Healthy LifestyleNCT06496503
Effect of a School Intervention With Physical Activity on Executive Functions
A study testing Physical activity Protocol in people with Healthy Lifestyle, run by State University of Londrina at 1 site in Brazil.
Trial summary
Previous studies have indicated the relationship between physical activity and cognitive performance, with movement being a promising tool for improving executive functions, especially during childhood, which is a period of intense brain development. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- What is being tested?
- Physical activity Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Sep 2024to 30 Apr 2025
- 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy
- Neurotypical.
Who cannot join
- Clinical or historical of cardiovascular disease
- Hypertension
- Insulin-dependent diabetes mellitus
- Neurodiversity
- Not be taking any drugs
- Cannot participated in sports practices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a School Intervention With Physical Activity on Executive Functions and Relationships With Cardiorespiratory Fitness and Motor Coordination: Randomized Clinical Trial
Previous studies have indicated the relationship between physical activity and cognitive performance, with movement being a promising tool for improving executive functions, especially during childhood, which is a period of intense brain development. Thus, the objective of this project is to verify a school physical activity intervention on executive functions and the relationships with cardiorespiratory fitness and motor coordination. This will be a randomized control trial in accordance with the Consort - Statement, including 118 children of both sexes; 60 in an experimental group and 58 in a control group. The children will follow their usual school routines, including Physical Education classes as part of the curriculum. The experimental group will also participate in an intervention for 12 weeks after school. The intervention will include three weekly physical exercise sessions, lasting between 50 and 60 minutes. The sessions will consist of activities involving games, sports, dance with a focus on aspects of motor coordination and cardiorespiratory fitness, as well as cognitive games. Assessments will be carried out at baseline, after 12 weeks of intervention and after the follow-up period. The students will undergo measurements of body mass and height, as well as nutritional classification using the body mass index (BMI). Following this, a general motor coordination test (KTK), a cardiorespiratory aptitude test (Léger), and tests to assess executive functions (Stroop and Corsi Block) will be applied. Data distribution will be verified using the Shapiro-Wilk's test. The comparisons between different moments (baseline, after 12 weeks, and at follow-up) will be performed using repeated measures ANOVA. Sphericity will be checked by Mauchly's test followed by the Greenhouse- Geisser correction when necessary. To identify differences, the Bonferroni correction will be applied. The significance level will be set at 5% (P<0.05).
Read the detailed description
During childhood, cognitive aspects of the prefrontal cortex are in the maturation phase. This process is associated with improvements in executive functions, in a continuous process, and although differentiated by its multiple aspects, it seems to correspond with the development peaks of the prefrontal cortex, which occur between 7 and 9 years of age. In addition to the biological alterations arising from the growth and development of the brain, physical activity performed regularly indicates a simple and effective way to improve the executive functions of children. Contreras-Osorio and colleagues stated that physical activity performed at moderate and vigorous intensities is positively related to working memory, reaction time, executive attention, cognitive flexibility, and planning in children and adolescents aged 10 to 12 years. Other authors highlight that activities involving cardiorespiratory fitness and motor coordination provide an increase in cognitive performance, with improvements in planning capacity, memory, self-control, and value judgment, among other fundamental components for social interaction and academic performance In a previous study, Visier-Alfonso and colleagues evaluated 186 school-age children aged 9 to 11 years and demonstrated positive effects on cardiorespiratory fitness, with increased physical activity, and positive changes in inhibitory control, working memory, and brain structure. Additionally, good levels of motor coordination are associated with complex movements and sport-specific skills, and are also essential for the development of higher levels of cognitive function. The relationships between motor skills and executive functions during childhood are based on coactivation events between the prefrontal cortex, the cerebellum, and the basal ganglia during different motor and cognitive tasks, especially when the task is complex, is a new task, or requires speed and concentration. This is because neural regions typically associated with cognitive operations can also be recruited during the performance of motor tasks.
