Physical ActivityNCT06319833
Effects of Brain Breaks on Educational Achievement in School Settings: The Break4Brain Project
A study testing Physical activity interacting with a video in people with Physical Activity, run by University of the Balearic Islands at 1 site in Spain.
Trial summary
A total of 600 children between 10 and 12 years of age will be randomized among two experimental conditions: physical activity interacting with a video (n = 300), and sedentary activity (n = 300). Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Physical activity interacting with a video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2024to Jul 2024
- 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.
Who cannot join
- Children who have serious physical or mental disorders (autism spectrum disorder, intellectual disability, and cerebral palsy) that would impede participation in the experimental conditions.
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
A total of 600 children between 10 and 12 years of age will be randomized among two experimental conditions: physical activity interacting with a video (n = 300), and sedentary activity (n = 300). The experimental condition will take place in the school settings during the school day through a between-subject design with a total of two measurements, pre, and post-test. Using the latest advances, the transient effects of the experimental conditions on cognitive and academic performance will be measured. The experimental condition was crafted through a qualitative design involving semi-structured interviews with teachers (n = 41) and members of the management team (n = 16), along with questionnaires administered to students (n = 600). To enhance and ensure its sustainability, the same process will be replicated after the intervention. Interviews and questionnaires were meticulously crafted by the RE-AIM framework, and subsequently validated through a rigorous process involving an expert panel (n = 30) utilizing the Delphi methodology. This project has the potential to substantially contribute to the field of acute physical activity and could have a meaningful transference on the educational system. This method might be prescribed as an effective teaching strategy.
- Conditions
- Physical Activity
- Being tested
- Physical activity interacting with a video
- Keywords
- active breaks, executive functions, academic performance, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interacting with a videoBehavioural
This experimental condition will be implemented five times a week, once per day, over 8 weeks. It will follow a structured format, including seven consecutive 40-second blocks of physical activity. The total video duration will amount to 9 minutes (40 seconds of activity followed by 20 seconds of rest, maintaining a 2:1 work-to-rest ratio). Additionally, participants will engage in 5 minutes of warm-up exercises and 5 minutes of cool-down activities. The experimental condition will consist of 10 videos, each centered around one of five different themes (a different one will be administered every day).
| Study group | Role | What they receive |
|---|---|---|
| Physical activity interacting with a video | Experimental | This experimental condition involves engaging in physical activity interspersed with rest periods. The type of exercises are based on phase I. Receives: Behavioral: Physical activity interacting with a video |
| Control condition | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Academic achievement
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: 8 weeks
Inhibition-attention and cognitive flexibility
The assessment of inhibition-attention and cognitive flexibility was conducted using the "Trail Making Test".
Measured: 8 weeks
Working memory
The measurement of working memory through "The Digit Memory Test," specifically focusing on auditory attention and verbal memory.
Measured: 8 weeks
Selective attention
The measurement of selective attention within a limited timeframe was carried out using the "D2 test."
Measured: 8 weeks
Design of active breaks: semi-structured questionnaires
Pre- and post-intervention, to guarantee a proper design and future sustainability of the experimental condition, semi-structured questionnaires are administered to students. The responses are systematically categorized.
Measured: 2 months (november and may)
Design of active breaks: semi-structured interviews
Pre- and post-intervention, to guarantee a proper design and future sustainability of the experimental condition, semi-structured interviews are administered to teachers and the management team. The responses are systematically categorized.
Measured: 2 months (november and may)
Secondary outcomes (8)
Physical activity patterns
Physical activity patterns will be measured through accelerometry using the ActiGraph wGT3X-BT. Additionally, the intensity of the brain breaks will also be calculated with the same tool.
Measured: 8 weeks
Self-report physical activity patterns
Physical activity levels over the preceding seven days were assessed using the PAQ-C.
Measured: 8 weeks
Self-report sedentary patterns
Sedentary patterns over the preceding 7 days were assessed using the YAP-S.
Measured: 8 weeks
Self-report physical fitness
The level of physical fitness was assessed using the self-administered IFIS questionnaire.
Measured: 8 weeks
Socioeconomic level
The socioeconomic status was assessed through the Family Affluence Scale-II.
Measured: 8 weeks
Student's behavior
The behavior of students in a regular classroom setting was examined using the "Child and Adolescent Behavior Inventory", inattention and hyperactivity-impulsivity parts, for teachers.
