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

August 25, 2025 updated by: Carly Wender, Kessler Foundation

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Kessler Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 59 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Seated Rest
Behavioral: Seated Rest In the seated rest control condition, participants will sit on the bike for 30 minutes. Interaction with researchers will be kept at a minimum, similar to that in other sessions. Heart rate will be recorded every two minutes and perceived exertion will be reported every four minutes.
Active Comparator: Exercise Only
Behavioral: Exercise Only In the exercise-only condition, participants will complete a total of 30-minutes on the stationary bike. This will include a) 5-min warm-up at low resistance, b) 20 minutes of moderate-vigorous intensity cycling, and c) a 5-min cool-down at low resistance. Interaction with researchers will be kept at a minimum, similar to that in other sessions. Heart rate will be recorded every two minutes and perceived exertion will be reported every four minutes.
Behavioral: Exercise Only
Cycling in a lab environment
Experimental: Exercise + Non-Immersive Virtual Reality
Behavioral: Exercise + Non-Immersive Virtual Reality In the exercise with non-immersive Virtual Reality condition, participants will complete a total of 30-minutes on the stationary bike while watching a video on an iPad. The cycling session will be identical to that in the Exercise Only condition (5-min warm-up, 20 minutes of moderate-vigorous intensity cycling, and 5-min cool down). During cycling, a YouTube video called "360° VR Cycling Newport Back Bay Sunset [30 MIN - NO MUSIC])" will play on an iPad placed on the front of the bike. Interaction with researchers will be kept at a minimum, similar to that in other sessions. Heart rate will be recorded every two minutes and perceived exertion will be reported every four minutes.
Behavioral: Exercise + Non-Immersive Virtual Reality
Cycling with an environment simulated by non-immersive virtual reality
Experimental: Exercise + Immersive Virtual Reality
Behavioral: Exercise + Immersive Virtual Reality In the exercise with immersive virtual reality condition, participants will complete a total of 30-minutes on the stationary bike while wearing Oculus Quest 2 goggles. The bout of cycling will be identical to the prescription given in the exercise only condition (5-min warm-up, 20 minutes of moderate-vigorous intensity cycling, and 5-min cool down). During cycling, the Oculus YouTubeVR app will play a 360° version of the YouTube video called "360° VR Cycling Newport Back Bay Sunset [30 MIN - NO MUSIC])". Interaction with researchers will be kept at a minimum, similar to that in other sessions. Heart Rate will be recorded every two minutes and perceived exertion will be reported every four minutes.
Behavioral: Exercise + Immersive Virtual Reality
Cycling with an environment simulated by immersive virtual reality

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 minutes (before and after the acute exercise intervention)
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.
30 minutes (before and after the acute exercise intervention)
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.
30 minutes (before and after the acute exercise intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 21, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R115220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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