NCT06631248

Brief Summary

The goal of this study was to determine whether a structured coordinative exercise program could improve physical fitness, motor competence, and inhibitory control in preschool children. The main questions it aimed to answer were: Does the exercise program improve children's physical fitness (agility, balance, vertical jump)? Does it enhance motor competence, particularly hand-eye coordination and balance? Does it affect inhibitory control, a key component of cognitive function? Researchers compared children who participated in an 8-week exercise program to those who followed their regular school activities. Participants: Took part in two 30-minute exercise sessions per week for 8 weeks Were assessed before and after the intervention on physical fitness, motor competence, and inhibitory control The study found significant improvements in physical fitness and motor competence, but no significant changes in inhibitory control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

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

Study Start

First participant enrolled

January 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

September 20, 2024

Last Update Submit

October 7, 2024

Conditions

Keywords

coordinationexercisepreschool children

Outcome Measures

Primary Outcomes (9)

  • Changes in Motor Competence: KTK3+ Backward Balancing (number of repetitions)

    Backward balancing is a component of the Körperkoordinationstest für Kinder (KTK3+) motor competence test battery. This test measures the ability to maintain balance while moving backwards on a balance beam. Unit of Measurement: number of repetitions (number of backward steps).

    before and at the end of the 8-week intervention.

  • Changes in Motor Competence: KTK3+ Move Sideways (Number of repetitions within 20 seconds)

    Move Sideways, is a component of the Körperkoordinationstest für Kinder (KTK3+) motor competence test battery. This test evaluates the ability to perform coordinated sideways movements. Unit of Measurement: Repetitions (Number of repetitions within 20 seconds).

    before and at the end of the 8-week intervention.

  • Changes in Motor Competence: KTK3+ Jumping Sideways (Number of repetitions within 15 seconds)

    jumping sideways is a component of the Körperkoordinationstest für Kinder (KTK3+) motor competence test battery. This test measures the ability to perform coordinated sideways jumps. Unit of Measurement: Repetitions (number of repetitions within 15 seconds)

    before and at the end of the 8-week intervention.

  • Changes in Motor Competence: KTK3+ Eye-Hand Coordination Task (Number of repetitions within 30 seconds)

    Eye-Hand Coordination is a component of the Körperkoordinationstest für Kinder (KTK3+) motor competence test battery. This task measures the ability to coordinate visual input with manual responses. It is a measurement method that involves throwing a tennis ball against a wall from a certain distance and holding it with the other hand. Unit of Measurement: Number of correct repetitions in 30 seconds.

    before and at the end of the 8-week intervention.

  • Changes in Counter Movement Jump Performance, (Highest jump height (cm))

    Counter Movement Jump Performance was assessed using an accelerometer system (IVMES Athlete, Ankara, Turkey). Unit of Measurement: Centimeter (cm) - Highest jump height

    before and at the end of the 8-week intervention.

  • Changes in Balance Performance - Static Balance (%)

    Balance performance was assessed with a static balance task using a movable platform (Sensbalance MiniBoard; Sensamove®, Utrecht, The Netherlands) that can be connected to a computer. Unit of Measurement: Automatically calculated scores in % were used.

    before and at the end of the 8-week intervention.

  • Changes in Balance Performance - Dynamic Balance (%)

    Balance performance was assessed with a dynamic balance task using a moving platform (Sensbalance MiniBoard; Sensamove®, Utrecht, The Netherlands) that can be connected to a computer. Unit of Measurement: Automatically calculated scores in % were used.

    before and at the end of the 8-week intervention.

  • Changes in Agility (time to complete the test - in seconds)

    It was evaluated using the Pro-Agility Test. Unit of Measurement: Seconds (s) - Time to complete the test

    before and at the end of the 8-week intervention.

  • Changes in Inhibitory Control

    Inhibitory control was assessed using the Go/No-Go test in the Early Years Toolbox, which measures the ability to suppress inappropriate responses. Unit of Measurement: Number of Correct Responses and reaction time of the number of correct responses (ms).

    before and at the end of the 8-week intervention.

Study Arms (2)

Coordinative exercise protocol

EXPERIMENTAL

coordinative exercise group

Other: Coordinative exercise protocol

control group

NO INTERVENTION

The control group continued the standard education curriculum in kindergarten and did not receive any intervention

Interventions

During the eight-week period, all children in the structured coordinative exercise intervention group participated in 30-minute sessions twice a week on the same day and time. The purpose-oriented basic movement patterns created in the coordinative exercise content were organised in a play-oriented manner suitable for the preschool age range.

Coordinative exercise protocol

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Typically developing children
  • Participants must not be taking medication
  • Must not have any cardiovascular, neurological, orthopaedic or psychiatric disease
  • Must be between 5-6 years of age

You may not qualify if:

  • Having any cardiovascular, neurological, orthopaedic or psychiatric disease
  • Having intellectual disability
  • Not being between 5-6 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdag Namik Kemal University, Sports Sciences Research and Development Centre

Tekirdağ, Suleymanpasa, 59030, Turkey (Türkiye)

Location

Related Publications (3)

  • Chang YK, Tsai YJ, Chen TT, Hung TM. The impacts of coordinative exercise on executive function in kindergarten children: an ERP study. Exp Brain Res. 2013 Mar;225(2):187-96. doi: 10.1007/s00221-012-3360-9. Epub 2012 Dec 13.

    PMID: 23239198BACKGROUND
  • Borioni F, Biino V, Tinagli V, Pesce C. Effects of Baby Swimming on Motor and Cognitive Development: A Pilot Trial. Percept Mot Skills. 2022 Aug;129(4):977-1000. doi: 10.1177/00315125221090203. Epub 2022 Apr 26.

    PMID: 35473471BACKGROUND
  • Sendil AM, Canli U, Sheeha BB, Alkhamees NH, Batrakoulis A, Al-Mhanna SB. The effects of structured coordinative exercise protocol on physical fitness, motor competence and inhibitory control in preschool children. Sci Rep. 2024 Nov 18;14(1):28462. doi: 10.1038/s41598-024-79811-3.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The research was divided into groups according to the convenience sampling method. Convenience sampling is a non-random sampling method in which the sample to be selected from the main mass is determined by the judgement of the researcher. In convenience sampling, data are collected from the main mass in the easiest, fastest and most economical way \[73,74\]. At this point, two classes in the same kindergarten, which accepted to participate in the study and met the conditions for participation in the study, was assigned as the control group (CG; n= 23) and the other class as the exercise group (EG; n= 18).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

September 20, 2024

First Posted

October 8, 2024

Study Start

January 20, 2023

Primary Completion

February 25, 2023

Study Completion

June 29, 2023

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

We plan to share the following individual participant data (IPD) from our study: Measurements: Data obtained from Physical Fitness, Motor Competence and Inhibitor control parameters will be shared. Data Anonymization: All shared IPD will be fully anonymized to protect participant privacy. Personal identifiers such as names, addresses, and contact information will be removed. Data will be aggregated where necessary to prevent re-identification of participants. Data Format: The data will be shared in a secure, standardized format (e.g., CSV or Excel files) to facilitate ease of use and analysis by other researchers. Access Control: Access to the shared IPD will be granted to qualified researchers who provide a valid research proposal and agree to comply with data use agreements that ensure the data will be used solely for research purposes and not for commercial gain.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 1 year after publication with no end date
Access Criteria
Access Control: Access to the shared IPD will be granted to qualified researchers who provide a valid research proposal and agree to comply with data use agreements that ensure the data will be used solely for research purposes and not for commercial gain.

Locations