CompletedNot Applicable

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

United States24 participantsStarted 2021-08-19

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change on Walking While Talking Test (WWT)

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

Change on N-Back Test (N-back)

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

Change on the Modified Flanker Test (MFT)

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

Trial details

NCT IDNCT04901286

SponsorKessler Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-21

View on ClinicalTrials.gov More Traumatic Brain Injury trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change on Walking While Talking Test (WWT)

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

Change on N-Back Test (N-back)

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

Change on the Modified Flanker Test (MFT)

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