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Behavioural Intervention

Exercise Treatment for Traumatic Brain Injury ((TOBI-SET) Trial)

N/A

Recruiting

Led By Jason M Bailie, Phd

Research Sponsored by United States Naval Medical Center, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Active duty, male or female, ages 18 to 55

Be between 18 and 65 years old

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new exercise treatment called sub-symptomatic adaptable exercise treatment (SAET) for military personnel with mild traumatic brain injury (mTBI). The study wants to see

Who is the study for?

This trial is for military service members (SMs) who have experienced a mild traumatic brain injury (mTBI), commonly known as a concussion, and are still dealing with symptoms. The program aims to be adaptable for individual medical needs and available resources.

What is being tested?

The study compares two approaches: Sub-symptomatic Adaptable Exercise Treatment (SAET), which is personalized exercise designed to reduce mTBI symptoms, versus a Stretching Control Group (SCG) that serves as the comparison group.

What are the potential side effects?

Since SAET involves physical exercise tailored below symptom-exacerbation thresholds, side effects may include typical exercise-related discomfort or fatigue. However, specific side effects will depend on the individual's condition and treatment intensity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an active duty service member between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of a neurological disease.

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I have a recent injury that stops me from doing study tasks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neurobehavioral Symptom Change

Secondary study objectives

Change in level of occupational performance

Cognitive Impairment Change

Maximal oxygen consumption

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sub-symptomatic Adaptable Exercise Treatment (SAET)Experimental Treatment1 Intervention

Participants 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.

Group II: Stretching Control Group (SCG)Active Control1 Intervention

0 / 3Eligibility criteria met