NCT06653088

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

October 16, 2024

Last Update Submit

October 21, 2024

Conditions

Keywords

physical fitnessfundamental movement skillsphysical activityAnthropometricsBlood pressure

Outcome Measures

Primary Outcomes (1)

  • 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).

    2 weeks

Secondary Outcomes (6)

  • Physical Activity Levels

    5 days

  • Physical Fitness Levels

    2 weeks

  • Physical Fitness Levels (speed-agility)

    2 weeks

  • Physical Fitness Levels (muscular musculoskeletal fitness)

    2 weeks

  • Body Mass Index (BMI)

    1 day for 10 minutes

  • +1 more secondary outcomes

Study Arms (2)

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.

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).

Interventions

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.

Intervention group with Physical Education program

Eligibility Criteria

Age3 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Preschool children, 3 to 4 years old

You may not qualify if:

  • Diagnosed physical or mental impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The National Board of Kindergartens

Santiago, Chile

Location

Related Publications (5)

  • 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.

    PMID: 27829405BACKGROUND
  • 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Paz Fernández-Valero

    Universidad Bernardo O'Higgins

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Education Teacher

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 22, 2024

Study Start

May 9, 2023

Primary Completion

January 12, 2024

Study Completion

January 12, 2024

Last Updated

October 22, 2024

Record last verified: 2024-10

Locations