Traumatic Brain InjuryTRAIN-VetsNCT06562127
TBI Rehabilitation and Activation in Veterans
A study testing TRAIN-Vets in people with Traumatic Brain Injury, run by Northern California Institute of Research and Education at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- TRAIN-Vets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 May 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
VA Palo Alto Health Care System
Palo Alto, California, 94304-1207
Jennifer K Fairchild, PhD, 650-493-5000 ext. 63432, JenniferKaci.Fairchild@va.gov
- Recruiting
San Francisco VA Health Care System
San Francisco, California, 94121
Carrie Peltz, PhD, 415-221-4810 ext. 3286, carrie.peltz2@va.gov
Kristine Yaffe, MD
About this study
Official title: TBI Rehabilitation and Activation in Veterans (TRAIN-Vets)
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.
Read the detailed description
The purpose of the proposed trial is to evaluate the impact of a multicomponent training program (TRAIN-Vets) on improving cognitive function and other outcomes over an 8-month period in older Veterans with TBI and cognitive complaints. The primary aim of the trial is to evaluate the efficacy of the TRAIN-Vets intervention to improve cognitive function in Veterans with TBI. Secondary aims of the proposed research are to evaluate the efficacy of TRAIN-Vets to improve: 1) individual cognitive domain scores, 2) psychological and social measures (sleep, mood, social and community engagement, diet, and life satisfaction), and 3) physical fitness.
The investigators will randomize 120 older Veterans with TBI and cognitive complaints aged 50 or older to TRAIN-Vets or Health Education Control (HEC). Participants randomized to the TRAIN-Vets group will engage in aquatic-based exercise training and cognitive training combined with personalized risk factor reduction related to their brain health risk factors. 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). Over the 8 months, Veterans in TRAIN-Vets will also participate virtually in monthly personalized risk reduction sessions based at SFVHCS focused on improving other risk factors and symptoms. Participants in the HEC group will be mailed educational materials about brain health and dementia risk factor reduction throughout the 8 months. HEC participants will be contacted monthly through phone calls to check in and maintain interest. All participants will complete a phone screening, baseline in person and virtual visits, and follow-up visits with blinded assessors (to assess outcomes) at approximately 6 and 8 months.
- Conditions
- Traumatic Brain Injury
- Being tested
- TRAIN-Vets, Health Education Control
- Keywords
- Cognition, Cognitive training, Physical exercise, Head injury, Traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic, Motor Activity, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAIN-VetsBehavioural
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.
Health Education ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TRAIN-Vets | Experimental | TRAIN-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. Receives: Behavioral: TRAIN-Vets |
| Health Education Control | Other | 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. Receives: Behavioral: Health Education Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
Secondary outcomes (5)
Cognitive Sub-Domain Change: Executive Function (Composite Score)
Change in executive function composite score calculated from the z-scores from all executive function measures (WAIS-IV Digit Span Sequencing, DKEFS Color-Word Interference (Stroop) Inhibition, Trails B, DKEFS Verbal Fluency Switching, DKEFS Stroop Inhibition-Switching). The total score is reported. Higher values signify higher executive function performance. A z-score of 0 represents the population mean.
Measured: 8 months
Cognitive Sub-Domain Change: Learning/Memory (Composite Score)
Change in learning/memory composite score calculated from the z-scores from all learning/memory measures (HVLT learning and delayed recall and Benson Figure recall). The total score is reported. Higher values signify higher learning/memory performance. A z-score of 0 represents the population mean.
Measured: 8 months
Targeted Risk Factor Change (Composite Score)
Change in targeted risk factor composite score calculated from the z-score from all risk factor measures [sleep quality (Pittsburgh Sleep Quality Inventory), mood (Patient Health Questionnaire - 9), social and community engagement (PROMIS Satisfaction with Participation in Discretionary Social Activities), and diet (MIND Diet Questionnaire)]. The total score is reported. Higher values signify more favorable risk factors. A z-score of 0 represents the population mean.
Measured: 8 months
Quality of Life Change
Change in life satisfaction (Satisfaction with Life Scale). Higher score indicates better quality of life; range = 5 to 35.
Measured: 8 months
Physical Fitness Change
Change in peak VO2, or VO2Max, defined as the minute volume of O2 utilization.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start12 May 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern California Institute of Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center, VA Palo Alto Health Care System
- Responsible party
- Sponsor
- Investigators
- Kristine Yaffe, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562127
- Sponsor's protocol ID
- HT9425-24-1-0720
- Other IDs
- HT9425-24-1-0720
- Acronym
- TRAIN-Vets
- Status last verified
- May 2025
- First submitted
- 18 Jul 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TBI Rehabilitation and Activation in Veterans (TRAIN-Vets)
- ClinicalTrials.gov ID
- NCT06562127
- Acronym / sponsor ID
- TRAIN-Vets / HT9425-24-1-0720
- Conditions
- Traumatic Brain Injury
- Keywords
- Cognition, Cognitive training, Physical exercise, Head injury, Traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Northern California Institute of Research and EducationUniversity, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center, VA Palo Alto Health Care System
- Study start
- 12 May 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the proposed trial is to evaluate the impact of a multicomponent training program (TRAIN-Vets) on improving cognitive function and other outcomes over an 8-month period in older Veterans with TBI and cognitive complaints. The primary aim of the trial is to evaluate the efficacy of the TRAIN-Vets intervention to improve cognitive function in Veterans with TBI. Secondary aims of the proposed research are to evaluate the efficacy of TRAIN-Vets to improve: 1) individual cognitive domain scores, 2) psychological and social measures (sleep, mood, social and community engagement, diet, and life satisfaction), and 3) physical fitness.
The investigators will randomize 120 older Veterans with TBI and cognitive complaints aged 50 or older to TRAIN-Vets or Health Education Control (HEC). Participants randomized to the TRAIN-Vets group will engage in aquatic-based exercise training and cognitive training combined with personalized risk factor reduction related to their brain health risk factors. 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). Over the 8 months, Veterans in TRAIN-Vets will also participate virtually in monthly personalized risk reduction sessions based at SFVHCS focused on improving other risk factors and symptoms. Participants in the HEC group will be mailed educational materials about brain health and dementia risk factor reduction throughout the 8 months. HEC participants will be contacted monthly through phone calls to check in and maintain interest. All participants will complete a phone screening, baseline in person and virtual visits, and follow-up visits with blinded assessors (to assess outcomes) at approximately 6 and 8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRAIN-Vets | Experimental | Behavioral: TRAIN-VetsTRAIN-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 | Other | Behavioral: Health Education ControlThe 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. |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRAIN-VetsThe 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. | Behavioural | TRAIN-Vets |
| Health Education ControlThe 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. | Behavioural | Health Education Control |
Primary outcome
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.
5 secondary outcomes
Cognitive Sub-Domain Change: Executive Function (Composite Score)
Time frame: 8 months
Cognitive Sub-Domain Change: Learning/Memory (Composite Score)
Time frame: 8 months
Targeted Risk Factor Change (Composite Score)
Time frame: 8 months
Quality of Life Change
Time frame: 8 months
Physical Fitness Change
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristine Yaffe, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAIN-Vets in people with Traumatic Brain Injury, run by Northern California Institute of Research and Education at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carrie Peltz, PhD (415-221-4810 ext. 3286, carrie.peltz2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Change (Composite Score) (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.