Smart Device-based Cardiac Rehabilitation After Myocardial Intervention

Study Overview
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Brief Summary
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The aim of this study is to evaluate the influence of cardiac rehabilitation based on smart band use and telemonitoring on functional capacity change and risk factors control among patients hospitalized for acute myocardial infarction.

Official Title
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Smart Device-based Cardiac Rehabilitation After Myocardial Intervention

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Device: Smart device-based cardiac rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent with the study Men and women >18 years of age Patients ≥1 and ≤6 months after type I myocardial infarction Physical inactivity before MI defined as the absence of moderate to vigorous exercise for at least 30 minutes 5 or more days a week Exclusion Criteria: Heart failure NYHA IIIB-IV Planned coronary revascularization Planned major surgery within the next 12 months Inability to walk for any reason Comorbidities that would preclude adherence to the rehabilitation program (e.g. arthrosis, active malignancy, major depression or other significant psychiatric disorder, cognitive impairment) - at the discretion of the physician Life expectancy less than 12 months Pregnancy Inability to operate the smart-watch

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart device-based rehabilitation<br>One month after myocardial infarction, patients will receive a smart band and a cellphone in order to transmit data on physical activity to electronic health record. A study nurse will periodically check compliance with recommended physical activity and intervene in the case of non-compliance. | Device: Smart device-based cardiac rehabilitation<br>* A smart device coupled with remote monitoring will be used to increase physical activity of patients after myocardial infarction with a history of low physical activity.<br>|
| No Intervention: Control group<br>Patients will receive a guideline directed recommendation to increase physical activity to 30 minutes of moderate physical activity a week. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity change | 6-minute walk test distance and maximal oxygen consumption (VO2 max) change after 3 months of the intervention | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference | Waist circumference change after 3 months of the intervention | 3 months | 
| Body fat percentage | Body fat percentage change after 3 months of the intervention | 3 months | 
| Smoking cessation | Smoking cessation after 3 months of the intervention | 3 months | 
| Lipid levels | Lipid levels change after 3 months of the intervention | 3 months | 
| Blood pressure | Blood pressure change after 3 months of the intervention | 3 months | 
| Glycated hemoglobin | Glycated hemoglobin change after 3 months of the intervention | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, cardiac rehabilitation, smart device, remote monitoring, telemonitoring, low physical activity, risk factors control