The Effect of Aerobic Exercise on Mild Traumatic Brain Injury

Not Applicable

Terminated

• Conditions: Traumatic Brain Injury
• Interventions: Other: aerobic exercise; Other: stretching/toning

• Registration Number: NCT00940615
• Lead Sponsor: US Department of Veterans Affairs

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.

Study Timeline

• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Study Start: 2009-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	aerobic exercise	participants in the aerobic exercise intervention
2	stretching/toning	participants in the stretching/toning control condition

Primary Outcome Measures

Name	Time	Method
Diffusion Tensor Imaging	16 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

North Florida/South Georgia Veterans Health System; 🇺🇸 Gainesville, Florida, United States