DepressionNCT01805479

Exercise Training in Depressed Traumatic Brain Injury Survivors

A study testing aerobic exercise and stretching and flexibility program in people with Depression and Traumatic Brain Injury, run by Virginia Commonwealth University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

The purpose of this study is to determine the feasibility of successfully delivering moderate intensity aerobic exercise training to depressed traumatic brain injury subjects between one and three years after injury. Read more about this study

Who is it for?: Ages 14 to 65 years
Conditions the study is for: Depression, Traumatic Brain Injury
What is being tested?: aerobic exercise and stretching and flexibility program
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteUnited States
Study dates: Feb 2013to Jun 2014
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 14 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

CT brain with subdural hematoma, subarachnoid hemorrhage, and/or cortical contusion
Glasgow outcome scale extended of 4 to 8
speaks English
Beck Depression Inventory -II score between 14 and 28
sedentary life style
one to three years after traumatic brain injury

Who cannot join

prior history of brain process (example, stroke, brain tumor)
aphasia
psychosis, mania, bipolar disorder, schizophrenia
pregnancy
inability to exercise via cycles or treadmill

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Commonwealth University
Richmond, Virginia, 23298-0568

Other trials in United States

About this study

Read the detailed description

Traumatic brain injury (TBI) alters the lives of many civilians and those involved in armed conflicts. Sequelae of TBI includes depression in up to 30% of cases. Appearance of depression after TBI impairs recovery and results in sub-optimal re-integration into society. Treatment of post TBI depression relies on oral medications, whose efficacy and side effect profile is sub-optimal. Exercise training is effective in spontaneous depression as a stand alone treatment and in conjunction with oral medications, and this may represent an alternative treatment option in the TBI population. Further, the pathophysiology of depression after TBI has yet to be examined with the full scientific rigor required. This project proposes to use exercise training of moderate intensity as a treatment for depression after TBI, while measuring biological markers as a way to investigate efficacy and provide insight into the pathophysiology.

Conditions: Depression, Traumatic Brain Injury
Being tested: aerobic exercise, stretching and flexibility program
Keywords: exercise, depression, traumatic brain injury
Medical subject headings: Depression, Brain Injuries, Traumatic, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

aerobic exerciseOther
the active arm will be asked to perform 60% of maximum heart rate
stretching and flexibility programOther
stretching and flexibility program for the Placebo Comparator Arm

Study groups in NCT01805479
Study group	Role	What they receive
stretching-flexibility	Placebo comparator	This group will use a stretching and flexibility program designed to utilize minimal levels of aerobic capacity. It was chosen in place of a education-based control group due to the high level of personal interaction that is found in the active arm. Receives: Other: stretching and flexibility program
aerobic exercise group	Active comparator	aerobic activity targeting 60% peak heart rate for 12 weeks is the active group. Receives: Other: aerobic exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

completion of exercise protocol
The primary aim is to measure the rate of completion of the exercise protocol.
Measured: 12 weeks

Secondary outcomes (5)

neuropsychological testing
cognitive testing battery will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects. Administered to both arms.
Measured: pre and post intervention, week zero and week 13
mood assessment
depression symptom inventories will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects. Administered to both arms.
Measured: week 0, week 13, and weekly during 12 week intervention
Columbia-Suicide Severity Rating Scale
Columbia-Suicide Severity Rating Scale was developed to meet the need for tracking changes in a person's suicidal thinking and behavior over time, and to determine who is most at risk. Administered to both arms.
Measured: week 0, week 13, and weekly during 12 week intervention
magnetic resonance imaging
MRI will be done before and after exercise protocol on a subset of subjects. Selection of these subjects will be done by randomization, starting once the MRI is available for use. The purpose is to examine the brain for exercise influenced volumetric changes. Administered to a subset of both arms of the study.
Measured: week 0, week 13
biochemical assays
brain-derived neurotrophic factor, vascular endothelial growth factor, insulin-like growth factor-1. The listed neurotrophic factors have been linked to depression and have been shown to be influenced by exercise. The impact of depression and exercise in the context of traumatic brain injury is unknown. Administered to both study arms.
Measured: week 0, week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Jun 2014

First posted6 Mar 2013 (estimated)
Study startFeb 2013
Primary completionJun 2014
Study completionJun 2014

Why it stopped: Unable to enroll participants. Sponsor requested study closure.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (129)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01805479
Sponsor's protocol ID: PT107574
Other IDs: 7K23HD067553
Status last verified: Dec 2015
First submitted: 1 Mar 2013
Last updated: 21 Dec 2015
Results posted: No
Data monitoring committee: Yes

