The Effect of Aerobic Exercise on Mild Traumatic Brain Injury

US Department of Veterans Affairs (VA)

Status: Terminated

Conditions: Traumatic Brain Injury

Treatments: Other: aerobic exercise; Other: stretching/toning

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00940615

B6859-M

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

1

Experimental group

Description:

participants in the aerobic exercise intervention

Treatment:

Other: aerobic exercise

2

Active Comparator group

Description:

participants in the stretching/toning control condition

Treatment:

Other: stretching/toning