Telehealth and Home-based Exercise and Rehabilitation Therapy for Acute Coronary Syndrome
NCT Number: NCT06473441
Acronym: TELE-HEART
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Coronary Syndrome|Coronary Artery Disease
Interventions: BEHAVIORAL: Tele-Rehabilitation Therapy|BEHAVIORAL: Health Education|BEHAVIORAL: Exercise Prescription|BEHAVIORAL: Home Exercise Equipment Use|BEHAVIORAL: Exercise Log|BEHAVIORAL: Follow-Up Calls
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-06-30

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.

Primary Outcome Measures: 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., 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., 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., Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Secondary Outcome Measures: 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., 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., 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., Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
Other Outcome Measures: 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)., 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)., 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., 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., 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., 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., 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., 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., Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.