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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04821518
• Other study ID #: 1/2021
• Status: Completed
• Start date: November 15, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mobile Applications
• Neoplasm Metastasis
• Secondary Prevention
• Stroke

Locations

Country	Name	City	State
Poland	Department of Rehabilitation and Physiotherapy Rehabilitation,	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate at rest	heart rate per minute	baseline
Primary	heart rate at rest	heart rate per minute	3 weeks
Primary	heart rate after SMWT	heart rate per minute	baseline
Primary	heart rate after SMWT	heart rate per minute	3 weeks
Primary	heart rate after SCT	heart rate per minute	baseline
Primary	heart rate after SCT	heart rate per minute	3 weeks
Primary	heart rhythm at rest	heart rhythm interpreting ECG (regular or irregular)	baseline
Primary	heart rhythm at rest	heart rhythm interpreting ECG (regular or irregular)	3 weeks
Primary	heart rhythm after SMWT	heart rhythm interpreting ECG (regular or irregular)	baseline
Primary	heart rhythm after SMWT	heart rhythm interpreting ECG (regular or irregular)	3 weeks
Primary	heart rhythm after SCT	heart rhythm interpreting ECG (regular or irregular)	baseline
Primary	heart rhythm after SCT	heart rhythm interpreting ECG (regular or irregular)	3 weeks
Primary	increased blood pressure at rest	blood pressure value [mm/Hg]	baseline
Primary	increased blood pressure at rest	blood pressure value [mm/Hg]	3 weeks
Primary	increased blood pressure after SMWT	blood pressure value [mm/Hg]	baseline
Primary	increased blood pressure after SMWT	blood pressure value [mm/Hg]	3 weeks
Primary	increased blood pressure after SCT	blood pressure value [mm/Hg]	baseline
Primary	increased blood pressure after SCT	blood pressure value [mm/Hg]	3 weeks
Primary	Distance of walk after SMWT	Distance (metres)	baseline
Primary	Distance of walk after SMWT	Distance (metres)	3 weeks
Primary	Distance of walk after SCT	Distance (metres)	baseline
Primary	Distance of walk after SCT	Distance (metres)	3 weeks
Primary	Steps after SMWT	Number of steps (number)	baseline
Primary	Steps after SMWT	Number of steps (number)	3 weeks
Primary	Steps after SCT	Number of steps (number)	baseline
Primary	Steps after SCT	Number of steps (number)	3 weeks
Primary	Velocity of walk after SMWT	Mean velocity (km/h)	baseline
Primary	Velocity of walk after SMWT	Mean velocity (km/h)	3 weeks
Primary	Velocity of walk after SCT	Mean velocity (km/h)	baseline
Primary	Velocity of walk after SCT	Mean velocity (km/h)	3 weeks