NCT06405854

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

May 4, 2024

Last Update Submit

May 31, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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 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

    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

  • 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

Study Arms (2)

Coordination-based exercise intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

The control group continued their regular preschool classes without any intervention.

Interventions

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,

Coordination-based exercise intervention

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monira Aldhahi

Riyadh, 12341, Saudi Arabia

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Monira I. Aldhahi

    College of Health and Rehabilitation Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants, specifically the preschool children, may not be informed of their group assignment (Exercise Group or Control Group) to prevent behavior changes based on perceived expectations.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 4, 2024

First Posted

May 9, 2024

Study Start

September 12, 2022

Primary Completion

October 28, 2022

Study Completion

January 10, 2023

Last Updated

June 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations