Clinical trial NCT06561100: Treatment Optimization of Brain-injured Warfighters
Official title: Treatment Optimization of Brain-injured Warfighters: A Prescribed Sub-symptomatic Exercise Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: Progressive Return to Activity
Warfighter Readiness
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2024-08-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to one or more study arms and each study arm will be allocated a different intervention.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurobehavioral Symptom Change
timeFrame: 6 Months
Secondary outcomes:
measure: Cognitive Impairment Change
timeFrame: 6 Months
measure: Maximal oxygen consumption
timeFrame: 6 Months
measure: Warfighter readiness based on Combat Fitness Test
timeFrame: 6 Months
measure: Change in level of occupational performance
timeFrame: 6 months
Other outcomes:
Locations:
city: Camp Pendleton
country: United States
facility: Intrepid Spirit Center
state: California
Study officials:
affiliation: Traumatic Brain Injury Center of Excellence (TBICoE)
name: Jason M Bailie, Phd
role: PRINCIPAL_INVESTIGATOR
References: