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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
Sponsor:
Information provided by (Responsible Party):
Kathleen Bell, University of Washington

Tracking Information
First Submitted Date  ICMJE December 10, 2007
First Posted Date  ICMJE December 12, 2007
Last Update Posted Date February 6, 2017
Study Start Date  ICMJE April 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2007)
Beck Depression Inventory [ Time Frame: 10 week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00571545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Exercise on Mood After Traumatic Brain Injury
Official Title  ICMJE The Effect of Exercise on Mood After Traumatic Brain Injury
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Traumatic Brain Injury
  • Depression
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Hoffman JM, Bell KR, Powell JM, Behr J, Dunn EC, Dikmen S, Bombardier CH. A randomized controlled trial of exercise to improve mood after traumatic brain injury. PM R. 2010 Oct;2(10):911-9. doi: 10.1016/j.pmrj.2010.06.008.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2007)
78
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00571545
Other Study ID Numbers  ICMJE 22868-B
H133A020508
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kathleen Bell, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kathleen R Bell, M.D. University of Washington
PRS Account University of Washington
Verification Date February 2017

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