Impact of Active Breaks in Elementary School Children

November 9, 2024 updated by: Marco Centorbi, University of Molise

Impact of Active Breaks in the Classroom on Physical, Mathematical and Cognitive Performance in Elementary School Children

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
159

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CB
      • Campobasso, CB, Italy, 86100
        • Università degli studi del molise

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • attending second and third elementary classroom

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
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
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.
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
The Combined group took active breaks by combining the Fitness protocol in the first break and the Creative protocol in the second.
Active Comparator: Control
Regular physical activity at school during the weeks.
Other: Control
Regular physical activity at school during the weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Height
Time Frame: after 12 weeks
after 12 weeks
Weight
Time Frame: after 12 weeks
after 12 weeks
Leaps forward on one foot
Time Frame: after 12 weeks
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
Time Frame: after 12 weeks
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
Time Frame: after 12 weeks
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
Time Frame: after 12 weeks
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
Time Frame: after 12 weeks
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
Time Frame: after 12 weeks
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
Time Frame: after 12 weeks
Perform as long a forward jump as possible starting from a standing position.
after 12 weeks
Fast shuttle run 10x5m
Time Frame: after 12 weeks
Run 5 m for 10 times at the highest possible speed
after 12 weeks
Assessment Test of Calculation Skills AC.MT 6-11
Time Frame: after 12 weeks
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
Time Frame: after 12 weeks
Measurement of complex processing speed
after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Molise

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Giuseppe Calcagno
Giovanni Fiorilli
Andrea Buonsenso
Alessandra di Cagno

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 61/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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