Clinical trial NCT04821518: The Use of Samsung Health and ECG M-Trace Base II Applications in the Secondary Prevention After Stroke
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mobile Applications
Secondary Prevention
Stroke
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 52
Sex: ALL
Minimum age (years): 42
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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).

Eligibility criteria: Inclusion criteria to the post-stroke group were as follows :

1. occurrence of hemiparesis after the first episode of ischaemic stroke
2. stroke confirmed in the diagnostic imaging records
3. score \>3 on Lovett's scale of muscle strength in the paretic limbs
4. score above 15 in Barthel's scale of performance in activities of daily living
5. score below 12 in the National Institutes of Health Stroke Scale (NIHSS)
6. available complete medical records concerning the assessed risk factors of recurrent CVD event
7. lack of concomitant pulmonary diseases including chronic obstructive pulmonary disease and bronchial asthma

Exclusion criteria from the post-stroke group were as follows:

1. hemiparesis or tetraparesis following many episodes of stroke,
2. lack of diagnostic imaging scans confirming the occurrence of stroke
3. hospital stay at the Department of Neurological Rehabilitation for more than 14 days from the occurrence of stroke
4. incomplete medical records concerning the assessed risk factors of recurrent CVD event
5. score \>3 on Lovett's scale of muscle strength in the paretic limbs
6. score below 14 in Barthel's scale of performance in activities of daily living
7. score above 13 in the NIHSS scale
8. occurrence of factors limiting walking ability, such as diagnosed pulmonary diseases, unstable angina, severe valvular heart diseases, cardiomyopathy, musculoskeletal or autoimmune diseases.

Primary outcomes:
measure: heart rate at rest
timeFrame: baseline
measure: heart rate at rest
timeFrame: 3 weeks
measure: heart rate after SMWT
timeFrame: baseline
measure: heart rate after SMWT
timeFrame: 3 weeks
measure: heart rate after SCT
timeFrame: baseline
measure: heart rate after SCT
timeFrame: 3 weeks
measure: heart rhythm at rest
timeFrame: baseline
measure: heart rhythm at rest
timeFrame: 3 weeks
measure: heart rhythm after SMWT
timeFrame: baseline
measure: heart rhythm after SMWT
timeFrame: 3 weeks
measure: heart rhythm after SCT
timeFrame: baseline
measure: heart rhythm after SCT
timeFrame: 3 weeks
measure: increased blood pressure at rest
timeFrame: baseline
measure: increased blood pressure at rest
timeFrame: 3 weeks
measure: increased blood pressure after SMWT
timeFrame: baseline
measure: increased blood pressure after SMWT
timeFrame: 3 weeks
measure: increased blood pressure after SCT
timeFrame: baseline
measure: increased blood pressure after SCT
timeFrame: 3 weeks
measure: Distance of walk after SMWT
timeFrame: baseline
measure: Distance of walk after SMWT
timeFrame: 3 weeks
measure: Distance of walk after SCT
timeFrame: baseline
measure: Distance of walk after SCT
timeFrame: 3 weeks
measure: Steps after SMWT
timeFrame: baseline
measure: Steps after SMWT
timeFrame: 3 weeks
measure: Steps after SCT
timeFrame: baseline
measure: Steps after SCT
timeFrame: 3 weeks
measure: Velocity of walk after SMWT
timeFrame: baseline
measure: Velocity of walk after SMWT
timeFrame: 3 weeks
measure: Velocity of walk after SCT
timeFrame: baseline
measure: Velocity of walk after SCT
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Rehabilitation and Physiotherapy Rehabilitation,
Study officials:
affiliation: Clinic Rehabilitation, University of Medical Sciences in Poznań
name: Ewa Chlebuś
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.