TBI Rehabilitation and Activation in Veterans
- Conditions
- Traumatic Brain Injury
- Interventions
- Behavioral: Health Education ControlBehavioral: TRAIN-Vets
- Registration Number
- NCT06562127
- Lead Sponsor
- Northern California Institute of Research and Education
- 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.
- Detailed Description
The purpose of the proposed trial is to evaluate the impact of a multicomponent training program (TRAIN-Vets) on improving cognitive function and other outcomes over an 8-month period in older Veterans with TBI and cognitive complaints. The primary aim of the trial is to evaluate the efficacy of the TRAIN-Vets intervention to improve cognitive function in Veterans with TBI. Secondary aims of the proposed research are to evaluate the efficacy of TRAIN-Vets to improve: 1) individual cognitive domain scores, 2) psychological and social measures (sleep, mood, social and community engagement, diet, and life satisfaction), and 3) physical fitness.
The investigators will randomize 120 older Veterans with TBI and cognitive complaints aged 50 or older to TRAIN-Vets or Health Education Control (HEC). Participants randomized to the TRAIN-Vets group will engage in aquatic-based exercise training and cognitive training combined with personalized risk factor reduction related to their brain health risk factors. 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). Over the 8 months, Veterans in TRAIN-Vets will also participate virtually in monthly personalized risk reduction sessions based at SFVHCS focused on improving other risk factors and symptoms. Participants in the HEC group will be mailed educational materials about brain health and dementia risk factor reduction throughout the 8 months. HEC participants will be contacted monthly through phone calls to check in and maintain interest. All participants will complete a phone screening, baseline in person and virtual visits, and follow-up visits with blinded assessors (to assess outcomes) at approximately 6 and 8 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Health Education Control Health Education Control The Health Education Control (HEC) receives mailed educational materials about brain health and healthy lifestyles over 8 months, as well as regular contact with study staff. TRAIN-Vets TRAIN-Vets TRAIN-Vets is an 8-month intervention with aquatic-based exercise training and cognitive training combined with lifestyle coaching related to cognitive impairment risk factors. 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 monthly lifestyle coaching based at SFVAHCS focused on other risk factors and symptoms.
- Primary Outcome Measures
Name Time Method Cognitive Change (Composite Score) 8 months 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.
- Secondary Outcome Measures
Name Time Method Cognitive Sub-Domain Change: Executive Function (Composite Score) 8 months 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.
Cognitive Sub-Domain Change: Learning/Memory (Composite Score) 8 months 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.
Physical Fitness Change 8 months Change in peak VO2, or VO2Max, defined as the minute volume of O2 utilization.
Targeted Risk Factor Change (Composite Score) 8 months 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.
Quality of Life Change 8 months Change in life satisfaction (Satisfaction with Life Scale). Higher score indicates better quality of life; range = 5 to 35.
Trial Locations
- Locations (2)
San Francisco VA Health Care System
🇺🇸San Francisco, California, United States
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States