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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
History of Changes
  Purpose

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.

Condition Intervention
Traumatic Brain Injury
Depression
 Behavioral: Aerobic exercise
Behavioral: No exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Exercise on Mood After Traumatic Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: 10 week ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: April 2004
Study Completion Date: October 2007
Arms Assigned Interventions
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.
 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.
2
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.

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571545

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Kathleen R Bell, M.D. University of Washington
  More Information

No publications provided

Responsible Party: Kathleen R. Bell, M.D., University of Washington
ClinicalTrials.gov Identifier: NCT00571545     History of Changes
Other Study ID Numbers: 02-5302-B05, H133A020508
Study First Received: December 10, 2007
Last Updated: June 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Traumatic brain injury
Depression
Exercise

Additional relevant MeSH terms:
Depression
Depressive Disorder
Brain Injuries
Behavioral Symptoms
Mood Disorders
Mental Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013