The Effect of Aerobic Exercise on Mild Traumatic Brain Injury

NCT ID: NCT00940615

Last Updated: 2015-06-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-09-30

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

participants in the aerobic exercise intervention

Group Type: EXPERIMENTAL

aerobic exercise

Intervention Type: OTHER

, 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

2

participants in the stretching/toning control condition

Group Type: ACTIVE_COMPARATOR

stretching/toning

Intervention Type: OTHER

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

Interventions

aerobic 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

Intervention Type: OTHER

stretching/toning

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Department of Veterans Affairs

Principal Investigators

David E Cox, PhD

Role: PRINCIPAL_INVESTIGATOR

North Florida/South Georgia Veterans Health System

Locations

North Florida/South Georgia Veterans Health System

Gainesville, Florida, United States

Countries

United States

Other Identifiers

B6859-M

Identifier Type: -

Identifier Source: org_study_id