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

C

Charles University, Czech Republic

Status

Completed

Conditions

Myocardial Infarction

Treatments

Device: Smart device-based cardiac rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT03926312
SmartRehab

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

64 participants in 2 patient groups

Smart device-based rehabilitation
Experimental group
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.
Treatment:
Device: Smart device-based cardiac rehabilitation
Control group
No Intervention group
Description:
Patients will receive a guideline directed recommendation to increase physical activity to 30 minutes of moderate physical activity a week.

Trial contacts and locations

1

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Central trial contact

Peter Wohlfahrt, MD, PhD

Data sourced from clinicaltrials.gov

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