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

NCT ID: NCT04821518

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-15
• Study Completion Date: 2021-03-01

Brief 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.

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).

Conditions

Mobile Applications; Secondary Prevention; Stroke

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

The control group

The control group was composed of 26 healthy individuals recruited from the hospital staff who did not experience stroke.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 42 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ewa Chlebuś

Role: PRINCIPAL_INVESTIGATOR

Clinic Rehabilitation, University of Medical Sciences in Poznań

Locations

Department of Rehabilitation and Physiotherapy Rehabilitation,

Poznan, , Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 34071967 (View on PubMed)

Other Identifiers

1/2021

Identifier Type: -

Identifier Source: org_study_id