Clinical trial Recruiting at 2 sites Interventional Ages 50 to 89

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 typeInterventional
Ages50 Years to 89 Years
SexAll
Enrollment120 (estimated)
SponsorNorthern California Institute of Research and Education
Academic / other
Locations2 sites (Palo Alto, California and 1 other locations)
StatusRecruiting
StartedMay 12, 2025
Main results expectedFebruary 2028
Study endsFebruary 2028
Registry record updatedMay 16, 2025
Trial IDNCT06562127 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.