- Conditions
- Healthy Lifestyle
- Being tested
- Physical activity Protocol
- Keywords
- cognitive function, child, physical activity, schoolchildren
- 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 ProtocolBehavioural
The children included in the experimental group will undergo 12 weeks of physical activity sessions, and it is mandatory that all children complete a minimum of two weekly sessions of physical activity for 50-60 minutes. The activities will consist of content such as motor and cognitive games, sports, dance, and gymnastics. The intensity of the sessions will be checked using accelerometry. The physical activity protocol is adapted from a previously described protocol (CMSP, 2021; Klem, Filha, Monteiro, 2017; Mazzoccante et al.; 2020; Paiano, 2019; Rodrigues, 2018; Rosini et al., 2014). Acceptance of the exercise program in the pediatric population has been previously observed in a pilot study.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The children included in the experimental group will undergo 12 weeks of physical activity sessions, and it is mandatory that all children complete a minimum of two weekly sessions of physical activity for 50-60 minutes. The activities will consist of content such as motor and cognitive games, sports, dance, and gymnastics. The intensity of the sessions will be checked using accelerometry. The physical activity protocol is adapted from a previously described protocol (CMSP, 2021; Klem, Filha, Monteiro, 2017; Mazzoccante et al.; 2020; Paiano, 2019; Rodrigues, 2018; Rosini et al., 2014). Acceptance of the exercise program in the pediatric population has been previously observed in a pilot study. Receives: Behavioral: Physical activity Protocol |
| Control group | No intervention | The children will follow their usual school routines, including Physical Education classes as part of the curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Functions
The executive functions will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention (follow-up period). Executive functions will be investigated in the domains of working memory, using the Corsi Block Test (Corsi, 1972; Kessels et al., 2000), and inhibitory control, investigated by the Stroop Test (Stroop, 1935; MacLeod, 1991). For both tests there will be familiarization and reproducibility of measurements for both the children and evaluator. The evaluation will be carried out by a single evaluator blind to group allocation.
Measured: Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.
Secondary outcomes (1)
Cardiorespiratory fitness
The test will be conducted in the field with cones at a distance of 20 meters and a pre-recorded audio track to indicate the speed of each stage. The first stage starts at 8.5 km/h, with an increase of 0.5 km/h every minute, which indicates a change of stage. The test is considered to end when the child is unable to maintain the imposed speed or complete a stage with less than two errors (Léger et al., 1998).
The prescription of training will be dependent on the individual results for each child based on the last stage completed in the progressive test. At baseline, two field tests will be performed, the first one being a familiarization test and the second being considered as the value prior to the training. In addition, reproducibility of measurements will be tested to indicate the reliability of the results.
Measured: Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start2 Sep 2024
- Primary completion26 Nov 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Healthy LifestyleStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be performed carefully following the recommendations proposed by the Cochrane Collaboration. The process will consist of two stages, firstly, the generation of numbers using a random number table, and secondly, allocation concealment, using opaque, sealed envelopes. After signing the consent form, an envelope will be opened for each child and they will be instructed as to which group they have been allocated, the experimental or control.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Cristiane Silva, State University of Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496503
- Sponsor's protocol ID
- UEL
- Status last verified
- Nov 2024
- First submitted
- 3 Jul 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Contreras-Osorio F, Guzman-Guzman IP, Cerda-Vega E, Chirosa-Rios L, Ramirez-Campillo R, Campos-Jara C. Effects of the Type of Sports Practice on the Executive Functions of Schoolchildren. Int J Environ Res Public Health. 2022 Mar 24;19(7):3886. doi: 10.3390/ijerph19073886.
PubMed 35409571Davis CL, Tomporowski PD, McDowell JE, Austin BP, Miller PH, Yanasak NE, Allison JD, Naglieri JA. Exercise improves executive function and achievement and alters brain activation in overweight children: a randomized, controlled trial. Health Psychol. 2011 Jan;30(1):91-8. doi: 10.1037/a0021766.
