Health TrialsbyHealthPanel

TBI Rehabilitation and Activation in Veterans

ConditionTraumatic Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-89
SponsorNorthern California Institute of Research and Education

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: TRAIN-VetsExperimental treatment 1 intervention
Group B: Health Education ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
8 months

Secondary outcomes

1

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.

Time frame
8 months
2

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.

Time frame
8 months
3

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.

Time frame
8 months
4

Quality of Life Change

Change in life satisfaction (Satisfaction with Life Scale). Higher score indicates better quality of life; range = 5 to 35.

Time frame
8 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northern California Institute of Research and Education

Lead sponsor

San Francisco Veterans Affairs Medical Center

Collaborator

VA Palo Alto Health Care System

Collaborator

Source ClinicalTrials.gov
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