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

NCT01175993 | Completed Phase 1

• 2 other identifiers: 10015010-CC-0150
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

fMRI; Adult; Traumatic Brain Injury

Keywords

Motor Training; Post-Traumatic Stress Disorder (PTSD); Balance

Outcome Measures

Primary Outcomes (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

  Primary outcomes are Hi-MAT score, reaction time during balance testing and the Hamilton Rating Scale for Depression (Ham-D).

  0, 2, and 4 months

Secondary Outcomes (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

  0, 2, and 4 months

Study Arms (1)

Eliptical training

ACTIVE COMPARATOR

Home base exercise

Other: Elliptical exercise

Interventions

Elliptical exercise OTHER

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.

Eliptical training

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ages 18 - 44, inclusive
• 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

You may not qualify if:

• 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
• Planning to make a change in medication or therapy during the enrollment period with the goal of improving mood, cognitive function or motor function.

Sponsors & Collaborators

• United States Department of Defense: collaborator
• Center for Neuroscience and Regenerative Medicine (CNRM): collaborator
• National Institutes of Health Clinical Center (CC): lead
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1097/01.JTN.0000337149.29549.28.

  PMID: 18820555 BACKGROUND

• 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. doi: 10.1016/j.apmr.2007.12.001.

  PMID: 18295647 BACKGROUND

• 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. doi: 10.1016/j.apmr.2003.11.020.

  PMID: 15179637 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Silvina G Horovitz, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 5, 2010
• Study Start: August 24, 2011
• Primary Completion: February 4, 2014
• Study Completion: February 4, 2014
• Last Updated: April 29, 2026

Record last verified: 2026-03-09

Locations

US (1)