TerminatedNot Applicable

The Effect of Aerobic Exercise on Mild Traumatic Brain Injury

Stopped: Primary Investigator is no longer employeed by the VA

United States24 participantsStarted 2009-09

Plain-language summary

The current project will examine the effects of aerobic exercise on cognition among a group of veterans who have suffered a mild traumatic brain injury.

Who can participate

Age range

18 Years – 50 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: * Anyone between 18 and 50 years of age, * from the geographic region served by the Malcolm Randall-North Florida-South Georgia VAMC, * who have sustained a TBI and demonstrate impairment on neuropsychological assessment (criteria for mTBI will be defined as a loss of consciousness for not more than 30 minutes and post-trauma amnesia of not more than 24 hours). Exclusion Criteria: * TBI occurring less than 6 months or greater than 5 years prior to enrollment, * any metal implants or shrapnel that may put them at risk for injury during an MRI scan, * significant cognitive impairment (MMSE\<24), * history of stroke, * B-12 deficiency, * hypothyroidism, * organ failure (renal, hepatic, cardiac, or lung), * substance abuse, * seizures, * or any limitation that would preclude them from safely engaging in the aerobic exercise regimen.

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

Diffusion Tensor Imaging

Timeframe: 16 weeks

Trial details

NCT IDNCT00940615

SponsorUS Department of Veterans Affairs

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2010-09

View on ClinicalTrials.gov More Traumatic Brain Injury trials

Who can participate

Age range

18 Years – 50 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.