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Clinical Trials/NCT00571545
NCT00571545
Completed
Not Applicable

The Effect of Exercise on Mood After Traumatic Brain Injury

University of Washington1 site in 1 country78 target enrollmentApril 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
University of Washington
Enrollment
78
Locations
1
Primary Endpoint
Beck Depression Inventory
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.
Registry
clinicaltrials.gov
Start Date
April 2004
End Date
October 2007
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kathleen Bell

Professor, Department of Rehabilitative Medicine

University of Washington

Eligibility Criteria

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

Outcomes

Primary Outcomes

Beck Depression Inventory

Time Frame: 10 week

Study Sites (1)

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