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NCT Number: NCT05689385

eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

Hung-Jui Chuang, MD

CONTACT

[email protected]

00886-2-23123456 ext. 67034

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥ 20 years of age.
  • Within 6 months after the onset of acute myocardial infarction.
  • At lowest to moderate risk according to the guideline from American Association of Cardiovascular and Pulmonary Rehabilitation.
  • Unable or refused to attend center-based cardiac rehabilitation.

Exclusion criteria

  • Unable to walk independently or use a stationary bike.
  • Unable to follow verbal command.
  • Not having a smartphone which can get on the internet.
  • Having contraindications for exercise according to American College of Sports Medicine's Guidelines for Exercise Testing and Prescription.
  • Unable to provide informed consent.

Treatment and study plan

eHealth-based cardiac rehabilitation

Other

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

  • Individualized exercise prescription according to the results of cardiopulmonary exercise test.
  • At least one session of in-person physical therapy to familiarize participants with the process of exercise training before the initiation of telerehabilitation.
  • 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)
  • Additional self-exercise to achieve the target volume of 150-minute moderate aerobic exercise and 2 sessions of resistance training per week.
  • Patient education for secondary prevention delivered regularly via a communication app on the smartphone.
  • Weekly follow-up call from a case manager via phone call or communication app.

Other names: eHCR

Primary outcomes

  1. Change of peak oxygen uptake

    Time frame: at baseline, 12 weeks(post-intervention), and 12 months.

    Peak oxygen uptake will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 12 months.

  2. Change of ventilatory anaerobic threshold

    Time frame: at baseline, 12 weeks(post-intervention), and 12 months.

    Ventilatory anaerobic threshold will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 12 months.

Secondary outcomes

  1. Adherence to prescribed exercise

    Time frame: at 12 weeks(post-intervention) and 12 months.

    The degree of completion of prescribed exercise will be assessed at 12 weeks and 12 months.

  2. Evaluation of Quality of life

    Time frame: at baseline, 12 weeks(post-intervention), and 12 months.

    The investigators will assess the change in 36-Item Short Form Survey(SF-36).

  3. Depression

    Time frame: at baseline, 12 weeks(post-intervention), and 12 months.

    The investigators will assess the change in Patient Health Questionnaire (PHQ-9). The PHQ-9 score ranges from 0-27. Higher scores indicate worsen symptoms.

  4. Anxiety

    Time frame: at baseline, 12 weeks(post-intervention), and 12 months.

    The investigators will assess the change in Generalized Anxiety Disorder scale (GAD-7). The GAD-7 score ranges 0-21. Higher scores indicate worsen symptoms.

  5. Evaluation of physical activity

    Time frame: at baseline, 12 weeks(post-intervention), and 12 months.

    The investigators will assess the change in physical activity using Long form International Physical Activity Questionnaire(IPAQ) Taiwan version.

  6. Evaluation of grip strength

    Time frame: at baseline, 12 weeks(post-intervention), and 12 months.

    The grip strength will be measured using a grip goniometer with the participants seated and the elbow flexed at 90 degrees.

  7. Evaluation of isometric knee extension strength

    Time frame: at baseline, 12 weeks(post-intervention), and 12 months.

    The isometric knee extension strength will be measured using a dynamometer with participants seated and knee flexed at 90 degrees.

Study contacts

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

Hung-Jui Chuang, MD

CONTACT

[email protected]

00886-2-23123456 ext. 67034

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

The Effectiveness of eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients：a Randomized Controlled Trial.

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 19, 2023
Registry last updated
Aug 28, 2025

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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