NCT06561100 · United States Naval Medical Center, San Diego
Treatment Optimization of Brain-injured Warfighters
((TOBI-SET))
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Sub-symptomatic Adaptable Exercise Treatment (SAET)
Each 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.
BEHAVIORAL
Stretching Control Group (SCG)
Each 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.
Primary outcome measures
Neurobehavioral Symptom Change
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Camp Pendleton, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2024 · Source of record for eligibility and locations