Treatment Optimization of Brain-injured Warfighters

Official title

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

Overview

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.

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. Re
• 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]

Secondary outcome measures (4)

• Cognitive Impairment Change [Time frame: 6 Months]
• Maximal oxygen consumption [Time frame: 6 Months]
• Warfighter readiness based on Combat Fitness Test [Time frame: 6 Months]
• Change in level of occupational performance [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Intrepid Spirit Center — Camp Pendleton

Identifiers

NCT: NCT06561100 · TP210450

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