The Use of Samsung Health and ECG M-Trace Base II Applications in the Secondary Prevention After Stroke
26. marts 2021 opdateret af: Poznan University of Medical Sciences
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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).
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
52
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Poznań, Polen, 61-545
- Department of Rehabilitation and Physiotherapy Rehabilitation,
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
42 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
heart rate at rest
Tidsramme: baseline
|
heart rate per minute
|
baseline
|
|
heart rate at rest
Tidsramme: 3 weeks
|
heart rate per minute
|
3 weeks
|
|
heart rate after SMWT
Tidsramme: baseline
|
heart rate per minute
|
baseline
|
|
heart rate after SMWT
Tidsramme: 3 weeks
|
heart rate per minute
|
3 weeks
|
|
heart rate after SCT
Tidsramme: baseline
|
heart rate per minute
|
baseline
|
|
heart rate after SCT
Tidsramme: 3 weeks
|
heart rate per minute
|
3 weeks
|
|
heart rhythm at rest
Tidsramme: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
|
|
heart rhythm at rest
Tidsramme: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
|
|
heart rhythm after SMWT
Tidsramme: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
|
|
heart rhythm after SMWT
Tidsramme: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
|
|
heart rhythm after SCT
Tidsramme: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
|
|
heart rhythm after SCT
Tidsramme: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
|
|
increased blood pressure at rest
Tidsramme: baseline
|
blood pressure value [mm/Hg]
|
baseline
|
|
increased blood pressure at rest
Tidsramme: 3 weeks
|
blood pressure value [mm/Hg]
|
3 weeks
|
|
increased blood pressure after SMWT
Tidsramme: baseline
|
blood pressure value [mm/Hg]
|
baseline
|
|
increased blood pressure after SMWT
Tidsramme: 3 weeks
|
blood pressure value [mm/Hg]
|
3 weeks
|
|
increased blood pressure after SCT
Tidsramme: baseline
|
blood pressure value [mm/Hg]
|
baseline
|
|
increased blood pressure after SCT
Tidsramme: 3 weeks
|
blood pressure value [mm/Hg]
|
3 weeks
|
|
Distance of walk after SMWT
Tidsramme: baseline
|
Distance (metres)
|
baseline
|
|
Distance of walk after SMWT
Tidsramme: 3 weeks
|
Distance (metres)
|
3 weeks
|
|
Distance of walk after SCT
Tidsramme: baseline
|
Distance (metres)
|
baseline
|
|
Distance of walk after SCT
Tidsramme: 3 weeks
|
Distance (metres)
|
3 weeks
|
|
Steps after SMWT
Tidsramme: baseline
|
Number of steps (number)
|
baseline
|
|
Steps after SMWT
Tidsramme: 3 weeks
|
Number of steps (number)
|
3 weeks
|
|
Steps after SCT
Tidsramme: baseline
|
Number of steps (number)
|
baseline
|
|
Steps after SCT
Tidsramme: 3 weeks
|
Number of steps (number)
|
3 weeks
|
|
Velocity of walk after SMWT
Tidsramme: baseline
|
Mean velocity (km/h)
|
baseline
|
|
Velocity of walk after SMWT
Tidsramme: 3 weeks
|
Mean velocity (km/h)
|
3 weeks
|
|
Velocity of walk after SCT
Tidsramme: baseline
|
Mean velocity (km/h)
|
baseline
|
|
Velocity of walk after SCT
Tidsramme: 3 weeks
|
Mean velocity (km/h)
|
3 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Ewa Chlebuś, Clinic Rehabilitation, University of Medical Sciences in Poznań
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. november 2020
Primær færdiggørelse (Faktiske)
1. marts 2021
Studieafslutning (Faktiske)
1. marts 2021
Datoer for studieregistrering
Først indsendt
8. marts 2021
Først indsendt, der opfyldte QC-kriterier
26. marts 2021
Først opslået (Faktiske)
29. marts 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1/2021
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .