Motor SkillsNCT06405854
Coordination-based Exercise Intervention in Preschool Children
A study testing Exercise in people with Motor Skills and Balance, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Skills, Balance, Fitness
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 Sep 2022to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- typically preschoolers between the aged between 4-6 years old
- not taking any medication
- absence of cardiovascular, neurological, orthopedic, or psychiatric illnesses.
Who cannot join
- children with physical disabilities or other conditions that might significantly impact their ability to participate in the physical activity interventions might be excluded,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Motor Skills, Balance, Fitness, Preschool
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise |
| Control | No intervention | The control group continued their regular preschool classes without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: at baseline and end of 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start12 Sep 2022
- Primary completion28 Oct 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor SkillsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Nourah Bint Abdulrahman University
- Sponsor type
- University, hospital or other
- Collaborators
- Namik Kemal University, Istanbul Aydın University, Bandırma Onyedi Eylül University
- Responsible party
- Principal investigator, Monira Aldhahi, Princess Nourah Bint Abdulrahman University
- Investigators
- Monira I. Aldhahi, Principal investigator, College of Health and Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405854
- Sponsor's protocol ID
- 2022.198.10.22
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coordination-based Exercise Intervention on Physical Fitness, Motor Competence and Executive Function in Preschool Children
- ClinicalTrials.gov ID
- NCT06405854
- Acronym / sponsor ID
- 2022.198.10.22
- Conditions
- Motor Skills, Balance, Fitness, Preschool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Princess Nourah Bint Abdulrahman UniversityUniversity, hospital or other
- Collaborators
- Namik Kemal University, Istanbul Aydın University, Bandırma Onyedi Eylül University
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Coordination-based exercise intervention | Experimental | Other: ExerciseDuring 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. |
| Control | No intervention | –The control group continued their regular preschool classes without any intervention. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- typically preschoolers between the aged between 4-6 years old
- not taking any medication
- absence of cardiovascular, neurological, orthopedic, or psychiatric illnesses.
Key exclusion criteria (1 listed)
- children with physical disabilities or other conditions that might significantly impact their ability to participate in the physical activity interventions might be excluded,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseChildren 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, | Other | Coordination-based exercise intervention |
Primary outcome
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
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monira I. Aldhahi principal investigator
College of Health and Rehabilitation Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Motor Skills and Balance, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor competence (time frame: at baseline and end of 8 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.