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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03391505
Other study ID # 59349 to H-16026885
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 5, 2018
Est. completion date April 30, 2018

Study information

Verified date May 2024
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overall aim of the study is to investigate the effects of an acute bout of physical activity on cognitive performance and long-term memory in elementary school children. Elaborating, the study seeks to investigate the effect of the intensity of the physical activity on cognitive performance and long-term memory in preadolescent children.


Description:

Based on a power analysis a total population of 100 children (four school classes) will be invited to participate in a 10-day protocol. The children will be randomly allocated, within their cluster (classes) and stratified for gender and soccer level, to one of 3 intervention groups. The groups consist of: A small-sides soccer game group (SSG), a walking soccer group (WSG) and a rest group watching soccer on TV (RES). At day 1 the children will complete a screening of their physical characteristics (height, weight, fat percentages, lean muscle mass and fitness status). On day 2 the children will complete a screening and a familiarization to the cognitive tasks used (cognitive performance and long-term memory) and the brain activity measuring devices (transportable EEG systems). On day 3 the children will complete the interventions, which first consist a long-term memory task, where the children will be asked to remember forty different pictures. Immediately after exposure to the forty pictures, the children will participate in 2 x 10 minutes of their respective interventions with 5 minutes break in between. During the break, the children will complete a short questionnaire to address their flow. Furthermore, during the intervention they will be equipped with heart rate monitors to quantify the physical demands of the intervention. Immediately after completing the 2 x 10 minutes interventions the children will be equipped with a transportable EEG system, and undergo a cognitive test (the Flanker task) to address their cognitive performance. The EEG recordings are used to measure the P3 amplitude and latency, biomarkers for cognitive performance. While equipping the children with the EEG system, the children will complete questionnaires about their participation. At day 10 the children will try to remember as many pictures of the forty pictures as possible to address the effect of the interventions on their long-term memory.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date April 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 14 Years
Eligibility Inclusion Criteria: - Informed consent from the childrens´ legal guardians. - Physical, linguistic and mental competencies to complete the intervention and testing. Exclusion Criteria: - Use of prescription-only drugs that kan affect learning ability. - Smoking. - Neurological diseases inclusive damages to the spinal cord. - Children who is not evaluated to being cable of completing the protocol among these psychological diseases or psychological unstable children.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Small-sided soccer game
The small-sided soccer game consists of a single bout (two times ten minutes) of small-sided soccer game (3v3) interspersed with a five minutes break.
Walking soccer game
The walking soccer game consists of a single bout (two times ten minutes) of small-sided walking soccer game (3v3) interspersed with a five minutes break.
Rest group watching soccer
The rest group watching soccer consists of watching a soccer game on a laptop (two times ten minutes) interspersed with a five minutes break.

Locations

Country Name City State
Denmark University of Southern Denmark Odense

Sponsors (2)

Lead Sponsor Collaborator
University of Southern Denmark University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Event-related brain potentials (P300) Electroencephalographic measures (mV) of the neuroelectric system that occur in response to, or in or in preparation for, a discrete event. 1 day
Primary Cognitive Response Speed Performance Measures of response speed (ms) during the computer-based Flanker task 1 day
Primary Cognitive Response Accuracy Performance Measures of response accuracy (%) during the computer-based Flanker task 1 day
Primary Long-term Memory Accuracy Performance Measures of response accuracy (%) during a tablet-based visual memory task 7 days
Secondary Height Measures of height (cm) with a Tanita Leicester portable altimeter 1 day
Secondary Weight Measures weight (kg) with an InBody 230 multifrequency body composition analyser 1 day
Secondary Fat Percentage Measures fat percentage (%) with an InBody 230 multifrequency body composition 1 day
Secondary Lean Body Mass Measures of lean body mass (kg) with an InBody 230 multifrequency body composition 1 day
Secondary Fitness Status Measures of distance covered during an maximal exercise test 1 day
Secondary Maximal Heart Rate Measures of maximal heart rate with heart rate monitors during an maximal exercise test 1 day
Secondary Flow Measures of flow with a danish translation og the flow questionnaire (Rheinberg et al., 2003) during the intervention 1 day
Secondary Motivation Measures of motivation with the Intrinsic Motivation Inventory (IMI) questionnaire (McAuley et al., 1987) after the intervention 1 day
Secondary Enjoyment Measures of self-perceived enjoyment with the Physical Activity Enjoyment Scale (PACES) (Kendzierski et al., 1991) questionnaire after the intervention 1 day
Secondary Intervention intensity Measures of heart rate with heart rate monitors during the intervention 1 day
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