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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Smart device-based cardiac rehabilitation
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring myocardial infarction, cardiac rehabilitation, smart device, remote monitoring, telemonitoring, low physical activity, risk factors control

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute for Clinical and Experimental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Smart device-based rehabilitation

Control group

Arm Description

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.

Patients will receive a guideline directed recommendation to increase physical activity to 30 minutes of moderate physical activity a week.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 21, 2019
Last Updated
October 5, 2023
Sponsor
Charles University, Czech Republic
Collaborators
Institute for Clinical and Experimental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03926312
Brief Title
Smart Device-based Cardiac Rehabilitation After Myocardial Intervention
Acronym
SmartRehab
Official Title
Smart Device-based Cardiac Rehabilitation After Myocardial Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
October 5, 2023 (Actual)
Study Completion Date
October 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
Collaborators
Institute for Clinical and Experimental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
myocardial infarction, cardiac rehabilitation, smart device, remote monitoring, telemonitoring, low physical activity, risk factors control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smart device-based rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will receive a guideline directed recommendation to increase physical activity to 30 minutes of moderate physical activity a week.
Intervention Type
Device
Intervention Name(s)
Smart device-based cardiac rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional capacity change
Description
6-minute walk test distance and maximal oxygen consumption (VO2 max) change after 3 months of the intervention
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Waist circumference
Description
Waist circumference change after 3 months of the intervention
Time Frame
3 months
Title
Body fat percentage
Description
Body fat percentage change after 3 months of the intervention
Time Frame
3 months
Title
Smoking cessation
Description
Smoking cessation after 3 months of the intervention
Time Frame
3 months
Title
Lipid levels
Description
Lipid levels change after 3 months of the intervention
Time Frame
3 months
Title
Blood pressure
Description
Blood pressure change after 3 months of the intervention
Time Frame
3 months
Title
Glycated hemoglobin
Description
Glycated hemoglobin change after 3 months of the intervention
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Wohlfahrt, MD, PhD
Organizational Affiliation
Institute for Clinical and Experimental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Clinical and Experimental Medicine
City
Prague
State/Province
CZEC
ZIP/Postal Code
14021
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Smart Device-based Cardiac Rehabilitation After Myocardial Intervention

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