Motor SkillsNCT06631248
Effects of Coordinative Exercise on Physical Fitness, Motor Competence, and Inhibitory Control in Preschoolers
A study testing Coordinative exercise protocol in people with Motor Skills and Inhibitory Control, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study was to determine whether a structured coordinative exercise program could improve physical fitness, motor competence, and inhibitory control in preschool children. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Skills, Inhibitory Control, Physical Fitness
- What is being tested?
- Coordinative exercise protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2023to 29 Jun 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 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Typically developing children
- Participants must not be taking medication
- Must not have any cardiovascular, neurological, orthopaedic or psychiatric disease
- Must be between 5-6 years of age
Who cannot join
- Having any cardiovascular, neurological, orthopaedic or psychiatric disease
- Having intellectual disability
- Not being between 5-6 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tekirdag Namik Kemal University, Sports Sciences Research and Development Centre
Tekirdağ, Suleymanpasa, 59030
About this study
Official title: The Effects of Structured Coordinative Exercise Protocol on Physical Fitness, Motor Competence and Inhibitory Control in Preschool Children
The goal of this study was to determine whether a structured coordinative exercise program could improve physical fitness, motor competence, and inhibitory control in preschool children. The main questions it aimed to answer were:
Does the exercise program improve children's physical fitness (agility, balance, vertical jump)? Does it enhance motor competence, particularly hand-eye coordination and balance? Does it affect inhibitory control, a key component of cognitive function? Researchers compared children who participated in an 8-week exercise program to those who followed their regular school activities.
Read more
Participants:
Took part in two 30-minute exercise sessions per week for 8 weeks Were assessed before and after the intervention on physical fitness, motor competence, and inhibitory control The study found significant improvements in physical fitness and motor competence, but no significant changes in inhibitory control.
Read the detailed description
Scope and Content of the Study
This study evaluated the effectiveness of a structured coordinative exercise protocol aimed at improving physical fitness, motor competence, and inhibitory control in preschool children. Early childhood is considered a critical period for both physical and cognitive development. During this phase, enhancing motor skills and physical fitness forms a crucial foundation for long-term health, social adaptation, and academic success. However, these developmental opportunities may be missed if children do not engage in sufficient levels of physical activity. In this context, the study sought to investigate the effects of exercise interventions that support both motor and cognitive skills in preschool-aged children.
The main goal of the study was to examine how coordinative exercises improve physical fitness and motor competence in preschool children. Additionally, the study explored the impact of these exercises on inhibitory control, a cognitive skill related to attention and impulse control. Inhibitory control is especially important during the preschool years, as it directly affects children\'s learning processes and social interactions, serving as a key component of executive functions.
Research Protocol and Exercise Intervention
This study was conducted with 41 children, who were randomly assigned to two groups: an exercise group and a control group. The exercise group participated in an 8-week program, consisting of 30-minute sessions twice a week. The program was designed to improve various motor skills such as balance, hand-eye coordination, jumping, and locomotor abilities through play-based activities. The control group continued with their regular school curriculum without additional physical activity interventions.
The exercise protocol included open-ended tasks that progressively moved from simple to complex, requiring movement planning. These play-based exercises aimed to create an engaging and active environment in which children could participate socially. The coordinative exercises focused on supporting a wide range of motor movements and control mechanisms, encouraging the coordination of different body components in harmony.
Assessed Parameters
In the study, children\'s physical fitness, motor competence, and inhibitory control were assessed both before and after the intervention:
Physical fitness was measured through tests of balance, agility, and vertical jumping.
Motor competence was evaluated using the KTK3+ test battery, which includes tasks such as hand-eye coordination, balancing, and jumping sideways.
Inhibitory control was measured using the Go/No-Go test from the Early Years Toolbox, assessing how well children manage attention and control impulses.
