Myocardial InfarctionNCT05689385
eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients
A study testing eHealth-based cardiac rehabilitation in people with Myocardial Infarction, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- eHealth-based cardiac rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Apr 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Hung-Jui Chuang, MD, 00886-2-23123456 ext. 67034, rexintwo@gmail.com
About this study
Official title: The Effectiveness of eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients：a Randomized Controlled Trial.
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.
Read the 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
- Being tested
- eHealth-based cardiac rehabilitation
- Keywords
- cardiac rehabilitation, telerehabilitation, myocardial infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth-based cardiac rehabilitationOther
Also called eHCR
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.
| Study group | Role | What they receive |
|---|---|---|
| eHealth-based cardiac rehabilitation | Experimental | Participants receive a 12-wk case manager-led eHealth-based cardiac rehabilitation program with follow-up at 12 week, 6 months and 12 months. Receives: Other: eHealth-based cardiac rehabilitation |
| Usual care | No intervention | Participants receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of peak oxygen uptake
Peak oxygen uptake will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 12 months.
Measured: at baseline, 12 weeks(post-intervention), and 12 months.
Change of ventilatory anaerobic threshold
Ventilatory anaerobic threshold will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 12 months.
Measured: at baseline, 12 weeks(post-intervention), and 12 months.
Secondary outcomes (7)
Adherence to prescribed exercise
The degree of completion of prescribed exercise will be assessed at 12 weeks and 12 months.
Measured: at 12 weeks(post-intervention) and 12 months.
Evaluation of Quality of life
The investigators will assess the change in 36-Item Short Form Survey(SF-36).
Measured: at baseline, 12 weeks(post-intervention), and 12 months.
Depression
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.
Measured: at baseline, 12 weeks(post-intervention), and 12 months.
Anxiety
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.
Measured: at baseline, 12 weeks(post-intervention), and 12 months.
Evaluation of physical activity
The investigators will assess the change in physical activity using Long form International Physical Activity Questionnaire(IPAQ) Taiwan version.
Measured: at baseline, 12 weeks(post-intervention), and 12 months.
Evaluation of grip strength
The grip strength will be measured using a grip goniometer with the participants seated and the elbow flexed at 90 degrees.
Measured: at baseline, 12 weeks(post-intervention), and 12 months.
Evaluation of isometric knee extension strength
The isometric knee extension strength will be measured using a dynamometer with participants seated and knee flexed at 90 degrees.
Measured: at baseline, 12 weeks(post-intervention), and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start20 Apr 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Jui Chuang, MD, Principal investigator, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689385
- Sponsor's protocol ID
- 202207060RINC
- Status last verified
- Aug 2025
- First submitted
- 3 Jan 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients：a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05689385
- Acronym / sponsor ID
- 202207060RINC
- Conditions
- Myocardial Infarction
- Keywords
- cardiac rehabilitation, telerehabilitation, myocardial infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eHealth-based cardiac rehabilitation | Experimental | Other: eHealth-based cardiac rehabilitationParticipants receive a 12-wk case manager-led eHealth-based cardiac rehabilitation program with follow-up at 12 week, 6 months and 12 months. |
| Usual care | No intervention | –Participants receive usual care. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHealth-based cardiac rehabilitationAlso: eHCRThe 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. | Other | eHealth-based cardiac rehabilitation |
Primary outcome
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.
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.
7 secondary outcomes
Adherence to prescribed exercise
Time frame: at 12 weeks(post-intervention) and 12 months.
Evaluation of Quality of life
Time frame: at baseline, 12 weeks(post-intervention), and 12 months.
Depression
Time frame: at baseline, 12 weeks(post-intervention), and 12 months.
Anxiety
Time frame: at baseline, 12 weeks(post-intervention), and 12 months.
Evaluation of physical activity
Time frame: at baseline, 12 weeks(post-intervention), and 12 months.
Evaluation of grip strength
Time frame: at baseline, 12 weeks(post-intervention), and 12 months.
Evaluation of isometric knee extension strength
Time frame: at baseline, 12 weeks(post-intervention), and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hung-Jui Chuang, MD principal investigator
Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth-based cardiac rehabilitation in people with Myocardial Infarction, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hung-Jui Chuang, MD (00886-2-23123456 ext. 67034, 103311@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of peak oxygen uptake (time frame: at baseline, 12 weeks(post-intervention), and 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.