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The Effect of Exercise on Mood After Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic exercise
No exercise
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic brain injury, Depression, Exercise

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

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.

Controls were wait-listed for the supervised exercise program but were not treated during the 10 week wait period.

Outcomes

Primary Outcome Measures

Beck Depression Inventory

Secondary Outcome Measures

Full Information

First Posted
December 10, 2007
Last Updated
February 2, 2017
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00571545
Brief Title
The Effect of Exercise on Mood After Traumatic Brain Injury
Official Title
The Effect of Exercise on Mood After Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Depression
Keywords
Traumatic brain injury, Depression, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Other
Arm Description
Controls were wait-listed for the supervised exercise program but were not treated during the 10 week wait period.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No exercise
Intervention Description
Controls were wait-listed for the exercise program during the 10 week study period.
Primary Outcome Measure Information:
Title
Beck Depression Inventory
Time Frame
10 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen R Bell, M.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20970760
Citation
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.
Results Reference
result

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The Effect of Exercise on Mood After Traumatic Brain Injury

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