Traumatic Brain InjuryNCT00571545
The Effect of Exercise on Mood After Traumatic Brain Injury
A study testing Aerobic exercise and No exercise in people with Traumatic Brain Injury and Depression, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Traumatic Brain Injury, Depression
- What is being tested?
- Aerobic exercise and No exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
- Participation in an aerobic exercise intervention will decrease the severity of depression in persons with chronic TBI.
- Participation in an aerobic exercise intervention will lead to improvements in negative symptoms associated with depression including anxiety, insomnia, pain, and impaired cognitive functioning.
- Participation in an aerobic exercise intervention will be related to improvements in activity and participation for patients with TBI.
- Participation in an aerobic exercise intervention will lead to improvements in perceptions of quality of life.
- Conditions
- Traumatic Brain Injury, Depression
- Being tested
- Aerobic exercise, No exercise
- Keywords
- Traumatic brain injury, Depression, Exercise
- Medical subject headings
- Brain Injuries, Traumatic, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
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 exerciseBehavioural
Controls were wait-listed for the exercise program during the 10 week study period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Aerobic exercise |
| 2 | Other | Controls were wait-listed for the supervised exercise program but were not treated during the 10 week wait period. Receives: Behavioral: No exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
Measured: 10 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startApr 2004
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Bell, University of Washington
- Investigators
- Kathleen R Bell, M.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571545
- Sponsor's protocol ID
- 22868-B
- Other IDs
- H133A020508
- Status last verified
- Feb 2017
- First submitted
- 10 Dec 2007
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20970760
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Mood After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00571545
- Acronym / sponsor ID
- 22868-B
- Conditions
- Traumatic Brain Injury, Depression
- Keywords
- Traumatic brain injury, Depression, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Oct 2007 (actual)
- First posted
- 12 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Participation in an aerobic exercise intervention will decrease the severity of depression in persons with chronic TBI.
- Participation in an aerobic exercise intervention will lead to improvements in negative symptoms associated with depression including anxiety, insomnia, pain, and impaired cognitive functioning.
- Participation in an aerobic exercise intervention will be related to improvements in activity and participation for patients with TBI.
- Participation in an aerobic exercise intervention will lead to improvements in perceptions of quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Aerobic exerciseSubjects 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 | Other | Behavioral: No exerciseControls were wait-listed for the supervised exercise program but were not treated during the 10 week wait period. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseA 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. | Behavioural | 1 |
| No exerciseControls were wait-listed for the exercise program during the 10 week study period. | Behavioural | 2 |
Primary outcome
Beck Depression Inventory
Time frame: 10 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Results publication: PubMed 20970760Hoffman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen R Bell, M.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and No exercise in people with Traumatic Brain Injury and Depression, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (time frame: 10 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00571545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.