Exercise Training in Depressed Traumatic Brain Injury Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exercise Training in Depressed Traumatic Brain Injury Survivors

Conditions
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Depression, Traumatic Brain Injury

Intervention / Treatment
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* Other: aerobic exercise
* Other: stretching and flexibility program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: stretching-flexibility<br>This group will use a stretching and flexibility program designed to utilize minimal levels of aerobic capacity. It was chosen in place of a education-based control group due to the high level of personal interaction that is found in the active arm. | Other: stretching and flexibility program<br>* stretching and flexibility program for the Placebo Comparator Arm<br>|
| Active Comparator: aerobic exercise group<br>aerobic activity targeting 60% peak heart rate for 12 weeks is the active group. | Other: aerobic exercise<br>* the active arm will be asked to perform 60% of maximum heart rate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| completion of exercise protocol | The primary aim is to measure the rate of completion of the exercise protocol. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | week 0, week 13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, depression, traumatic brain injury