The purpose of this study is to determine the feasibility of successfully delivering moderate intensity aerobic exercise training to depressed traumatic brain injury subjects between one and three years after injury.
Traumatic brain injury (TBI) alters the lives of many civilians and those involved in armed conflicts. Sequelae of TBI includes depression in up to 30% of cases. Appearance of depression after TBI impairs recovery and results in sub-optimal re-integration into society. Treatment of post TBI depression relies on oral medications, whose efficacy and side effect profile is sub-optimal. Exercise training is effective in spontaneous depression as a stand alone treatment and in conjunction with oral medications, and this may represent an alternative treatment option in the TBI population. Further, the pathophysiology of depression after TBI has yet to be examined with the full scientific rigor required. This project proposes to use exercise training of moderate intensity as a treatment for depression after TBI, while measuring biological markers as a way to investigate efficacy and provide insight into the pathophysiology.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
the active arm will be asked to perform 60% of maximum heart rate
stretching and flexibility program for the Placebo Comparator Arm
Virginia Commonwealth University
Richmond, Virginia, United States
completion of exercise protocol
The primary aim is to measure the rate of completion of the exercise protocol.
Time frame: 12 weeks
neuropsychological testing
cognitive testing battery will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects. Administered to both arms.
Time frame: pre and post intervention, week zero and week 13
mood assessment
depression symptom inventories will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects. Administered to both arms.
Time frame: week 0, week 13, and weekly during 12 week intervention
Columbia-Suicide Severity Rating Scale
Columbia-Suicide Severity Rating Scale was developed to meet the need for tracking changes in a person's suicidal thinking and behavior over time, and to determine who is most at risk. Administered to both arms.
Time frame: week 0, week 13, and weekly during 12 week intervention
magnetic resonance imaging
MRI will be done before and after exercise protocol on a subset of subjects. Selection of these subjects will be done by randomization, starting once the MRI is available for use. The purpose is to examine the brain for exercise influenced volumetric changes. Administered to a subset of both arms of the study.
Time frame: week 0, week 13
biochemical assays
brain-derived neurotrophic factor, vascular endothelial growth factor, insulin-like growth factor-1. The listed neurotrophic factors have been linked to depression and have been shown to be influenced by exercise. The impact of depression and exercise in the context of traumatic brain injury is unknown. Administered to both study arms.
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Time frame: week 0, week 13