The Effect of Exercise on Mood After Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT00571545|
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : February 6, 2017
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury Depression||Behavioral: Aerobic exercise Behavioral: No exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of Exercise on Mood After Traumatic Brain Injury|
|Study Start Date :||April 2004|
|Actual Study Completion Date :||October 2007|
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
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.
Controls were wait-listed for the supervised exercise program but were not treated during the 10 week wait period.
Behavioral: No exercise
Controls were wait-listed for the exercise program during the 10 week study period.
- Beck Depression Inventory [ Time Frame: 10 week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571545
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Kathleen R Bell, M.D.||University of Washington|