An interventional study of Tele-Rehabilitation Therapy and Health Education in Acute Coronary Syndrome and Coronary Artery Disease, sponsored by National Taiwan University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
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.
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This study's planned enrollment of 60 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
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Exclusion Criteria:
Participants in this group will receive a 12-week home-based rehabilitation program. They will be provided with health education and an exercise prescription based on individual assessments by the research team. Rehabilitation equipment, including a home exercise bike, resistance bands, respiratory muscle training device, and a portable heart rate monitor, will be supplied. Participants will log their daily exercise intensity and duration in a rehabilitation diary. Regular follow-up calls will be made to monitor progress and address any issues.
Behavioral: Health Education · Behavioral: Exercise Prescription · Behavioral: Home Exercise Equipment Use · Behavioral: Exercise Log · Behavioral: Follow-Up Calls
Participants in this group will undergo a hybrid rehabilitation program. For the first 6 weeks, they will receive tele-rehabilitation therapy, involving twice-weekly sessions where therapists remotely supervise and guide exercises. This will be followed by 6 weeks of the same home rehabilitation program as Arm 1, with health education, exercise prescriptions, and regular follow-up calls.
Behavioral: Tele-Rehabilitation Therapy · Behavioral: Health Education · Behavioral: Exercise Prescription · Behavioral: Home Exercise Equipment Use · Behavioral: Exercise Log · Behavioral: Follow-Up Calls
Participants in this group will receive 12 weeks of combined tele-rehabilitation and home rehabilitation. They will have twice-weekly tele-rehabilitation sessions with remote supervision and guidance from therapists throughout the entire period. In addition, they will follow the same home rehabilitation protocol as described for Arm 1, with provided equipment, exercise logs, and regular follow-up calls to ensure adherence and address any difficulties.
Behavioral: Tele-Rehabilitation Therapy · Behavioral: Health Education · Behavioral: Exercise Prescription · Behavioral: Home Exercise Equipment Use · Behavioral: Exercise Log · Behavioral: Follow-Up Calls
Twice-weekly sessions with remote supervision and guidance from therapists.
Health education based on individual assessments.
Exercise prescription tailored to individual needs.
Use of a home exercise bike, resistance bands, respiratory muscle training device, and a portable heart rate monitor.
Logging daily exercise intensity and duration in a rehabilitation diary
Regular follow-up calls to monitor progress and address any issues.
Maximal Oxygen Uptake (VO2 max)
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.
Time frame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Anaerobic Threshold
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.
Time frame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Oxygen Pulse
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.
Time frame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Muscle strength
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.
Time frame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Six-Minute Walk Test (6MWT)
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.
Time frame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Sit-to-Stand Test
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.
Time frame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Depression Assessment (PHQ-9)
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).
Time frame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Anxiety and Depression Assessment (HADS)
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).
Time frame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Quality of Life Assessment (SF-36)
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.
Time frame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Lipid Profile Analysis
Blood tests will measure levels of total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides to evaluate participants' lipid profile.
Time frame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Glucose and Hemoglobin A1C Measurement
Blood tests will measure levels of fasting glucose and hemoglobin A1C to evaluate participants' blood sugar control.
Time frame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Cardiac Biomarker Analysis
Blood tests will measure levels of troponin, creatine kinase, myoglobin, and NT-proBNP to assess participants' cardiac health.
Time frame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Inflammatory Marker Analysis
Blood tests will measure levels of D-dimers, C-reactive protein, and albumin to evaluate participants' inflammatory status.
Time frame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Physical Activity Assessment (IPAQ)
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.
Time frame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
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Plan to share: No
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National Taiwan University Hospital