Coordination-based Exercise Intervention in Preschool Children

May 31, 2024 updated by: Monira Aldhahi, Princess Nourah Bint Abdulrahman University

Effect of Coordination-based Exercise Intervention on Physical Fitness, Motor Competence and Executive Function in Preschool Children

This study intended to assess the impact of coordination-based exercise interventions on physical fitness, motor competence, and executive function among preschoolers aged 4 to 6 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Forty-four preschool children (22 boys and 22 girls), with a mean age of 5.90 years (SD = 0.28). Participants will be randomly assigned to an Exercise Group (n = 19) or a Control Group (n = 25). The Exercise Group will engage in 20-minute, fun, and game-based sessions focusing on foundational movement patterns appropriate for preschoolers, conducted twice weekly over eight weeks. In contrast, the Control Group continued with their regular unstructured school activities. Physical fitness was evaluated using agility tests, static-dynamic balance, and vertical jumping. Motor competence was assessed through the KTK3+ test battery, and inhibition control was measured using the Go/No-Go test. The study concluded that coordination-based exercises, structured around fun and engaging activities suitable for preschoolers, potentially enhance physical fitness, motor skills, and executive functions. These areas are essential for early childhood development, suggesting that integrating such exercises into preschool activities could be beneficial. However, specific results regarding the effectiveness of the interventions on the tested competencies would need to be detailed to confirm these hypothesized benefits fully. The study highlights the importance of structured physical activity in early childhood education settings for promoting essential developmental skills.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • typically preschoolers between the aged between 4-6 years old
  • not taking any medication
  • absence of cardiovascular, neurological, orthopedic, or psychiatric illnesses.

Exclusion Criteria:

• children with physical disabilities or other conditions that might significantly impact their ability to participate in the physical activity interventions might be excluded,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Coordination-based exercise intervention
During the eight weeks, children in the coordinative exercise intervention group participated in sessions twice a week, each lasting 20 minutes. The foundational movement patterns tailored to the specific purpose were organized in a game format suitable for preschool-aged children. These foundational movement patterns comprise open-ended tasks progressing from simple to complex, with motor planning as a prerequisite. As the exercise intervention was game-based, the sessions were maintained as a fun, active, and social learning environment for the children.
Other: Exercise
Children in the coordinative exercise intervention group will be encouraged to participate in sessions twice a week, each lasting 20 minutes. The foundational movement patterns tailored to the specific purpose were organized in a game format suitable for preschool-aged children. These foundational movement patterns comprise open-ended tasks progressing from simple to complex, with motor planning as a prerequisite. As the exercise intervention was game-based, the sessions were maintained as a fun, active, and social learning environment for the children. Duration of the intervention is eight weeks,
No Intervention: Control
The control group continued their regular preschool classes without any intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Countermovement jump test
Time Frame: at baseline and end of 8 week
Vertical jump performance was measured using an accelerometer (iVMES Athlete, Ankara, Turkey). During the test, the participants will be encouraged to jump as high as possible. The test was conducted twice with a 30-second rest between trials.
at baseline and end of 8 week
Motor competence
Time Frame: at baseline and end of 8 week
Motor competence will be assessed through the Body Coordination Test for Children (KTK). The Body Coordination Test for Children (KTK)+ test battery, supported by a hand-eye coordination task, will be used to assess the children's motor competence and it measures general gross motor coordination The Body Coordination Test for Children (KTK) test items include backward balancing (BB), sideways movement (MS), sideways jumping (JS), and hand-eye coordination tasks (EHC). All test items demonstrated good test-retest reliability: BB = 0.80, MS = 0.84, JS = 0.95, and EHC 0.87
at baseline and end of 8 week
Inhibition control (IC)
Time Frame: at baseline and end of 8 week
IC will be measured using the Go/No-Go test. The Go/No-Go task is a protocol commonly used to measure inhibitory control in young children. The convergent validity of inhibitory control measurement has been observed to be good in this age group, with a strong correlation with the NIH Toolbox, which is frequently used and has a similar structure (r (80) = .40, p < 0.001). Additionally, internal consistency analyses of the Go/No-Go task revealed good reliability for the "Go" stimulus (Cronbach α = 0.95) and the "No-Go" stimulus (Cronbach 'sα = 0.84). In the Go/No-Go task, the children will be instructed to respond to the "go" stimulus (catch fish) by pressing the screen and to withhold their response to the "no-go" stimulus (avoid sharks). The practice trials consisted of 5 blocks of "catch fish" trials, five blocks of "avoid sharks" trials, and then a mixed block of 10 trials. After a short rest period, the task was completed with 75 stimulus trials divided into three test blocks (each
at baseline and end of 8 week
agility test
Time Frame: at baseline and end of 8 week
The test course will be set with markers placed five yards (4.57m) to the left and right of the starting line, with indicators (motivational for the participants' age) placed accordingly. A photocell gate will be placed at the starting line to record repeated passage times. Before the start of the application, the participants took their position and when ready, they touched the marker on the right first, then the marker on the left, and finally crossed the starting line to complete the test.
at baseline and end of 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Princess Nourah Bint Abdulrahman University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bandırma Onyedi Eylül University
Istanbul Aydın University
Namik Kemal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Monira I. Aldhahi, College of Health and Rehabilitation Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022.198.10.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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