The Effect of Exercise on Mood After Traumatic Brain Injury

This study has been completed.
Sponsor:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00571545
First received: December 10, 2007
Last updated: June 2, 2008
Last verified: June 2008

December 10, 2007
June 2, 2008
April 2004
Not Provided
Beck Depression Inventory [ Time Frame: 10 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00571545 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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The Effect of Exercise on Mood After Traumatic Brain Injury
The Effect of Exercise on Mood After Traumatic Brain Injury

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:

  1. Participation in an aerobic exercise intervention will decrease the severity of depression in persons with chronic TBI.
  2. Participation in an aerobic exercise intervention will lead to improvements in negative symptoms associated with depression including anxiety, insomnia, pain, and impaired cognitive functioning.
  3. Participation in an aerobic exercise intervention will be related to improvements in activity and participation for patients with TBI.
  4. Participation in an aerobic exercise intervention will lead to improvements in perceptions of quality of life.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Traumatic Brain Injury
  • Depression
  • 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.
  • Behavioral: No exercise
    Controls were wait-listed for the exercise program during the 10 week study period.
  • Experimental: 1
    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.
    Intervention: Behavioral: Aerobic exercise
  • 2
    Controls were wait-listed for the supervised exercise program but were not treated during the 10 week wait period.
    Intervention: Behavioral: No exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
October 2007
Not Provided

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
Both
16 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00571545
02-5302-B05, H133A020508
No
Kathleen R. Bell, M.D., University of Washington
University of Washington
Not Provided
Principal Investigator: Kathleen R Bell, M.D. University of Washington
University of Washington
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP