eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients

NCT ID: NCT05689385

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2028-12-31

Brief Summary

The goal of this randomized controlled trial is to compare the effect of eHealth-based cardiac rehabilitation with the effect of usual care on exercise capacity and qualify of life in patients after myocardial infarction.

Detailed Description

Cardiac rehabilitation can improve exercise capacity, life of quality, readmission rate and mortality rate for patients after myocardial infarction. International guidelines list cardiac rehabilitation after myocardial infarction as class IA recommendation. However, low participation rate of cardiac rehabilitation due to barriers such as lacking of time, transport or affordability issues is an unsolved problem worldwide.

eHealth, consisting of telemedicine, mobile health and personalized care using wearable devices has the potential to remove the barriers and become an effective model to deliver cardiac rehabilitation. Thus, we design a randomized controlled trial to compare the effect of a case manager-led eHealth-based cardiac rehabilitation program with usual care on the compliance, physical activity, quality of life, and cardiorespiratory fitness in patients after myocardial infarction.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

eHealth-based cardiac rehabilitation

Participants receive a 12-wk case manager-led eHealth-based cardiac rehabilitation program with follow-up at 12 week, 6 months and 12 months.

Group Type: EXPERIMENTAL

eHealth-based cardiac rehabilitation

Intervention Type: OTHER

The 12-wk case manager-led eHCR program includes:

1. Individualized exercise prescription according to the results of cardiopulmonary exercise test.

2. At least one session of in-person physical therapy to familiarize participants with the process of exercise training before the initiation of telerehabilitation.

3. Telerehabilitation: a 30-minute moderate aerobic exercise training with remote monitoring and instruction using video conferencing. (Frequency: twice per week in the first 4 weeks, once per week in the 5th-8th week, once every 2 weeks in the 9th-12th week)

4. Additional self-exercise to achieve the target volume of 150-minute moderate aerobic exercise and 2 sessions of resistance training per week.

5. Patient education for secondary prevention delivered regularly via a communication app on the smartphone.

6. Weekly follow-up call from a case manager via phone call or communication app.

Usual care

Participants receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

eHealth-based cardiac rehabilitation

The 12-wk case manager-led eHCR program includes:

1. Individualized exercise prescription according to the results of cardiopulmonary exercise test.

2. At least one session of in-person physical therapy to familiarize participants with the process of exercise training before the initiation of telerehabilitation.

3. Telerehabilitation: a 30-minute moderate aerobic exercise training with remote monitoring and instruction using video conferencing. (Frequency: twice per week in the first 4 weeks, once per week in the 5th-8th week, once every 2 weeks in the 9th-12th week)

4. Additional self-exercise to achieve the target volume of 150-minute moderate aerobic exercise and 2 sessions of resistance training per week.

5. Patient education for secondary prevention delivered regularly via a communication app on the smartphone.

6. Weekly follow-up call from a case manager via phone call or communication app.

Intervention Type: OTHER

Other Intervention Names

eHCR

Eligibility Criteria

Inclusion Criteria

1. ≥ 20 years of age.

2. Within 6 months after the onset of acute myocardial infarction.

3. At lowest to moderate risk according to the guideline from American Association of Cardiovascular and Pulmonary Rehabilitation.

4. Unable or refused to attend center-based cardiac rehabilitation.

Exclusion Criteria

1. Unable to walk independently or use a stationary bike.

2. Unable to follow verbal command.

3. Not having a smartphone which can get on the internet.

4. Having contraindications for exercise according to American College of Sports Medicine's Guidelines for Exercise Testing and Prescription.

5. Unable to provide informed consent.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hung-Jui Chuang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hung-Jui Chuang, MD

Role: CONTACT

103311@ntuh.gov.tw

00886-2-23123456 ext. 67034

Facility Contacts

Hung-Jui Chuang, MD

Role: primary

rexintwo@gmail.com

00886-2-23123456 ext. 67034

Other Identifiers

202207060RINC

Identifier Type: -

Identifier Source: org_study_id