Mobile ApplicationsNCT04821518
The Use of Samsung Health and ECG M-Trace Base II Applications in the Secondary Prevention After Stroke
An observational study of Mobile Applications and Secondary Prevention, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
The aim of the present study was to quantitatively assess the risk factors that may affect the re-occurrence of a CVD event and the use of a commercially available mobile application Samsung Health for the assessment of parameters of exercise tolerance and the ECG M-Trace Base II application for the assessment of… Read more about this study
- Who is it for?
- Ages 42 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mobile Applications, Secondary Prevention, Stroke
- How many people
- 52 participants
- Where
- 1 sitePoland
- Study dates
- 15 Nov 2020to 1 Mar 2021
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- 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 42 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study group (post-stroke) consisted of 26 patients (mean age 54.9±7.1) in whom ischaemic stroke occurred within 14 days before the admission to the Clinical Department. The control group was composed of 26 healthy (mean age 55.6±6.1) individuals recruited from the hospital staff who did not experience stroke.
Inclusion criteria to the post-stroke group were as follows :
- occurrence of hemiparesis after the first episode of ischaemic stroke
- stroke confirmed in the diagnostic imaging records
- score >3 on Lovett's scale of muscle strength in the paretic limbs
- score above 15 in Barthel's scale of performance in activities of daily living
- score below 12 in the National Institutes of Health Stroke Scale (NIHSS)
- available complete medical records concerning the assessed risk factors of recurrent CVD event
- lack of concomitant pulmonary diseases including chronic obstructive pulmonary disease and bronchial asthma
Exclusion criteria from the post-stroke group were as follows:
- hemiparesis or tetraparesis following many episodes of stroke,
- lack of diagnostic imaging scans confirming the occurrence of stroke
- hospital stay at the Department of Neurological Rehabilitation for more than 14 days from the occurrence of stroke
- incomplete medical records concerning the assessed risk factors of recurrent CVD event
- score >3 on Lovett's scale of muscle strength in the paretic limbs
- score below 14 in Barthel's scale of performance in activities of daily living
- score above 13 in the NIHSS scale
- occurrence of factors limiting walking ability, such as diagnosed pulmonary diseases, unstable angina, severe valvular heart diseases, cardiomyopathy, musculoskeletal or autoimmune diseases.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Rehabilitation and Physiotherapy Rehabilitation,
Poznan, 61-545
About this study
Official title: The Use of Samsung Health and ECG M-Trace Base II Applications for the Assessment of Exercise Tolerance as the Secondary Prevention in Patients After Brain Stroke
The aim of the present study was to quantitatively assess the risk factors that may affect the re-occurrence of a CVD event and the use of a commercially available mobile application Samsung Health for the assessment of parameters of exercise tolerance and the ECG M-Trace Base II application for the assessment of cardiological parameters.
Read the detailed description
In the post-stroke group and in the control group, SMWT (Six Minute Walk Test) and SCT( Stair Climb Test) were preceded by a 10-minute rest in sitting position. The time of test performance, the walked distance and steps made as well as the mean and maximum gait velocity and the calories burned were assessed using the above-mentioned Samsung Health application . ECG results were assessed with the use of ECG M-Trace Base II application described above. In addition, cardiological parameters such as: systolic blood pressure (SBP) and diastolic blood pressure (DBP), heart rate (HR) and arterial blood saturation were assessed. The measurements were performed at rest and directly after SCMT and SCT. Additionally, after the tests, the level of dyspnoea and fatigue was assessed according to the modified Borg scale (score 0-10).
