NCT03852368

Brief 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). 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

Same day

First QC Date

February 21, 2019

Last Update Submit

February 9, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • The Effects of Light, Moderate and Heavy Exercise on Attention

    Attention will be tested with the Hearts and Flowers test

    4 weeks

  • The Effects of Light, Moderate and Heavy Exercise on Working Memory

    Working Memory will be tested with the Hearts and Flowers test

    4 weeks

  • The Effects of Light, Moderate and Heavy Exercise on Inhibition

    Inhibition will be tested with Stroop Color-Word test

    4 weeks

  • The Effects of Light, Moderate and Heavy Exercise on Cognitive Flexibility

    Cognitive Flexibility will be tested with Stroop Color-Word test

    4 weeks

Secondary Outcomes (1)

  • The Effects of Light, Moderate and Heavy Exercise on temporal dynamics of executive function processes

    4 weeks

Study Arms (3)

The Effects of Light Exercise in Executive Functions

EXPERIMENTAL

The effects of light exercise in executive functions of adolescents

Other: Exercise

The Effects of Moderate Exercise in Executive Functions

EXPERIMENTAL

The effects of moderate exercise in executive functions of adolescents

Other: Exercise

The Effects of Heavy Exercise in Executive Functions

EXPERIMENTAL

The effects of heavy exercise in executive functions of adolescents

Other: Exercise

Interventions

The effects of exercise with different intensity on the executive functions of adolescents

The Effects of Heavy Exercise in Executive FunctionsThe Effects of Light Exercise in Executive FunctionsThe Effects of Moderate Exercise in Executive Functions

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Exercise and Genomics Research Center, University of California, Irvine

Irvine, California, 92697/92617, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 25, 2019

Study Start

September 6, 2017

Primary Completion

September 6, 2017

Study Completion

September 6, 2017

Last Updated

February 12, 2021

Record last verified: 2021-02

Locations