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Completed

NCT Number: NCT03926312

Smart Device-based Cardiac Rehabilitation After Myocardial Intervention

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Clinical and Experimental Medicine

Prague, CZEC, 14021, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smart device-based cardiac rehabilitation

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • Institute for Clinical and Experimental Medicine

Registry information

Acronym: SmartRehab

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2019
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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