Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

The Use of Samsung Health and ECG M-Trace Base II Applications in the Secondary Prevention After Stroke

26. mars 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Detaljert 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).

Studietype

Observasjonsmessig

Registrering (Faktiske)

52

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Poznań, Polen, 61-545
        • Department of Rehabilitation and Physiotherapy Rehabilitation,

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

42 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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 :

  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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Ewa Chlebuś, Clinic Rehabilitation, University of Medical Sciences in Poznań

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. november 2020

Primær fullføring (Faktiske)

1. mars 2021

Studiet fullført (Faktiske)

1. mars 2021

Datoer for studieregistrering

Først innsendt

8. mars 2021

Først innsendt som oppfylte QC-kriteriene

26. mars 2021

Først lagt ut (Faktiske)

29. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

3
Abonnere