TBI Rehabilitation and Activation in Veterans

Part of paid clinical trials in Palo Alto, California.

Sponsor
Northern California Institute of Research and Education
Study ID
NCT06562127
Status
Recruiting
Apply to this trial

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
50 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • TRAIN-Vets — BEHAVIORAL
    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 Control — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
May 12, 2025
Status verified
May 2025
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TRAIN-Vets
    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.
  • Other: 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 Measure

Cognitive Change (Composite Score) [ Time Frame: 8 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
VA Palo Alto Health Care SystemPalo AltoCalifornia94304-1207
Jennifer K Fairchild, PhD
[email protected]
650-493-5000
San Francisco VA Health Care SystemSan FranciscoCalifornia94121
Carrie Peltz, PhD
[email protected]
415-221-4810
Kristine Yaffe, MD (PRINCIPAL_INVESTIGATOR)

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VA Palo Alto Health Care System· Palo Alto, CASan Francisco VA Health Care System· San Francisco, CA

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