The Effect of Exercise on Mood After Traumatic Brain Injury

Study Overview
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Brief Summary
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We proposed to examine the effect of an aerobic exercise intervention on depression in persons with Traumatic Brain Injury (TBI). We will compare persons with chronic brain injury who are assigned to receive the exercise intervention with those in the control group to determine the effect of exercise on levels of depression and specific symptoms related to depression including anxiety, pain, sleep, and cognition. In addition, the effect of exercise on activity, participation level, and quality of life will be examined. HYPOTHESES: Participation in an aerobic exercise intervention will decrease the severity of depression in persons with chronic TBI. Participation in an aerobic exercise intervention will lead to improvements in negative symptoms associated with depression including anxiety, insomnia, pain, and impaired cognitive functioning. Participation in an aerobic exercise intervention will be related to improvements in activity and participation for patients with TBI. Participation in an aerobic exercise intervention will lead to improvements in perceptions of quality of life.

Official Title
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The Effect of Exercise on Mood After Traumatic Brain Injury

Conditions
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Traumatic Brain Injury, Depression

Intervention / Treatment
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* Behavioral: Aerobic exercise
* Behavioral: No exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Traumatic brain injury 1-5 years prior to enrollment Current depression as measured by a score of 5 or greater on the depression portion of the Physician Health Questionnaire (PHQ). Sufficient cognitive ability to maintain participation in the study Sufficient English language ability to allow participation without an interpreter Exclusion Criteria: Current suicidal ideation with intent or plan Currently pregnant History of significant cardiovascular or respiratory disease History of significant cardiovascular or respiratory disease Physical barriers to the use of standard aerobic exercise equipment

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Subjects recruited from the community with a history of traumatic brain injury were enrolled into a 10 week supervised exercise program and encouraged to exercise at home as well. | Behavioral: Aerobic exercise<br>* A supervised aerobic exercise program occurred weekly for 30 minutes with a 15 minute warm-up and a 15 minute cool down. A half hour educational session on aspects of exercise and overcoming barriers to exercise was also instituted.<br>|
| Other: 2<br>Controls were wait-listed for the supervised exercise program but were not treated during the 10 week wait period. | Behavioral: No exercise<br>* Controls were wait-listed for the exercise program during the 10 week study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory |  | 10 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic brain injury, Depression, Exercise