Traumatic Brain InjuryVITALNCT04901286
The Environment's Impact on Thinking When Added to Leg Cycling in People With TBI: VITAL
A study testing Exercise Only, Exercise + Non-Immersive Virtual Reality and Exercise + Immersive Virtual Reality in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Exercise Only, Exercise + Non-Immersive Virtual Reality and Exercise + Immersive Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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\
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Exercise Only, Exercise + Non-Immersive Virtual Reality, Exercise + Immersive Virtual Reality
- Keywords
- Brain Injuries, Traumatic, Aerobic Exercise, Leg Cycling, Virtual Reality
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise OnlyBehavioural
Cycling in a lab environment
Exercise + Non-Immersive Virtual RealityBehavioural
Cycling with an environment simulated by non-immersive virtual reality
Exercise + Immersive Virtual RealityBehavioural
Cycling with an environment simulated by immersive virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Seated Rest | No intervention | 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. |
| Exercise Only | Active comparator | 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. Receives: Behavioral: Exercise Only |
| Exercise + Non-Immersive Virtual Reality | Experimental | 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. Receives: Behavioral: Exercise + Non-Immersive Virtual Reality |
| Exercise + Immersive Virtual Reality | Experimental | 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. Receives: Behavioral: Exercise + Immersive Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 30 minutes (before and after the acute exercise intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start19 Aug 2021
- Primary completion21 Feb 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carly Wender, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901286
- Sponsor's protocol ID
- R115220
- Acronym
- VITAL
- Status last verified
- Oct 2023
- First submitted
- 19 May 2021
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04901286
- Acronym / sponsor ID
- VITAL / R115220
- Conditions
- Traumatic Brain Injury
- Keywords
- Brain Injuries, Traumatic, Aerobic Exercise, Leg Cycling, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Seated Rest | No intervention | –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. |
| Exercise Only | Active comparator | Behavioral: Exercise OnlyBehavioral: 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. |
| Exercise + Non-Immersive Virtual Reality | Experimental | Behavioral: Exercise + Non-Immersive Virtual RealityBehavioral: 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. |
| Exercise + Immersive Virtual Reality | Experimental | Behavioral: Exercise + Immersive Virtual RealityBehavioral: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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\
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise OnlyCycling in a lab environment | Behavioural | Exercise Only |
| Exercise + Non-Immersive Virtual RealityCycling with an environment simulated by non-immersive virtual reality | Behavioural | Exercise + Non-Immersive Virtual Reality |
| Exercise + Immersive Virtual RealityCycling with an environment simulated by immersive virtual reality | Behavioural | Exercise + Immersive Virtual Reality |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Only, Exercise + Non-Immersive Virtual Reality and Exercise + Immersive Virtual Reality in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on Walking While Talking Test (WWT) (time frame: 30 minutes (before and after the acute exercise intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.