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Recruiting NCT05689385

eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients

No phase Interventional Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: eHealth-based cardiac rehabilitation.
Who it may be relevant to
Registry conditions: Myocardial Infarction. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other 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, o

Primary outcome measures

  • Change of peak oxygen uptake [Time frame: at baseline, 12 weeks(post-intervention), and 12 months.]
  • Change of ventilatory anaerobic threshold [Time frame: at baseline, 12 weeks(post-intervention), and 12 months.]
Secondary outcome measures (7)
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT05689385 · 202207060RINC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