ADHDNCT06303674
Effects of Brain Breaks on Educational Achievement in Laboratory Settings: The Break4Brain Project
A study testing Physical activity with engaging cognitively and Physical activity without engaging cognitively in people with ADHD, run by University of the Balearic Islands at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- Physical activity with engaging cognitively and Physical activity without engaging cognitively
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 27 Feb 2023to Sep 2025
- 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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 10-12 years diagnosed with ADHD by a recognized diagnostic procedure.
- Children aged 10-12 years without any neurodevelopmental impairment.
Who cannot join
- Children who have serious physical or mental disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- ADHD
- Being tested
- Physical activity with engaging cognitively, Physical activity without engaging cognitively
- Keywords
- brain breaks, exercise, brain function, executive function, academic performance
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity with engaging cognitivelyBehavioural
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".
Physical activity without engaging cognitivelyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Physical activity with engaging cognitively | Experimental | This experimental condition involves engaging in physical activity interspersed with rest periods based on cognitive tasks. Receives: Behavioral: Physical activity with engaging cognitively |
| Physical activity without engaging cognitively | Experimental | This experimental condition involves engaging in physical activity interspersed with rest periods (without cognitive tasks). Receives: Behavioral: Physical activity without engaging cognitively |
| Cognitively engaging control conditions | No intervention | In this condition, participants will be suggested to watch a video while seating/resting for 10 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Academic achievement
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.
Measured: 4 times (during 4 weeks)
Inhibition
Flanker Test: Assessed inhibitory control of irrelevant stimuli. Congruent stimuli facilitated processing, while incongruent ones hindered it.
Measured: 4 times (during 4 weeks)
Working memory
n-back Test: Evaluated working memory's information updating. Participants matched stimuli to the one 'n' items ago, with increasing difficulty.
Measured: 4 times (during 4 weeks)
Sustained attention
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.
Measured: 4 times (during 4 weeks)
Brain function
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).
Measured: 4 times (during 4 weeks)
Secondary outcomes (9)
Physical fitness and body composition
Were measured using the ALPHA Physical Fitness Test Battery.
Measured: baseline
Physical activity levels and sleep
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).
Measured: baseline
Self-reported sedentary patterns
Sedentary lifestyle levels were also gauged using the Youth Activity Profile (YAP).
Measured: baseline
Motor proficiency
Was assessed using the Bruininks-Oseretsky Test of Motor Proficiency.
Measured: baseline
Biological maturation
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.
Measured: baseline
ADHD symptoms
Was evaluated utilizing the Conners Scales 3-Parent Version.
Measured: baseline
IQ
Was assessed using the Kaufmann Brief Intelligence Test (K-BIT).
Measured: baseline
Socioeconomic levels
The parents' socioeconomic status was determined using the Family Affluence Scale-II.
Measured: baseline
Educational levels
The parents' educational level was determined using a custom questionnaire.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start27 Feb 2023
- Primary completionJul 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The design of the study is a within-participants crossover pretest-posttest comparison design under laboratory settings will be used. In this design, all participants will engage in all experimental conditions (on separate days), with the order of the experimental conditions being counterbalanced across participants and outcomes assessed following each experimental condition.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain, European Regional Development Fund, State Research Agency, Spain
- Responsible party
- Principal investigator, Josep1, University of the Balearic Islands
- Investigators
- Adrià Muntaner-Mas, PhD, Principal investigator, University of the Balearic Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303674
- Sponsor's protocol ID
- 301CER22
- Other IDs
- PID2021-123357OA-I00
- Status last verified
- Mar 2024
- First submitted
- 1 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Brain Breaks on Educational Achievement in Children With and Without ADHD: The Break4Brain Project
- ClinicalTrials.gov ID
- NCT06303674
- Acronym / sponsor ID
- 301CER22
- Conditions
- ADHD
- Keywords
- brain breaks, exercise, brain function, executive function, academic performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain, European Regional Development Fund, State Research Agency, Spain
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 12 Mar 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The design of the study is a within-participants crossover pretest-posttest comparison design under laboratory settings will be used. In this design, all participants will engage in all experimental conditions (on separate days), with the order of the experimental conditions being counterbalanced across participants and outcomes assessed following each experimental condition.
| Arm | Type | Receives |
|---|---|---|
| Physical activity with engaging cognitively | Experimental | Behavioral: Physical activity with engaging cognitivelyThis experimental condition involves engaging in physical activity interspersed with rest periods based on cognitive tasks. |
| Physical activity without engaging cognitively | Experimental | Behavioral: Physical activity without engaging cognitivelyThis experimental condition involves engaging in physical activity interspersed with rest periods (without cognitive tasks). |
| Cognitively engaging control conditions | No intervention | –In this condition, participants will be suggested to watch a video while seating/resting for 10 minutes. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 10-12 years diagnosed with ADHD by a recognized diagnostic procedure.
- Children aged 10-12 years without any neurodevelopmental impairment.
Key exclusion criteria (1 listed)
- Children who have serious physical or mental disorders.
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 |
|---|---|---|
| Physical activity with engaging cognitivelyThis 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". | Behavioural | Physical activity with engaging cognitively |
| Physical activity without engaging cognitivelyThis 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 | Behavioural | Physical activity without engaging cognitively |
Primary outcome
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.
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.
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.
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.
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).
9 secondary outcomes
Physical fitness and body composition
Time frame: baseline
Physical activity levels and sleep
Time frame: baseline
Self-reported sedentary patterns
Time frame: baseline
Motor proficiency
Time frame: baseline
Biological maturation
Time frame: baseline
ADHD symptoms
Time frame: baseline
IQ
Time frame: baseline
Socioeconomic levels
Time frame: baseline
Educational levels
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
Adrià Muntaner-Mas, PhD principal investigator
University of the Balearic Islands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity with engaging cognitively and Physical activity without engaging cognitively in people with ADHD, run by University of the Balearic Islands at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 12 Mar 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 Spain. 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?
Results are not available in the source record.
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?
Academic achievement (time frame: 4 times (during 4 weeks)). The study lists 5 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 Mar 2024.