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The Effect of Exercise on Mood After Traumatic Brain Injury

The Effect of Exercise on Mood After Traumatic Brain Injury

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00571545
Enrollment
78
Registered
2007-12-12
Start date
2004-04-30
Completion date
2007-10-31
Last updated
2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Traumatic Brain Injury

Keywords

Traumatic brain injury, Depression, Exercise

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.

Interventions

BEHAVIORALAerobic 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.

BEHAVIORALNo exercise

Controls were wait-listed for the exercise program during the 10 week study period.

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Beck Depression Inventory10 week

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026