TBI Rehabilitation and Activation in Veterans
TRAIN-Vets
1 other identifier
interventional
120
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2024
CompletedFirst Posted
Study publicly available on registry
August 20, 2024
CompletedStudy Start
First participant enrolled
May 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
May 16, 2025
May 1, 2025
2.7 years
July 18, 2024
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognitive Change (Composite Score)
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.
8 months
Secondary Outcomes (5)
Cognitive Sub-Domain Change: Executive Function (Composite Score)
8 months
Cognitive Sub-Domain Change: Learning/Memory (Composite Score)
8 months
Targeted Risk Factor Change (Composite Score)
8 months
Quality of Life Change
8 months
Physical Fitness Change
8 months
Study Arms (2)
TRAIN-Vets
EXPERIMENTALTRAIN-Vets is an 8-month intervention with aquatic-based exercise training and cognitive training combined with personalized dementia risk factor reduction sessions. This 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.
Health Education Control
OTHERThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Palo Alto Health Care System
Palo Alto, California, 94304-1207, United States
San Francisco VA Health Care System
San Francisco, California, 94121, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristine Yaffe, MD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2024
First Posted
August 20, 2024
Study Start
May 12, 2025
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
May 16, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share