PubMed 21299297de Greeff JW, Bosker RJ, Oosterlaan J, Visscher C, Hartman E. Effects of physical activity on executive functions, attention and academic performance in preadolescent children: a meta-analysis. J Sci Med Sport. 2018 May;21(5):501-507. doi: 10.1016/j.jsams.2017.09.595. Epub 2017 Oct 10.
PubMed 29054748Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
PubMed 23020641Diamond A, Lee K. Interventions shown to aid executive function development in children 4 to 12 years old. Science. 2011 Aug 19;333(6045):959-64. doi: 10.1126/science.1204529.
PubMed 21852486Evenson KR, Catellier DJ, Gill K, Ondrak KS, McMurray RG. Calibration of two objective measures of physical activity for children. J Sports Sci. 2008 Dec;26(14):1557-65. doi: 10.1080/02640410802334196.
PubMed 18949660Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Fuster JM. The prefrontal cortex--an update: time is of the essence. Neuron. 2001 May;30(2):319-33. doi: 10.1016/s0896-6273(01)00285-9. No abstract available.
PubMed 11394996Kessels RP, van Zandvoort MJ, Postma A, Kappelle LJ, de Haan EH. The Corsi Block-Tapping Task: standardization and normative data. Appl Neuropsychol. 2000;7(4):252-8. doi: 10.1207/S15324826AN0704_8.
PubMed 11296689Leger LA, Mercier D, Gadoury C, Lambert J. The multistage 20 metre shuttle run test for aerobic fitness. J Sports Sci. 1988 Summer;6(2):93-101. doi: 10.1080/02640418808729800.
PubMed 3184250MacLeod CM. Half a century of research on the Stroop effect: an integrative review. Psychol Bull. 1991 Mar;109(2):163-203. doi: 10.1037/0033-2909.109.2.163. No abstract available.
PubMed 2034749Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
PubMed 20332511Moreira JPA, Lopes MC, Miranda-Junior MV, Valentini NC, Lage GM, Albuquerque MR. Korperkoordinationstest Fur Kinder (KTK) for Brazilian Children and Adolescents: Factor Analysis, Invariance and Factor Score. Front Psychol. 2019 Nov 19;10:2524. doi: 10.3389/fpsyg.2019.02524. eCollection 2019.
PubMed 31803092Nascimento WMD, Henrique NR, Marques MDS. KTK MOTOR TEST: REVIEW OF THE MAIN INFLUENCING VARIABLES. Rev Paul Pediatr. 2019 Jun 19;37(3):372-381. doi: 10.1590/1984-0462/;2019;37;3;00013. eCollection 2019.
PubMed 31241688Serrien DJ, Ivry RB, Swinnen SP. The missing link between action and cognition. Prog Neurobiol. 2007 Jun;82(2):95-107. doi: 10.1016/j.pneurobio.2007.02.003. Epub 2007 Feb 23.
PubMed 17399884
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a School Intervention With Physical Activity on Executive Functions and Relationships With Cardiorespiratory Fitness and Motor Coordination: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06496503
- Acronym / sponsor ID
- UEL
- Conditions
- Healthy Lifestyle
- Keywords
- cognitive function, child, physical activity, schoolchildren
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- State University of LondrinaUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 11 Jul 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.
