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Completed

NCT Number: NCT06653088

Move Kids-24h Physical Education Program

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.

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Key information

Age range

3 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The National Board of Kindergartens

Santiago, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preschool children, 3 to 4 years old

Exclusion criteria

  • Diagnosed physical or mental impairments.

Treatment and study plan

Physical Education program

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Physical Activity Levels

    Time frame: 5 days

    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.

  2. Physical Fitness Levels

    Time frame: 2 weeks

    PREFIT battery encompasses the following tests: handgrip strength for assessing muscular musculoskeletal fitness

  3. Physical Fitness Levels (speed-agility)

    Time frame: 2 weeks

    PREFIT battery encompasses the following tests: The 4x10 m shuttle-run for assessing speed-agility.

  4. Physical Fitness Levels (muscular musculoskeletal fitness)

    Time frame: 2 weeks

    PREFIT battery encompasses the following tests: standing long-jump tests for assessing muscular musculoskeletal fitness.

  5. Body Mass Index (BMI)

    Time frame: 1 day for 10 minutes

    Weight (kg) and height (cm) will be measured, and then the equation kg/m2 will be applied to determine BMI values.

  6. Blood Pressure Levels (systolic and diastolic blood pressure)

    Time frame: 1 day for 15 minutes

    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.

Sponsors and collaborators

Lead sponsor

Universidad Bernardo O'Higgins

Other

Collaborators

  • Universidad Mayor
  • Universidade Lusófona de Humanidades e Tecnologias
  • Universidade do Porto
  • University of Minho

Registry information

Official study title

Move Kids-24 h - The Effects of a Physical Education Intervention on Fundamental Movement Skills in Preschoolers

Acronym: Move Kids-24 h

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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