NCT03926312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 19, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

4.3 years

First QC Date

April 21, 2019

Last Update Submit

October 5, 2023

Conditions

Myocardial Infarction

Keywords

myocardial infarctioncardiac rehabilitationsmart deviceremote monitoringtelemonitoringlow physical activityrisk factors control

Outcome Measures

Primary Outcomes (1)

  • Functional capacity change

    6-minute walk test distance and maximal oxygen consumption (VO2 max) change after 3 months of the intervention

    3 months

Secondary Outcomes (6)

  • Waist circumference

    3 months

  • Body fat percentage

    3 months

  • Smoking cessation

    3 months

  • Lipid levels

    3 months

  • Blood pressure

    3 months

  • +1 more secondary outcomes

Study Arms (2)

Smart device-based rehabilitation

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients will receive a guideline directed recommendation to increase physical activity to 30 minutes of moderate physical activity a week.

Interventions

Smart device-based cardiac rehabilitationDEVICE

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.

Smart device-based rehabilitation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, CZEC, 14021, Czechia

Location

Related Publications (1)

  • Wohlfahrt P, Jenca D, Melenovsky V, Mrazkova J, Sramko M, Kotrc M, Zelizko M, Adamkova V, Lopez-Jimenez F, Pitha J, Kautzner J. Remote, Smart Device-Based Cardiac Rehabilitation After Myocardial Infarction: A Pilot, Randomized Cross-Over SmartRehab Study. Mayo Clin Proc Digit Health. 2024 Jun 20;2(3):352-360. doi: 10.1016/j.mcpdig.2024.06.001. eCollection 2024 Sep.

    PMID: 40206122DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Peter Wohlfahrt, MD, PhD

    Institute for Clinical and Experimental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2019

First Posted

April 24, 2019

Study Start

June 19, 2019

Primary Completion

October 5, 2023

Study Completion

October 5, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)