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NCT Number: NCT06561100

Treatment Optimization of Brain-injured Warfighters

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.

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Key information

Conditions

Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intrepid Spirit Center

Camp Pendleton, California, 92055, United States

Location status: Recruiting

Location contact

Jeffrey D Bullock, DPT

CONTACT

[email protected]

760-763-9384

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sub-symptomatic Adaptable Exercise Treatment (SAET)

Behavioral

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.

Stretching Control Group (SCG)

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. Cognitive Impairment Change

    Time frame: 6 Months

    There will be a change in the Global Deficit Scores (GDS; an overall measure of cognitive impairment) post intervention.

  2. Maximal oxygen consumption

    Time frame: 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.

  3. Warfighter readiness based on Combat Fitness Test

    Time frame: 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.

  4. Change in level of occupational performance

    Time frame: 6 months

    Ratings of occupational performance by a direct supervisor using a modified Checklist of Military Activities of Daily Living (M-ADL).

Study contacts

Contact information is provided by the study sponsor or research team.

Jason M Bailie, PhD

CONTACT

[email protected]

(760) 719-4202

Juan J Lopez, BA

CONTACT

[email protected]

(760) 719-4229

Sponsors and collaborators

Lead sponsor

United States Naval Medical Center, San Diego

Fed

Registry information

Official study title

Treatment Optimization of Brain-injured Warfighters: A Prescribed Sub-symptomatic Exercise Treatment

Acronym: (TOBI-SET)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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