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Behavioral Intervention

Health Education Control for Traumatic Brain Injury (TRAIN-Vets Trial)

N/A
Waitlist Available
Led By Kristine Yaffe, MD
Research Sponsored by Northern California Institute of Research and Education
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Awards & highlights

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.

Who is the study for?
This trial is for older veterans who have had a traumatic brain injury (TBI) and are experiencing cognitive issues. Participants must be willing to undergo an 8-month program and can't already be involved in another TBI study or have conditions that interfere with the trial.
What is being tested?
The study compares TRAIN-Vets, which includes aquatic exercise, cognitive training, and lifestyle coaching, against a control group receiving educational materials on brain health over eight months to see which improves cognitive function in TBI patients more effectively.
What are the potential side effects?
Since this trial involves non-drug interventions like exercise and education, side effects may include muscle soreness from physical activity or stress due to lifestyle changes. Cognitive training typically does not have direct side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cognitive Change (Composite Score)
Secondary study objectives
Cognitive Sub-Domain Change: Executive Function (Composite Score)
Cognitive Sub-Domain Change: Learning/Memory (Composite Score)
Physical Fitness Change
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: TRAIN-VetsExperimental Treatment1 Intervention
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.
Group II: Health Education ControlExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Health Education Control
2005
Completed Phase 2
~1420

Find a Location

Who is running the clinical trial?

San Francisco Veterans Affairs Medical CenterFED
49 Previous Clinical Trials
210,720 Total Patients Enrolled
Northern California Institute of Research and EducationLead Sponsor
28 Previous Clinical Trials
9,964 Total Patients Enrolled
VA Palo Alto Health Care SystemFED
92 Previous Clinical Trials
58,041 Total Patients Enrolled
~80 spots leftby Feb 2028
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