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

26 mars 2021 uppdaterad 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.

Studieöversikt

Detaljerad beskrivning

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).

Studietyp

Observationell

Inskrivning (Faktisk)

52

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

42 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
heart rate at rest
Tidsram: baseline
heart rate per minute
baseline
heart rate at rest
Tidsram: 3 weeks
heart rate per minute
3 weeks
heart rate after SMWT
Tidsram: baseline
heart rate per minute
baseline
heart rate after SMWT
Tidsram: 3 weeks
heart rate per minute
3 weeks
heart rate after SCT
Tidsram: baseline
heart rate per minute
baseline
heart rate after SCT
Tidsram: 3 weeks
heart rate per minute
3 weeks
heart rhythm at rest
Tidsram: baseline
heart rhythm interpreting ECG (regular or irregular)
baseline
heart rhythm at rest
Tidsram: 3 weeks
heart rhythm interpreting ECG (regular or irregular)
3 weeks
heart rhythm after SMWT
Tidsram: baseline
heart rhythm interpreting ECG (regular or irregular)
baseline
heart rhythm after SMWT
Tidsram: 3 weeks
heart rhythm interpreting ECG (regular or irregular)
3 weeks
heart rhythm after SCT
Tidsram: baseline
heart rhythm interpreting ECG (regular or irregular)
baseline
heart rhythm after SCT
Tidsram: 3 weeks
heart rhythm interpreting ECG (regular or irregular)
3 weeks
increased blood pressure at rest
Tidsram: baseline
blood pressure value [mm/Hg]
baseline
increased blood pressure at rest
Tidsram: 3 weeks
blood pressure value [mm/Hg]
3 weeks
increased blood pressure after SMWT
Tidsram: baseline
blood pressure value [mm/Hg]
baseline
increased blood pressure after SMWT
Tidsram: 3 weeks
blood pressure value [mm/Hg]
3 weeks
increased blood pressure after SCT
Tidsram: baseline
blood pressure value [mm/Hg]
baseline
increased blood pressure after SCT
Tidsram: 3 weeks
blood pressure value [mm/Hg]
3 weeks
Distance of walk after SMWT
Tidsram: baseline
Distance (metres)
baseline
Distance of walk after SMWT
Tidsram: 3 weeks
Distance (metres)
3 weeks
Distance of walk after SCT
Tidsram: baseline
Distance (metres)
baseline
Distance of walk after SCT
Tidsram: 3 weeks
Distance (metres)
3 weeks
Steps after SMWT
Tidsram: baseline
Number of steps (number)
baseline
Steps after SMWT
Tidsram: 3 weeks
Number of steps (number)
3 weeks
Steps after SCT
Tidsram: baseline
Number of steps (number)
baseline
Steps after SCT
Tidsram: 3 weeks
Number of steps (number)
3 weeks
Velocity of walk after SMWT
Tidsram: baseline
Mean velocity (km/h)
baseline
Velocity of walk after SMWT
Tidsram: 3 weeks
Mean velocity (km/h)
3 weeks
Velocity of walk after SCT
Tidsram: baseline
Mean velocity (km/h)
baseline
Velocity of walk after SCT
Tidsram: 3 weeks
Mean velocity (km/h)
3 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 november 2020

Primärt slutförande (Faktisk)

1 mars 2021

Avslutad studie (Faktisk)

1 mars 2021

Studieregistreringsdatum

Först inskickad

8 mars 2021

Först inskickad som uppfyllde QC-kriterierna

26 mars 2021

Första postat (Faktisk)

29 mars 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 mars 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 mars 2021

Senast verifierad

1 mars 2021

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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