Acute Coronary Syndrome, Coronary Artery Disease
Conditions
Keywords
Acute coronary syndrome, Coronary artery disease, Cardiac rehabilitation, Telerehabilitation, Home-based training
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.
Interventions
BEHAVIORALTele-Rehabilitation Therapy
Twice-weekly sessions with remote supervision and guidance from therapists.
BEHAVIORALHealth Education
Health education based on individual assessments.
BEHAVIORALExercise Prescription
Exercise prescription tailored to individual needs.
BEHAVIORALHome Exercise Equipment Use
Use of a home exercise bike, resistance bands, respiratory muscle training device, and a portable heart rate monitor.
BEHAVIORALExercise Log
Logging daily exercise intensity and duration in a rehabilitation diary
BEHAVIORALFollow-Up Calls
Regular follow-up calls to monitor progress and address any issues.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Oxygen Uptake (VO2 max) | Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention. | his measure will evaluate cardiopulmonary function by assessing the maximal oxygen uptake (VO2 max). VO2 max is the maximum amount of oxygen the body can utilize during intense exercise and is an indicator of cardiovascular and respiratory efficiency. |
| Anaerobic Threshold | Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention. | This measure will evaluate cardiopulmonary function by assessing the anaerobic threshold. The anaerobic threshold is the exercise intensity at which lactate begins to accumulate in the blood, indicating the transition from aerobic to anaerobic metabolism. |
| Oxygen Pulse | Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention. | This measure will evaluate cardiopulmonary function by assessing the oxygen pulse, which is the amount of oxygen used by the body per heartbeat during exercise. It provides insights into cardiovascular efficiency and respiratory function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six-Minute Walk Test (6MWT) | Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention. | This measure will assess physical function through the six-minute walk test (6MWT). The test evaluates improvements in participants' walking endurance and overall physical capabilities. |
| Sit-to-Stand Test | Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention. | This measure will assess physical function through the sit-to-stand test. The test evaluates improvements in participants' lower body strength and functional mobility. This measure will assess physical function through the sit-to-stand test. The test evaluates improvements in participants' lower body strength and functional mobility. This measure will assess physical function through the sit-to-stand test. The test evaluates improvements in participants' lower body strength and functional mobility. |
| Muscle strength | Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention. | This measure will assess physical function through the muscle strength tests (manual muscle testing). These tests will evaluate improvements in participants' muscular strength and endurance by measuring the maximum force that muscles can exert against resistance. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Biomarker Analysis | Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention. | Blood tests will measure levels of troponin, creatine kinase, myoglobin, and NT-proBNP to assess participants' cardiac health. |
| Inflammatory Marker Analysis | Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention. | Blood tests will measure levels of D-dimers, C-reactive protein, and albumin to evaluate participants' inflammatory status. |
| Physical Activity Assessment (IPAQ) | Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention. | Daily physical activity will be monitored using the International Physical Activity Questionnaire (IPAQ), which assesses the frequency and duration of physical activities performed by participants. The IPAQ provides scores for total physical activity and categorizes participants into low, moderate, or high activity levels based on MET (Metabolic Equivalent of Task) minutes per week. |
| Depression Assessment (PHQ-9) | Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention. | Psychological well-being will be measured using the Patient Health Questionnaire-9 (PHQ-9) to assess levels of depression among participants. The PHQ-9 scores range from 0 to 27, with higher scores indicating greater severity of depression: 0-4 (minimal depression), 5-9 (mild depression), 10-14 (moderate depression), 15-19 (moderately severe depression), and 20-27 (severe depression). |
| Anxiety and Depression Assessment (HADS) | Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention. | Psychological well-being will be measured using the Hospital Anxiety and Depression Scale (HADS) to assess levels of anxiety and depression among participants. The HADS consists of 14 items, with scores ranging from 0 to 21 for both anxiety and depression subscales. Higher scores indicate greater severity: 0-7 (normal), 8-10 (borderline abnormal), and 11-21 (abnormal). |
| Quality of Life Assessment (SF-36) | Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention. | Psychological well-being will be measured using the SF-36 questionnaire to assess participants' overall quality of life. The SF-36 scores range from 0 to 100, with higher scores indicating better quality of life. It includes eight subscales: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. |
| Lipid Profile Analysis | Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention. | Blood tests will measure levels of total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides to evaluate participants' lipid profile. |
| Glucose and Hemoglobin A1C Measurement | Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention. | Blood tests will measure levels of fasting glucose and hemoglobin A1C to evaluate participants' blood sugar control. |
Contacts
Primary ContactSHU-MEI YANG, MD
Outcome results
None listed