Previous studies have indicated the relationship between physical activity and cognitive performance, with movement being a promising tool for improving executive functions, especially during childhood, which is a period of intense brain development. Thus, the objective of this project is to verify a school physical activity intervention on executive functions and the relationships with cardiorespiratory fitness and motor coordination. This will be a randomized control trial in accordance with the Consort - Statement, including 118 children of both sexes; 60 in an experimental group and 58 in a control group. The children will follow their usual school routines, including Physical Education classes as part of the curriculum. The experimental group will also participate in an intervention for 12 weeks after school. The intervention will include three weekly physical exercise sessions, lasting between 50 and 60 minutes. The sessions will consist of activities involving games, sports, dance with a focus on aspects of motor coordination and cardiorespiratory fitness, as well as cognitive games. Assessments will be carried out at baseline, after 12 weeks of intervention and after the follow-up period. The students will undergo measurements of body mass and height, as well as nutritional classification using the body mass index (BMI). Following this, a general motor coordination test (KTK), a cardiorespiratory aptitude test (Léger), and tests to assess executive functions (Stroop and Corsi Block) will be applied. Data distribution will be verified using the Shapiro-Wilk's test. The comparisons between different moments (baseline, after 12 weeks, and at follow-up) will be performed using repeated measures ANOVA. Sphericity will be checked by Mauchly's test followed by the Greenhouse- Geisser correction when necessary. To identify differences, the Bonferroni correction will be applied. The significance level will be set at 5% (P<0.05).
Detailed description
During childhood, cognitive aspects of the prefrontal cortex are in the maturation phase. This process is associated with improvements in executive functions, in a continuous process, and although differentiated by its multiple aspects, it seems to correspond with the development peaks of the prefrontal cortex, which occur between 7 and 9 years of age. In addition to the biological alterations arising from the growth and development of the brain, physical activity performed regularly indicates a simple and effective way to improve the executive functions of children. Contreras-Osorio and colleagues stated that physical activity performed at moderate and vigorous intensities is positively related to working memory, reaction time, executive attention, cognitive flexibility, and planning in children and adolescents aged 10 to 12 years. Other authors highlight that activities involving cardiorespiratory fitness and motor coordination provide an increase in cognitive performance, with improvements in planning capacity, memory, self-control, and value judgment, among other fundamental components for social interaction and academic performance In a previous study, Visier-Alfonso and colleagues evaluated 186 school-age children aged 9 to 11 years and demonstrated positive effects on cardiorespiratory fitness, with increased physical activity, and positive changes in inhibitory control, working memory, and brain structure. Additionally, good levels of motor coordination are associated with complex movements and sport-specific skills, and are also essential for the development of higher levels of cognitive function. The relationships between motor skills and executive functions during childhood are based on coactivation events between the prefrontal cortex, the cerebellum, and the basal ganglia during different motor and cognitive tasks, especially when the task is complex, is a new task, or requires speed and concentration. This is because neural regions typically associated with cognitive operations can also be recruited during the performance of motor tasks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will be performed carefully following the recommendations proposed by the Cochrane Collaboration. The process will consist of two stages, firstly, the generation of numbers using a random number table, and secondly, allocation concealment, using opaque, sealed envelopes. After signing the consent form, an envelope will be opened for each child and they will be instructed as to which group they have been allocated, the experimental or control.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Physical activity ProtocolThe children included in the experimental group will undergo 12 weeks of physical activity sessions, and it is mandatory that all children complete a minimum of two weekly sessions of physical activity for 50-60 minutes. The activities will consist of content such as motor and cognitive games, sports, dance, and gymnastics. The intensity of the sessions will be checked using accelerometry. The physical activity protocol is adapted from a previously described protocol (CMSP, 2021; Klem, Filha, Monteiro, 2017; Mazzoccante et al.; 2020; Paiano, 2019; Rodrigues, 2018; Rosini et al., 2014). Acceptance of the exercise program in the pediatric population has been previously observed in a pilot study. |
| Control group | No intervention | –The children will follow their usual school routines, including Physical Education classes as part of the curriculum |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy
- Neurotypical.
Key exclusion criteria (6 listed)
- Clinical or historical of cardiovascular disease
- Hypertension
- Insulin-dependent diabetes mellitus
- Neurodiversity
- Not be taking any drugs
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 ProtocolThe children included in the experimental group will undergo 12 weeks of physical activity sessions, and it is mandatory that all children complete a minimum of two weekly sessions of physical activity for 50-60 minutes. The activities will consist of content such as motor and cognitive games, sports, dance, and gymnastics. The intensity of the sessions will be checked using accelerometry. The physical activity protocol is adapted from a previously described protocol (CMSP, 2021; Klem, Filha, Monteiro, 2017; Mazzoccante et al.; 2020; Paiano, 2019; Rodrigues, 2018; Rosini et al., 2014). Acceptance of the exercise program in the pediatric population has been previously observed in a pilot study. | Behavioural | Experimental group |
Primary outcome
Executive Functions
Time frame: Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.
