Improving cognitive function in older veterans with traumatic brain injury
TBI Rehabilitation and Activation in Veterans (TRAIN-Vets)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 50 Years to 89 Years |
| Sex | All |
| Sponsor | Northern California Institute of Research and Education Academic / other |
| Locations | 2 sites (Palo Alto, California and 1 other locations) |
| Trial ID | NCT06562127 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are Veterans aged 50-89 with a history of mild or moderate TBI and subjective cognitive complaints.
Not a fit: Patients with severe psychiatric disorders, dementia, or recent TBI may not benefit from this study.
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 performed: Other studies have shown promise in using combined cognitive and physical training approaches for improving outcomes in similar populations.
Eligibility criteria
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 this trial is running
Palo Alto, California and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.