NCT04821518

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 8, 2021

Last Update Submit

March 26, 2021

Conditions

Mobile ApplicationsSecondary PreventionStroke

Outcome Measures

Primary Outcomes (30)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age42 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation and Physiotherapy Rehabilitation,

Poznan, 61-545, Poland

Location

Related Publications (1)

  • 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.

    PMID: 34071967DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ewa Chlebuś

    Clinic Rehabilitation, University of Medical Sciences in Poznań

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 29, 2021

Study Start

November 15, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

March 29, 2021

Record last verified: 2021-03

Locations

PL(1)