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Completed

NCT Number: NCT04901286

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

East Hanover, New Jersey, 07936, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise only

Behavioral

Cycling in a lab environment

Exercise + Non-Immersive Virtual Reality

Behavioral

Cycling with an environment simulated by non-immersive virtual reality

Exercise + Immersive Virtual Reality

Behavioral

Cycling with an environment simulated by immersive virtual reality

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Official study title

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

Acronym: VITAL

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 25, 2021
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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