- Conditions
- Mobile Applications, Secondary Prevention, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The study group (post-stroke) | The study group consisted of 26 patients in whom ischaemic brain stroke occurred within 14 days before the admission to the Clinical Department, and were hospitalised at the Department of Neurological Rehabilitation of the Clinical Department of Rehabilitation in the Wiktor Dega Orthopaedic and Rehabilitation Clinical Hospital in Poznań | |
| The control group | The control group was composed of 26 healthy individuals recruited from the hospital staff who did not experience stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate at rest
heart rate per minute
Measured: baseline
heart rate at rest
heart rate per minute
Measured: 3 weeks
heart rate after SMWT
heart rate per minute
Measured: baseline
heart rate after SMWT
heart rate per minute
Measured: 3 weeks
heart rate after SCT
heart rate per minute
Measured: baseline
heart rate after SCT
heart rate per minute
Measured: 3 weeks
heart rhythm at rest
heart rhythm interpreting ECG (regular or irregular)
Measured: baseline
heart rhythm at rest
heart rhythm interpreting ECG (regular or irregular)
Measured: 3 weeks
heart rhythm after SMWT
heart rhythm interpreting ECG (regular or irregular)
Measured: baseline
heart rhythm after SMWT
heart rhythm interpreting ECG (regular or irregular)
Measured: 3 weeks
heart rhythm after SCT
heart rhythm interpreting ECG (regular or irregular)
Measured: baseline
heart rhythm after SCT
heart rhythm interpreting ECG (regular or irregular)
Measured: 3 weeks
increased blood pressure at rest
blood pressure value [mm/Hg]
Measured: baseline
increased blood pressure at rest
blood pressure value [mm/Hg]
Measured: 3 weeks
increased blood pressure after SMWT
blood pressure value [mm/Hg]
Measured: baseline
increased blood pressure after SMWT
blood pressure value [mm/Hg]
Measured: 3 weeks
increased blood pressure after SCT
blood pressure value [mm/Hg]
Measured: baseline
increased blood pressure after SCT
blood pressure value [mm/Hg]
Measured: 3 weeks
Distance of walk after SMWT
Distance (metres)
Measured: baseline
Distance of walk after SMWT
Distance (metres)
Measured: 3 weeks
Distance of walk after SCT
Distance (metres)
Measured: baseline
Distance of walk after SCT
Distance (metres)
Measured: 3 weeks
Steps after SMWT
Number of steps (number)
Measured: baseline
Steps after SMWT
Number of steps (number)
Measured: 3 weeks
Steps after SCT
Number of steps (number)
Measured: baseline
Steps after SCT
Number of steps (number)
Measured: 3 weeks
Velocity of walk after SMWT
Mean velocity (km/h)
Measured: baseline
Velocity of walk after SMWT
Mean velocity (km/h)
Measured: 3 weeks
Velocity of walk after SCT
Mean velocity (km/h)
Measured: baseline
Velocity of walk after SCT
Mean velocity (km/h)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start15 Nov 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
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 Mobile ApplicationsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewa Chlebuś, Principal investigator, Clinic Rehabilitation, University of Medical Sciences in Poznań
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821518
- Sponsor's protocol ID
- 1/2021
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lucki M, Chlebus E, Warenczak A, Lisinski P. The Use of Samsung Health and ECG M-Trace Base II Applications for the Assessment of Exercise Tolerance in the Secondary Prevention in Patients after Ischemic Stroke. Int J Environ Res Public Health. 2021 May 27;18(11):5753. doi: 10.3390/ijerph18115753.
PubMed 34071967
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Samsung Health and ECG M-Trace Base II Applications for the Assessment of Exercise Tolerance as the Secondary Prevention in Patients After Brain Stroke
- ClinicalTrials.gov ID
- NCT04821518
- Acronym / sponsor ID
- 1/2021
- Conditions
- Mobile Applications, Secondary Prevention, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 29 Mar 2021 (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 the present study was to quantitatively assess the risk factors that may affect the re-occurrence of a CVD event and the use of a commercially available mobile application Samsung Health for the assessment of parameters of exercise tolerance and the ECG M-Trace Base II application for the assessment of cardiological parameters.
