Smart Device-based Cardiac Rehabilitation After Myocardial Intervention

Myocardial Infarction Clinical Trial

— SmartRehab  

Official title:

Smart Device-based Cardiac Rehabilitation After Myocardial Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03926312
• Other study ID #: SmartRehab
• Status: Completed
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: October 5, 2023

Study information

• Verified date: October 2023
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 5, 2023
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Device:
• Smart device-based cardiac rehabilitation
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.

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine	Prague	CZEC

Sponsors (2)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Institute for Clinical and Experimental Medicine

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity change	6-minute walk test distance and maximal oxygen consumption (VO2 max) change after 3 months of the intervention	3 months
Secondary	Waist circumference	Waist circumference change after 3 months of the intervention	3 months
Secondary	Body fat percentage	Body fat percentage change after 3 months of the intervention	3 months
Secondary	Smoking cessation	Smoking cessation after 3 months of the intervention	3 months
Secondary	Lipid levels	Lipid levels change after 3 months of the intervention	3 months
Secondary	Blood pressure	Blood pressure change after 3 months of the intervention	3 months
Secondary	Glycated hemoglobin	Glycated hemoglobin change after 3 months of the intervention	3 months