- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06684808
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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
159
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
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.
|
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.
|
Regular physical activity at school during the weeks.
|
What is the study measuring?
Primary Outcome Measures
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
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)
December 1, 2023
Primary Completion (Actual)
April 30, 2024
Study Completion (Actual)
May 31, 2024
Study Registration Dates
First Submitted
November 8, 2024
First Submitted That Met QC Criteria
November 9, 2024
First Posted (Estimated)
November 12, 2024
Study Record Updates
Last Update Posted (Estimated)
November 12, 2024
Last Update Submitted That Met QC Criteria
November 9, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Other Study ID 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.
Clinical Trials on Academic Acheivement
-
University of Southern DenmarkIMK FondenCompletedPhysical Activity | Academic Acheivement
-
Istanbul University - CerrahpasaNot yet recruitingAcademic Acheivement | Attention | Students | Breathing Exercises | Exam Anxiety
-
Kocaeli UniversitySakarya University of Applied SciencesCompletedNursing Education | Academic Acheivement | Satisfaction | Vital Signs | AnimationTurkey
-
University of South CarolinaCompleted
-
Nagihan AcetCompletedAcademic Acheivement | Internet Addiction | Smartphone Addiction | Technology Literacy | Reading HabitsTurkey (Türkiye)
-
XIE HUIJUANEnrolling by invitationAcademic PerformanceChina
-
Mbarara University of Science and TechnologyUniversity of Calgary; Alberta Children's Hospital Research Institute; The ELMA... and other collaboratorsRecruiting
-
Anhui Medical UniversityNot yet recruitingAcademic Self-efficacy
-
University College CopenhagenUniversity of Copenhagen; UCL University College, DenmarkRecruitingAcademic PerformanceDenmark
-
Ivan David Lozada-MartinezCompleted
Clinical Trials on Fitness
-
University of WashingtonCenters for Disease Control and PreventionRecruitingArthritis | Osteoarthritis | Rheumatoid Arthritis | Fibromyalgia | Gout | Lupus or SLEUnited States
-
Mike O'Callaghan Military HospitalCompletedType II Diabetes MellitusUnited States
-
Colorado State UniversityCompleted
-
University of AarhusCentral Denmark Region; TRYG Foundation; Randers Municipality, DenmarkCompletedPhysical Activity | Health Behavior | Motivation | Cardiorespiratory Fitness | IntentionDenmark
-
University of MichiganAmerican Diabetes AssociationCompletedMetabolic SyndromeUnited States
-
University Hospital TuebingenUnknownCancer | Fatigue | Physical ActivityGermany
-
University of PennsylvaniaCompleted
-
Universitat de LleidaNot yet recruitingExercise | Hemodynamics | ACL Injury | ACL - Anterior Cruciate Ligament Rupture | Oxygen Consumption Based Assessment of Hemodynamics
-
Pennington Biomedical Research CenterAmerican Diabetes Association; Louisiana State University, Baton Rouge; American...CompletedFeasibility of the Camp Power Up Program on Children's Body Weight and Quality of Life (CampPowerUp)Quality of Life | Obesity, Childhood | Weight Change, BodyUnited States
-
University of KansasUniversity of Kansas Medical CenterCompletedOlder Adults | Mobility DisabilityUnited States