The Effect of Aerobic Exercise on Mild Traumatic Brain Injury

Study Overview
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Brief Summary
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The current project will examine the effects of aerobic exercise on cognition among a group of veterans who have suffered a mild traumatic brain injury.

Detailed Description
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There is substantial evidence that a large number of individuals who experience TBI will demonstrate life-long deficits in cognitive or social functions. An estimated 80-90,000 Americans with TBI suffer life-long impairment of physical, cognitive, and psychosocial skills to the degree that they are unable to return to school or work. Research on rehabilitation for mTBI has been minimal and typically has focused on speech, pain management, dizziness, fatigue, irritability, and sensory disorders. The results of the few studies that have examined long-term cognitive effects of mTBI have offered conflicting results. The current research will investigate the efficacy of an aerobic exercise intervention among individuals with mild traumatic brain injury (mTBI). This project will examine changes in fractional anisotropy (FA) values and cognitive functioning among individuals diagnosed with mTBI in a monitored aerobic exercise regimen, versus a low impact stretching and toning control group.

Official Title
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Aerobic Exercise in TBI: White Matter Integrity and Cognition

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Other: aerobic exercise
* Other: stretching/toning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anyone between 18 and 50 years of age, from the geographic region served by the Malcolm Randall-North Florida-South Georgia VAMC, who have sustained a TBI and demonstrate impairment on neuropsychological assessment (criteria for mTBI will be defined as a loss of consciousness for not more than 30 minutes and post-trauma amnesia of not more than 24 hours). Exclusion Criteria: TBI occurring less than 6 months or greater than 5 years prior to enrollment, any metal implants or shrapnel that may put them at risk for injury during an MRI scan, significant cognitive impairment (MMSE<24), history of stroke, B-12 deficiency, hypothyroidism, organ failure (renal, hepatic, cardiac, or lung), substance abuse, seizures, or any limitation that would preclude them from safely engaging in the aerobic exercise regimen.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>participants in the aerobic exercise intervention | Other: aerobic exercise<br>* , participants assigned to the exercise treatment group of the proposed study will participate in an aerobic exercise regimen of brisk walking on a treadmill for a 60 minute interval, three times a week<br>|
| Active Comparator: 2<br>participants in the stretching/toning control condition | Other: stretching/toning<br>* Individuals in the control group will participate in a low intensity stretching and toning session for 60 minutes, three times a week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diffusion Tensor Imaging |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trail Making Test - Part A |  | 16 weeks | 
| Symbol Search |  | 16 weeks | 
| California Verbal Learning Test - Second Edition (CVLT-II). |  | 16 weeks | 
| Brief Visual Memory Test - Revised (BVMT-R). |  | 16 weeks | 
| Adaptive Digit Ordering Test (DOT-A). |  | 16 weeks | 
| Continuous Performance Test of Attention (CPT-A). |  | 16 weeks | 
| Delis-Kaplin Executive Function System Tower Test |  | 16 weeks | 
| Trail Making Test - Part B. |  | 16 weeks | 
| Controlled Oral Word Association Test (COWAT). |  | 16 weeks | 
| Boston Naming Test (BNT). |  | 16 weeks | 
| Judgment-Line Orientation (JLO). |  | 16 weeks | 
| Grooved Pegboard Test |  | 16 weeks | 
| Hand Dynamometer |  | 16 weeks | 
| Finger Tapping Test |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic brain injury, aerobic exercise, Diffusion Tensor Imaging, Neuropsychology, Rehabilitation