NCT06684808

Brief Summary

The purpose of the study was to evaluate the effects of 12 weeks of Active Breaks on motor, academic and cognitive performance in elementary school children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

November 8, 2024

Last Update Submit

November 9, 2024

Conditions

Keywords

active breakschildrenacademic achievementphysical activityschool time

Outcome Measures

Primary Outcomes (12)

  • Height

    after 12 weeks

  • Weight

    after 12 weeks

  • Leaps forward on one foot

    Hopping forward on one foot along a line for 10 meters. This test consists of 4 items (what to do), each with specific execution criteria (what to observe). Generally, these criteria represent a mature execution pattern for that skill. Children receive 1 point if they perform the item correctly and 0 points if not

    after 12 weeks

  • Side Gallop

    Gallop sideways for 10 meters. This test consists of 4 items (what to do), each with specific execution criteria (what to observe). Generally, these criteria represent a mature execution pattern for that skill. Children receive 1 point if they perform the item correctly and 0 points if not

    after 12 weeks

  • Alternating forward hops on one foot

    Hopping forward by alternating the supporting foot for 10 meters. This test consists of 4 items (what to do), each with specific execution criteria (what to observe). Generally, these criteria represent a mature execution pattern for that skill. Children receive 1 point if they perform the item correctly and 0 points if not

    after 12 weeks

  • Throwing a ball with one hand

    Throw the ball against the wall 10 meters away. This test consists of 4 items (what to do), each with specific execution criteria (what to observe). Generally, these criteria represent a mature execution pattern for that skill. Children receive 1 point if they perform the item correctly and 0 points if not

    after 12 weeks

  • Receiving with the hands a thrown ball

    Catch the ball on the fly from a distance of 5 meters. This test consists of 4 items (what to do), each with specific execution criteria (what to observe). Generally, these criteria represent a mature execution pattern for that skill. Children receive 1 point if they perform the item correctly and 0 points if not

    after 12 weeks

  • Hitting the ball with a tennis racket

    hitting the ball from a distance of 5 meters. This test consists of 4 items (what to do), each with specific execution criteria (what to observe). Generally, these criteria represent a mature execution pattern for that skill. Children receive 1 point if they perform the item correctly and 0 points if not

    after 12 weeks

  • Long jump from a standing start

    Perform as long a forward jump as possible starting from a standing position.

    after 12 weeks

  • Fast shuttle run 10x5m

    Run 5 m for 10 times at the highest possible speed

    after 12 weeks

  • Assessment Test of Calculation Skills AC.MT 6-11

    AC-MT 6-11 test proposes tests to ascertain the level of learning of calculus, basic assessment, and problem solving

    after 12 weeks

  • Reynolds Interference Task (RIT) test

    Measurement of complex processing speed

    after 12 weeks

Study Arms (4)

Fitness

EXPERIMENTAL

The Fitness group engaged in active breaks aimed at improving cardiovascular efficiency. These breaks were designed to provide moderate to vigorous physical activity, incorporating both strength and aerobic exercises such as squats, jumping jacks, lunges, and running in place. Children were instructed to imitate the teacher's movements

Other: Fitness

Creative

EXPERIMENTAL

The Creative group participated in active breaks that combined cognitive-creative and physical demands, incorporating activities like improvisations, dramatizations of events or short stories, simulation, and imitation games. These activities aimed to stimulate the creative process and enhance emotional expression within environmental constraints. Constraints, set by the teacher-such as specific rules, partner positioning, or speed of execution-limited movement options, encouraging students to explore new solutions to complete each task.

Other: Creative

Combined

EXPERIMENTAL

The Combined group took active breaks by combining the Fitness protocol in the first break and the Creative protocol in the second.

Other: Combined

Control

ACTIVE COMPARATOR

Regular physical activity at school during the weeks.

Other: Control

Interventions

FitnessOTHER

The Fitness group engaged in active breaks aimed at improving cardiovascular efficiency. These breaks were designed to provide moderate to vigorous physical activity, incorporating both strength and aerobic exercises such as squats, jumping jacks, lunges, and running in place. Children were instructed to imitate the teacher's movements.

Fitness

The Creative group participated in active breaks that combined cognitive-creative and physical demands, incorporating activities like improvisations, dramatizations of events or short stories, simulation, and imitation games. These activities aimed to stimulate the creative process and enhance emotional expression within environmental constraints. Constraints, set by the teacher-such as specific rules, partner positioning, or speed of execution-limited movement options, encouraging students to explore new solutions to complete each task.

Creative

The Combined group took active breaks by combining the Fitness protocol in the first break and the Creative protocol in the second.

Combined
ControlOTHER

Regular physical activity at school during the weeks.

Control

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • attending second and third elementary classroom

You may not qualify if:

  • to be free from injury, which could preclude the PA practice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli Studi del Molise

Campobasso, CB, 86100, Italy

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2024

First Posted

November 12, 2024

Study Start

December 1, 2023

Primary Completion

April 30, 2024

Study Completion

May 31, 2024

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations