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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Smart Device-based Cardiac Rehabilitation After Myocardial Intervention

Clinicaltrials.gov identifier NCT03926312

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted June 21, 2019

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.

  • Condition or Disease:Myocardial Infarction
  • Intervention/Treatment: Device: Smart device-based cardiac rehabilitation
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 88 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Smart Device-based Cardiac Rehabilitation After Myocardial Intervention
  • Estimated Study Start Date: June 2019
  • Estimated Primary Completion Date: December 2022
  • Estimated Study Completion Date: December 2022
Arms and interventions
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.
Outcome Measures
  • Primary Outcome Measures: 1. Functional capacity change [ Time Frame: 3 months ]
    6-minute walk test distance and maximal oxygen consumption (VO2 max) change after 3 months of the intervention
  • Secondary Outcome Measures: 1. Waist circumference [ Time Frame: 3 months ]
    Waist circumference change after 3 months of the intervention
  • 2. Body fat percentage [ Time Frame: 3 months ]
    Body fat percentage change after 3 months of the intervention
  • 3. Smoking cessation [ Time Frame: 3 months ]
    Smoking cessation after 3 months of the intervention
  • 4. Lipid levels [ Time Frame: 3 months ]
    Lipid levels change after 3 months of the intervention
  • 5. Blood pressure [ Time Frame: 3 months ]
    Blood pressure change after 3 months of the intervention
  • 6. Glycated hemoglobin [ Time Frame: 3 months ]
    Glycated hemoglobin change after 3 months of the intervention
Eligibility Criteria
  • Ages Eligible for Study: 18 to 99 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts

Contact: Peter Wohlfahrt, MD, PhD 00420739777244 wohlfp@gmail.com

Locations

Czechia, CZEC
Institute for Clinical and Experimental Medicine
Prague

Sponsors and Collaborators

Charles University, Czech Republic

Institute for Clinical and Experimental Medicine

Investigators

Principal Investigator: Peter Wohlfahrt, MD, PhD Institute for Clinical and Experimental Medicine

More Information
  • Responsible Party: Charles University, Czech Republic
  • ClinicalTrials.gov Identifier: NCT03926312 History of Changes
  • Other Study ID Numbers: SmartRehab
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: June 21, 2019
  • Last Verified: June 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Charles University, Czech Republic: myocardial infarction
    cardiac rehabilitation
    smart device
    remote monitoring
    telemonitoring
    low physical activity
    risk factors control
  • Additional relevant MeSH terms: Myocardial Infarction Infarction