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
measure: Six-Minute Walk Test (6MWT)
timeFrame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
measure: Sit-to-Stand Test
timeFrame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Other outcomes:
measure: Depression Assessment (PHQ-9)
timeFrame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
measure: Anxiety and Depression Assessment (HADS)
timeFrame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
measure: Quality of Life Assessment (SF-36)
timeFrame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
measure: Lipid Profile Analysis
timeFrame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
measure: Glucose and Hemoglobin A1C Measurement
timeFrame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
measure: Cardiac Biomarker Analysis
timeFrame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
measure: Inflammatory Marker Analysis
timeFrame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
measure: Physical Activity Assessment (IPAQ)
timeFrame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Shu-mei Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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