Fundamental Movement SkillsMove Kids-24 hNCT06653088
Move Kids-24h Physical Education Program
A study testing Physical Education program in people with Fundamental Movement Skills and Preschool, run by Universidad Bernardo O'Higgins at 1 site in Chile.
Trial summary
Introduction: The development of fundamental movement skills (FMS) is essential to acquiring the necessary skills that allow children to be competent in several sports, games and dances. Competence is acquired from FMS skills through practice and experiences during childhood. Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Fundamental Movement Skills, Preschool
- What is being tested?
- Physical Education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- 9 May 2023to 12 Jan 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 3 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preschool children, 3 to 4 years old
Who cannot join
- Diagnosed physical or mental impairments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Move Kids-24 h - The Effects of a Physical Education Intervention on Fundamental Movement Skills in Preschoolers
Introduction: The development of fundamental movement skills (FMS) is essential to acquiring the necessary skills that allow children to be competent in several sports, games and dances. Competence is acquired from FMS skills through practice and experiences during childhood. However, evidence from previous studies showed low levels of FMS, given that 4.4% of the preschoolers were delayed in gross motor skills, and 8.8% were at risk of delay.
Aim: To evaluate the effects of a structured physical education (PE) program on preschoolers' FMS, implemented and delivered by PE teachers. Secondary aims are to evaluate the effects of the physical education program on (i) preschoolers' movement behaviors, (ii) physical fitness levels, and (iii) blood pressure.
Read more
Methods: Cluster randomized controlled trial study. Sample: 40 preschool children, aged 3 to 4 years old. Primary Outcomes are FMS, assessed with the Test of Gross Motor Development- Third Edition. Secondary outcomes are physical activity (PA), physical fitness, blood pressure and Body Mass Index (BMI).
Expected results: Participation in the PE program will likely have a positive effect on the development of FMS, potentially increasing PA levels and improving physical fitness. It is also expected that FMS show a consistent positive association with BMI and blood pressure levels. The results of this randomized controlled trial (RCT) have the potential to inform future guidelines for PE classes in Chilean preschoolers and strengthen the scientific knowledge on this type of intervention in this population.
Read the detailed description
Data from children and adolescents has shown that FMS have a significant association and reciprocal longitudinal relationship with PA. Strong evidence to supports a low-to-moderate positive association between FMS and moderate-to-vigorous and vigorous and vigorous PA in preschool-aged children. Conversely, when analyzing results within the 24-hour movement behaviors spectrum, there is evidence that preschoolers who spend more time in sedentary behavior have lower FMS' scores. Short sleep durations can adversely affect the development of FMS. Previous findings also show that proficient FMS may benefit children's physical fitness, specifically cardiorespiratory and musculoskeletal fitness.
FMS' development should begin in the early years; however, data shows that many preschoolers lack adequate FMS proficiency for their age. Additionally, some data show that the Covid-19 worldwide pandemic damaged preschoolers' FMS, together with the motor competence of children aged 6-9 years old, highlighting the need for tailored interventions. Indeed, FMS intervention programs effectively improve FMS, as well as other health-related behaviors and outcomes in preschoolers. Unfortunately, in Chile, many preschools and primary schools do not have structured PE programs, but rather recreation periods in which children participate in free play. However, it has been shown that young children spend only half of their free play time engaged in PA and that PE interventions are an effective mean for developing FMS in preschoolers, but only when implemented by specialized PE teachers. However, in Chile, it is not common to find PE teachers in preschoolers.
Therefore, this research's main aim is to evaluate the effects of a structured PE program on preschoolers' FMS implemented and delivered by PE teachers. The secondary aims are to evaluate the effects of the PE program on (i) preschoolers' movement behaviors, (ii) physical fitness levels, and (iii) blood pressure.
The hypothesis is that a structured physical education program positively modifies fundamental movement skills, movement behaviors, physical fitness levels, and blood pressure.
- Conditions
- Fundamental Movement Skills, Preschool
- Being tested
- Physical Education program
- Keywords
- physical fitness, fundamental movement skills, physical activity, Anthropometrics, Blood pressure
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Education programBehavioural
A four-month intervention will be implemented, led by the PE teacher, with three sessions per week. These sessions will last 45 minutes each (Koolwikh et al., 2023), divided into 5 minutes of warm-up, 35 minutes of intervention content, and 5 minutes of return to calm.
