- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06653088
Move Kids-24h Physical Education Program (Move Kids-24 h)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Santiago, Chile
- The National Board of Kindergartens
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Preschool children, 3 to 4 years old
Exclusion Criteria:
- Diagnosed physical or mental impairments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention group with Physical Education program
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.
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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. |
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No Intervention: Control group without programmed PE classes
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fundamental Movement Skills
Time Frame: 2 weeks
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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).
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2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physical Activity Levels
Time Frame: 5 days
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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.
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5 days
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Physical Fitness Levels
Time Frame: 2 weeks
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PREFIT battery encompasses the following tests: handgrip strength for assessing muscular musculoskeletal fitness
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2 weeks
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Physical Fitness Levels (speed-agility)
Time Frame: 2 weeks
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PREFIT battery encompasses the following tests: The 4x10 m shuttle-run for assessing speed-agility.
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2 weeks
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Physical Fitness Levels (muscular musculoskeletal fitness)
Time Frame: 2 weeks
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PREFIT battery encompasses the following tests: standing long-jump tests for assessing muscular musculoskeletal fitness.
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2 weeks
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Body Mass Index (BMI)
Time Frame: 1 day for 10 minutes
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Weight (kg) and height (cm) will be measured, and then the equation kg/m2 will be applied to determine BMI values.
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1 day for 10 minutes
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Blood Pressure Levels (systolic and diastolic blood pressure)
Time Frame: 1 day for 15 minutes
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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.
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1 day for 15 minutes
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paz Fernández-Valero, Universidad Bernardo O'Higgins
Publications and helpful links
General 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.
- Garcia-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.
- Loras 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.
- Hassan 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.
- Engel 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- no 029
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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