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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Spain
    • Balearic Islands
      • Palma, Balearic Islands, Spain, 07122
        • University of the Balearic Islands

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Physical activity with engaging cognitively
This experimental condition involves engaging in physical activity interspersed with rest periods based on cognitive tasks.
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".
Experimental: Physical activity without engaging cognitively
This experimental condition involves engaging in physical activity interspersed with rest periods (without cognitive tasks).
Behavioral: 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
No Intervention: Cognitively engaging control conditions
In this condition, participants will be suggested to watch a video while seating/resting for 10 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
4 times (during 4 weeks)
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.
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.
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.
4 times (during 4 weeks)
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).
4 times (during 4 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical fitness and body composition
Time Frame: baseline
Were measured using the ALPHA Physical Fitness Test Battery.
baseline
Physical activity levels and sleep
Time Frame: baseline
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
Self-reported sedentary patterns
Time Frame: baseline
Sedentary lifestyle levels were also gauged using the Youth Activity Profile (YAP).
baseline
Motor proficiency
Time Frame: baseline
Was assessed using the Bruininks-Oseretsky Test of Motor Proficiency.
baseline
Biological maturation
Time Frame: baseline
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
ADHD symptoms
Time Frame: baseline
Was evaluated utilizing the Conners Scales 3-Parent Version.
baseline
IQ
Time Frame: baseline
Was assessed using the Kaufmann Brief Intelligence Test (K-BIT).
baseline
Socioeconomic levels
Time Frame: baseline
The parents' socioeconomic status was determined using the Family Affluence Scale-II.
baseline
Educational levels
Time Frame: baseline
The parents' educational level was determined using a custom questionnaire.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of the Balearic Islands

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Regional Development Fund
Spanish State Research Agency
Ministry of Science and Innovation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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