NCT04753047

Brief Summary

The project focuses on two central issues:

  1. 1.The impact of intensity of sport on the cognitive functioning and brain waves of children in late childhood (10-12 years old);
  2. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
179

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

2 active sites

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

January 2, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

January 29, 2021

Last Update Submit

April 19, 2022

Conditions

Keywords

cognitive functionsportfootballgymnasticschildren

Outcome Measures

Primary Outcomes (7)

  • 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.

    Baseline

  • 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)

    Baseline

  • Short-term memory of verbal material material

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

    Baseline

  • Visual-spatial material

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

    Baseline

  • Executive functions

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

    Baseline

  • Language functions

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

    Baseline

  • 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).

    Baseline

Secondary Outcomes (3)

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

    Baseline

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

    Baseline

  • Temperament by EAS Buss & Plomin Questionnaire (Buss, Plomin, 1997)

    Baseline

Study Arms (3)

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

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

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

Interventions

No intervention

Children practicing footballChildren practicing gymnasticsComparative group

Eligibility Criteria

Age10 Years - 12 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • \- Polish-speaking children

You may not qualify if:

  • mental illness;
  • non-Polish speaking children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Gdansk

Gdansk, Gdansk, 80-309, Poland

Location

University of Gdansk

Gdansk, 80-309, Poland

Location

Related Publications (1)

  • 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.

Study Officials

  • Ilona Bidzan-Bluma, MS

    University of Gdansk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 12, 2021

Study Start

January 2, 2020

Primary Completion

January 2, 2022

Study Completion

January 2, 2022

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations