Treatment Optimization of Brain-injured Warfighters
NCT Number: NCT06561100
Acronym: (TOBI-SET)
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mild Traumatic Brain Injury
Interventions: BEHAVIORAL: Sub-symptomatic Adaptable Exercise Treatment (SAET)|BEHAVIORAL: Stretching Control Group (SCG)
Sponsor: United States Naval Medical Center, San Diego
Sex: ALL
Age: ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-27
Completion Date: 2026-09
Locations: Intrepid Spirit Center, Camp Pendleton, California, 92055, United States

Summary:
Prescribed sub-symptomatic adaptable exercise treatment (SAET) is a potential solution that promotes recovery needs following a TBI. SAET has been shown to benefit the mind and body in ways that decrease the severity and frequency of mild TBI (mTBI) symptoms. This study aims to validate SAET as an alternative, adaptable treatment or SMs with mTBI that focuses on reducing symptoms, improving mental health, increasing physiological functioning, and ultimately returning to duty.

The objective of this study is to develop a prescribed exercise treatment program for warfighters with mTBI that can be personalized for SM's needs (i.e., medical and occupational) and is adaptable to various clinical resources (e.g., forward operating bases, rural clinics, and mTBI specialty programs). The key question raised by this study is whether SAET is more effective than a stretching control group (SCG) in reducing neurobehavioral symptoms among SMs with persistent complaints following a mTBI.

Primary Outcome Measures: Neurobehavioral Symptom Change, Change in the Neurobehavioral Symptoms Inventory (NSI) from pre- to post-SAET.

Neurobehavioral symptoms will be assessed using the Neurobehavioral Symptom Inventory (NSI) which captures multiple neurobehavioral symptoms including cognitive, somatosensory, vestibular, and affective. Furthermore, this 22 item self-report questionnaire is well validated in research studies on TBI in military populations, it has known reliability and validity, as well as guidelines for assessment of change., 6 Months
Secondary Outcome Measures: Cognitive Impairment Change, There will be a change in the Global Deficit Scores (GDS; an overall measure of cognitive impairment) post intervention., 6 Months|Maximal oxygen consumption, We will measure cardiovascular fitness levels by administering an estimated maximal Oxygen consumption (est. VO2 max) test. Fitness levels will be determined based on VO2 percentage and categorized by very low, low, fair, good, excellent, or superior fitness level., 6 Months|Warfighter readiness based on Combat Fitness Test, We will measure changes in locomotion, physical performance (based on the Marine Corps Combat Fitness Test (CFT)), after completion of treatment and 3 months post-treatment. A CFT classification score ranging from 1st class through 3rd class or failed, will be given based on their performance., 6 Months|Change in level of occupational performance, Ratings of occupational performance by a direct supervisor using a modified Checklist of Military Activities of Daily Living (M-ADL)., 6 months