The Effects of Exercise on Executive Functions

February 9, 2021 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697/92617
        • Pediatric Exercise and Genomics Research Center, University of California, Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The Effects of Light Exercise in Executive Functions
The effects of light exercise in executive functions of adolescents
Other: Exercise
The effects of exercise with different intensity on the executive functions of adolescents
Experimental: The Effects of Moderate Exercise in Executive Functions
The effects of moderate exercise in executive functions of adolescents
Other: Exercise
The effects of exercise with different intensity on the executive functions of adolescents
Experimental: The Effects of Heavy Exercise in Executive Functions
The effects of heavy exercise in executive functions of adolescents
Other: Exercise
The effects of exercise with different intensity on the executive functions of adolescents

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Effects of Light, Moderate and Heavy Exercise on Attention
Time Frame: 4 weeks
Attention will be tested with the Hearts and Flowers test
4 weeks
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
4 weeks
The Effects of Light, Moderate and Heavy Exercise on Inhibition
Time Frame: 4 weeks
Inhibition will be tested with Stroop Color-Word test
4 weeks
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
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Effects of Light, Moderate and Heavy Exercise on temporal dynamics of executive function processes
Time Frame: 4 weeks
The temporal dynamics of executive function processes will be measured with EEG/Event-Related Potential (ERP) test
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-3836

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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