Improving cognitive function in older veterans with traumatic brain injury
Official title: TBI Rehabilitation and Activation in Veterans (TRAIN-Vets)
Run by Northern California Institute of Research and Education · NCT06562127 · Data updated 2026-11-12
This study is testing a new program that combines exercise, brain training, and lifestyle coaching to see if it can help older veterans with traumatic brain injuries improve their thinking skills.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years to 89 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Northern California Institute of Research and Education Academic / other |
| Locations | 2 sites (Palo Alto, California and 1 other locations) |
| Status | Recruiting |
| Started | May 12, 2025 |
| Main results expected | February 2028 |
| Study ends | February 2028 |
| Registry record updated | May 16, 2025 |
| Trial ID | NCT06562127 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Veterans aged 50-89 with a history of mild or moderate TBI and subjective cognitive complaints.
✕Probably not a fit
Patients with severe psychiatric disorders, dementia, or recent TBI may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial evaluates the impact of a multicomponent program called TRAIN-Vets on cognitive function in older Veterans with traumatic brain injury (TBI) over an 8-month period. Participants will be randomly assigned to either the TRAIN-Vets intervention, which includes aquatic-based exercise, cognitive training, and lifestyle coaching, or a Health Education Control group that receives educational materials. The primary aim is to assess improvements in cognitive function, while secondary aims include evaluating psychological, social, and physical fitness outcomes. The study involves 120 Veterans aged 50 or older with a history of TBI and cognitive complaints.
Why it matters
Potential benefit: If successful, this program could significantly enhance cognitive function and overall quality of life for older Veterans with TBI.
How similar studies have gone: Other studies have shown promise in using combined cognitive and physical training approaches for improving outcomes in similar populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veteran, age 50-89 years * History (more than 6 months post injury) of mild or moderate TBI defined by the Ohio State University TBI Identification Method and DOD/VA Clinical Practice Guidelines for Definition of TBI * Sufficient vision and hearing to allow cognitive testing * Willingness to participate in water-based exercise program + cognitive training program for eight months * Approval of primary medical provider to participate in a water-based exercise program * Subjective cognitive complaints as evidenced by self-report * English proficiency to allow for cognitive testing * Internet connected device to participate in testing and cognitive training Exclusion Criteria: * Current severe and unstable psychiatric disorder * Diagnosis of dementia, Montreal Cognitive Assessment score less than 18, or delirium * TBI within the past 6 months * Acute illness or unstable chronic illness * Current severe cardiac disease * Severe TBI or open head injury * Inability to exercise consistently * Inability to read, verbalize understanding, and voluntarily sign the Informed Consent
Where it's running
-
VA Palo Alto Health Care System
Palo Alto, California, United States Recruiting -
San Francisco VA Health Care System
San Francisco, California, United States Recruiting
Study contacts
- Principal investigator: Kristine Yaffe, MD — University of California, San Francisco
- Study coordinator: Carrie Peltz, PhD
- Email: carrie.peltz2@va.gov
- Phone: 415-221-4810
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.