The Environment's Impact on Thinking When Added to Leg Cycling in People With TBI: VITAL

Kessler Foundation24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Traumatic Brain Injury

Interventions

Exercise OnlyBEHAVIORAL

Cycling in a lab environment

Exercise + Non-Immersive Virtual RealityBEHAVIORAL

Cycling with an environment simulated by non-immersive virtual reality

Exercise + Immersive Virtual RealityBEHAVIORAL

Cycling with an environment simulated by immersive virtual reality

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Kessler Foundation

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Change on Walking While Talking Test (WWT)

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

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

Change on N-Back Test (N-back)

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.

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

Change on the Modified Flanker Test (MFT)

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

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

Data from ClinicalTrials.gov

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