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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Mobile Applications; Secondary Prevention

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Principal Investigator: Ewa Chlebuś, Clinic Rehabilitation, University of Medical Sciences in Poznań

Publications and helpful links

General Publications

• Lucki M, Chlebus E, Warenczak A, Lisinski P. The Use of Samsung Health and ECG M-Trace Base II Applications for the Assessment of Exercise Tolerance in the Secondary Prevention in Patients after Ischemic Stroke. Int J Environ Res Public Health. 2021 May 27;18(11):5753. doi: 10.3390/ijerph18115753.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplastic Processes; Stroke; Neoplasm Metastasis
• Other Study ID Numbers: 1/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No