NCT05689385

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Apr 2023Dec 2028

First Submitted

Initial submission to the registry

January 3, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

5.6 years

First QC Date

January 3, 2023

Last Update Submit

August 21, 2025

Conditions

Myocardial Infarction

Keywords

cardiac rehabilitationtelerehabilitationmyocardial infarction

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

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

Secondary Outcomes (7)

  • Adherence to prescribed exercise

    at 12 weeks(post-intervention) and 12 months.

  • Evaluation of Quality of life

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

  • Depression

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

  • Anxiety

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

  • Evaluation of physical activity

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

  • +2 more secondary outcomes

Study Arms (2)

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.

Other: eHealth-based cardiac rehabilitation

Usual care

NO INTERVENTION

Participants receive usual care.

Interventions

eHealth-based cardiac rehabilitationOTHER

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.

Also known as: eHCR
eHealth-based cardiac rehabilitation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Hung-Jui Chuang, MD

    Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Jui Chuang, MD

CONTACT

00886-2-23123456103311@ntuh.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 19, 2023

Study Start

April 20, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)