Healthy PreschoolersFMS-EF-RCTNCT07725354
Fundamental Movement Skills Training Improves Executive Functions in Preschoolers
A study testing Fundamental Movement Skills Training and Regular Physical Activity in people with Healthy Preschoolers, run by Xi'an Physical Education University at 1 site in China.
Trial summary
This randomized controlled trial investigated the effects of a 12-week structured fundamental movement skills (FMS) training program on executive functions in 34 healthy preschoolers aged 5-6 years. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Preschoolers
- What is being tested?
- Fundamental Movement Skills Training and Regular Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Jul 2024
- 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
- Age between 5 and 6 years
- Good physical health without severe cognitive or motor impairments
- Parental or guardian consent to participate
Who cannot join
- Severe cognitive impairment or neurodevelopmental disorders
- Physical conditions unsuitable for moderate-intensity physical activity
- Severe motor developmental delay or impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fundamental Movement Skills Training Improves Executive Functions in Preschoolers: A Randomized Controlled Trial
This randomized controlled trial investigated the effects of a 12-week structured fundamental movement skills (FMS) training program on executive functions in 34 healthy preschoolers aged 5-6 years. Participants were randomly assigned to an FMS training group (n = 17) or a regular physical activity control group (n = 17). The FMS group participated in two 35-minute sessions per week for 12 weeks, while the control group engaged in free play. Executive functions were assessed using the Go/No-Go, Mr. Ant, and Card Sorting tasks from the Early Years Toolbox at baseline and after the intervention.
- Conditions
- Healthy Preschoolers
- Being tested
- Fundamental Movement Skills Training, Regular Physical Activity
- Keywords
- Fundamental Movement Skills, Executive Functions, Preschoolers, Randomized Controlled Trial, Inhibitory Control, Working Memory, Cognitive Flexibility, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fundamental Movement Skills TrainingBehavioural
Structured FMS training program including locomotor, object control, and stability skills, 2 sessions per week, 35 minutes per session for 12 weeks.
Regular Physical ActivityBehavioural
Regular physical activities including free play and simple exercises (e.g., rope jumping, ball bouncing, musical chairs), 2 sessions per week, 35 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| FMS Training Group | Experimental | 12-week structured fundamental movement skills training, 2 sessions per week, 35 minutes per session, including locomotor, object control, and stability skills with progressive difficulty. Receives: Behavioral: Fundamental Movement Skills Training |
| Regular Physical Activity Control Group | Active comparator | Regular physical activities including free play and simple exercises, 2 sessions per week, 35 minutes per session. Receives: Behavioral: Regular Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working Memory - Mr. Ant Task
Children were required to remember the locations of colored stickers on a cartoon ant ("Mr. Ant") and reposition them after the stickers disappeared. The task consisted of 8 levels with progressively increasing difficulty. The score was the number of levels correctly completed (range: 0-8).
Measured: Baseline and 12 weeks post-intervention
Inhibitory Control - Go/No-Go Task
Children were instructed to tap the screen when a clownfish appeared (Go trials) and to refrain from tapping when a shark appeared (No-Go trials). The task comprised 75 trials (60 Go, 15 No-Go). The score was calculated as the product of accuracy rates on Go and No-Go trials.
Measured: Baseline and 12 weeks post-intervention
Cognitive Flexibility - Card Sorting Task
Children were required to sort patterns (boats or rabbits) according to color or shape rules. The task comprised three phases: color sorting, shape sorting, and mixed sorting, with 6 trials per phase, totaling 18 trials. The score was the total number of correct sorts (range: 0-18).
