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Exercise Treatment for Mild Traumatic Brain Injury in Warfighters

This study is looking at two types of exercise programs for active duty service members (ages 18-55) who have had a mild traumatic brain injury (mTBI) more than a month ago and are still having symptoms. It compares a program called Sub-symptomatic Adaptable Exercise Treatment (SAET), which includes stretching and light to moderate aerobic exercise, to a Stretching Control Group (SCG) that focuses only on stretching. The goal is to see if SAET can reduce symptoms, improve mental health, and help service members return to duty. We want to see if SAET is better at reducing neurobehavioral symptoms (changes in thinking, behavior, and emotions) after 6 months. You cannot join if you've had a TBI recently, a severe TBI, or certain other health conditions. The current recruitment status is unclear, and the study plans to enroll 140 participants.

Study design
This is a randomized clinical trial, meaning participants will be randomly assigned to either the SAET or SCG group. The study plans to enroll 140 active duty service members.
What's involved
Each exercise session will be 50-60 minutes long, with specific instructions for each group. The primary outcome will be measured at 6 months.
Compensation
Not stated in the trial record.
Follow-up
Neurobehavioral symptoms will be measured at 6 months, and cognitive improvement will also be assessed after the SAET program.

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NCT06561100

Treatment Optimization of Brain-injured Warfighters

Recruiting
NAAges 18–55InterventionalTreatment
United States Naval Medical Center, San Diego
~140 participants
Updated 2024-08-19 on ClinicalTrials.gov
What's tested:Sub-symptomatic Adaptable Exercise Treatment (SAET)Stretching Control Group (SCG)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neurobehavioral Symptom Change
Measured over 6 Months

Conditions

Mild Traumatic Brain Injury

Explore related trials

Concussion

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Jason M Bailie, Phd · PRINCIPAL_INVESTIGATOR · Traumatic Brain Injury Center of Excellence (TBICoE)

Who to contact

Jason M Bailie, PhD
[email protected]
(760) 719-4202
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Neurobehavioral Symptom Change6 Months

    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.