Physical PerformanceNCT06684808
Impact of Active Breaks in Elementary School Children
A study testing Fitness, Creative and Combined in people with Physical Performance and Cognitive Performance, run by University of Molise at 1 site in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Physical Performance, Cognitive Performance, Academic Acheivement
- What is being tested?
- Fitness, Creative and Combined
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- attending second and third elementary classroom
Who cannot join
- to be free from injury, which could preclude the PA practice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Being tested
- Fitness, Creative, Combined, Control
- Keywords
- active breaks, children, academic achievement, physical activity, school time
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
CreativeOther
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.
CombinedOther
The Combined group took active breaks by combining the Fitness protocol in the first break and the Creative protocol in the second.
ControlOther
Regular physical activity at school during the weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Other: Combined |
| Control | Active comparator | Regular physical activity at school during the weeks. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
Measured: after 12 weeks
Weight
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: after 12 weeks
Long jump from a standing start
Perform as long a forward jump as possible starting from a standing position.
Measured: after 12 weeks
Fast shuttle run 10x5m
Run 5 m for 10 times at the highest possible speed
Measured: 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
Measured: after 12 weeks
Reynolds Interference Task (RIT) test
Measurement of complex processing speed
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Dec 2023
- Primary completion30 Apr 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Molise
- Sponsor type
- University, hospital or other
- Collaborators
- Alessandra di Cagno, Giuseppe Calcagno, Giovanni Fiorilli, Andrea Buonsenso
- Responsible party
- Principal investigator, Marco Centorbi, University of Molise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684808
- Sponsor's protocol ID
- 61/2020
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Active Breaks in the Classroom on Physical, Mathematical and Cognitive Performance in Elementary School Children
- ClinicalTrials.gov ID
- NCT06684808
- Acronym / sponsor ID
- 61/2020
- Keywords
- active breaks, children, academic achievement, physical activity, school time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University of MoliseUniversity, hospital or other
- Collaborators
- Alessandra di Cagno, Giuseppe Calcagno, Giovanni Fiorilli, Andrea Buonsenso
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fitness | Experimental | Other: FitnessThe 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 |
| Creative | Experimental | Other: CreativeThe 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. |
| Combined | Experimental | Other: CombinedThe Combined group took active breaks by combining the Fitness protocol in the first break and the Creative protocol in the second. |
| Control | Active comparator | Other: ControlRegular physical activity at school during the weeks. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- attending second and third elementary classroom
Key exclusion criteria (1 listed)
- to be free from injury, which could preclude the PA practice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitnessThe 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 |
| CreativeThe 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 |
| CombinedThe Combined group took active breaks by combining the Fitness protocol in the first break and the Creative protocol in the second. | Other | Combined |
| ControlRegular physical activity at school during the weeks. | Other | Control |
Primary outcome
Height
Time frame: after 12 weeks
Weight
Time frame: 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
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
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
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
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
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
Long jump from a standing start
Time frame: after 12 weeks
Perform as long a forward jump as possible starting from a standing position.
Fast shuttle run 10x5m
Time frame: after 12 weeks
Run 5 m for 10 times at the highest possible speed
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
Reynolds Interference Task (RIT) test
Time frame: after 12 weeks
Measurement of complex processing speed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitness, Creative and Combined in people with Physical Performance and Cognitive Performance, run by University of Molise at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height (time frame: after 12 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.