Detailed description
In the post-stroke group and in the control group, SMWT (Six Minute Walk Test) and SCT( Stair Climb Test) were preceded by a 10-minute rest in sitting position. The time of test performance, the walked distance and steps made as well as the mean and maximum gait velocity and the calories burned were assessed using the above-mentioned Samsung Health application . ECG results were assessed with the use of ECG M-Trace Base II application described above. In addition, cardiological parameters such as: systolic blood pressure (SBP) and diastolic blood pressure (DBP), heart rate (HR) and arterial blood saturation were assessed. The measurements were performed at rest and directly after SCMT and SCT. Additionally, after the tests, the level of dyspnoea and fatigue was assessed according to the modified Borg scale (score 0-10).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The study group (post-stroke) | – | –The study group consisted of 26 patients in whom ischaemic brain stroke occurred within 14 days before the admission to the Clinical Department, and were hospitalised at the Department of Neurological Rehabilitation of the Clinical Department of Rehabilitation in the Wiktor Dega Orthopaedic and Rehabilitation Clinical Hospital in Poznań |
| The control group | – | –The control group was composed of 26 healthy individuals recruited from the hospital staff who did not experience stroke. |
Who may qualify
- Ages
- 42 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study group (post-stroke) consisted of 26 patients (mean age 54.9±7.1) in whom ischaemic stroke occurred within 14 days before the admission to the Clinical Department. The control group was composed of 26 healthy (mean age 55.6±6.1) individuals recruited from the hospital staff who did not experience stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
heart rate at rest
Time frame: baseline
heart rate per minute
heart rate at rest
Time frame: 3 weeks
heart rate per minute
heart rate after SMWT
Time frame: baseline
heart rate per minute
heart rate after SMWT
Time frame: 3 weeks
heart rate per minute
heart rate after SCT
Time frame: baseline
heart rate per minute
heart rate after SCT
Time frame: 3 weeks
heart rate per minute
heart rhythm at rest
Time frame: baseline
heart rhythm interpreting ECG (regular or irregular)
heart rhythm at rest
Time frame: 3 weeks
heart rhythm interpreting ECG (regular or irregular)
heart rhythm after SMWT
Time frame: baseline
heart rhythm interpreting ECG (regular or irregular)
heart rhythm after SMWT
Time frame: 3 weeks
heart rhythm interpreting ECG (regular or irregular)
heart rhythm after SCT
Time frame: baseline
heart rhythm interpreting ECG (regular or irregular)
heart rhythm after SCT
Time frame: 3 weeks
heart rhythm interpreting ECG (regular or irregular)
increased blood pressure at rest
Time frame: baseline
blood pressure value [mm/Hg]
increased blood pressure at rest
Time frame: 3 weeks
blood pressure value [mm/Hg]
increased blood pressure after SMWT
Time frame: baseline
blood pressure value [mm/Hg]
increased blood pressure after SMWT
Time frame: 3 weeks
blood pressure value [mm/Hg]
increased blood pressure after SCT
Time frame: baseline
blood pressure value [mm/Hg]
increased blood pressure after SCT
Time frame: 3 weeks
blood pressure value [mm/Hg]
Distance of walk after SMWT
Time frame: baseline
Distance (metres)
Distance of walk after SMWT
Time frame: 3 weeks
Distance (metres)
Distance of walk after SCT
Time frame: baseline
Distance (metres)
Distance of walk after SCT
Time frame: 3 weeks
Distance (metres)
Steps after SMWT
Time frame: baseline
Number of steps (number)
Steps after SMWT
Time frame: 3 weeks
Number of steps (number)
Steps after SCT
Time frame: baseline
Number of steps (number)
Steps after SCT
Time frame: 3 weeks
Number of steps (number)
Velocity of walk after SMWT
Time frame: baseline
Mean velocity (km/h)
Velocity of walk after SMWT
Time frame: 3 weeks
Mean velocity (km/h)
Velocity of walk after SCT
Time frame: baseline
Mean velocity (km/h)
Velocity of walk after SCT
Time frame: 3 weeks
Mean velocity (km/h)
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 29 Mar 2021.
- Derived from this study: PubMed 34071967Lucki M, Chlebus E, Warenczak A, Lisinski P. The Use of Samsung Health and ECG M-Trace Base II Applications for the Assessment of Exercise Tolerance in the Secondary Prevention in Patients after Ischemic Stroke. Int J Environ Res Public Health. 2021 May 27;18(11):5753. doi: 10.3390/ijerph18115753.
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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.
Ewa Chlebuś principal investigator
Clinic Rehabilitation, University of Medical Sciences in Poznań
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mobile Applications and Secondary Prevention, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Mar 2021. 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 Poland. 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?
heart rate at rest (time frame: baseline). The study lists 30 primary outcomes in all. 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 NCT04821518, 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 29 Mar 2021.