Traumatic Brain InjuryNCT00940615
The Effect of Aerobic Exercise on Mild Traumatic Brain Injury
A study testing aerobic exercise and stretching/toning in people with Traumatic Brain Injury, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- aerobic exercise and stretching/toning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
About this study
Official title: 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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- aerobic exercise, stretching/toning
- Keywords
- traumatic brain injury, aerobic exercise, Diffusion Tensor Imaging, Neuropsychology, Rehabilitation
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseOther
, 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/toningOther
Individuals in the control group will participate in a low intensity stretching and toning session for 60 minutes, three times a week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | participants in the aerobic exercise intervention Receives: Other: aerobic exercise |
| 2 | Active comparator | participants in the stretching/toning control condition Receives: Other: stretching/toning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusion Tensor Imaging
Measured: 16 weeks
Secondary outcomes (14)
Trail Making Test - Part A
Measured: 16 weeks
Symbol Search
Measured: 16 weeks
California Verbal Learning Test - Second Edition (CVLT-II).
Measured: 16 weeks
Brief Visual Memory Test - Revised (BVMT-R).
Measured: 16 weeks
Adaptive Digit Ordering Test (DOT-A).
Measured: 16 weeks
Continuous Performance Test of Attention (CPT-A).
Measured: 16 weeks
Delis-Kaplin Executive Function System Tower Test
Measured: 16 weeks
Trail Making Test - Part B.
Measured: 16 weeks
Controlled Oral Word Association Test (COWAT).
Measured: 16 weeks
Boston Naming Test (BNT).
Measured: 16 weeks
Judgment-Line Orientation (JLO).
Measured: 16 weeks
Grooved Pegboard Test
Measured: 16 weeks
Hand Dynamometer
Measured: 16 weeks
Finger Tapping Test
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Primary Investigator is no longer employeed by the VA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- David E Cox, PhD, Principal investigator, North Florida/South Georgia Veterans Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940615
- Sponsor's protocol ID
- B6859-M
- Status last verified
- Jun 2015
- First submitted
- 14 Jul 2009
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise in TBI: White Matter Integrity and Cognition
- ClinicalTrials.gov ID
- NCT00940615
- Acronym / sponsor ID
- B6859-M
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, aerobic exercise, Diffusion Tensor Imaging, Neuropsychology, Rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary Investigator is no longer employeed by the VA
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 16 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: aerobic exerciseparticipants in the aerobic exercise intervention |
| 2 | Active comparator | Other: stretching/toningparticipants in the stretching/toning control condition |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | 1 |
| stretching/toningIndividuals in the control group will participate in a low intensity stretching and toning session for 60 minutes, three times a week | Other | 2 |
Primary outcome
Diffusion Tensor Imaging
Time frame: 16 weeks
14 secondary outcomes
Trail Making Test - Part A
Time frame: 16 weeks
Symbol Search
Time frame: 16 weeks
California Verbal Learning Test - Second Edition (CVLT-II).
Time frame: 16 weeks
Brief Visual Memory Test - Revised (BVMT-R).
Time frame: 16 weeks
Adaptive Digit Ordering Test (DOT-A).
Time frame: 16 weeks
Continuous Performance Test of Attention (CPT-A).
Time frame: 16 weeks
Delis-Kaplin Executive Function System Tower Test
Time frame: 16 weeks
Trail Making Test - Part B.
Time frame: 16 weeks
Controlled Oral Word Association Test (COWAT).
Time frame: 16 weeks
Boston Naming Test (BNT).
Time frame: 16 weeks
Judgment-Line Orientation (JLO).
Time frame: 16 weeks
Grooved Pegboard Test
Time frame: 16 weeks
Hand Dynamometer
Time frame: 16 weeks
Finger Tapping Test
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Primary Investigator is no longer employeed by the VA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E Cox, PhD principal investigator
North Florida/South Georgia Veterans Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise and stretching/toning in people with Traumatic Brain Injury, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Primary Investigator is no longer employeed by the VA). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffusion Tensor Imaging (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2015.