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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 23, 2013