- Conditions
- Motor Skills, Inhibitory Control, Physical Fitness
- Being tested
- Coordinative exercise protocol
- Keywords
- coordination, exercise, preschool children
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coordinative exercise protocolOther
During the eight-week period, all children in the structured coordinative exercise intervention group participated in 30-minute sessions twice a week on the same day and time. The purpose-oriented basic movement patterns created in the coordinative exercise content were organised in a play-oriented manner suitable for the preschool age range.
| Study group | Role | What they receive |
|---|---|---|
| Coordinative exercise protocol | Experimental | coordinative exercise group Receives: Other: Coordinative exercise protocol |
| control group | No intervention | The control group continued the standard education curriculum in kindergarten and did not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Motor Competence: KTK3+ Backward Balancing (number of repetitions)
Backward balancing is a component of the Körperkoordinationstest für Kinder (KTK3+) motor competence test battery. This test measures the ability to maintain balance while moving backwards on a balance beam.
Unit of Measurement: number of repetitions (number of backward steps).
Measured: before and at the end of the 8-week intervention.
Changes in Motor Competence: KTK3+ Move Sideways (Number of repetitions within 20 seconds)
Move Sideways, is a component of the Körperkoordinationstest für Kinder (KTK3+) motor competence test battery. This test evaluates the ability to perform coordinated sideways movements.
Unit of Measurement: Repetitions (Number of repetitions within 20 seconds).
Measured: before and at the end of the 8-week intervention.
Changes in Motor Competence: KTK3+ Jumping Sideways (Number of repetitions within 15 seconds)
jumping sideways is a component of the Körperkoordinationstest für Kinder (KTK3+) motor competence test battery. This test measures the ability to perform coordinated sideways jumps.
Unit of Measurement: Repetitions (number of repetitions within 15 seconds)
Measured: before and at the end of the 8-week intervention.
Changes in Motor Competence: KTK3+ Eye-Hand Coordination Task (Number of repetitions within 30 seconds)
Eye-Hand Coordination is a component of the Körperkoordinationstest für Kinder (KTK3+) motor competence test battery. This task measures the ability to coordinate visual input with manual responses. It is a measurement method that involves throwing a tennis ball against a wall from a certain distance and holding it with the other hand.
Unit of Measurement: Number of correct repetitions in 30 seconds.
Measured: before and at the end of the 8-week intervention.
Changes in Counter Movement Jump Performance, (Highest jump height (cm))
Counter Movement Jump Performance was assessed using an accelerometer system (IVMES Athlete, Ankara, Turkey).
Unit of Measurement: Centimeter (cm) - Highest jump height
Measured: before and at the end of the 8-week intervention.
Changes in Balance Performance - Static Balance (%)
Balance performance was assessed with a static balance task using a movable platform (Sensbalance MiniBoard; Sensamove®, Utrecht, The Netherlands) that can be connected to a computer.
Unit of Measurement: Automatically calculated scores in % were used.
Measured: before and at the end of the 8-week intervention.
Changes in Balance Performance - Dynamic Balance (%)
Balance performance was assessed with a dynamic balance task using a moving platform (Sensbalance MiniBoard; Sensamove®, Utrecht, The Netherlands) that can be connected to a computer.
Unit of Measurement: Automatically calculated scores in % were used.
Measured: before and at the end of the 8-week intervention.
Changes in Agility (time to complete the test - in seconds)
It was evaluated using the Pro-Agility Test. Unit of Measurement: Seconds (s) - Time to complete the test
Measured: before and at the end of the 8-week intervention.
Changes in Inhibitory Control
Inhibitory control was assessed using the Go/No-Go test in the Early Years Toolbox, which measures the ability to suppress inappropriate responses.
Unit of Measurement: Number of Correct Responses and reaction time of the number of correct responses (ms).
Measured: before and at the end of the 8-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start20 Jan 2023
- Primary completion25 Feb 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The research was divided into groups according to the convenience sampling method. Convenience sampling is a non-random sampling method in which the sample to be selected from the main mass is determined by the judgement of the researcher. In convenience sampling, data are collected from the main mass in the easiest, fastest and most economical way \[73,74\]. At this point, two classes in the same kindergarten, which accepted to participate in the study and met the conditions for participation in the study, was assigned as the control group (CG; n= 23) and the other class as the exercise group (EG; n= 18).
