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Effects of Rapid-Resisted Exercise and Bright Light Therapy on Ambulatory Adults With Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01175993
Recruitment Status : Completed
First Posted : August 5, 2010
Last Update Posted : July 1, 2022
Sponsor:
Collaborators:
Center for Neuroscience and Regenerative Medicine (CNRM)
Henry M. Jackson Foundation for the Advancement of Military Medicine
United States Department of Defense
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Adult Traumatic Brain Injury fMRI Other: Elliptical exercise Phase 1 Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Rapid-Resisted Exercise on Ambulatory Adults With Traumatic Brain Injury
Actual Study Start Date : August 24, 2011
Actual Primary Completion Date : February 4, 2014
Actual Study Completion Date : February 4, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Eliptical training
Home base exercise
Other: Elliptical exercise
Each participant with TBI will participate in an exercise intervention which will be done in the home. The exercise device in this protocol will be an elliptical trainer that requires coordinated reciprocal movements of both the legs and the arms. Primary emphasis will be placed on maintaining a near maximal speed of movement and to progressively increase this over time. Mild resistance to the leg motion will be provided initially and will be progressively increased once speed and coordination are optimized. The device will be loaned to them to use in the home, and will be delivered to the home fully assembled. Participants will be monitored by phone the first week and thereafter every two weeks and progressed as indicated. The exercise program will be performed 5 days a week for 30 minutes per session, for a total duration of 12 weeks. All will record the length, speed and resistance of each session on a paper-based log sheet.




Primary Outcome Measures :
  1. 1. HiMAT is a composite measure of high functioning mobility skills. 2. Limits of Stability instrumented balance test wih a focus on response speed3. Hamilton Depression (HAM-D) inventory to evaluate changesin emotional health [ Time Frame: 0, 2, and 4 months ]
    Primary outcomes are Hi-MAT score, reaction time during balance testing and the Hamilton Rating Scale for Depression (Ham-D).


Secondary Outcome Measures :
  1. 1. movement speed and reaction time during a range of motor tasks2. Other aspects of balance tests (e.g. directionality)3. scores on neuropsychological tests4. analysis of brain pathway volume and connectivity [ Time Frame: 0, 2, and 4 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175993


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Center for Neuroscience and Regenerative Medicine (CNRM)
Henry M. Jackson Foundation for the Advancement of Military Medicine
United States Department of Defense
Investigators
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Principal Investigator: Diane L Damiano, Ph.D. National Institutes of Health Clinical Center (CC)
Additional Information:
Publications:
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01175993    
Other Study ID Numbers: 100150
10-CC-0150
First Posted: August 5, 2010    Key Record Dates
Last Update Posted: July 1, 2022
Last Verified: October 20, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC):
Motor Training
Post-Traumatic Stress Disorder (PTSD)
Balance
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System