Myocardial InfarctionSmartRehabNCT03926312
Smart Device-based Cardiac Rehabilitation After Myocardial Intervention
A study testing Smart device-based cardiac rehabilitation in people with Myocardial Infarction, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Smart device-based cardiac rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCzechia
- Study dates
- 19 Jun 2019to 5 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Institute for Clinical and Experimental Medicine
Prague, CZEC, 14021
About this study
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.
- Conditions
- Myocardial Infarction
- Being tested
- Smart device-based cardiac rehabilitation
- Keywords
- myocardial infarction, cardiac rehabilitation, smart device, remote monitoring, telemonitoring, low physical activity, risk factors control
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity change
6-minute walk test distance and maximal oxygen consumption (VO2 max) change after 3 months of the intervention
Measured: 3 months
Secondary outcomes (6)
Waist circumference
Waist circumference change after 3 months of the intervention
Measured: 3 months
Body fat percentage
Body fat percentage change after 3 months of the intervention
Measured: 3 months
Smoking cessation
Smoking cessation after 3 months of the intervention
Measured: 3 months
Lipid levels
Lipid levels change after 3 months of the intervention
Measured: 3 months
Blood pressure
Blood pressure change after 3 months of the intervention
Measured: 3 months
Glycated hemoglobin
Glycated hemoglobin change after 3 months of the intervention
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start19 Jun 2019
- Primary completion5 Oct 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Clinical and Experimental Medicine
- Responsible party
- Principal investigator, Peter Wohlfahrt, Institute for Clinical and Experimental Medicine
- Investigators
- Peter Wohlfahrt, MD, PhD, Principal investigator, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926312
- Sponsor's protocol ID
- SmartRehab
- Acronym
- SmartRehab
- Status last verified
- Oct 2023
- First submitted
- 21 Apr 2019
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40206122
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Device-based Cardiac Rehabilitation After Myocardial Intervention
- ClinicalTrials.gov ID
- NCT03926312
- Acronym / sponsor ID
- SmartRehab / SmartRehab
- Conditions
- Myocardial Infarction
- Keywords
- myocardial infarction, cardiac rehabilitation, smart device, remote monitoring, telemonitoring, low physical activity, risk factors control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Institute for Clinical and Experimental Medicine
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart device-based rehabilitation | Experimental | Device: Smart device-based cardiac rehabilitationOne 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. |
| Control group | No intervention | –Patients will receive a guideline directed recommendation to increase physical activity to 30 minutes of moderate physical activity a week. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart device-based cardiac rehabilitationA 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. | Device | Smart device-based rehabilitation |
Primary outcome
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
6 secondary outcomes
Waist circumference
Time frame: 3 months
Body fat percentage
Time frame: 3 months
Smoking cessation
Time frame: 3 months
Lipid levels
Time frame: 3 months
Blood pressure
Time frame: 3 months
Glycated hemoglobin
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 40206122Wohlfahrt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Wohlfahrt, MD, PhD principal investigator
Institute for Clinical and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart device-based cardiac rehabilitation in people with Myocardial Infarction, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity change (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03926312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.