- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06303674
Effects of Brain Breaks on Educational Achievement in Laboratory Settings: The Break4Brain Project
March 4, 2024 updated by: Josep1, University of the Balearic Islands
Effects of Brain Breaks on Educational Achievement in Children With and Without ADHD: The Break4Brain Project
Advancement in teaching methods, together with the frenetic change in the lifestyles of the school population, provides a unique opportunity to advance scientific knowledge.
The current project, called "The Break4Brain Project", aims to examine the acute (transient) effects of physical activity on brain function, cognition, and academic performance in children with and without Attention Deficit Hyperactivity Disorder (ADHD).
Specifically, a total of 60 children between 10 and 12 years old will be included with (n=30) and without (n=30) ADHD.
The study will use an intra-subject design of isolated conditions with four measurement moments where the children will perform three different experimental conditions lasting 10 minutes, which will be randomized in a counterbalanced manner.
These experimental conditions will be based on physical activity engaging cognitively, physical activity without engaging cognitively, and cognitively engaging control condition.
This project could have a significant impact in the educational field, since, if brain function, cognition, and academic performance prove to be favorably stimulated, acutely, by physical activity through active breaks, these could be prescribed as an effective teaching strategy for children with and without ADHD in the school setting.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
60
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
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Balearic Islands
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Palma, Balearic Islands, Spain, 07122
- University of the Balearic Islands
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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
Yes
Description
Inclusion Criteria:
- Children aged 10-12 years diagnosed with ADHD by a recognized diagnostic procedure.
- Children aged 10-12 years without any neurodevelopmental impairment.
Exclusion Criteria:
- Children who have serious physical or mental disorders.
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: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physical activity with engaging cognitively
This experimental condition involves engaging in physical activity interspersed with rest periods based on cognitive tasks.
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This experimental condition will follow the following structure: involving 10 consecutive, 30 second-blocks of physical activity.
This experimental condition will focus on aerobic metabolism.
The total exercise time commitment is 10 minutes (30 seconds of working - 30 seconds of executing an engaging cognitive task, 1:1 work-to-rest ratio), plus 5 minutes of warm-ups and 5 minutes of cool-down activities.
The cognitive task consists of solving various "tangrams".
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Experimental: Physical activity without engaging cognitively
This experimental condition involves engaging in physical activity interspersed with rest periods (without cognitive tasks).
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This experimental condition will replicate the structure of the preceding one.
Participants will engage in physical activity, guided by video observation and imitation.
However, during the rest periods, they will refrain from engaging in cognitive tasks
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No Intervention: Cognitively engaging control conditions
In this condition, participants will be suggested to watch a video while seating/resting for 10 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Academic achievement
Time Frame: 4 times (during 4 weeks)
|
In this research, only the general academic fluency index was administered, consisting of the reading, mathematics, and writing fluency subtests.
Reading fluency assessed the participant's capacity to read simple sentences rapidly, mathematical fluency gauged the ability to quickly solve simple addition, subtraction, and multiplication problems, and writing fluency measured the skill to formulate and write sentences promptly.
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4 times (during 4 weeks)
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Inhibition
Time Frame: 4 times (during 4 weeks)
|
Flanker Test: Assessed inhibitory control of irrelevant stimuli.
Congruent stimuli facilitated processing, while incongruent ones hindered it.
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4 times (during 4 weeks)
|
|
Working memory
Time Frame: 4 times (during 4 weeks)
|
n-back Test: Evaluated working memory's information updating.
Participants matched stimuli to the one 'n' items ago, with increasing difficulty.
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4 times (during 4 weeks)
|
|
Sustained attention
Time Frame: 4 times (during 4 weeks)
|
Conners CPT-3 Attention Test: Examined sustained attention with 360 trials, 18 blocks, and varying intervals.
90% featured non-X target stimuli.
Assessment included scaled scores for attentional capacity (d'), error categorization, and reaction metrics.
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4 times (during 4 weeks)
|
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Brain function
Time Frame: 4 times (during 4 weeks)
|
Event-related brain potentials (ERPs), acquired from the electroencephalogram, served as a metric for brain response to discrete events.
Neuroelectric activity was captured from 14 scalp electrode sites, arranged using the EMOTIV EPOC X and its corresponding software.
Selected components of event-related brain potentials were assessed, with a focus on analyzing the amplitude and latency of P3 (also referred to as P300).
A higher P3 amplitude was considered indicative of an enhanced ability to enlist attentional resources, while a lower P3 latency was considered indicative of heightened cognitive processing speed.
In study I, ERPs were concurrently recorded during cognitive function (not CPT-3).
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4 times (during 4 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical fitness and body composition
Time Frame: baseline
|
Were measured using the ALPHA Physical Fitness Test Battery.
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baseline
|
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Physical activity levels and sleep
Time Frame: baseline
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Were assessed using Actigraph wGT3X-BT accelerometers, which participants carried throughout their four-week involvement in the project.
Additionally, sedentary lifestyle levels were gauged using the Youth Activity Profile (YAP).
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baseline
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Self-reported sedentary patterns
Time Frame: baseline
|
Sedentary lifestyle levels were also gauged using the Youth Activity Profile (YAP).
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baseline
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Motor proficiency
Time Frame: baseline
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Was assessed using the Bruininks-Oseretsky Test of Motor Proficiency.
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baseline
|
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Biological maturation
Time Frame: baseline
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Was measured using maximum height velocity (PHV), an indicator reflecting the peak velocity of height growth during childhood.
Weight, height, and sitting height were utilized to calculate VPM based on Moore's equations.
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baseline
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ADHD symptoms
Time Frame: baseline
|
Was evaluated utilizing the Conners Scales 3-Parent Version.
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baseline
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IQ
Time Frame: baseline
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Was assessed using the Kaufmann Brief Intelligence Test (K-BIT).
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baseline
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Socioeconomic levels
Time Frame: baseline
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The parents' socioeconomic status was determined using the Family Affluence Scale-II.
|
baseline
|
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Educational levels
Time Frame: baseline
|
The parents' educational level was determined using a custom questionnaire.
|
baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Adrià Muntaner-Mas, PhD, University of the Balearic Islands
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)
February 27, 2023
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
February 1, 2024
First Submitted That Met QC Criteria
March 4, 2024
First Posted (Actual)
March 12, 2024
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 301CER22
- PID2021-123357OA-I00 (Other Grant/Funding Number: Ministry of Science and Innovation - Spanish State Research Agency - European Regional Development Fund)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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