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

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

• Adult
• Traumatic Brain Injury
• fMRI

Interventions

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.

Sponsors & Collaborators

• Center for Neuroscience and Regenerative Medicine (CNRM)

  collaborator FED

• Henry M. Jackson Foundation for the Advancement of Military Medicine

  collaborator OTHER

• United States Department of Defense

  collaborator FED

• National Institutes of Health Clinical Center (CC)

  lead NIH

Principal Investigators

• Silvina G Horovitz, Ph.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

44 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-08-24

Primary Completion

2014-02-04

Completion

2014-02-04

Countries

• United States

Study Locations