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出境医 / 临床实验 / Smart Device-based Cardiac Rehabilitation After Myocardial Intervention (SmartRehab)

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

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

Study Design
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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
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.
No Intervention: Control group
Patients will receive a guideline directed recommendation to increase physical activity to 30 minutes of moderate physical activity a week.
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
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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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE April 21, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date June 21, 2019
Estimated Study Start Date  ICMJE June 19, 2019
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019) 		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
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		Functional capacity change [ Time Frame: 6 months ]
Maximal oxygen consumption (VO2 max) change after 6 months of the intervention
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2019)
  • Waist circumference [ Time Frame: 3 months ]
    Waist circumference change after 3 months of the intervention
  • Body fat percentage [ Time Frame: 3 months ]
    Body fat percentage change after 3 months of the intervention
  • Smoking cessation [ Time Frame: 3 months ]
    Smoking cessation after 3 months of the intervention
  • Lipid levels [ Time Frame: 3 months ]
    Lipid levels change after 3 months of the intervention
  • Blood pressure [ Time Frame: 3 months ]
    Blood pressure change after 3 months of the intervention
  • Glycated hemoglobin [ Time Frame: 3 months ]
    Glycated hemoglobin change after 3 months of the intervention
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Waist circumference [ Time Frame: 6 months ]
    Waist circumference change after 6 months of the intervention
  • Body fat percentage [ Time Frame: 6 months ]
    Body fat percentage change after 6 months of the intervention
  • Smoking cessation [ Time Frame: 6 months ]
    Smoking cessation after 6 months of the intervention
  • Lipid levels [ Time Frame: 6 months ]
    Lipid levels change after 6 months of the intervention
  • Blood pressure [ Time Frame: 6 months ]
    Blood pressure change after 6 months of the intervention
  • Glycated hemoglobin [ Time Frame: 6 months ]
    Glycated hemoglobin change after 6 months of the intervention
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smart Device-based Cardiac Rehabilitation After Myocardial Intervention
Official Title  ICMJE Smart Device-based Cardiac Rehabilitation After Myocardial Intervention
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Smart device-based cardiac rehabilitation
  • No Intervention: Control group
    Patients will receive a guideline directed recommendation to increase physical activity to 30 minutes of moderate physical activity a week.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019) 		88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peter Wohlfahrt, MD, PhD 00420739777244 wohlfp@gmail.com
Listed Location Countries  ICMJE Czechia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926312
Other Study ID Numbers  ICMJE SmartRehab
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peter Wohlfahrt, Institute for Clinical and Experimental Medicine
Study Sponsor  ICMJE Charles University, Czech Republic
Collaborators  ICMJE Institute for Clinical and Experimental Medicine
Investigators  ICMJE
Principal Investigator: Peter Wohlfahrt, MD, PhD Institute for Clinical and Experimental Medicine
PRS Account Charles University, Czech Republic
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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