Smart Device-based Cardiac Rehabilitation After Myocardial Intervention (SmartRehab)

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Device: Smart device-based cardiac rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Wohlfahrt, MD, PhD; Phone Number: 00420739777244; Email: wohlfp@gmail.com

Study Locations

• Czechia
  • CZEC
    • Prague, CZEC, Czechia, 14021
      • Institute for Clinical and Experimental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smart device-based 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.	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.
No Intervention: Control group; 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?

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

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: Institute for Clinical and Experimental Medicine
• Investigators: Principal Investigator: Peter Wohlfahrt, MD, PhD, Institute for Clinical and Experimental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2019
• Primary Completion (Actual): October 5, 2023
• Study Completion (Actual): October 5, 2023

Study Registration Dates

• First Submitted: April 21, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: myocardial infarction; telemonitoring; remote monitoring; cardiac rehabilitation; smart device; low physical activity; risk factors control
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: SmartRehab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No