Measured: 8 weeks
Body composition
Parents self-reported the body composition. In this case, parents will just report height (cm) and weight (kg).
Measured: 8 weeks
Creativity
Participants were required to complete the maximum number of unusual uses for two objects within a 5-minute timeframe.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start8 Jan 2024
- Primary completionApr 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319833
- Sponsor's protocol ID
- 348CER23
- Status last verified
- Mar 2024
- First submitted
- 2 Feb 2024
- Last updated
- 20 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 20 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
- NCT06319833
- Acronym / sponsor ID
- 348CER23
- Conditions
- Physical Activity
- Keywords
- active breaks, executive functions, academic performance, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 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
- 8 Jan 2024 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 20 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.
A total of 600 children between 10 and 12 years of age will be randomized among two experimental conditions: physical activity interacting with a video (n = 300), and sedentary activity (n = 300). The experimental condition will take place in the school settings during the school day through a between-subject design with a total of two measurements, pre, and post-test. Using the latest advances, the transient effects of the experimental conditions on cognitive and academic performance will be measured. The experimental condition was crafted through a qualitative design involving semi-structured interviews with teachers (n = 41) and members of the management team (n = 16), along with questionnaires administered to students (n = 600). To enhance and ensure its sustainability, the same process will be replicated after the intervention. Interviews and questionnaires were meticulously crafted by the RE-AIM framework, and subsequently validated through a rigorous process involving an expert panel (n = 30) utilizing the Delphi methodology. This project has the potential to substantially contribute to the field of acute physical activity and could have a meaningful transference on the educational system. This method might be prescribed as an effective teaching strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity interacting with a video | Experimental | Behavioral: Physical activity interacting with a videoThis experimental condition involves engaging in physical activity interspersed with rest periods. The type of exercises are based on phase I. |
| Control condition | No intervention | – |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 10-12 years.
Key exclusion criteria (1 listed)
- Children who have serious physical or mental disorders (autism spectrum disorder, intellectual disability, and cerebral palsy) that would impede participation in the experimental conditions.
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 interacting with a videoThis experimental condition will be implemented five times a week, once per day, over 8 weeks. It will follow a structured format, including seven consecutive 40-second blocks of physical activity. The total video duration will amount to 9 minutes (40 seconds of activity followed by 20 seconds of rest, maintaining a 2:1 work-to-rest ratio). Additionally, participants will engage in 5 minutes of warm-up exercises and 5 minutes of cool-down activities. The experimental condition will consist of 10 videos, each centered around one of five different themes (a different one will be administered every day). | Behavioural | Physical activity interacting with a video |
Primary outcome
Academic achievement
Time frame: 8 weeks
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-attention and cognitive flexibility
Time frame: 8 weeks
The assessment of inhibition-attention and cognitive flexibility was conducted using the "Trail Making Test".
Working memory
Time frame: 8 weeks
The measurement of working memory through "The Digit Memory Test," specifically focusing on auditory attention and verbal memory.
Selective attention
Time frame: 8 weeks
The measurement of selective attention within a limited timeframe was carried out using the "D2 test."
Design of active breaks: semi-structured questionnaires
Time frame: 2 months (november and may)
Pre- and post-intervention, to guarantee a proper design and future sustainability of the experimental condition, semi-structured questionnaires are administered to students. The responses are systematically categorized.
Design of active breaks: semi-structured interviews
Time frame: 2 months (november and may)
Pre- and post-intervention, to guarantee a proper design and future sustainability of the experimental condition, semi-structured interviews are administered to teachers and the management team. The responses are systematically categorized.
8 secondary outcomes
Physical activity patterns
Time frame: 8 weeks
Self-report physical activity patterns
Time frame: 8 weeks
Self-report sedentary patterns
Time frame: 8 weeks
Self-report physical fitness
Time frame: 8 weeks
Socioeconomic level
Time frame: 8 weeks
Student's behavior
Time frame: 8 weeks
Body composition
Time frame: 8 weeks
Creativity
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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.
The record lists no contact. Use the official record to reach the sponsor.
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 interacting with a video in people with Physical Activity, 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 1 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 20 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: 8 weeks). The study lists 6 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 20 Mar 2024.