The Effect of Exercise on Mood After Traumatic Brain Injury

Depression Clinical Trial

Official title:

The Effect of Exercise on Mood After Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571545
• Other study ID #: 22868-B
• Secondary ID: H133A020508
• Status: Completed
• Phase: N/A
• First received: December 10, 2007
• Last updated: February 2, 2017
• Start date: April 2004
• Est. completion date: October 2007

Study information

• Verified date: February 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Depression
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.
• No exercise
Controls were wait-listed for the exercise program during the 10 week study period.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory		10 week