NCT06562127 · Northern California Institute of Research and Education
TBI Rehabilitation and Activation in Veterans
(TRAIN-Vets)
What this study is about
This trial will evaluate the impact of a multicomponent program (TBI Rehabilitation and Activation in Veterans; TRAIN-Vets) on improving cognitive function over an 8-month trial period in older Veterans with traumatic brain injury (TBI).
View original scientific description
This trial will evaluate the impact of a multicomponent program (TBI Rehabilitation and Activation in Veterans; TRAIN-Vets) on improving cognitive function over an 8-month trial period in older Veterans with traumatic brain injury (TBI). Older Veterans with a history of TBI and subjective cognitive complaints will be enrolled and randomly assign to either the TRAIN-Vets intervention (consisting of aquatic-based exercise training, cognitive training, and lifestyle coaching) or the Health Education Control, where they will receive educational materials about brain health and healthy lifestyles.
Interventions
BEHAVIORAL
TRAIN-Vets
The TRAIN-Vets intervention entails 6 months of thrice-weekly aquatic-based exercise training at Veterans Affairs Palo Alto Health Care System (VAPAHCS). After completion of the 6-months of exercise training, Veterans in this condition will participate in 2 months of weekly structured on-line cognitive training focused on improvement of executive function and attention based out of the San Francisco Veterans Affairs Health Care System (SFVAHCS). Concurrently, Veterans in TRAIN-Vets will also participate virtually in personalized risk factor reduction sessions based at SFVAHCS focused on other risk factors and symptoms.
BEHAVIORAL
Health Education Control
The Health Education Control (HEC) receives mailed educational materials about brain health and dementia risk factor reduction over 8 months, as well as regular contact with study staff.
Primary outcome measures
Cognitive Change (Composite Score)
Time frame: 8 months
Change in global composite score calculated from the z-scores from all cognitive measures \[Wechsler Adult Intelligence Scale, 4th edition (WAIS-IV) Digit Span Forward, WAIS-IV Digit Span Backwards, WAIS-IV Digit Span Sequencing, Trail Making Test A and B; Delis-Kaplan Executive Function System (DKEFS) Stroop Inhibition Time \& Errors; DKEFS Stroop Inhibition-Switching Time \& Errors; DKEFS Verbal Fluency Switching; Benson Figure Copy and Recall; Hopkins Verbal Learning Test (HVLT) Learning and Delayed Recall Trials\]. The total score is reported. Higher values signify higher cognitive performance. A z-score of 0 represents the population mean.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Palo Alto, California
- San Francisco, California
Collaborators
San Francisco Veterans Affairs Medical Center, VA Palo Alto Health Care System
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 16, 2025 · Source of record for eligibility and locations