The Effect of Aerobic Exercise on Mild Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Aerobic Exercise in TBI: White Matter Integrity and Cognition

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00940615
• Other study ID #: B6859-M
• Status: Terminated
• Phase: N/A
• First received: July 14, 2009
• Last updated: June 25, 2015
• Start date: September 2009
• Est. completion date: September 2010

Study information

• Verified date: June 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Traumatic Brain Injury

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

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diffusion Tensor Imaging		16 weeks	No
Secondary	Trail Making Test - Part A		16 weeks	No
Secondary	Symbol Search		16 weeks	No
Secondary	California Verbal Learning Test - Second Edition (CVLT-II).		16 weeks	No
Secondary	Brief Visual Memory Test - Revised (BVMT-R).		16 weeks	No
Secondary	Adaptive Digit Ordering Test (DOT-A).		16 weeks	No
Secondary	Continuous Performance Test of Attention (CPT-A).		16 weeks	No
Secondary	Delis-Kaplin Executive Function System Tower Test		16 weeks	No
Secondary	Trail Making Test - Part B.		16 weeks	No
Secondary	Controlled Oral Word Association Test (COWAT).		16 weeks	No
Secondary	Boston Naming Test (BNT).		16 weeks	No
Secondary	Judgment-Line Orientation (JLO).		16 weeks	No
Secondary	Grooved Pegboard Test		16 weeks	No
Secondary	Hand Dynamometer		16 weeks	No
Secondary	Finger Tapping Test		16 weeks	No