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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926312
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : June 21, 2019
Sponsor:
Collaborator:
Institute for Clinical and Experimental Medicine
Information provided by (Responsible Party):
Peter Wohlfahrt, Institute for Clinical and Experimental Medicine

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 Intervention/treatment Phase
Myocardial Infarction Device: Smart device-based cardiac rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 19, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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.



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926312


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

Locations
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Czechia
Institute for Clinical and Experimental Medicine Recruiting
Prague, CZEC, Czechia, 14021
Contact: Peter Wohlfahrt, MD, PhD    420739777244 ext 420739777244      
Sponsors and Collaborators
Charles University, Czech Republic
Institute for Clinical and Experimental Medicine
Investigators
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Principal Investigator: Peter Wohlfahrt, MD, PhD Institute for Clinical and Experimental Medicine
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Responsible Party: Peter Wohlfahrt, Principal Investigator, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT03926312    
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Wohlfahrt, Institute for Clinical and Experimental Medicine:
myocardial infarction
cardiac rehabilitation
smart device
remote monitoring
telemonitoring
low physical activity
risk factors control
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases