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Completed

NCT Number: NCT04821518

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

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Key information

Conditions

Mobile Applications Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Secondary Prevention Stroke Vascular Diseases

Age range

42 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Rehabilitation and Physiotherapy Rehabilitation,

Poznan, 61-545, Poland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. heart rate at rest

    Time frame: baseline

    heart rate per minute

  2. heart rate at rest

    Time frame: 3 weeks

    heart rate per minute

  3. heart rate after SMWT

    Time frame: baseline

    heart rate per minute

  4. heart rate after SMWT

    Time frame: 3 weeks

    heart rate per minute

  5. heart rate after SCT

    Time frame: baseline

    heart rate per minute

  6. heart rate after SCT

    Time frame: 3 weeks

    heart rate per minute

  7. heart rhythm at rest

    Time frame: baseline

    heart rhythm interpreting ECG (regular or irregular)

  8. heart rhythm at rest

    Time frame: 3 weeks

    heart rhythm interpreting ECG (regular or irregular)

  9. heart rhythm after SMWT

    Time frame: baseline

    heart rhythm interpreting ECG (regular or irregular)

  10. heart rhythm after SMWT

    Time frame: 3 weeks

    heart rhythm interpreting ECG (regular or irregular)

  11. heart rhythm after SCT

    Time frame: baseline

    heart rhythm interpreting ECG (regular or irregular)

  12. heart rhythm after SCT

    Time frame: 3 weeks

    heart rhythm interpreting ECG (regular or irregular)

  13. increased blood pressure at rest

    Time frame: baseline

    blood pressure value [mm/Hg]

  14. increased blood pressure at rest

    Time frame: 3 weeks

    blood pressure value [mm/Hg]

  15. increased blood pressure after SMWT

    Time frame: baseline

    blood pressure value [mm/Hg]

  16. increased blood pressure after SMWT

    Time frame: 3 weeks

    blood pressure value [mm/Hg]

  17. increased blood pressure after SCT

    Time frame: baseline

    blood pressure value [mm/Hg]

  18. increased blood pressure after SCT

    Time frame: 3 weeks

    blood pressure value [mm/Hg]

  19. Distance of walk after SMWT

    Time frame: baseline

    Distance (metres)

  20. Distance of walk after SMWT

    Time frame: 3 weeks

    Distance (metres)

  21. Distance of walk after SCT

    Time frame: baseline

    Distance (metres)

  22. Distance of walk after SCT

    Time frame: 3 weeks

    Distance (metres)

  23. Steps after SMWT

    Time frame: baseline

    Number of steps (number)

  24. Steps after SMWT

    Time frame: 3 weeks

    Number of steps (number)

  25. Steps after SCT

    Time frame: baseline

    Number of steps (number)

  26. Steps after SCT

    Time frame: 3 weeks

    Number of steps (number)

  27. Velocity of walk after SMWT

    Time frame: baseline

    Mean velocity (km/h)

  28. Velocity of walk after SMWT

    Time frame: 3 weeks

    Mean velocity (km/h)

  29. Velocity of walk after SCT

    Time frame: baseline

    Mean velocity (km/h)

  30. Velocity of walk after SCT

    Time frame: 3 weeks

    Mean velocity (km/h)

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2021
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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