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Telehealth and Home-based Exercise and Rehabilitation Therapy for Acute Coronary Syndrome (TELE-HEART)

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National Taiwan University

Status

Not yet enrolling

Conditions

Coronary Artery Disease
Acute Coronary Syndrome

Treatments

Behavioral: Tele-Rehabilitation Therapy
Behavioral: Exercise Log
Behavioral: Health Education
Behavioral: Exercise Prescription
Behavioral: Follow-Up Calls
Behavioral: Home Exercise Equipment Use

Study type

Interventional

Funder types

Other

Identifiers

NCT06473441
202310018RIND

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 3 patient groups

12-Week Home Rehabilitation
Experimental group
Description:
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.
Treatment:
Behavioral: Home Exercise Equipment Use
Behavioral: Follow-Up Calls
Behavioral: Exercise Prescription
Behavioral: Health Education
Behavioral: Exercise Log
6-Week Tele-Rehabilitation plus 6-Week Home Rehabilitation
Experimental group
Description:
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.
Treatment:
Behavioral: Home Exercise Equipment Use
Behavioral: Follow-Up Calls
Behavioral: Exercise Prescription
Behavioral: Health Education
Behavioral: Exercise Log
Behavioral: Tele-Rehabilitation Therapy
12-Week Tele-Rehabilitation and Home Rehabilitation
Experimental group
Description:
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.
Treatment:
Behavioral: Home Exercise Equipment Use
Behavioral: Follow-Up Calls
Behavioral: Exercise Prescription
Behavioral: Health Education
Behavioral: Exercise Log
Behavioral: Tele-Rehabilitation Therapy

Trial contacts and locations

0

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Central trial contact

SHU-MEI YANG, MD

Data sourced from clinicaltrials.gov

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