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Cognitive FunctionNCT04753047

The Cognitive Functioning of Young Athletes Including Bioelectrical Brain Function

An observational study of Cognitive Function, run by University of Gdansk at 2 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 10 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Function
How many people
179 participants
Where
2 sitesPoland
Study dates
2 Jan 2020to 2 Jan 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

  • Polish-speaking children

Who cannot join

  • mental illness;
  • non-Polish speaking children

Trial locations and contacts

2 sites in 1 country.

Poland2 sites

  • University of Gdansk

    Gdansk, Gdansk, 80-309

  • University of Gdansk

    Gdansk, 80-309

Other trials in Poland

About this study

Official title: 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.
Being tested
No intervention
Keywords
cognitive function, sport, football, gymnastics, children

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention

Study groups in NCT04753047
Study groupRoleWhat they receive
Children practicing footballChildren 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)
Receives: Other: No intervention
Children practicing gymnasticsChildren 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)
Receives: Other: No intervention
Comparative groupA comparative group of children that do not attend sport classes or sports clubs, but carrying out sports activity and / or in other areas
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Attention

    • 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.

    Measured: Baseline

  2. Brain Waves

    • EEG Biofeedback - bioelectric recording of brain activity from a centrally placed electrode to measure fast brainwaves (Alpha, Beta1, Beta2) and slow brainwaves (Delta, Theta)

    Measured: Baseline

  3. Short-term memory of verbal material material

    • PU1 Battery (Borkowska, SajewiczRadtke, Lipowska, Kalka, 2016). Higher score means better short-term memory of verbal material

    Measured: Baseline

  4. Visual-spatial material

    • PU1 Battery (Borkowska, SajewiczRadtke, Lipowska, Kalka, 2016). Higher score means better visual-spatial material.

    Measured: Baseline

  5. Executive functions

    • PU1 Battery (Borkowska, SajewiczRadtke, Lipowska, Kalka, 2016). Higher score means better executive functions.

    Measured: Baseline

  6. Language functions

    • PU1 Battery (Borkowska, SajewiczRadtke, Lipowska, Kalka, 2016). Higher score means better language functions.

    Measured: Baseline

  7. Episodic memory of visual-spatial material

    • 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).

    Measured: Baseline

Secondary outcomes (3)

  1. Sports Intensity by International Physical Activity Questionnaire (in a modified version, relating to children) (Biernat, 2007)

    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)

    Measured: Baseline

  2. Intelligence by CFT 20-R, The Culture Fair Intelligence Test (CFIT) - version 2, part 1 only (Cattell, Weiss, adapt. Stańczak,2013)

    Measurement of fluid intelligence. Higher score means higher fluid intelligence (maximum number of points: 56, minimal: 0).

    Measured: Baseline

  3. Temperament by EAS Buss & Plomin Questionnaire (Buss, Plomin, 1997)

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2021
  2. Study start2 Jan 2020
  3. Primary completion2 Jan 2022
  4. Study completion2 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04753047
Sponsor's protocol ID
UGdansk
Status last verified
Apr 2022
First submitted
29 Jan 2021
Last updated
20 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bidzan-Bluma I. Twin-To-Twin Transfusion Syndrome Donor and Recipient and Their Subsequent Cognitive Functioning in Late Childhood as Juvenile Athletes-A Case Study. Int J Environ Res Public Health. 2021 Mar 4;18(5):2545. doi: 10.3390/ijerph18052545.

    PubMed 33806653

Questions about this trial

What is this clinical trial studying?

An observational study of Cognitive Function, run by University of Gdansk at 2 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Attention (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04753047, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.

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