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The Effect of Aerobic Exercise on Mild Traumatic Brain Injury

Aerobic Exercise in TBI: White Matter Integrity and Cognition

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00940615
Enrollment
24
Registered
2009-07-16
Start date
2009-09-30
Completion date
2010-09-30
Last updated
2015-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury, aerobic exercise, Diffusion Tensor Imaging, Neuropsychology, Rehabilitation

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.

Interventions

OTHERaerobic exercise

, 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

Individuals in the control group will participate in a low intensity stretching and toning session for 60 minutes, three times a week

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Diffusion Tensor Imaging16 weeks

Secondary

MeasureTime frame
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 Test16 weeks
Trail Making Test - Part B.16 weeks
Controlled Oral Word Association Test (COWAT).16 weeks
California Verbal Learning Test - Second Edition (CVLT-II).16 weeks
Judgment-Line Orientation (JLO).16 weeks
Grooved Pegboard Test16 weeks
Hand Dynamometer16 weeks
Finger Tapping Test16 weeks
Trail Making Test - Part A16 weeks
Symbol Search16 weeks
Boston Naming Test (BNT).16 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026