The program content of the intervention group will contemplate a warm-up with several activities, such as dancing or games. The intervention part will be composed of circuit-based exercises with several stations and games involving locomotion skills, namely run, gallop, slide, skip, jump, hop, etc.; games that integrate manipulative skills, such as throwing, catching, kicking, punting, striking, rolling and bouncing/dribbling; balance games involving swinging, turning, pulling, etc. Games involving perceptual motor skills, such as body schema, laterality, temporality, and spatiality, and games focused on PA. The return to calm will include activities such as yoga, meditation, and flexibility.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group with Physical Education program | Experimental | A four-month intervention will be implemented, led by the PE teacher, with three sessions per week. These sessions will last 45 minutes each (Koolwikh et al., 2023), divided into 5 minutes of warm-up, 35 minutes of intervention content, and 5 minutes of return to calm. The program content of the intervention group will contemplate a warm-up with several activities, such as dancing or games. The intervention part will be composed of circuit-based exercises with several stations and games involving locomotion skills, namely run, gallop, slide, skip, jump, hop, etc.; games that integrate manipulative skills, such as throwing, catching, kicking, punting, striking, rolling and bouncing/dribbling; balance games involving swinging, turning, pulling, etc. Games involving perceptual motor skills, such as body schema, laterality, temporality, and spatiality, and games focused on PA. The return to calm will include activities such as yoga, meditation, and flexibility. Receives: Behavioral: Physical Education program |
| Control group without programmed PE classes | No intervention | The control group will continue with their normal activity; however, they will receive the same training after the intervention, so it can also be implemented in their preschools if they wish so (Engel et al., 2022; Santos et al., 2016). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fundamental Movement Skills
The standardized instrument called the Test of Gross Motor Development (TGMD-3) will be used, which measures 6 locomotor skills (run, gallop, one-legged hop, skip, jump, and slide) and 7 ball skills (two-hand strike, one-hand strike, catch, kick, dribble, overhand throw and underhand throw).
Measured: 2 weeks
Secondary outcomes (6)
Physical Activity Levels
Accelerometer. The equipment will be placed on the right hip with an adjustable elastic belt. Data will be recorded with an interval of 15 seconds (time) and a frequency of 30 Hz, using Actilife-6 software.
Measured: 5 days
Physical Fitness Levels
PREFIT battery encompasses the following tests: handgrip strength for assessing muscular musculoskeletal fitness
Measured: 2 weeks
Physical Fitness Levels (speed-agility)
PREFIT battery encompasses the following tests: The 4x10 m shuttle-run for assessing speed-agility.
Measured: 2 weeks
Physical Fitness Levels (muscular musculoskeletal fitness)
PREFIT battery encompasses the following tests: standing long-jump tests for assessing muscular musculoskeletal fitness.
Measured: 2 weeks
Body Mass Index (BMI)
Weight (kg) and height (cm) will be measured, and then the equation kg/m2 will be applied to determine BMI values.
Measured: 1 day for 10 minutes
Blood Pressure Levels (systolic and diastolic blood pressure)
Say here the name of the device. Measured in the right arm, the child will be staying quiet for 3-5 min before measurement, with the back supported and feet uncrossed on the floor.
Measured: 1 day for 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start9 May 2023
- Primary completion12 Jan 2024
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fundamental Movement 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Bernardo O'Higgins
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minho, Universidad Mayor, Universidade Lusófona de Humanidades e Tecnologias, Universidade do Porto
- Responsible party
- Principal investigator, Paz Fernández-Valero, Universidad Bernardo O'Higgins
- Investigators
- Paz Fernández-Valero, Principal investigator, Universidad Bernardo O'Higgins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653088
- Sponsor's protocol ID
- no 029
- Acronym
- Move Kids-24 h
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Santos R, Cliff DP, Howard SJ, Veldman SL, Wright IM, Sousa-Sa E, Pereira JR, Okely AD. "GET-UP" study rationale and protocol: a cluster randomised controlled trial to evaluate the effects of reduced sitting on toddlers' cognitive development. BMC Pediatr. 2016 Nov 9;16(1):182. doi: 10.1186/s12887-016-0723-6.
PubMed 27829405Garcia-Hermoso A, Alonso-Martinez AM, Ramirez-Velez R, Perez-Sousa MA, Ramirez-Campillo R, Izquierdo M. Association of Physical Education With Improvement of Health-Related Physical Fitness Outcomes and Fundamental Motor Skills Among Youths: A Systematic Review and Meta-analysis. JAMA Pediatr. 2020 Jun 1;174(6):e200223. doi: 10.1001/jamapediatrics.2020.0223. Epub 2020 Jun 1.
PubMed 32250414Loras H. The Effects of Physical Education on Motor Competence in Children and Adolescents: A Systematic Review and Meta-Analysis. Sports (Basel). 2020 Jun 15;8(6):88. doi: 10.3390/sports8060088.
PubMed 32549319Hassan MA, Liu W, McDonough DJ, Su X, Gao Z. Comparative Effectiveness of Physical Activity Intervention Programs on Motor Skills in Children and Adolescents: A Systematic Review and Network Meta-Analysis. Int J Environ Res Public Health. 2022 Sep 21;19(19):11914. doi: 10.3390/ijerph191911914.