Measured: Baseline and 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Mar 2024
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PreschoolersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xi'an Physical Education University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Ying, Xi'an Physical Education University
- Investigators
- Ying Lu, Principal investigator, Xi'an Physical Education University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725354
- Sponsor's protocol ID
- XPEU-2024-012
- Acronym
- FMS-EF-RCT
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size and the involvement of young children, individual participant data will not be shared to protect participant privacy. No data sharing agreement is in place for this study.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fundamental Movement Skills Training Improves Executive Functions in Preschoolers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07725354
- Acronym / sponsor ID
- FMS-EF-RCT / XPEU-2024-012
- Conditions
- Healthy Preschoolers
- Keywords
- Fundamental Movement Skills, Executive Functions, Preschoolers, Randomized Controlled Trial, Inhibitory Control, Working Memory, Cognitive Flexibility, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Xi'an Physical Education UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 24 Jul 2026 (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 randomized controlled trial investigated the effects of a 12-week structured fundamental movement skills (FMS) training program on executive functions in 34 healthy preschoolers aged 5-6 years. Participants were randomly assigned to an FMS training group (n = 17) or a regular physical activity control group (n = 17). The FMS group participated in two 35-minute sessions per week for 12 weeks, while the control group engaged in free play. Executive functions were assessed using the Go/No-Go, Mr. Ant, and Card Sorting tasks from the Early Years Toolbox at baseline and after the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMS Training Group | Experimental | Behavioral: Fundamental Movement Skills Training12-week structured fundamental movement skills training, 2 sessions per week, 35 minutes per session, including locomotor, object control, and stability skills with progressive difficulty. |
| Regular Physical Activity Control Group | Active comparator | Behavioral: Regular Physical ActivityRegular physical activities including free play and simple exercises, 2 sessions per week, 35 minutes per session. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 5 and 6 years
- Good physical health without severe cognitive or motor impairments
- Parental or guardian consent to participate
Key exclusion criteria (3 listed)
- Severe cognitive impairment or neurodevelopmental disorders
- Physical conditions unsuitable for moderate-intensity physical activity
- Severe motor developmental delay or impairment
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 |
|---|---|---|
| Fundamental Movement Skills TrainingStructured FMS training program including locomotor, object control, and stability skills, 2 sessions per week, 35 minutes per session for 12 weeks. | Behavioural | FMS Training Group |
| Regular Physical ActivityRegular physical activities including free play and simple exercises (e.g., rope jumping, ball bouncing, musical chairs), 2 sessions per week, 35 minutes per session. | Behavioural | Regular Physical Activity Control Group |
Primary outcome
Working Memory - Mr. Ant Task
Time frame: Baseline and 12 weeks post-intervention
Children were required to remember the locations of colored stickers on a cartoon ant ("Mr. Ant") and reposition them after the stickers disappeared. The task consisted of 8 levels with progressively increasing difficulty. The score was the number of levels correctly completed (range: 0-8).
Inhibitory Control - Go/No-Go Task
Time frame: Baseline and 12 weeks post-intervention
Children were instructed to tap the screen when a clownfish appeared (Go trials) and to refrain from tapping when a shark appeared (No-Go trials). The task comprised 75 trials (60 Go, 15 No-Go). The score was calculated as the product of accuracy rates on Go and No-Go trials.
Cognitive Flexibility - Card Sorting Task
Time frame: Baseline and 12 weeks post-intervention
Children were required to sort patterns (boats or rabbits) according to color or shape rules. The task comprised three phases: color sorting, shape sorting, and mixed sorting, with 6 trials per phase, totaling 18 trials. The score was the total number of correct sorts (range: 0-18).
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 24 Jul 2026.
- Individual participant dataSharing planned: No. Due to the small sample size and the involvement of young children, individual participant data will not be shared to protect participant privacy. No data sharing agreement is in place for this study.
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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.
Ying Lu principal investigator
Xi'an Physical Education University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fundamental Movement Skills Training and Regular Physical Activity in people with Healthy Preschoolers, run by Xi'an Physical Education University at 1 site in China.
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 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 24 Jul 2026. 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 China. 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?
Working Memory - Mr. Ant Task (time frame: Baseline and 12 weeks post-intervention). The study lists 3 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 24 Jul 2026.