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The Effect of Aerobic Exercise on Mild Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aerobic exercise
stretching/toning
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury, aerobic exercise, Diffusion Tensor Imaging, Neuropsychology, Rehabilitation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • North Florida/South Georgia Veterans Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

participants in the aerobic exercise intervention

participants in the stretching/toning control condition

Outcomes

Primary Outcome Measures

Diffusion Tensor Imaging

Secondary Outcome Measures

Trail Making Test - Part A
Symbol Search
California Verbal Learning Test - Second Edition (CVLT-II).
Brief Visual Memory Test - Revised (BVMT-R).
Adaptive Digit Ordering Test (DOT-A).
Continuous Performance Test of Attention (CPT-A).
Delis-Kaplin Executive Function System Tower Test
Trail Making Test - Part B.
Controlled Oral Word Association Test (COWAT).
Boston Naming Test (BNT).
Judgment-Line Orientation (JLO).
Grooved Pegboard Test
Hand Dynamometer
Finger Tapping Test

Full Information

First Posted
July 14, 2009
Last Updated
June 25, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00940615
Brief Title
The Effect of Aerobic Exercise on Mild Traumatic Brain Injury
Official Title
Aerobic Exercise in TBI: White Matter Integrity and Cognition
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Primary Investigator is no longer employeed by the VA
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
traumatic brain injury, aerobic exercise, Diffusion Tensor Imaging, Neuropsychology, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
participants in the aerobic exercise intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
participants in the stretching/toning control condition
Intervention Type
Other
Intervention Name(s)
aerobic exercise
Intervention Description
, 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
Intervention Name(s)
stretching/toning
Intervention Description
Individuals in the control group will participate in a low intensity stretching and toning session for 60 minutes, three times a week
Primary Outcome Measure Information:
Title
Diffusion Tensor Imaging
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Trail Making Test - Part A
Time Frame
16 weeks
Title
Symbol Search
Time Frame
16 weeks
Title
California Verbal Learning Test - Second Edition (CVLT-II).
Time Frame
16 weeks
Title
Brief Visual Memory Test - Revised (BVMT-R).
Time Frame
16 weeks
Title
Adaptive Digit Ordering Test (DOT-A).
Time Frame
16 weeks
Title
Continuous Performance Test of Attention (CPT-A).
Time Frame
16 weeks
Title
Delis-Kaplin Executive Function System Tower Test
Time Frame
16 weeks
Title
Trail Making Test - Part B.
Time Frame
16 weeks
Title
Controlled Oral Word Association Test (COWAT).
Time Frame
16 weeks
Title
Boston Naming Test (BNT).
Time Frame
16 weeks
Title
Judgment-Line Orientation (JLO).
Time Frame
16 weeks
Title
Grooved Pegboard Test
Time Frame
16 weeks
Title
Hand Dynamometer
Time Frame
16 weeks
Title
Finger Tapping Test
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Cox, PhD
Organizational Affiliation
North Florida/South Georgia Veterans Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

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The Effect of Aerobic Exercise on Mild Traumatic Brain Injury

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