NCT05587907

Brief Summary

Investigation of the effect of an exercise program with visual stimuli on reaction time, cognitive function and physical fitness of children and adolescent soccer players.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

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

Study Start

First participant enrolled

April 21, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

8 months

First QC Date

September 29, 2022

Last Update Submit

October 18, 2022

Conditions

Neuroplasticity

Keywords

Reaction TimeCognitive FunctionPhysical FitnessFITLIGHT TrainerVisual FieldVRsoccer players

Outcome Measures

Primary Outcomes (2)

  • Reaction time (sec)

    VR game, FITLIGHT Trainer

    6 months

  • Cognitive function (sec)

    Cognitive Function Scanner Mobile

    6 months

Secondary Outcomes (1)

  • Physical fitness

    6 months

Study Arms (2)

Group 1

EXPERIMENTAL

18 soccer players follow a 6-month exercise program with visual stimuli, 5 times a week and lasting 15 minutes each time, which precedes their regular soccer training program.

Device: FitLight Trainer

Group 2

NO INTERVENTION

20 soccer players follow a regular soccer training program.

Interventions

FitLight TrainerDEVICE

Evaluation of the reaction time before and after special training program using visual stimuli.

Also known as: Cognitive Function Scanner Mobile, VR game, Eurofit Physical Fitness Test Battery, ALPHA-Fitness test battery
Group 1

Eligibility Criteria

Age10 Years - 15 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Sport Medicine, Department of Physical Education and Sports Sciences Aristotle University of Thessaloniki

Thessaloniki, 57001, Greece

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • EVANGELIA KOUIDI, PhD

    Department of Physical Education and Sports Sciences Aristotle University of Thessaloniki, Greece

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Around half of the participants follow a 6-month exercise program with visual stimuli, 5 times a week and lasting 15 minutes each time, which precedes their regular soccer training program. The other half of the participants will continue their regular soccer training program. After the end of the 6 months, the initial measurements will be repeated in both groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Sports Medicine

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 20, 2022

Study Start

April 21, 2021

Primary Completion

December 12, 2021

Study Completion

August 31, 2022

Last Updated

October 20, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)