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Nourah Bint Abdulrahman University
- Responsible party
- Principal investigator, umut canlı, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631248
- Sponsor's protocol ID
- NamikemalU
- Status last verified
- Oct 2024
- First submitted
- 20 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the following individual participant data (IPD) from our study: Measurements: Data obtained from Physical Fitness, Motor Competence and Inhibitor control parameters will be shared. Data Anonymization: All shared IPD will be fully anonymized to protect participant privacy. Personal identifiers such as names, addresses, and contact information will be removed. Data will be aggregated where necessary to prevent re-identification of participants. Data Format: The data will be shared in a secure, standardized format (e.g., CSV or Excel files) to facilitate ease of use and analysis by other researchers. Access Control: Access to the shared IPD will be granted to qualified researchers who provide a valid research proposal and agree to comply with data use agreements that ensure the data will be used solely for research purposes and not for commercial gain.
Publications
Chang YK, Tsai YJ, Chen TT, Hung TM. The impacts of coordinative exercise on executive function in kindergarten children: an ERP study. Exp Brain Res. 2013 Mar;225(2):187-96. doi: 10.1007/s00221-012-3360-9. Epub 2012 Dec 13.
PubMed 23239198Borioni F, Biino V, Tinagli V, Pesce C. Effects of Baby Swimming on Motor and Cognitive Development: A Pilot Trial. Percept Mot Skills. 2022 Aug;129(4):977-1000. doi: 10.1177/00315125221090203. Epub 2022 Apr 26.
PubMed 35473471Sendil AM, Canli U, Sheeha BB, Alkhamees NH, Batrakoulis A, Al-Mhanna SB. The effects of structured coordinative exercise protocol on physical fitness, motor competence and inhibitory control in preschool children. Sci Rep. 2024 Nov 18;14(1):28462. doi: 10.1038/s41598-024-79811-3.
PubMed 39558052
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Structured Coordinative Exercise Protocol on Physical Fitness, Motor Competence and Inhibitory Control in Preschool Children
- ClinicalTrials.gov ID
- NCT06631248
- Acronym / sponsor ID
- NamikemalU
- Conditions
- Motor Skills, Inhibitory Control, Physical Fitness
- Keywords
- coordination, exercise, preschool children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Collaborators
- Princess Nourah Bint Abdulrahman University
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 8 Oct 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.
The goal of this study was to determine whether a structured coordinative exercise program could improve physical fitness, motor competence, and inhibitory control in preschool children. The main questions it aimed to answer were:
Does the exercise program improve children's physical fitness (agility, balance, vertical jump)? Does it enhance motor competence, particularly hand-eye coordination and balance? Does it affect inhibitory control, a key component of cognitive function? Researchers compared children who participated in an 8-week exercise program to those who followed their regular school activities.
Participants:
Took part in two 30-minute exercise sessions per week for 8 weeks Were assessed before and after the intervention on physical fitness, motor competence, and inhibitory control The study found significant improvements in physical fitness and motor competence, but no significant changes in inhibitory control.
Detailed description
Scope and Content of the Study
This study evaluated the effectiveness of a structured coordinative exercise protocol aimed at improving physical fitness, motor competence, and inhibitory control in preschool children. Early childhood is considered a critical period for both physical and cognitive development. During this phase, enhancing motor skills and physical fitness forms a crucial foundation for long-term health, social adaptation, and academic success. However, these developmental opportunities may be missed if children do not engage in sufficient levels of physical activity. In this context, the study sought to investigate the effects of exercise interventions that support both motor and cognitive skills in preschool-aged children.
The main goal of the study was to examine how coordinative exercises improve physical fitness and motor competence in preschool children. Additionally, the study explored the impact of these exercises on inhibitory control, a cognitive skill related to attention and impulse control. Inhibitory control is especially important during the preschool years, as it directly affects children\'s learning processes and social interactions, serving as a key component of executive functions.
