RecruitingNot ApplicableNCT06562127

TBI Rehabilitation and Activation in Veterans

TBI Rehabilitation and Activation in Veterans (TRAIN-Vets)

Sponsor

Northern California Institute of Research and Education

Enrollment

120 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Conditions

Traumatic Brain Injury

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.

Eligibility

Min Age: 50 YearsMax Age: 89 Years

Inclusion Criteria8

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 Criteria8

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

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Interventions

BEHAVIORALTRAIN-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.

BEHAVIORALHealth 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.