Treatment Optimization of Brain-injured Warfighters
(TOBI-SET)
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 27, 2023
CompletedFirst Submitted
Initial submission to the registry
June 21, 2024
CompletedFirst Posted
Study publicly available on registry
August 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
August 19, 2024
August 1, 2024
2.9 years
June 21, 2024
August 16, 2024
Conditions
Keywords
Outcome Measures
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.
6 Months
Secondary Outcomes (4)
Cognitive Impairment Change
6 Months
Maximal oxygen consumption
6 Months
Warfighter readiness based on Combat Fitness Test
6 Months
Change in level of occupational performance
6 months
Study Arms (2)
Sub-symptomatic Adaptable Exercise Treatment (SAET)
EXPERIMENTALParticipants 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.
Stretching Control Group (SCG)
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Intrepid Spirit Center
Camp Pendleton, California, 92055, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason M Bailie, Phd
Traumatic Brain Injury Center of Excellence (TBICoE)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants will be randomized into either the exercise or stretching condition in a 1:1 fashion. The outcome assessors will be blinded at all times while the intervention specialist (study trainers) will unblind themselves prior to the participants first intervention appointment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2024
First Posted
August 19, 2024
Study Start
September 27, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
August 19, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be uploaded and available after study completion. IT is unsure for how long the data is available but FITBIR's confidentiality certificate is approved till 16 July 2032.
- Access Criteria
- In order to access FITBIR's data repository, an account has to be created in which access is then granted to the user.
All surveys, questionnaires, and other instruments will be aligned with Federal Interagency Traumatic Brain Injury Research Informatics System (FITBIR) when possible. FITBIR is a central repository for data from TBI studies built by the National Institute of Health and the Department of Defense.