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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06405854
Other study ID # 2022.198.10.22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 12, 2022
Est. completion date January 10, 2023

Study information

Verified date May 2024
Source Princess Nourah Bint Abdulrahman University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date January 10, 2023
Est. primary completion date October 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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,

Locations

Country Name City State
Saudi Arabia Monira Aldhahi Riyadh

Sponsors (4)

Lead Sponsor Collaborator
Princess Nourah Bint Abdulrahman University Bandirma Onyedi Eylül University, Istanbul Aydin University, Namik Kemal University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Motor competence 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
Primary Inhibition control (IC) 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 a = 0.95) and the "No-Go" stimulus (Cronbach 'sa = 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
Primary agility test 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
Primary Countermovement jump test 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
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