Recruiting

Rehabilitation

Sponsor:

Northern California Institute of Research and Education

Code:

NCT06562127

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

TRAIN-Vets

Health Education Control

Study Details

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.

Conditions

Traumatic Brain Injury

Study ID

NCT06562127

Start date

May 12, 2025

Status verified date

May, 2025

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 and Locations

Central contacts

Carrie Peltz, PhD

415-221-4810carrie.peltz2@va.gov

Julia Cheunkarndee

415-221-4810julia.cheunkarndee@ncire.org

Locations

VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304-1207

Contacts

Jennifer K Fairchild, PhD

650-493-5000JenniferKaci.Fairchild@va.gov

San Francisco VA Health Care System

Recruiting

San Francisco, California, United States, 94121

Contacts

Carrie Peltz, PhD

415-221-4810carrie.peltz2@va.gov

Principal Investigator:

Kristine Yaffe, MD

More Information

Sponsor

Northern California Institute of Research and Education

Last update posted

May 16, 2025

Last verified

May, 2025

Keywords

  • Cognition
  • Cognitive training
  • Physical exercise
  • Head injury
  • Traumatic brain injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northern California Institute of Research and Education on 2025-05-16.