TBI Rehabilitation and Activation in Veterans
NCT Number: NCT06562127
Acronym: TRAIN-Vets
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Traumatic Brain Injury
Interventions: BEHAVIORAL: TRAIN-Vets|BEHAVIORAL: Health Education Control
Sponsor: Northern California Institute of Research and Education
Collaborators: San Francisco Veterans Affairs Medical Center|VA Palo Alto Health Care System
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2028-02
Locations: VA Palo Alto Health Care System, Palo Alto, California, 94304-1207, United States

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.

Primary Outcome Measures: Cognitive Change (Composite Score), Change in global composite score calculated from the z-scores from all cognitive measures \[Wechsler Adult Intelligence Scale, 4th edition (WAIS-IV) Digit Span Forward, WAIS-IV Digit Span Backwards, WAIS-IV Digit Span Sequencing, Trail Making Test A and B; Delis-Kaplan Executive Function System (DKEFS) Stroop Inhibition Time \& Errors; DKEFS Stroop Inhibition-Switching Time \& Errors; DKEFS Verbal Fluency Switching; Benson Figure Copy; Trail Making Test A and Benson Figure Copy and Recall; Hopkins Verbal Learning Test (HVLT) Learning and Delayed Recall Trials\]. The total score is reported. Higher values signify higher cognitive performance. A z-score of 0 represents the population mean., 8 months
Secondary Outcome Measures: 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., 8 months|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., 8 months|Targeted Risk Factor Change (Composite Score), Change in targeted risk factor composite score calculated from the z-score from all risk factor measures \[sleep quality (Pittsburgh Sleep Quality Inventory), mood (Patient Health Questionnaire - 9), social and community engagement (Mayo-Portland Adaptability Inventory Participation Scale), and diet (MIND Diet Questionnaire)\]. The total score is reported. Higher values signify more favorable risk factors. A z-score of 0 represents the population mean., 8 months|Quality of Life Change, Change in life satisfaction (Satisfaction with Life Scale). Higher score indicates better quality of life; range = 5 to 35., 8 months|Physical Fitness Change, Change in peak VO2, or VO2Max, defined as the minute volume of O2 utilization., 8 months