Effects of Brain Breaks on Educational Achievement in Laboratory Settings: The Break4Brain Project

ADHD Clinical Trial

Official title:

Effects of Brain Breaks on Educational Achievement in Children With and Without ADHD: The Break4Brain Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06303674
• Other study ID #: 301CER22
• Secondary ID: PID2021-123357OA
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 27, 2023
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: University of the Balearic Islands
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• Physical activity with engaging cognitively
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 cognitively
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

Locations

Country	Name	City	State
Spain	University of the Balearic Islands	Palma	Balearic Islands

Sponsors (4)

Lead Sponsor	Collaborator
University of the Balearic Islands	European Regional Development Fund, Ministry of Science and Innovation, Spanish State Research Agency

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 times (during 4 weeks)
Primary	Inhibition	Flanker Test: Assessed inhibitory control of irrelevant stimuli. Congruent stimuli facilitated processing, while incongruent ones hindered it.	4 times (during 4 weeks)
Primary	Working memory	n-back Test: Evaluated working memory's information updating. Participants matched stimuli to the one 'n' items ago, with increasing difficulty.	4 times (during 4 weeks)
Primary	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.	4 times (during 4 weeks)
Primary	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).	4 times (during 4 weeks)
Secondary	Physical fitness and body composition	Were measured using the ALPHA Physical Fitness Test Battery.	baseline
Secondary	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).	baseline
Secondary	Self-reported sedentary patterns	Sedentary lifestyle levels were also gauged using the Youth Activity Profile (YAP).	baseline
Secondary	Motor proficiency	Was assessed using the Bruininks-Oseretsky Test of Motor Proficiency.	baseline
Secondary	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.	baseline
Secondary	ADHD symptoms	Was evaluated utilizing the Conners Scales 3-Parent Version.	baseline
Secondary	IQ	Was assessed using the Kaufmann Brief Intelligence Test (K-BIT).	baseline
Secondary	Socioeconomic levels	The parents' socioeconomic status was determined using the Family Affluence Scale-II.	baseline
Secondary	Educational levels	The parents' educational level was determined using a custom questionnaire.	baseline