Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04901286
Acronym
VITAL
Enrollment
24
Registered
2021-05-25
Start date
2021-08-19
Completion date
2023-03-30
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

Brain Injuries, Traumatic, Aerobic Exercise, Leg Cycling, Virtual Reality

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.

Interventions

BEHAVIORALExercise Only

Cycling in a lab environment

BEHAVIORALExercise + Non-Immersive Virtual Reality

Cycling with an environment simulated by non-immersive virtual reality

BEHAVIORALExercise + Immersive Virtual Reality

Cycling with an environment simulated by immersive virtual reality

Sponsors

Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Masking description

The PI will be blinded to the order of conditions for each participant.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change on Walking While Talking Test (WWT)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.
Change on N-Back Test (N-back)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)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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026