Protocol Details
Effects of Rapid-Resisted Exercise on Ambulatory Adults with Traumatic Brain Injury
This study is NOT currently recruiting participants.
Summary
Number | 10-CC-0150 |
Sponsoring Institute | National Institutes of Health Clinical Center (CC) |
Recruitment Detail | Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 44 Years |
Referral Letter Required | No |
Population Exclusion(s) | Children |
Keywords | Motor Training;
Post-Traumatic Stress Disorder (PTSD);
Balance |
Recruitment Keyword(s) | None |
Condition(s) | Adult;
Traumatic Brain Injury;
fMRI |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | Other: Elliptical exercise
|
Supporting Site | NIH Clinical CenterCenter for Neuroscience and Regenerative Medicine (CNRM)Henry Jackson FoundationDepartment of Defense |
Background:
- Traumatic brain injury may have a range of effects, from severe and permanent disability to more subtle functional and cognitive deficits that often go undetected during initial treatment. To improve treatments and therapies and to provide a uniform quality of care, more research is needed into different treatments for traumatic brain injury.
- Exercise has been shown to improve movement and balance in people with strokes, cerebral palsy, and other conditions that affect the brain, and can improve symptoms of memory problems or depression. Bright light therapy has also been shown to improve mood in people with depression. Researchers are interested in studying problems with movement, balance, thinking, and mood in people with traumatic brain injury. By comparing the effects of exercise and bright light exposure on brain function, new treatments may be developed for acute traumatic brain injury.
Objectives:
- To compare the effects of exercise and bright light therapy on the brain function of individuals with traumatic brain injury.
Eligibility:
- Individuals between 18 and 44 years of age who either have been diagnosed with traumatic brain injury or are healthy volunteers.
Design:
- Individuals with traumatic brain injury will have four outpatient evaluation visits at the clinical center, a 3-month home exercise program, and a 3-month bright light exposure program at home. Healthy volunteers will have one evaluation visit at the clinical center.
- At the first study visit, all participants will have a full physical examination and medical history. Individuals with traumatic brain injury will also have an eye exam to determine if it is safe for them to receive light therapy.
- All participants will have the following initial tests:
- Tests of walking and movement, including monitoring by a physical therapist; tests to record joint movement and evaluate muscle function; tests that combine movement, thinking, and speaking; and balance and reaction time tests.
- Magnetic resonance imaging scans
- Tests of thinking and mood, including questionnaires, computerized tests, and simple action tests.
- Participants with traumatic brain injury will have separate 3-month sessions of exercise and bright light therapy, with additional evaluation visits between each 3-month session and at the end of the study. Between the 3-month sessions, participants will have 1 month with no intervention.
- Exercise sessions will involve regular workouts on an elliptical machine for 30 minutes for 5 days a week, and bright light therapy sessions will involve sitting in front of a light box for 30 minutes for 5 days a week. Participants will keep a journal to monitor the effects of the therapy.
Eligibility
INLCUSION CRITERIA:
Inclusion criteria for all subjects (healthy volunteers and those with TBI) include:
-ages 18 - 44, inclusive
Additional inclusion criteria for those with TBI include:diagnosis of traumatic brain injury
-at least 6 months from initial brain injury
-ability to stand and walk independently and safely without assistance
-sufficient attention and cognition to complete the assessments without a proxy
-capable of providing own consent
EXCLUSION CRITERIA:
-presence of an injury to any extremity, or other medical condition that would affect motor function or the ability to perform the assessments or the exercise program, specifically balance problems due to Vestibulopathy, that would affect your ability to perform the assessments or the exercise program
-have any of the following contraindications to having an MRI scan:
--Pregnancy: For any female of childbearing potential who is not pregnant, a pregnancy test will be done.
--A ventriculo-peritoneal shunt
--Have claustrophobia and are not comfortable in small enclosed spaces.
--have metal in your body that would make having an MRI scan unsafe such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear or ear implant, transdermal medication patch (nitroglycerine), any metallic implants or objects, body piercing that cannot be removed, bone or joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal embedded (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near your eyes). If you have a question about any metal objects being present in your body, you should ask the study doctor.
--Excessive startle reaction to or fear of loud noises
--You are not able to fit in the scanner
Additional exclusion criteria for those with TBI include:
-Planning to make a change in medication or therapy during the enrollment period with the goal of improving mood, cognitive function or motor function.
Citations:
Martin EM, Lu WC, Helmick K, French L, Warden DL. Traumatic brain injuries sustained in the Afghanistan and Iraq wars. J Trauma Nurs. 2008 Jul-Sep;15(3):94-9; quiz 100-1. Brown AW, Elovic EP, Kothari S, Flanagan SR, Kwasnica C. Congenital and acquired brain injury. 1. Epidemiology, pathophysiology, prognostication, innovative treatments, and prevention. Arch Phys Med Rehabil. 2008 Mar;89(3 Suppl 1):S3-8. Katz DI, White DK, Alexander MP, Klein RB. Recovery of ambulation after traumatic brain injury. Arch Phys Med Rehabil. 2004 Jun;85(6):865-9.
Contacts:
Clinical Trials Number:
NCT01175993