Clinical trial NCT06303674: Effects of Brain Breaks on Educational Achievement in Laboratory Settings: The Break4Brain Project
Official title: Effects of Brain Breaks on Educational Achievement in Children With and Without ADHD: The Break4Brain Project
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ADHD
Keywords: brain breaks
exercise
brain function
executive function
academic performance
Lead sponsor: University of the Balearic Islands
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Innovation, Spain
name: European Regional Development Fund
name: State Research Agency, Spain
First posted: 2024-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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, 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Academic achievement
timeFrame: 4 times (during 4 weeks)
measure: Inhibition
timeFrame: 4 times (during 4 weeks)
measure: Working memory
timeFrame: 4 times (during 4 weeks)
measure: Sustained attention
timeFrame: 4 times (during 4 weeks)
measure: Brain function
timeFrame: 4 times (during 4 weeks)
Secondary outcomes:
measure: Physical fitness and body composition
timeFrame: baseline
measure: Physical activity levels and sleep
timeFrame: baseline
measure: Self-reported sedentary patterns
timeFrame: baseline
measure: Motor proficiency
timeFrame: baseline
measure: Biological maturation
timeFrame: baseline
measure: ADHD symptoms
timeFrame: baseline
measure: IQ
timeFrame: baseline
measure: Socioeconomic levels
timeFrame: baseline
measure: Educational levels
timeFrame: baseline
Other outcomes:
Locations:
city: Palma
country: Spain
facility: University of the Balearic Islands
state: Balearic Islands
Study officials:
affiliation: University of the Balearic Islands
name: Adrià Muntaner-Mas, PhD
role: PRINCIPAL_INVESTIGATOR
References: