ClinicalTrials.gg
CompletedNCT06684808Updated Nov 12, 2024

Impact of Active Breaks in Elementary School Children

An interventional study of Fitness and Creative in Physical Performance, Cognitive Performance and Academic Acheivement, sponsored by University of Molise. Completed at 1 site in Italy. Open to participants aged 6 Years to 8 Years. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by University of Molise · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Dec 2023, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
6 Years to 8 Years
Sex
All
01

Study 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.

Read the detailed description

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. 159 children were recruited: 92 for experimental group (EG) and 67 for Control Group(CG); after the baseline assessment, the EG classes were randomly assigned into three experimental groups: creativity AB (CREAT; n = 30 ), fitness AB (FIT; n =31 ) and combined AB (COM; n= 31 ) . Specifically, the EG carried out an active break intervention for 12 weeks during curricular time, repeated twice a day, with the duration of 10 minutes, three times a week. CG did not performed any type of active breaks.

02

Conditions studied

  • Physical Performance
  • Cognitive Performance
  • Academic Acheivement

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Keywords

  • active breaks
  • children
  • academic achievement
  • physical activity
  • school time
03

In context

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

This study's enrollment of 159 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

University of Molise is the lead sponsor of 19 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • attending second and third elementary classroom

Exclusion criteria

Exclusion Criteria:

  • to be free from injury, which could preclude the PA practice.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
159 participants (actual)

Study arms

  • Experimental
    Fitness

    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

  • Experimental
    Creative

    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

  • Experimental
    Combined

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

    Other: Combined

  • Active comparator
    Control

    Regular physical activity at school during the weeks.

    Other: Control

Interventions

  • OtherFitness

    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.

  • OtherCreative

    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.

  • OtherCombined

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

  • OtherControl

    Regular physical activity at school during the weeks.

06

What researchers measure

Primary outcomes

  1. Height

    Time frame: after 12 weeks

  2. Weight

    Time frame: after 12 weeks

  3. 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

    Time frame: after 12 weeks

  4. 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

    Time frame: after 12 weeks

  5. 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

    Time frame: after 12 weeks

  6. 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

    Time frame: after 12 weeks

  7. 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

    Time frame: after 12 weeks

  8. 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

    Time frame: after 12 weeks

  9. Long jump from a standing start

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

    Time frame: after 12 weeks

  10. Fast shuttle run 10x5m

    Run 5 m for 10 times at the highest possible speed

    Time frame: after 12 weeks

  11. 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

    Time frame: after 12 weeks

  12. Reynolds Interference Task (RIT) test

    Measurement of complex processing speed

    Time frame: after 12 weeks

07

Study locations

1 site
  • Università degli Studi del Molise
    Campobasso, CB 86100, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2023 to primary completion in Apr 2024, 4 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 4 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2024
First posted
Nov 12, 2024
StartActual
Dec 1, 2023
Primary completionActual
Apr 30, 2024
CompletionActual
May 31, 2024
Last update
Nov 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06684808
Lead sponsor
University of Molise
Collaborators
Alessandra di Cagno, Giuseppe Calcagno, Giovanni Fiorilli, Andrea Buonsenso
Responsible party
Marco Centorbi (Principal Investigator, University of Molise) — Principal investigator
First posted
Nov 12, 2024
Start date
Dec 1, 2023
Primary completion
Apr 30, 2024
Completion
May 31, 2024
Last update
Nov 12, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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