The executive functions will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention (follow-up period). Executive functions will be investigated in the domains of working memory, using the Corsi Block Test (Corsi, 1972; Kessels et al., 2000), and inhibitory control, investigated by the Stroop Test (Stroop, 1935; MacLeod, 1991). For both tests there will be familiarization and reproducibility of measurements for both the children and evaluator. The evaluation will be carried out by a single evaluator blind to group allocation.
1 secondary outcome
Cardiorespiratory fitness
Time frame: Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Background: PubMed 35409571Contreras-Osorio F, Guzman-Guzman IP, Cerda-Vega E, Chirosa-Rios L, Ramirez-Campillo R, Campos-Jara C. Effects of the Type of Sports Practice on the Executive Functions of Schoolchildren. Int J Environ Res Public Health. 2022 Mar 24;19(7):3886. doi: 10.3390/ijerph19073886.
- Background: PubMed 21299297Davis CL, Tomporowski PD, McDowell JE, Austin BP, Miller PH, Yanasak NE, Allison JD, Naglieri JA. Exercise improves executive function and achievement and alters brain activation in overweight children: a randomized, controlled trial. Health Psychol. 2011 Jan;30(1):91-8. doi: 10.1037/a0021766.
- Background: PubMed 29054748de Greeff JW, Bosker RJ, Oosterlaan J, Visscher C, Hartman E. Effects of physical activity on executive functions, attention and academic performance in preadolescent children: a meta-analysis. J Sci Med Sport. 2018 May;21(5):501-507. doi: 10.1016/j.jsams.2017.09.595. Epub 2017 Oct 10.
- Background: PubMed 23020641Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
- Background: PubMed 21852486Diamond A, Lee K. Interventions shown to aid executive function development in children 4 to 12 years old. Science. 2011 Aug 19;333(6045):959-64. doi: 10.1126/science.1204529.
- Background: PubMed 18949660Evenson KR, Catellier DJ, Gill K, Ondrak KS, McMurray RG. Calibration of two objective measures of physical activity for children. J Sports Sci. 2008 Dec;26(14):1557-65. doi: 10.1080/02640410802334196.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Background: PubMed 11394996Fuster JM. The prefrontal cortex--an update: time is of the essence. Neuron. 2001 May;30(2):319-33. doi: 10.1016/s0896-6273(01)00285-9. No abstract available.
- Background: PubMed 11296689Kessels RP, van Zandvoort MJ, Postma A, Kappelle LJ, de Haan EH. The Corsi Block-Tapping Task: standardization and normative data. Appl Neuropsychol. 2000;7(4):252-8. doi: 10.1207/S15324826AN0704_8.
- Background: PubMed 3184250Leger LA, Mercier D, Gadoury C, Lambert J. The multistage 20 metre shuttle run test for aerobic fitness. J Sports Sci. 1988 Summer;6(2):93-101. doi: 10.1080/02640418808729800.
- Background: PubMed 2034749MacLeod CM. Half a century of research on the Stroop effect: an integrative review. Psychol Bull. 1991 Mar;109(2):163-203. doi: 10.1037/0033-2909.109.2.163. No abstract available.
- Background: PubMed 20332511Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
- Individual participant dataSharing planned: No
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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 Protocol in people with Healthy Lifestyle, run by State University of Londrina at 1 site in Brazil.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 14 May 2025. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Executive Functions (time frame: Will be assessed pre-protocol, after 12 weeks, and 8 weeks after the end of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06496503, which also lists 20 linked publications.
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 14 May 2025.