The Effect of Aerobic Exercise on Mild Traumatic Brain Injury

Aerobic Exercise in TBI: White Matter Integrity and Cognition

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.

Study Overview

• Status: Terminated
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: aerobic exercise; Other: stretching/toning

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • North Florida/South Georgia Veterans Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; participants in the aerobic exercise intervention	Other: 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
Active Comparator: 2; participants in the stretching/toning control condition	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diffusion Tensor Imaging	16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Trail Making Test - Part A	16 weeks
Symbol Search	16 weeks
California Verbal Learning Test - Second Edition (CVLT-II).	16 weeks
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 Test	16 weeks
Trail Making Test - Part B.	16 weeks
Controlled Oral Word Association Test (COWAT).	16 weeks
Boston Naming Test (BNT).	16 weeks
Judgment-Line Orientation (JLO).	16 weeks
Grooved Pegboard Test	16 weeks
Hand Dynamometer	16 weeks
Finger Tapping Test	16 weeks

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: David E Cox, PhD, North Florida/South Georgia Veterans Health System

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: July 14, 2009
• First Submitted That Met QC Criteria: July 15, 2009
• First Posted (Estimate): July 16, 2009

Study Record Updates

• Last Update Posted (Estimate): June 26, 2015
• Last Update Submitted That Met QC Criteria: June 25, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Rehabilitation; aerobic exercise; Diffusion Tensor Imaging; traumatic brain injury; Neuropsychology
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: B6859-M