The Cognitive Functioning of Young Athletes Including Bioelectrical Brain Function

April 19, 2022 updated by: Ilona Bidzan-Bluma, University of Gdańsk

The Cognitive Functioning of Young Athletes (10-12 Years Old) Undertaking Various Sports Activities (Gymnastics, Football) Including Bioelectrical Brain Function

The project focuses on two central issues:

  1. The impact of intensity of sport on the cognitive functioning and brain waves of children in late childhood (10-12 years old);
  2. The specific impact of individual forms of sporting competitions classified according to dynamic, static components as well as closed / open skill exercise. The variables will be age, gender, and fluid intelligence. Additionally, children's temperament will be examined in order to assess its relationship with the preferences for choosing a particular type of sport activity and the intensity of this activity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
179

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdansk, Poland, 80-309
        • University of Gdansk
    • Gdansk
      • Gdańsk, Gdansk, Poland, 80-309
        • University of Gdansk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participants will be recruited for research via Szkoły Mistrzostwa Sportowego [Sports Championship Schools] (criterion groups), sports clubs, as well as by establishing contact with other primary schools. Selecting 40 - 45 people aged 10-12 for each of the 2 control groups differentiated by the dynamic, static factor and nature of the sport close / open skill and for the comparative group of 40-45 children who are cognitively stimulated through physical activity and / or otherwise.

They will be enrolled to the study after giving their and their parents written consent to participate in the study.

Description

Inclusion Criteria:

- Polish-speaking children

Exclusion Criteria:

  • mental illness;
  • non-Polish speaking children

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Children practicing football
Children in late childhood (age 10-12 years) practicing sport, which is high dynamic (> 75%), and low static (<10&) and in the same time it is open skill exercise sport (football)
Other: No intervention
No intervention
Children practicing gymnastics
Children in late childhood (age 10-12 years) practicing sport, which is low dynamic (<50%), high static (>30%) and in the same time it is closed skill exercise sport (sport gymnastics)
Other: No intervention
No intervention
Comparative group
A comparative group of children that do not attend sport classes or sports clubs, but carrying out sports activity and / or in other areas
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Attention
Time Frame: Baseline
- PU1 Battery (Borkowska, SajewiczRadtke, Lipowska, Kalka, 2016) - attention (the ability to orientate on stimulus, motor speed, maintain attention on the visual stimulus, distinguishing significant and non-significant material). Higher score means better attention.
Baseline
Brain Waves
Time Frame: Baseline
- EEG Biofeedback - bioelectric recording of brain activity from a centrally placed electrode to measure fast brainwaves (Alpha, Beta1, Beta2) and slow brainwaves (Delta, Theta)
Baseline
Short-term memory of verbal material material
Time Frame: Baseline
- PU1 Battery (Borkowska, SajewiczRadtke, Lipowska, Kalka, 2016). Higher score means better short-term memory of verbal material
Baseline
Visual-spatial material
Time Frame: Baseline
- PU1 Battery (Borkowska, SajewiczRadtke, Lipowska, Kalka, 2016). Higher score means better visual-spatial material.
Baseline
Executive functions
Time Frame: Baseline
- PU1 Battery (Borkowska, SajewiczRadtke, Lipowska, Kalka, 2016). Higher score means better executive functions.
Baseline
Language functions
Time Frame: Baseline
- PU1 Battery (Borkowska, SajewiczRadtke, Lipowska, Kalka, 2016). Higher score means better language functions.
Baseline
Episodic memory of visual-spatial material
Time Frame: Baseline
- Diagnosis of Brain Injury (DUM) (Weidlich, Lamberti, 1996) [assessment of episodic memory of visual-spatial material (the rate of acquiring new information, the process of consolidation - the ability to transfer information from short-term to long-term memory)]. Higher score means better episodic memory of visual-spatial material (maximal points: 54, minimal: 0).
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sports Intensity by International Physical Activity Questionnaire (in a modified version, relating to children) (Biernat, 2007)
Time Frame: Baseline
Higher scores mean a better physical activity. In test there are 3 categories of activity: insufficient (less than 600), sufficient (600 - 1500 or 600 - 3000) or high (more than 1500 or 3000 MET-min / week)
Baseline
Intelligence by CFT 20-R, The Culture Fair Intelligence Test (CFIT) - version 2, part 1 only (Cattell, Weiss, adapt. Stańczak,2013)
Time Frame: Baseline
Measurement of fluid intelligence. Higher score means higher fluid intelligence (maximum number of points: 56, minimal: 0).
Baseline
Temperament by EAS Buss & Plomin Questionnaire (Buss, Plomin, 1997)
Time Frame: Baseline
A questionnaire for parents, coaches, teachers. It consists of 20 items - statements, which suitableness is rated by the subject on a five-point scale (from "Never true" to "Always true"). This version has four scales: Shyness, Sociability, Activity, and Emotionality and has 20 items relating to each of the 4 temperaments. There is a 5-point rating scale (from 1: "not characteristic or typical of your child" to 5 : "very characteristic or typical of your child"). These scores belong to each temperament and they are summed.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Gdańsk

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ilona Bidzan-Bluma, MS, University of Gdansk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UGdansk

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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