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

June 18, 2024 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 12-Week Home Rehabilitation
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
Health education based on individual assessments.
Behavioral: Exercise Prescription
Exercise prescription tailored to individual needs.
Behavioral: Home Exercise Equipment Use
Use of a home exercise bike, resistance bands, respiratory muscle training device, and a portable heart rate monitor.
Behavioral: Exercise Log
Logging daily exercise intensity and duration in a rehabilitation diary
Behavioral: Follow-Up Calls
Regular follow-up calls to monitor progress and address any issues.
Experimental: 6-Week Tele-Rehabilitation plus 6-Week Home Rehabilitation
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: Health Education
Health education based on individual assessments.
Behavioral: Exercise Prescription
Exercise prescription tailored to individual needs.
Behavioral: Home Exercise Equipment Use
Use of a home exercise bike, resistance bands, respiratory muscle training device, and a portable heart rate monitor.
Behavioral: Exercise Log
Logging daily exercise intensity and duration in a rehabilitation diary
Behavioral: Follow-Up Calls
Regular follow-up calls to monitor progress and address any issues.
Behavioral: Tele-Rehabilitation Therapy
Twice-weekly sessions with remote supervision and guidance from therapists.
Experimental: 12-Week Tele-Rehabilitation and Home Rehabilitation
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: Health Education
Health education based on individual assessments.
Behavioral: Exercise Prescription
Exercise prescription tailored to individual needs.
Behavioral: Home Exercise Equipment Use
Use of a home exercise bike, resistance bands, respiratory muscle training device, and a portable heart rate monitor.
Behavioral: Exercise Log
Logging daily exercise intensity and duration in a rehabilitation diary
Behavioral: Follow-Up Calls
Regular follow-up calls to monitor progress and address any issues.
Behavioral: Tele-Rehabilitation Therapy
Twice-weekly sessions with remote supervision and guidance from therapists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
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.
Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
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.
Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
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.
Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
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.
Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
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).
Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
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.
Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
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.
Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
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.
Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
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.
Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
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.
Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.
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.
Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Shu-mei Yang, MD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202310018RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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