Clinical trial NCT05689385: eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients
Official title: The Effectiveness of eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients：a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Keywords: cardiac rehabilitation
telerehabilitation
myocardial infarction
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

1. ≥ 20 years of age.
2. Within 6 months after the onset of acute myocardial infarction.
3. At lowest to moderate risk according to the guideline from American Association of Cardiovascular and Pulmonary Rehabilitation.
4. Unable or refused to attend center-based cardiac rehabilitation.

Exclusion criteria:

1. Unable to walk independently or use a stationary bike.
2. Unable to follow verbal command.
3. Not having a smartphone which can get on the internet.
4. Having contraindications for exercise according to American College of Sports Medicine's Guidelines for Exercise Testing and Prescription.
5. Unable to provide informed consent.

Primary outcomes:
measure: Change of peak oxygen uptake
timeFrame: at baseline, 12 weeks(post-intervention), and 12 months.
measure: Change of ventilatory anaerobic threshold
timeFrame: at baseline, 12 weeks(post-intervention), and 12 months.
Secondary outcomes:
measure: Adherence to prescribed exercise
timeFrame: at 12 weeks(post-intervention) and 12 months.
measure: Evaluation of Quality of life
timeFrame: at baseline, 12 weeks(post-intervention), and 12 months.
measure: Depression
timeFrame: at baseline, 12 weeks(post-intervention), and 12 months.
measure: Anxiety
timeFrame: at baseline, 12 weeks(post-intervention), and 12 months.
measure: Evaluation of physical activity
timeFrame: at baseline, 12 weeks(post-intervention), and 12 months.
measure: Evaluation of grip strength
timeFrame: at baseline, 12 weeks(post-intervention), and 12 months.
measure: Evaluation of isometric knee extension strength
timeFrame: at baseline, 12 weeks(post-intervention), and 12 months.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
name: Hung-Jui Chuang, MD
role: PRINCIPAL_INVESTIGATOR
References: