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Clinical Trials/NCT05689385
NCT05689385
Recruiting
Not Applicable

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

National Taiwan University Hospital1 site in 1 country150 target enrollmentApril 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Infarction
Sponsor
National Taiwan University Hospital
Enrollment
150
Locations
1
Primary Endpoint
Change of ventilatory anaerobic threshold
Status
Recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2023
End Date
December 1, 2028
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Evaluation of Quality of life(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.)
  • Adherence to prescribed exercise(at 12 weeks(post-intervention) and 12 months.)
  • Depression(at baseline, 12 weeks(post-intervention), and 12 months.)
  • Evaluation of grip strength(at baseline, 12 weeks(post-intervention), and 12 months.)
  • Evaluation of isometric knee extension strength(at baseline, 12 weeks(post-intervention), and 12 months.)

Study Sites (1)

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