PubMed 36231213Engel A, Broderick C, van Doorn N, Hardy L, Ward R, Kwai N, Parmenter B. Effect of a Fundamental Motor Skills Intervention on Fundamental Motor Skill and Physical Activity in a Preschool Setting: A Cluster Randomized Controlled Trial. Pediatr Exerc Sci. 2022 May 1;34(2):57-66. doi: 10.1123/pes.2021-0021. Epub 2021 Oct 25.
PubMed 34697254
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move Kids-24 h - The Effects of a Physical Education Intervention on Fundamental Movement Skills in Preschoolers
- ClinicalTrials.gov ID
- NCT06653088
- Acronym / sponsor ID
- Move Kids-24 h / no 029
- Conditions
- Fundamental Movement Skills, Preschool
- Keywords
- physical fitness, fundamental movement skills, physical activity, Anthropometrics, Blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Bernardo O'HigginsUniversity, hospital or other
- Collaborators
- University of Minho, Universidad Mayor, Universidade Lusófona de Humanidades e Tecnologias, Universidade do Porto
- Study start
- 9 May 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 22 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.
Introduction: The development of fundamental movement skills (FMS) is essential to acquiring the necessary skills that allow children to be competent in several sports, games and dances. Competence is acquired from FMS skills through practice and experiences during childhood. However, evidence from previous studies showed low levels of FMS, given that 4.4% of the preschoolers were delayed in gross motor skills, and 8.8% were at risk of delay.
Aim: To evaluate the effects of a structured physical education (PE) program on preschoolers' FMS, implemented and delivered by PE teachers. Secondary aims are to evaluate the effects of the physical education program on (i) preschoolers' movement behaviors, (ii) physical fitness levels, and (iii) blood pressure.
Methods: Cluster randomized controlled trial study. Sample: 40 preschool children, aged 3 to 4 years old. Primary Outcomes are FMS, assessed with the Test of Gross Motor Development- Third Edition. Secondary outcomes are physical activity (PA), physical fitness, blood pressure and Body Mass Index (BMI).
Expected results: Participation in the PE program will likely have a positive effect on the development of FMS, potentially increasing PA levels and improving physical fitness. It is also expected that FMS show a consistent positive association with BMI and blood pressure levels. The results of this randomized controlled trial (RCT) have the potential to inform future guidelines for PE classes in Chilean preschoolers and strengthen the scientific knowledge on this type of intervention in this population.
Detailed description
Data from children and adolescents has shown that FMS have a significant association and reciprocal longitudinal relationship with PA. Strong evidence to supports a low-to-moderate positive association between FMS and moderate-to-vigorous and vigorous and vigorous PA in preschool-aged children. Conversely, when analyzing results within the 24-hour movement behaviors spectrum, there is evidence that preschoolers who spend more time in sedentary behavior have lower FMS' scores. Short sleep durations can adversely affect the development of FMS. Previous findings also show that proficient FMS may benefit children's physical fitness, specifically cardiorespiratory and musculoskeletal fitness.
FMS' development should begin in the early years; however, data shows that many preschoolers lack adequate FMS proficiency for their age. Additionally, some data show that the Covid-19 worldwide pandemic damaged preschoolers' FMS, together with the motor competence of children aged 6-9 years old, highlighting the need for tailored interventions. Indeed, FMS intervention programs effectively improve FMS, as well as other health-related behaviors and outcomes in preschoolers. Unfortunately, in Chile, many preschools and primary schools do not have structured PE programs, but rather recreation periods in which children participate in free play. However, it has been shown that young children spend only half of their free play time engaged in PA and that PE interventions are an effective mean for developing FMS in preschoolers, but only when implemented by specialized PE teachers. However, in Chile, it is not common to find PE teachers in preschoolers.
Therefore, this research's main aim is to evaluate the effects of a structured PE program on preschoolers' FMS implemented and delivered by PE teachers. The secondary aims are to evaluate the effects of the PE program on (i) preschoolers' movement behaviors, (ii) physical fitness levels, and (iii) blood pressure.
The hypothesis is that a structured physical education program positively modifies fundamental movement skills, movement behaviors, physical fitness levels, and blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group with Physical Education program | Experimental | Behavioral: Physical Education programA four-month intervention will be implemented, led by the PE teacher, with three sessions per week. These sessions will last 45 minutes each (Koolwikh et al., 2023), divided into 5 minutes of warm-up, 35 minutes of intervention content, and 5 minutes of return to calm. The program content of the intervention group will contemplate a warm-up with several activities, such as dancing or games. The intervention part will be composed of circuit-based exercises with several stations and games involving locomotion skills, namely run, gallop, slide, skip, jump, hop, etc.; games that integrate manipulative skills, such as throwing, catching, kicking, punting, striking, rolling and bouncing/dribbling; balance games involving swinging, turning, pulling, etc. Games involving perceptual motor skills, such as body schema, laterality, temporality, and spatiality, and games focused on PA. The return to calm will include activities such as yoga, meditation, and flexibility. |
| Control group without programmed PE classes | No intervention | –The control group will continue with their normal activity; however, they will receive the same training after the intervention, so it can also be implemented in their preschools if they wish so (Engel et al., 2022; Santos et al., 2016). |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preschool children, 3 to 4 years old
Key exclusion criteria (1 listed)
- Diagnosed physical or mental impairments.
