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RecruitingNCT06561100

Treatment Optimization of Brain-injured Warfighters

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Trial Parameters

ConditionMild Traumatic Brain Injury
SponsorUnited States Naval Medical Center, San Diego
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment140
SexALL
Min Age18 Years
Max Age55 Years
Start Date2023-09-27
Completion2026-09
Interventions
Sub-symptomatic Adaptable Exercise Treatment (SAET)Stretching Control Group (SCG)

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Brief 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.

Eligibility Criteria

Inclusion Criteria: * Active duty, male or female, ages 18 to 55 * History of at least one mTBI sustained more than 1 month ago * Service members (SMs) with ongoing symptoms Exclusion Criteria: * SMs who sustained a TBI of any severity within 1 month of enrollment * History of moderate, severe, or penetrating TBI * Current substance use disorder * History of a neurological disease (e.g., multiple sclerosis, cerebral vascular accident, brain tumor, neurodegenerative disease, or neuro-motor disorder) * An acute orthopedic injury that limits the capacity to complete study procedures

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