Research Protocol and Exercise Intervention
This study was conducted with 41 children, who were randomly assigned to two groups: an exercise group and a control group. The exercise group participated in an 8-week program, consisting of 30-minute sessions twice a week. The program was designed to improve various motor skills such as balance, hand-eye coordination, jumping, and locomotor abilities through play-based activities. The control group continued with their regular school curriculum without additional physical activity interventions.
The exercise protocol included open-ended tasks that progressively moved from simple to complex, requiring movement planning. These play-based exercises aimed to create an engaging and active environment in which children could participate socially. The coordinative exercises focused on supporting a wide range of motor movements and control mechanisms, encouraging the coordination of different body components in harmony.
Assessed Parameters
In the study, children\'s physical fitness, motor competence, and inhibitory control were assessed both before and after the intervention:
Physical fitness was measured through tests of balance, agility, and vertical jumping.
Motor competence was evaluated using the KTK3+ test battery, which includes tasks such as hand-eye coordination, balancing, and jumping sideways.
Inhibitory control was measured using the Go/No-Go test from the Early Years Toolbox, assessing how well children manage attention and control impulses.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The research was divided into groups according to the convenience sampling method. Convenience sampling is a non-random sampling method in which the sample to be selected from the main mass is determined by the judgement of the researcher. In convenience sampling, data are collected from the main mass in the easiest, fastest and most economical way [73,74]. At this point, two classes in the same kindergarten, which accepted to participate in the study and met the conditions for participation in the study, was assigned as the control group (CG; n= 23) and the other class as the exercise group (EG; n= 18).
| Arm | Type | Receives |
|---|---|---|
| Coordinative exercise protocol | Experimental | Other: Coordinative exercise protocolcoordinative exercise group |
| control group | No intervention | –The control group continued the standard education curriculum in kindergarten and did not receive any intervention |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Typically developing children
- Participants must not be taking medication
- Must not have any cardiovascular, neurological, orthopaedic or psychiatric disease
- Must be between 5-6 years of age
Key exclusion criteria (3 listed)
- Having any cardiovascular, neurological, orthopaedic or psychiatric disease
- Having intellectual disability
- Not being between 5-6 years old
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 |
|---|---|---|
| Coordinative exercise protocolDuring the eight-week period, all children in the structured coordinative exercise intervention group participated in 30-minute sessions twice a week on the same day and time. The purpose-oriented basic movement patterns created in the coordinative exercise content were organised in a play-oriented manner suitable for the preschool age range. | Other | Coordinative exercise protocol |
Primary outcome
Changes in Motor Competence: KTK3+ Backward Balancing (number of repetitions)
Time frame: before and at the end of the 8-week intervention.
Backward balancing is a component of the Körperkoordinationstest für Kinder (KTK3+) motor competence test battery. This test measures the ability to maintain balance while moving backwards on a balance beam. Unit of Measurement: number of repetitions (number of backward steps).
Changes in Motor Competence: KTK3+ Move Sideways (Number of repetitions within 20 seconds)
Time frame: before and at the end of the 8-week intervention.
Move Sideways, is a component of the Körperkoordinationstest für Kinder (KTK3+) motor competence test battery. This test evaluates the ability to perform coordinated sideways movements. Unit of Measurement: Repetitions (Number of repetitions within 20 seconds).
Changes in Motor Competence: KTK3+ Jumping Sideways (Number of repetitions within 15 seconds)
Time frame: before and at the end of the 8-week intervention.
jumping sideways is a component of the Körperkoordinationstest für Kinder (KTK3+) motor competence test battery. This test measures the ability to perform coordinated sideways jumps. Unit of Measurement: Repetitions (number of repetitions within 15 seconds)
Changes in Motor Competence: KTK3+ Eye-Hand Coordination Task (Number of repetitions within 30 seconds)
Time frame: before and at the end of the 8-week intervention.
