- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03852368
The Effects of Exercise on Executive Functions
9. února 2021 aktualizováno: University of California, Irvine
UC Reliance# 3107: Exercise and the Brain: Measuring Executive Functions During and Following an Acute Bout of Aerobic Exercise
The purpose of this research is to develop an assessment protocol that can be used to study the effect of different intensities of exercise on executive functions (EF: attention, working memory, inhibition, and cognitive flexibility).
It has been shown that exercise has the potential to improve the development of EF in healthy and special needs children.
However, many exercise interventions in the literature lack rigorous control of critical components, such as intensity, making it difficult to draw conclusions about what type and how much exercise might be most beneficial for EF.
In addition, to date, no studies have been able to demonstrate the engagement of EF during exercise.
This study will focus on developing an assay that measures important self-regulation or EF sub-processes (e.g., attention and inhibitory control) as well as examining engagement of these targets during different exercise intensities.
Participants will exercise in different intensities on a cycle ergometer and perform cognitive assessments before, during, and after exercise to evaluate EF.
This research will allow us to develop an assessment protocol that can be used in future research to understand the underlying mechanisms underpinning the effects of exercise on EF.
Přehled studie
Postavení
Staženo
Intervence / Léčba
Detailní popis
Self-regulation, self-control, and executive functioning are umbrella constructs that encompass processes involved in exerting control over cognitive and behavioral processes.
Self-regulation was described as an ability reflecting mature cognition: Mature cognition is characterized by abilities that include being able: (a) to hold information in mind, including complicated representational structures, to mentally manipulate that information and to act on the basis of it, (b) to act on the basis of choice rather than impulse, exercising self-control (or self-regulation) by resisting inappropriate behaviors and responding appropriately, and (c) to quickly and flexibly adapt behavior to changing situations.
These abilities are referred to respectively as working memory, inhibition, and cognitive flexibility.
Together they are key components of both "cognitive control" and "executive functions…" Some researchers have proposed an integrative framework of self-regulation than encompasses executive functions and self-control.
Thus, in this proposal, we have adopted such an integrative framework whereby self-regulation encompasses executive functions, self-control, and other sub-processes.
As noted in the specific aims, our meta-analysis and narrative review examining the impact of 28 physical activity (PA) and exercise interventions on EF outcomes in healthy children reported that the targets often shown to improve after exercise were attention, working memory, inhibition, and cognitive flexibility, and preliminary research suggests the strongest effects are on attention and inhibition.
The goal of this project is to develop an assay to examine engagement of attention and inhibitory control across several rigorously controlled exercise conditions.
This proposal is built on an integrative framework whereby self-regulation encompasses executive functions (EF), self-control, and other sub-processes.
Although there is a growing awareness of the benefits of exercise on self-regulatory processes in children including EF, there are still many critical gaps in the research.
A recent publication which is a meta-analysis and narrative review examining the impact of 28 physical activity and exercise interventions on EF outcomes in healthy children that highlights some of these gaps.
Although earlier results showed that interventions had a significant, small to moderate positive effect on EF, the effects varied widely across studies.
This research informed this application in several ways.
First, no study demonstrated how or why the interventions improved EF outcomes.
Additionally, the behavioral assays or measures varied widely targeting numerous components of EF.
The EF targets most often shown to improve after exercise were attention, working memory, inhibition, and cognitive flexibility (each improved in at least five of the included studies).
These findings are consistent with recent work at the UC Irvine Pediatric Exercise and Genomics Research Center (PERC); in studies with healthy children and children with special needs, improvements were found after exercise in all four components.
Few, if any, studies have been able to demonstrate empirically why participants exhibit improvements in EF after exercise, and studies have not yet demonstrated engagement of EF during exercise.
Thus, there is a need to understand why exercise seems to improve these targets.
However, the tools used in exercise research to date are limited.
Many have been adopted from developmental or educational research, rather than developed specifically to test targets in exercise research; our search yielded only one published measure of self-regulation (cognitive, affective, and motor self-regulation) that has been administered during physical activity.
This proposal begins to address these gaps in the literature, by focusing on the development of an assay for important EF targets are improved through exercise and by testing engagement of these targets during exercise of varying intensity
Typ studie
Intervenční
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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California
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Irvine, California, Spojené státy, 92697/92617
- Pediatric Exercise and Genomics Research Center, University of California, Irvine
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
10 let až 15 let (Dítě)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Absence of health problems that would preclude participation in exercise
- Male or female between the ages of 10-15 years inclusive at the time of consent
- Minimum level of intellectual functioning, as determined by an IQ (based on cognitive testing) score of 80 or above
- Ability to complete EF testing in English
Exclusion Criteria:
- Other limitations which in the opinion of a physician would preclude ability to perform exercise testing
- Use of illegal drugs or abuse of alcohol based on self-report during screening (this will occur during the one-on-one brief psychological evaluation)
- Pregnancy or breastfeeding based on urine sample test
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: The Effects of Light Exercise in Executive Functions
The effects of light exercise in executive functions of adolescents
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The effects of exercise with different intensity on the executive functions of adolescents
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Experimentální: The Effects of Moderate Exercise in Executive Functions
The effects of moderate exercise in executive functions of adolescents
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The effects of exercise with different intensity on the executive functions of adolescents
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Experimentální: The Effects of Heavy Exercise in Executive Functions
The effects of heavy exercise in executive functions of adolescents
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The effects of exercise with different intensity on the executive functions of adolescents
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The Effects of Light, Moderate and Heavy Exercise on Attention
Časové okno: 4 weeks
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Attention will be tested with the Hearts and Flowers test
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4 weeks
|
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The Effects of Light, Moderate and Heavy Exercise on Working Memory
Časové okno: 4 weeks
|
Working Memory will be tested with the Hearts and Flowers test
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4 weeks
|
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The Effects of Light, Moderate and Heavy Exercise on Inhibition
Časové okno: 4 weeks
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Inhibition will be tested with Stroop Color-Word test
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4 weeks
|
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The Effects of Light, Moderate and Heavy Exercise on Cognitive Flexibility
Časové okno: 4 weeks
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Cognitive Flexibility will be tested with Stroop Color-Word test
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4 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The Effects of Light, Moderate and Heavy Exercise on temporal dynamics of executive function processes
Časové okno: 4 weeks
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The temporal dynamics of executive function processes will be measured with EEG/Event-Related Potential (ERP) test
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4 weeks
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
6. září 2017
Primární dokončení (Aktuální)
6. září 2017
Dokončení studie (Aktuální)
6. září 2017
Termíny zápisu do studia
První předloženo
21. února 2019
První předloženo, které splnilo kritéria kontroly kvality
21. února 2019
První zveřejněno (Aktuální)
25. února 2019
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
12. února 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. února 2021
Naposledy ověřeno
1. února 2021
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 2017-3836
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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