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eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients

Not Applicable
Recruiting
Conditions
Myocardial Infarction
Interventions
Other: eHealth-based cardiac rehabilitation
Registration Number
NCT05689385
Lead Sponsor
National Taiwan University Hospital
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
150
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
eHealth-based cardiac rehabilitationeHealth-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.
Primary Outcome Measures
NameTimeMethod
Change of peak oxygen uptakeat 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 thresholdat 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 Outcome Measures
NameTimeMethod
Depressionat 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.

Evaluation of grip strengthat 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.

Evaluation of isometric knee extension strengthat 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.

Evaluation of Quality of lifeat baseline, 12 weeks(post-intervention), and 12 months.

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

Anxietyat 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.

Evaluation of physical activityat 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.

Adherence to prescribed exerciseat 12 weeks(post-intervention) and 12 months.

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

Trial Locations

Locations (1)

National Taiwan University Hospital

🇨🇳

Taipei, Taiwan

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