Treatment Optimization of Brain-injured Warfighters
ConditionMild Traumatic Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUnited States Naval Medical Center, San Diego
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Sub-symptomatic Adaptable Exercise Treatment (SAET)
BehavioralEach workout will be structured in a similar format. The first 5 minutes will be devoted to stretching and warm up exercises. Then the next 20 minute segment devoted to light to moderate aerobic exercise. The second 20 minutes of each exercise session will be composed of a series of 5 predetermined exercises that rotate every day. Each workout will have one or two alternatives that the patient can complete either for modification to accommodate a physical limitation or to optimize preference. Resistance training each day will include multi-joint functional movements along with stability work. The last five minutes of the session will include more mobility work, and/or cooling down.
Stretching Control Group (SCG)
BehavioralEach workout will be 50-60 minutes long and participants are instructed to not do any other type of exercise that may elevate their heart rate. Modifications will be available for stretches that may be too advanced for the individual.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Sub-symptomatic Adaptable Exercise Treatment (SAET)Experimental treatment 1 intervention
Group B: Stretching Control Group (SCG)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 MonthsSecondary outcomes
1
Cognitive Impairment Change
There will be a change in the Global Deficit Scores (GDS; an overall measure of cognitive impairment) post intervention.
Time frame
6 Months2
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.
Time frame
6 Months3
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.
Time frame
6 Months4
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).
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov