Smart Device-based Cardiac Rehabilitation After Myocardial Intervention

Not Applicable

Completed

• Conditions: Myocardial Infarction
• Interventions: Device: Smart device-based cardiac rehabilitation

• Registration Number: NCT03926312
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-21
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-24
• Study Start: 2019-06-19
• Status Verified: 2023-10
• Primary Completion: 2023-10-05
• Study Completion: 2023-10-05
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Signed informed consent with the study
2. Men and women >18 years of age
3. Patients ≥1 and ≤6 months after type I myocardial infarction
4. 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

1. Heart failure NYHA IIIB-IV
2. Planned coronary revascularization
3. Planned major surgery within the next 12 months
4. Inability to walk for any reason
5. 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
6. Life expectancy less than 12 months
7. Pregnancy
8. Inability to operate the smart-watch

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Smart device-based rehabilitation	Smart device-based cardiac rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Functional capacity change	3 months	6-minute walk test distance and maximal oxygen consumption (VO2 max) change after 3 months of the intervention

Secondary Outcome Measures

Name	Time	Method
Body fat percentage	3 months	Body fat percentage change after 3 months of the intervention
Waist circumference	3 months	Waist circumference change after 3 months of the intervention
Blood pressure	3 months	Blood pressure change after 3 months of the intervention
Smoking cessation	3 months	Smoking cessation after 3 months of the intervention
Lipid levels	3 months	Lipid levels change after 3 months of the intervention
Glycated hemoglobin	3 months	Glycated hemoglobin change after 3 months of the intervention

Trial Locations

Locations (1)

Institute for Clinical and Experimental Medicine; 🇨🇿 Prague, CZEC, Czechia