The Effect of Exercise on Mood After Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Depression; Traumatic Brain Injury
• Interventions: Behavioral: Aerobic exercise; Behavioral: No exercise

• Registration Number: NCT00571545
• Lead Sponsor: University of Washington

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 available

Study Timeline

• Study Start: 2004-04
• Study Completion: 2007-10
• Study First Submitted: 2007-12-10
• Study First Submitted QC: 2007-12-11
• Study First Posted: 2007-12-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Aerobic exercise	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.
2	No exercise	Controls were wait-listed for the supervised exercise program but were not treated during the 10 week wait period.

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory	10 week

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States