Treatment Optimization of Brain-injured Warfighters
- Conditions
- Mild Traumatic Brain Injury
- Interventions
- Behavioral: Stretching Control Group (SCG)Behavioral: Sub-symptomatic Adaptable Exercise Treatment (SAET)
- Registration Number
- NCT06561100
- Lead Sponsor
- United States Naval Medical Center, San Diego
- 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.
- Detailed Description
The study will be a randomized clinical trial among active duty service members (SMs) with persistent cognitive complaints following mTBI, comparing a prescribed sub-symptomatic adaptable exercise treatment (SAET) to an active stretching control group (SCG). SAET's overall effectiveness will be assessed by neurobehavioral symptom resolution. Additional exploratory aims will include cognitive performance, physiological adaptation and locomotion as well as functional changes in military performance. These items will be addressed in the following aims.
Primary Aim:
To determine whether SAET is more effective than the control condition in reducing neurobehavioral symptoms among SMs with persistent complaints following mTBI. Hypothesis 1: There will be a greater reduction in the Neurobehavioral Symptoms Inventory (NSI) from pre- to post-SAET compared to the control condition. A similar finding will continue from immediate to 3 month post-SAET.
Secondary Aims:
Sub-aim 1 Cognitive Status: To determine if SAET is effective at improving cognitive impairment among SMs with persistent complaints from mTBI. Sub-hypothesis 1: There will be a greater decrease in the Global Deficit Scores (GDS; an overall measure of cognitive impairment) post SAET in comparison to the control condition.
Sub-aim 2 Physiological Adaptation: To measure physiological adaptation associated with SAET compared to the control condition. Sub-hypothesis 2: SAET will be associated with improved cerebrovascular blood flow regulation, as measured by Transcranial Doppler and improved cardiovascular function, as measured by changes in heart rate variability (HRV) and estimated maximal oxygen consumption (est. VO2 max) compared to the control condition.
Sub-aim 3 Warfighter Performance: To determine if SAET participants will have improved locomotion and a higher level of occupational performance compared to the control condition. Sub-hypothesis 3: SAET participants will have improved locomotion and physical performance (based on the Marine Corps Combat Fitness Test(CFT)) and higher ratings of occupational performance (based on supervisor ratings on the Checklist of Military Activities of Daily Living \[M-ADL\]) after completion of treatment and 3 months post-treatment compared to the control condition.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stretching Control Group (SCG) Stretching Control Group (SCG) Participants will attend two in-clinic sessions per week with either a licensed Physical Therapist or Exercise Physiologist and complete three sessions per week independently outside of the clinic. Each session will be 1 hour in duration, 5 days a week for 8 weeks, for a total of 40 hours. The stretching exercises are designed not to increase heart rate or have excessive head motion consist of static stretching and yoga based movements. Sub-symptomatic Adaptable Exercise Treatment (SAET) Sub-symptomatic Adaptable Exercise Treatment (SAET) Participants will attend two in-clinic sessions per week with either a licensed Physical Therapist or Exercise Physiologist and complete three sessions per week independently outside of the clinic. Each session will be 1 hour in duration, 5 days a week for 8 weeks, for a total of 40 hours. Participants will complete a combination of aerobic and resistance training exercises prescribed and adapted to the participant's personal needs based on evaluations by the Physical Therapist and Exercise Physiologist. Exercise will be adjusted to maintain sub-symptomatic levels, meaning that if a participant's neurobehavioral symptoms increase with activity, the intensity and/or exercise will be modified. Furthermore, participants will be asked to fill out an Exercise Habits Questionnaire (EHQ) in order to capture the exercises they are currently doing.
- Primary Outcome Measures
Name Time Method Neurobehavioral Symptom Change 6 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.
- Secondary Outcome Measures
Name Time Method Maximal oxygen consumption 6 Months 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.
Warfighter readiness based on Combat Fitness Test 6 Months 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.
Cognitive Impairment Change 6 Months There will be a change in the Global Deficit Scores (GDS; an overall measure of cognitive impairment) post intervention.
Change in level of occupational performance 6 months Ratings of occupational performance by a direct supervisor using a modified Checklist of Military Activities of Daily Living (M-ADL).
Trial Locations
- Locations (1)
Intrepid Spirit Center
🇺🇸Camp Pendleton, California, United States