Wireless ECG Body Sensor During Field Testing

NCT04786509 | Completed

• 1 other identifier: 02-1359/18-2
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Wireless body ECG sensor is a feasible solution for reliable and accurate long-term heart rhythm monitoring. However, there were no studies that delt with usability of this sensor in field testing. Accordingly, the aim of the study is to evaluate the quality of ECG signal measured with wearable wireless ECG body-sensor when used in field test settings and to determine how different types of sensors' fixation affect quality of the ECG signal during submaximal and maximal running settings. Twenty-three participants, 10 females and 13 males, were included in the study (20.56±1.19 years). All subjects performed shuttle run (SR), Cooper 2400 m (C), and 100 m sprint test (S), once wearing the sensor attached to self-adhesive skin electrodes, additionally fixed with self-adhesive tapes, and secondly with the sensor attached to Polar belt and strapped around the chests. Test outcomes were compared applying Student t-test for dependent variables, or non-parametric Wilcoxon test, depending on the results of normality test.

Conditions

ECG Electrode Site Reaction

Keywords

telemetry; exercise testing; prevention; ECG; field tests

Outcome Measures

Primary Outcomes (1)

• Detected QRS

  Number of detected QRS during field tests

  10 weeks

Study Arms (1)

ECG sensor

All subjects performed shuttle run (SR), Cooper 2400 m (C), and 100 m sprint test (S), once wearing the sensor attached to self-adhesive skin electrodes, additionally fixed with self-adhesive tapes, and secondly with the sensor attached to Polar belt and strapped around the chests.

Diagnostic Test: Field tests

Interventions

Field tests DIAGNOSTIC_TEST

In this study we used three different standardized running tests, one sub-maximal test - Cooper 2400 m (C), and two maximal (all-out) tests - 100 m sprint (S) and shuttle run (SR).

ECG sensor

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Twenty-three were included, 13 males and 10 females, age between 19 and 23 years (Age = 20.56±1.19 years; Body height = 177.28±9.76 cm; Body mass = 70.11±7.68 kg). All participants were physically active non-athletes, with daily involvement (3-5 times per week, 30 to 60 minutes of moderate to high intensity) in various physical activities (team sports, cyclic activities, resistance training). To meet the criteria for participation in the study, participants had to confirm they were healthy, and without known previous cardiac problems.

You may qualify if:

• Physically active participants

You may not qualify if:

• Heart diseases

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

Faculty of Sport and Physical Education

Belgrade, 11000, Serbia

Location

MeSH Terms

Interventions

Visual Field Tests

Intervention Hierarchy (Ancestors)

Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Vladimir Ilić, PhD

  Faculty of Sport and Physical Education, University of Belgrade

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: June 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)