Smart Device-based Cardiac Rehabilitation After Myocardial Intervention

NCT ID: NCT03926312

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-19

Study Completion Date

2023-10-05

Brief Summary

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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

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Smart device-based cardiac rehabilitation

Intervention Type 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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Peter Wohlfahrt

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Wohlfahrt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Clinical and Experimental Medicine

Locations

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Institute for Clinical and Experimental Medicine

Prague, CZEC, Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type DERIVED
PMID: 40206122 (View on PubMed)

Other Identifiers

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SmartRehab

Identifier Type: -

Identifier Source: org_study_id

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