The Effect of Aerobic Exercise on Mild Traumatic Brain Injury

This study has been terminated.
(Primary Investigator is no longer employeed by the VA)
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00940615
First received: July 14, 2009
Last updated: September 16, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
Other: aerobic exercise
Other: stretching/toning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aerobic Exercise in TBI: White Matter Integrity and Cognition

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Diffusion Tensor Imaging [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trail Making Test - Part A [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Symbol Search [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • California Verbal Learning Test - Second Edition (CVLT-II). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Brief Visual Memory Test - Revised (BVMT-R). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Adaptive Digit Ordering Test (DOT-A). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Continuous Performance Test of Attention (CPT-A). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Delis-Kaplin Executive Function System Tower Test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Trail Making Test - Part B. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Controlled Oral Word Association Test (COWAT). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Boston Naming Test (BNT). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Judgment-Line Orientation (JLO). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Grooved Pegboard Test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Hand Dynamometer [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Finger Tapping Test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940615

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Investigators
Principal Investigator: David E Cox, PhD North Florida/South Georgia Veterans Health System
  More Information

No publications provided

Responsible Party: Cox, David - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00940615     History of Changes
Other Study ID Numbers: B6859M
Study First Received: July 14, 2009
Last Updated: September 16, 2010
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
traumatic brain injury
aerobic exercise
Diffusion Tensor Imaging
Neuropsychology
Rehabilitation

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 19, 2014