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NCT Number: NCT06473441

Telehealth and Home-based Exercise and Rehabilitation Therapy for Acute Coronary Syndrome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tele-Rehabilitation Therapy

Behavioral

Twice-weekly sessions with remote supervision and guidance from therapists.

Health Education

Behavioral

Health education based on individual assessments.

Exercise Prescription

Behavioral

Exercise prescription tailored to individual needs.

Home Exercise Equipment Use

Behavioral

Use of a home exercise bike, resistance bands, respiratory muscle training device, and a portable heart rate monitor.

Exercise Log

Behavioral

Logging daily exercise intensity and duration in a rehabilitation diary

Follow-Up Calls

Behavioral

Regular follow-up calls to monitor progress and address any issues.

Primary outcomes

  1. Maximal Oxygen Uptake (VO2 max)

    Time frame: 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.

  2. Anaerobic Threshold

    Time frame: 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.

  3. Oxygen Pulse

    Time frame: 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 outcomes

  1. Muscle strength

    Time frame: 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.

  2. Six-Minute Walk Test (6MWT)

    Time frame: 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.

  3. Sit-to-Stand Test

    Time frame: 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.

Other outcomes

  1. Depression Assessment (PHQ-9)

    Time frame: 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).

  2. Anxiety and Depression Assessment (HADS)

    Time frame: 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).

  3. Quality of Life Assessment (SF-36)

    Time frame: 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.

  4. Lipid Profile Analysis

    Time frame: 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.

  5. Glucose and Hemoglobin A1C Measurement

    Time frame: 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.

  6. Cardiac Biomarker Analysis

    Time frame: 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.

  7. Inflammatory Marker Analysis

    Time frame: 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.

  8. Physical Activity Assessment (IPAQ)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

SHU-MEI YANG, MD

CONTACT

[email protected]

886-0972653754

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Comparative Effectiveness of Three Home-Based Rehabilitation Programs in Patients With Acute Coronary Syndrome: A Randomized Controlled Trial

Acronym: TELE-HEART

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 25, 2024
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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