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 |
|---|---|---|
| Physical Education programA four-month intervention will be implemented, led by the PE teacher, with three sessions per week. These sessions will last 45 minutes each (Koolwikh et al., 2023), divided into 5 minutes of warm-up, 35 minutes of intervention content, and 5 minutes of return to calm. The program content of the intervention group will contemplate a warm-up with several activities, such as dancing or games. The intervention part will be composed of circuit-based exercises with several stations and games involving locomotion skills, namely run, gallop, slide, skip, jump, hop, etc.; games that integrate manipulative skills, such as throwing, catching, kicking, punting, striking, rolling and bouncing/dribbling; balance games involving swinging, turning, pulling, etc. Games involving perceptual motor skills, such as body schema, laterality, temporality, and spatiality, and games focused on PA. The return to calm will include activities such as yoga, meditation, and flexibility. | Behavioural | Intervention group with Physical Education program |
Primary outcome
Fundamental Movement Skills
Time frame: 2 weeks
The standardized instrument called the Test of Gross Motor Development (TGMD-3) will be used, which measures 6 locomotor skills (run, gallop, one-legged hop, skip, jump, and slide) and 7 ball skills (two-hand strike, one-hand strike, catch, kick, dribble, overhand throw and underhand throw).
6 secondary outcomes
Physical Activity Levels
Time frame: 5 days
Physical Fitness Levels
Time frame: 2 weeks
Physical Fitness Levels (speed-agility)
Time frame: 2 weeks
Physical Fitness Levels (muscular musculoskeletal fitness)
Time frame: 2 weeks
Body Mass Index (BMI)
Time frame: 1 day for 10 minutes
Blood Pressure Levels (systolic and diastolic blood pressure)
Time frame: 1 day for 15 minutes
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 22 Oct 2024.
- Background: PubMed 27829405Santos R, Cliff DP, Howard SJ, Veldman SL, Wright IM, Sousa-Sa E, Pereira JR, Okely AD. "GET-UP" study rationale and protocol: a cluster randomised controlled trial to evaluate the effects of reduced sitting on toddlers' cognitive development. BMC Pediatr. 2016 Nov 9;16(1):182. doi: 10.1186/s12887-016-0723-6.
- Results publication: PubMed 32250414Garcia-Hermoso A, Alonso-Martinez AM, Ramirez-Velez R, Perez-Sousa MA, Ramirez-Campillo R, Izquierdo M. Association of Physical Education With Improvement of Health-Related Physical Fitness Outcomes and Fundamental Motor Skills Among Youths: A Systematic Review and Meta-analysis. JAMA Pediatr. 2020 Jun 1;174(6):e200223. doi: 10.1001/jamapediatrics.2020.0223. Epub 2020 Jun 1.
- Results publication: PubMed 32549319Loras H. The Effects of Physical Education on Motor Competence in Children and Adolescents: A Systematic Review and Meta-Analysis. Sports (Basel). 2020 Jun 15;8(6):88. doi: 10.3390/sports8060088.
- Results publication: PubMed 36231213Hassan MA, Liu W, McDonough DJ, Su X, Gao Z. Comparative Effectiveness of Physical Activity Intervention Programs on Motor Skills in Children and Adolescents: A Systematic Review and Network Meta-Analysis. Int J Environ Res Public Health. 2022 Sep 21;19(19):11914. doi: 10.3390/ijerph191911914.
- Results publication: PubMed 34697254Engel A, Broderick C, van Doorn N, Hardy L, Ward R, Kwai N, Parmenter B. Effect of a Fundamental Motor Skills Intervention on Fundamental Motor Skill and Physical Activity in a Preschool Setting: A Cluster Randomized Controlled Trial. Pediatr Exerc Sci. 2022 May 1;34(2):57-66. doi: 10.1123/pes.2021-0021. Epub 2021 Oct 25.
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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.
Paz Fernández-Valero principal investigator
Universidad Bernardo O'Higgins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Education program in people with Fundamental Movement Skills and Preschool, run by Universidad Bernardo O'Higgins at 1 site in Chile.
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 1 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 22 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 Chile. 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?
Fundamental Movement Skills (time frame: 2 weeks). 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 NCT06653088, which also lists 5 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 22 Oct 2024.