Depression, Traumatic Brain Injury
Conditions
Keywords
exercise, depression, traumatic brain injury
Brief summary
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.
Detailed description
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.
Interventions
OTHERaerobic exercise
the active arm will be asked to perform 60% of maximum heart rate
OTHERstretching and flexibility program
stretching and flexibility program for the Placebo Comparator Arm
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* CT brain with subdural hematoma, subarachnoid hemorrhage, and/or cortical contusion * Glasgow outcome scale extended of 4 to 8 * speaks English * Beck Depression Inventory -II score between 14 and 28 * sedentary life style * one to three years after traumatic brain injury
Exclusion criteria
* prior history of brain process (example, stroke, brain tumor) * aphasia * psychosis, mania, bipolar disorder, schizophrenia * pregnancy * inability to exercise via cycles or treadmill
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| completion of exercise protocol | 12 weeks | The primary aim is to measure the rate of completion of the exercise protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| neuropsychological testing | pre and post intervention, week zero and week 13 | cognitive testing battery will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects. Administered to both arms. |
| mood assessment | week 0, week 13, and weekly during 12 week intervention | depression symptom inventories will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects. Administered to both arms. |
| Columbia-Suicide Severity Rating Scale | week 0, week 13, and weekly during 12 week intervention | 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. |
| magnetic resonance imaging | week 0, week 13 | 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. |
| biochemical assays | week 0, week 13 | 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. |
Countries
United States
Outcome results
None listed