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Clinical Trials/NCT04901286
NCT04901286
Completed
Not Applicable

The Effects of a Single Bout of Moderate Intensity Aerobic Exercise Combined With Different Environments on Executive Function and Processing Speed in Individuals With TBI

Kessler Foundation1 site in 1 country24 target enrollmentAugust 19, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Kessler Foundation
Enrollment
24
Locations
1
Primary Endpoint
Change on N-Back Test (N-back)
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

Aerobic exercise is a promising treatment modality for cognition in persons with TBI, but effects are consistently small. This study aims to investigate the effect of difference environments during moderate intensity cycling sessions on cognition.

Detailed Description

The proposed research study would be the first to investigate the acute effects of aerobic exercise with different environments relative to control and comparison conditions on several domains of cognition in people with TBI. This critical investigation will be a first step toward systematically identifying an optimal exercise training intervention for managing common cognitive consequences of TBI.

Registry
clinicaltrials.gov
Start Date
August 19, 2021
End Date
March 30, 2023
Last Updated
8 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Principal Investigator
Principal Investigator

Carly Wender

Research Scientist

Kessler Foundation

Eligibility Criteria

Inclusion Criteria

  • Be at least 18 years of age and younger than 59 years of age
  • Speak English as their primary language
  • Have had a previous TBI at least one year prior\\

Exclusion Criteria

  • Have contraindications to moderate or high intensity physical activity, based on the Physical Activity Readiness Questionnaire (PAR-Q)
  • Have a history of psychiatric illness (ex: major depression, bipolar disorder, schizophrenia), neurological disorders beyond TBI (ex: stroke, seizure disorder), or substance abuse
  • Currently use medications that might impact cognition (ex: steroids, benzodiazepines, neuroleptics)
  • Be currently pregnant
  • Have visual impairments not otherwise corrected by contact lenses (ex: stereo blindness, colorblindness)
  • Have a high likelihood of motion sickness

Outcomes

Primary Outcomes

Change on N-Back Test (N-back)

Time Frame: 30 minutes (before and after the acute exercise intervention)

The N-Back is a measure that requires participants to listen to a sequence of numbers and decide if the current number is the same as the one presented N trials ago.

Change on the Modified Flanker Test (MFT)

Time Frame: 30 minutes (before and after the acute exercise intervention)

This task requires individuals to correctly respond to a target symbol amid other symbols, ignoring irrelevant information.

Change on Walking While Talking Test (WWT)

Time Frame: 30 minutes (before and after the acute exercise intervention)

The WWT measures multitasking by comparing performance on a single motor task to the motor performance during a simultaneous motor + cognitive dual task.

Study Sites (1)

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