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Completed

NCT Number: NCT00571545

The Effect of Exercise on Mood After Traumatic Brain Injury

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.

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Key information

Conditions

Traumatic Brain Injury Behavior Behavioral Symptoms Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Depression Motor Activity Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Behavioral

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

Behavioral

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

Primary outcomes

  1. Beck Depression Inventory

    Time frame: 10 week

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2004
Study completion
2007
First posted
Dec 12, 2007
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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