NCT03391505

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 21, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 5, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

December 21, 2017

Last Update Submit

May 7, 2024

Conditions

Mental Health Wellness 1

Keywords

CognitionPhysical activityMemoryHealth

Outcome Measures

Primary Outcomes (4)

  • 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

  • Cognitive Response Speed Performance

    Measures of response speed (ms) during the computer-based Flanker task

    1 day

  • Cognitive Response Accuracy Performance

    Measures of response accuracy (%) during the computer-based Flanker task

    1 day

  • Long-term Memory Accuracy Performance

    Measures of response accuracy (%) during a tablet-based visual memory task

    7 days

Secondary Outcomes (10)

  • Height

    1 day

  • Weight

    1 day

  • Fat Percentage

    1 day

  • Lean Body Mass

    1 day

  • Fitness Status

    1 day

  • +5 more secondary outcomes

Study Arms (3)

Treatment Group 1

EXPERIMENTAL

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.

Behavioral: Small-sided soccer game

Treatment Group 2

EXPERIMENTAL

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.

Behavioral: Walking soccer game

Control Group

PLACEBO COMPARATOR

The rest group watching soccer consists of watching a soccer game on a laptop (two times ten minutes) interspersed with a five minutes break.

Behavioral: Rest group watching soccer

Interventions

Small-sided soccer gameBEHAVIORAL

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.

Also known as: SSG
Treatment Group 1
Walking soccer gameBEHAVIORAL

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.

Also known as: WSG
Treatment Group 2
Rest group watching soccerBEHAVIORAL

The rest group watching soccer consists of watching a soccer game on a laptop (two times ten minutes) interspersed with a five minutes break.

Also known as: RES
Control Group

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Informed consent from the childrens´ legal guardians.
  • Physical, linguistic and mental competencies to complete the intervention and testing.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, 5700, Denmark

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Peter Krustrup

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 21, 2017

First Posted

January 5, 2018

Study Start

February 5, 2018

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)