RECRUITING

TBI Rehabilitation and Activation in Veterans

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

TBI Rehabilitation and Activation in Veterans (TRAIN-Vets)

Quick Facts

Study Start:2025-05-12
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06562127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veteran, age 50-89 years
  2. * 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
  3. * Sufficient vision and hearing to allow cognitive testing
  4. * Willingness to participate in water-based exercise program + cognitive training program for eight months
  5. * Approval of primary medical provider to participate in a water-based exercise program
  6. * Subjective cognitive complaints as evidenced by self-report
  7. * English proficiency to allow for cognitive testing
  8. * Internet connected device to participate in testing and cognitive training
  1. * Current severe and unstable psychiatric disorder
  2. * Diagnosis of dementia, Montreal Cognitive Assessment score less than 18, or delirium
  3. * TBI within the past 6 months
  4. * Acute illness or unstable chronic illness
  5. * Current severe cardiac disease
  6. * Severe TBI or open head injury
  7. * Inability to exercise consistently
  8. * Inability to read, verbalize understanding, and voluntarily sign the Informed Consent

Contacts and Locations

Study Contact

Carrie Peltz, PhD
CONTACT
415-221-4810
carrie.peltz2@va.gov
Julia Cheunkarndee
CONTACT
415-221-4810
julia.cheunkarndee@ncire.org

Principal Investigator

Kristine Yaffe, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Northern California Institute of Research and Education

  • Kristine Yaffe, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-12
Study Completion Date2028-02

Study Record Updates

Study Start Date2025-05-12
Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Traumatic Brain Injury