Clinical trial NCT00940615: The Effect of Aerobic Exercise on Mild Traumatic Brain Injury
Official title: Aerobic Exercise in TBI: White Matter Integrity and Cognition
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
aerobic exercise
Diffusion Tensor Imaging
Neuropsychology
Rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-07-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diffusion Tensor Imaging
timeFrame: 16 weeks
Secondary outcomes:
measure: Trail Making Test - Part A
timeFrame: 16 weeks
measure: Symbol Search
timeFrame: 16 weeks
measure: California Verbal Learning Test - Second Edition (CVLT-II).
timeFrame: 16 weeks
measure: Brief Visual Memory Test - Revised (BVMT-R).
timeFrame: 16 weeks
measure: Adaptive Digit Ordering Test (DOT-A).
timeFrame: 16 weeks
measure: Continuous Performance Test of Attention (CPT-A).
timeFrame: 16 weeks
measure: Delis-Kaplin Executive Function System Tower Test
timeFrame: 16 weeks
measure: Trail Making Test - Part B.
timeFrame: 16 weeks
measure: Controlled Oral Word Association Test (COWAT).
timeFrame: 16 weeks
measure: Boston Naming Test (BNT).
timeFrame: 16 weeks
measure: Judgment-Line Orientation (JLO).
timeFrame: 16 weeks
measure: Grooved Pegboard Test
timeFrame: 16 weeks
measure: Hand Dynamometer
timeFrame: 16 weeks
measure: Finger Tapping Test
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System
name: David E Cox, PhD
role: PRINCIPAL_INVESTIGATOR
References: