NCT06303674

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

February 1, 2024

Last Update Submit

March 4, 2024

Conditions

Keywords

brain breaksexercisebrain functionexecutive functionacademic performance

Outcome Measures

Primary Outcomes (5)

  • 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)

  • Inhibition

    Flanker Test: Assessed inhibitory control of irrelevant stimuli. Congruent stimuli facilitated processing, while incongruent ones hindered it.

    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.

    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.

    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).

    4 times (during 4 weeks)

Secondary Outcomes (9)

  • Physical fitness and body composition

    baseline

  • Physical activity levels and sleep

    baseline

  • Self-reported sedentary patterns

    baseline

  • Motor proficiency

    baseline

  • Biological maturation

    baseline

  • +4 more secondary outcomes

Study Arms (3)

Physical activity with engaging cognitively

EXPERIMENTAL

This experimental condition involves engaging in physical activity interspersed with rest periods based on cognitive tasks.

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).

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.

Interventions

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 with 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

Physical activity without engaging cognitively

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 10-12 years diagnosed with ADHD by a recognized diagnostic procedure.
  • Children aged 10-12 years without any neurodevelopmental impairment.

You may not qualify if:

  • Children who have serious physical or mental disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Balearic Islands

Palma, Balearic Islands, 07122, Spain

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Adrià Muntaner-Mas, PhD

    University of the Balearic Islands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

February 1, 2024

First Posted

March 12, 2024

Study Start

February 27, 2023

Primary Completion

July 1, 2024

Study Completion

September 1, 2025

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations