The Effect of Exercise on Mood After Traumatic Brain Injury

NCT00571545 | Completed

• 2 other identifiers: 22868-BH133A020508
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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. 1.Participation in an aerobic exercise intervention will decrease the severity of depression in persons with chronic TBI.
2. 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. 3.Participation in an aerobic exercise intervention will be related to improvements in activity and participation for patients with TBI.
4. 4.Participation in an aerobic exercise intervention will lead to improvements in perceptions of quality of life.

Conditions

Traumatic Brain Injury; Depression

Keywords

Traumatic brain injury; Depression; Exercise

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory

  10 week

Study Arms (2)

1

EXPERIMENTAL

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.

Behavioral: Aerobic exercise

2

OTHER

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

Behavioral: No exercise

Interventions

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.

1

No exercise BEHAVIORAL

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

2

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related 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.

  PMID: 20970760 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic; Depression; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kathleen R Bell, M.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Rehabilitative Medicine

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 12, 2007
• Study Start: April 1, 2004
• Study Completion: October 1, 2007
• Last Updated: February 6, 2017

Record last verified: 2017-02

Locations

US (1)