Effects of Rapid-Resisted Exercise and Bright Light Therapy on Ambulatory Adults With Traumatic Brain Injury
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 44 |
| Updated: | 4/6/2019 |
| Start Date: | June 22, 2010 |
| End Date: | February 4, 2014 |
Effects of Rapid-Resisted Exercise on Ambulatory Adults With Traumatic Brain Injury
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.
- 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.
We will: 1) compare performance of healthy volunteers and ambulatory adults with traumatic
brain injury (TBI) on a range of motor, neurobehavioral and brain imaging outcomes; and 2)
evaluate effects of rapid, reciprocal arm and leg exercise with an elliptical trainer on
high-level motor coordination and balance, and neurobehavioral and cognitive functioning in
persons with TBI. Brain connectivity and changes in connectivity in response to intervention
will be quantified. We hypothesize even highly functional adults with TBI will have poorer
scores on all measures than controls; exercise will lead to significant improvements in motor
performance and balance,and neurobehavioral and cognitive functioncompared to an equivalent
length of time during which they were not participating in training . We further hypothesize
that improvements in cortical connectivity and representation will relate directly to
functional ones.
Study Population: 80 adults (50 with TBI) will be recruited so that 20 with TBI and 20
healthy volunteers complete the study. Only the TBI group will receive intervention.
Design: Healthy controls with have a single assessment that includes motor,
neuropsychological and brain imaging tests. Participants with TBI will have 3 visits with the
same motor, neuropsychological and brain imaging tests as the healthy controls. They will
perform 2 months of fast elliptical training. . Assessments will occur at 0, 2, and 4 months.
The exercise device will be an elliptical trainer that exercises the legs and arms with the
emphasis on maintaining a fast speed. Mild resistance will be provided initially and
progressively increased once speed is optimized. . The training will be performed in the home
5 days per week for 30 minutes.
Outcome Measures: Performance on complex motor and balance tasks will be assessed with 3D
motion capture & EMG, the Smart Balance Measurement System and the High Level Mobility
Assessment Tool (Hi-MAT). Primary outcomes are Hi-MAT score, reaction time during balance
testing and the Hamilton Rating Scale for Depression (Ham-D). Secondary outcomes will include
measures of motor speed and reaction time, dual task performance, memory, anxiety, sleep
quality, and responses to stress. Cortical connectivity will be quantified using resting
state functional connectivity magnetic resonance imaging (MRI) and Diffusion Tensor Imaging
(DTI), which evaluates white matter tracts. Cortical activation patterns during imagined
walking will be quantified with fMRI.
brain injury (TBI) on a range of motor, neurobehavioral and brain imaging outcomes; and 2)
evaluate effects of rapid, reciprocal arm and leg exercise with an elliptical trainer on
high-level motor coordination and balance, and neurobehavioral and cognitive functioning in
persons with TBI. Brain connectivity and changes in connectivity in response to intervention
will be quantified. We hypothesize even highly functional adults with TBI will have poorer
scores on all measures than controls; exercise will lead to significant improvements in motor
performance and balance,and neurobehavioral and cognitive functioncompared to an equivalent
length of time during which they were not participating in training . We further hypothesize
that improvements in cortical connectivity and representation will relate directly to
functional ones.
Study Population: 80 adults (50 with TBI) will be recruited so that 20 with TBI and 20
healthy volunteers complete the study. Only the TBI group will receive intervention.
Design: Healthy controls with have a single assessment that includes motor,
neuropsychological and brain imaging tests. Participants with TBI will have 3 visits with the
same motor, neuropsychological and brain imaging tests as the healthy controls. They will
perform 2 months of fast elliptical training. . Assessments will occur at 0, 2, and 4 months.
The exercise device will be an elliptical trainer that exercises the legs and arms with the
emphasis on maintaining a fast speed. Mild resistance will be provided initially and
progressively increased once speed is optimized. . The training will be performed in the home
5 days per week for 30 minutes.
Outcome Measures: Performance on complex motor and balance tasks will be assessed with 3D
motion capture & EMG, the Smart Balance Measurement System and the High Level Mobility
Assessment Tool (Hi-MAT). Primary outcomes are Hi-MAT score, reaction time during balance
testing and the Hamilton Rating Scale for Depression (Ham-D). Secondary outcomes will include
measures of motor speed and reaction time, dual task performance, memory, anxiety, sleep
quality, and responses to stress. Cortical connectivity will be quantified using resting
state functional connectivity magnetic resonance imaging (MRI) and Diffusion Tensor Imaging
(DTI), which evaluates white matter tracts. Cortical activation patterns during imagined
walking will be quantified with fMRI.
- 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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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