The Effects of Exercise on Executive FunctionsNCT03852368
The Effects of Exercise on Executive Functions
A study testing Exercise in people with The Effects of Exercise on Executive Functions, run by University of California, Irvine at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- The Effects of Exercise on Executive Functions
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2017to 6 Sep 2017
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Exercise and Genomics Research Center, University of California, Irvine
Irvine, California, 92697/92617
About this study
Official title: 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.
Read the detailed description
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
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The effects of exercise with different intensity on the executive functions of adolescents
| Study group | Role | What they receive |
|---|---|---|
| The Effects of Light Exercise in Executive Functions | Experimental | The effects of light exercise in executive functions of adolescents Receives: Other: Exercise |
| The Effects of Moderate Exercise in Executive Functions | Experimental | The effects of moderate exercise in executive functions of adolescents Receives: Other: Exercise |
| The Effects of Heavy Exercise in Executive Functions | Experimental | The effects of heavy exercise in executive functions of adolescents Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effects of Light, Moderate and Heavy Exercise on Attention
Attention will be tested with the Hearts and Flowers test
Measured: 4 weeks
The Effects of Light, Moderate and Heavy Exercise on Working Memory
Working Memory will be tested with the Hearts and Flowers test
Measured: 4 weeks
The Effects of Light, Moderate and Heavy Exercise on Inhibition
Inhibition will be tested with Stroop Color-Word test
Measured: 4 weeks
The Effects of Light, Moderate and Heavy Exercise on Cognitive Flexibility
Cognitive Flexibility will be tested with Stroop Color-Word test
Measured: 4 weeks
Secondary outcomes (1)
The Effects of Light, Moderate and Heavy Exercise on temporal dynamics of executive function processes
The temporal dynamics of executive function processes will be measured with EEG/Event-Related Potential (ERP) test
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start6 Sep 2017
- Primary completion6 Sep 2017
- Study completion6 Sep 2017
Why it stopped: Nonapplicable clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Effects of Exercise on Executive FunctionsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852368
- Sponsor's protocol ID
- 2017-3836
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2019
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UC Reliance# 3107: Exercise and the Brain: Measuring Executive Functions During and Following an Acute Bout of Aerobic Exercise
- ClinicalTrials.gov ID
- NCT03852368
- Acronym / sponsor ID
- 2017-3836
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Nonapplicable clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 6 Sep 2017 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 25 Feb 2019 (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.
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.
Detailed description
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Effects of Light Exercise in Executive Functions | Experimental | Other: ExerciseThe effects of light exercise in executive functions of adolescents |
| The Effects of Moderate Exercise in Executive Functions | Experimental | Other: ExerciseThe effects of moderate exercise in executive functions of adolescents |
| The Effects of Heavy Exercise in Executive Functions | Experimental | Other: ExerciseThe effects of heavy exercise in executive functions of adolescents |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| ExerciseThe effects of exercise with different intensity on the executive functions of adolescents | Other | The Effects of Heavy Exercise in Executive Functions, The Effects of Light Exercise in Executive Functions, The Effects of Moderate Exercise in Executive Functions |
Primary outcome
The Effects of Light, Moderate and Heavy Exercise on Attention
Time frame: 4 weeks
Attention will be tested with the Hearts and Flowers test
The Effects of Light, Moderate and Heavy Exercise on Working Memory
Time frame: 4 weeks
Working Memory will be tested with the Hearts and Flowers test
The Effects of Light, Moderate and Heavy Exercise on Inhibition
Time frame: 4 weeks
Inhibition will be tested with Stroop Color-Word test
The Effects of Light, Moderate and Heavy Exercise on Cognitive Flexibility
Time frame: 4 weeks
Cognitive Flexibility will be tested with Stroop Color-Word test
1 secondary outcome
The Effects of Light, Moderate and Heavy Exercise on temporal dynamics of executive function processes
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
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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 Exercise in people with The Effects of Exercise on Executive Functions, run by University of California, Irvine at 1 site in United States.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 12 Feb 2021. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
The Effects of Light, Moderate and Heavy Exercise on Attention (time frame: 4 weeks). The study lists 4 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 12 Feb 2021.