- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06405854
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
44
Phase
- 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
-
-
-
Riyadh, Saudi Arabia, 12341
- Monira Aldhahi
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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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.
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at baseline and end of 8 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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)
September 12, 2022
Primary Completion (Actual)
October 28, 2022
Study Completion (Actual)
January 10, 2023
Study Registration Dates
First Submitted
May 4, 2024
First Submitted That Met QC Criteria
May 4, 2024
First Posted (Actual)
May 9, 2024
Study Record Updates
Last Update Posted (Actual)
June 3, 2024
Last Update Submitted That Met QC Criteria
May 31, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID 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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