Eye-Hand Coordination is a component of the Körperkoordinationstest für Kinder (KTK3+) motor competence test battery. This task measures the ability to coordinate visual input with manual responses. It is a measurement method that involves throwing a tennis ball against a wall from a certain distance and holding it with the other hand. Unit of Measurement: Number of correct repetitions in 30 seconds.
Changes in Counter Movement Jump Performance, (Highest jump height (cm))
Time frame: before and at the end of the 8-week intervention.
Counter Movement Jump Performance was assessed using an accelerometer system (IVMES Athlete, Ankara, Turkey). Unit of Measurement: Centimeter (cm) - Highest jump height
Changes in Balance Performance - Static Balance (%)
Time frame: before and at the end of the 8-week intervention.
Balance performance was assessed with a static balance task using a movable platform (Sensbalance MiniBoard; Sensamove®, Utrecht, The Netherlands) that can be connected to a computer. Unit of Measurement: Automatically calculated scores in % were used.
Changes in Balance Performance - Dynamic Balance (%)
Time frame: before and at the end of the 8-week intervention.
Balance performance was assessed with a dynamic balance task using a moving platform (Sensbalance MiniBoard; Sensamove®, Utrecht, The Netherlands) that can be connected to a computer. Unit of Measurement: Automatically calculated scores in % were used.
Changes in Agility (time to complete the test - in seconds)
Time frame: before and at the end of the 8-week intervention.
It was evaluated using the Pro-Agility Test. Unit of Measurement: Seconds (s) - Time to complete the test
Changes in Inhibitory Control
Time frame: before and at the end of the 8-week intervention.
Inhibitory control was assessed using the Go/No-Go test in the Early Years Toolbox, which measures the ability to suppress inappropriate responses. Unit of Measurement: Number of Correct Responses and reaction time of the number of correct responses (ms).
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 8 Oct 2024.
- Background: PubMed 23239198Chang YK, Tsai YJ, Chen TT, Hung TM. The impacts of coordinative exercise on executive function in kindergarten children: an ERP study. Exp Brain Res. 2013 Mar;225(2):187-96. doi: 10.1007/s00221-012-3360-9. Epub 2012 Dec 13.
- Background: PubMed 35473471Borioni F, Biino V, Tinagli V, Pesce C. Effects of Baby Swimming on Motor and Cognitive Development: A Pilot Trial. Percept Mot Skills. 2022 Aug;129(4):977-1000. doi: 10.1177/00315125221090203. Epub 2022 Apr 26.
- Derived from this study: PubMed 39558052Sendil AM, Canli U, Sheeha BB, Alkhamees NH, Batrakoulis A, Al-Mhanna SB. The effects of structured coordinative exercise protocol on physical fitness, motor competence and inhibitory control in preschool children. Sci Rep. 2024 Nov 18;14(1):28462. doi: 10.1038/s41598-024-79811-3.
- Individual participant dataSharing planned: Yes. We plan to share the following individual participant data (IPD) from our study: Measurements: Data obtained from Physical Fitness, Motor Competence and Inhibitor control parameters will be shared. Data Anonymization: All shared IPD will be fully anonymized to protect participant privacy. Personal identifiers such as names, addresses, and contact information will be removed. Data will be aggregated where necessary to prevent re-identification of participants. Data Format: The data will be shared in a secure, standardized format (e.g., CSV or Excel files) to facilitate ease of use and analysis by other researchers. Access Control: Access to the shared IPD will be granted to qualified researchers who provide a valid research proposal and agree to comply with data use agreements that ensure the data will be used solely for research purposes and not for commercial gain.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coordinative exercise protocol in people with Motor Skills and Inhibitory Control, run by Namik Kemal University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 8 Oct 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 Turkey (Türkiye). 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?
Changes in Motor Competence: KTK3+ Backward Balancing (number of repetitions) (time frame: before and at the end of the 8-week intervention.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06631248, which also lists 3 linked publications.
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 8 Oct 2024.