Publications

Dunn AL, Trivedi MH, Kampert JB, Clark CG, Chambliss HO. The DOSE study: a clinical trial to examine efficacy and dose response of exercise as treatment for depression. Control Clin Trials. 2002 Oct;23(5):584-603. doi: 10.1016/s0197-2456(02)00226-x.
PubMed 12392873
Dunn AL, Trivedi MH, Kampert JB, Clark CG, Chambliss HO. Exercise treatment for depression: efficacy and dose response. Am J Prev Med. 2005 Jan;28(1):1-8. doi: 10.1016/j.amepre.2004.09.003.
PubMed 15626549
Hudak A, Warner M, Marquez de la Plata C, Moore C, Harper C, Diaz-Arrastia R. Brain morphometry changes and depressive symptoms after traumatic brain injury. Psychiatry Res. 2011 Mar 31;191(3):160-5. doi: 10.1016/j.pscychresns.2010.10.003.
PubMed 21310594
Jorge RE, Robinson RG, Arndt SV, Starkstein SE, Forrester AW, Geisler F. Depression following traumatic brain injury: a 1 year longitudinal study. J Affect Disord. 1993 Apr;27(4):233-43. doi: 10.1016/0165-0327(93)90047-n.
PubMed 8509524
Fann JR, Katon WJ, Uomoto JM, Esselman PC. Psychiatric disorders and functional disability in outpatients with traumatic brain injuries. Am J Psychiatry. 1995 Oct;152(10):1493-9. doi: 10.1176/ajp.152.10.1493.
PubMed 7573589
van Reekum R, Bolago I, Finlayson MA, Garner S, Links PS. Psychiatric disorders after traumatic brain injury. Brain Inj. 1996 May;10(5):319-27. doi: 10.1080/026990596124340.
PubMed 8735663
Gomez-Hernandez R, Max JE, Kosier T, Paradiso S, Robinson RG. Social impairment and depression after traumatic brain injury. Arch Phys Med Rehabil. 1997 Dec;78(12):1321-6. doi: 10.1016/s0003-9993(97)90304-x.
PubMed 9421985
Rapoport MJ, Kiss A, Feinstein A. The impact of major depression on outcome following mild-to-moderate traumatic brain injury in older adults. J Affect Disord. 2006 Jun;92(2-3):273-6. doi: 10.1016/j.jad.2005.05.022. Epub 2006 Feb 28.
PubMed 16504305
Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.
PubMed 12813115
Silver JM, Kramer R, Greenwald S, Weissman M. The association between head injuries and psychiatric disorders: findings from the New Haven NIMH Epidemiologic Catchment Area Study. Brain Inj. 2001 Nov;15(11):935-45. doi: 10.1080/02699050110065295.
PubMed 11689092
Simpson G, Tate R. Suicidality after traumatic brain injury: demographic, injury and clinical correlates. Psychol Med. 2002 May;32(4):687-97. doi: 10.1017/s0033291702005561.
PubMed 12102383
Teasdale TW, Engberg AW. Suicide after traumatic brain injury: a population study. J Neurol Neurosurg Psychiatry. 2001 Oct;71(4):436-40. doi: 10.1136/jnnp.71.4.436.
PubMed 11561024
Satz P, Forney DL, Zaucha K, Asarnow RR, Light R, McCleary C, Levin H, Kelly D, Bergsneider M, Hovda D, Martin N, Namerow N, Becker D. Depression, cognition, and functional correlates of recovery outcome after traumatic brain injury. Brain Inj. 1998 Jul;12(7):537-53. doi: 10.1080/026990598122313.
PubMed 9653518
Deb S, Lyons I, Koutzoukis C, Ali I, McCarthy G. Rate of psychiatric illness 1 year after traumatic brain injury. Am J Psychiatry. 1999 Mar;156(3):374-8. doi: 10.1176/ajp.156.3.374.
PubMed 10080551
Levin HS, Brown SA, Song JX, McCauley SR, Boake C, Contant CF, Goodman H, Kotrla KJ. Depression and posttraumatic stress disorder at three months after mild to moderate traumatic brain injury. J Clin Exp Neuropsychol. 2001 Dec;23(6):754-69. doi: 10.1076/jcen.23.6.754.1021.
PubMed 11910542

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exercise Training in Depressed Traumatic Brain Injury Survivors
ClinicalTrials.gov ID: NCT01805479
Acronym / sponsor ID: PT107574
Conditions: Depression, Traumatic Brain Injury
Keywords: exercise, depression, traumatic brain injury
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Unable to enroll participants. Sponsor requested study closure.
Enrolment: 0 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Feb 2013
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 6 Mar 2013 (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.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
stretching-flexibility	Placebo comparator	Other: stretching and flexibility programThis group will use a stretching and flexibility program designed to utilize minimal levels of aerobic capacity. It was chosen in place of a education-based control group due to the high level of personal interaction that is found in the active arm.
aerobic exercise group	Active comparator	Other: aerobic exerciseaerobic activity targeting 60% peak heart rate for 12 weeks is the active group.

Who may qualify

Ages: 14 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

CT brain with subdural hematoma, subarachnoid hemorrhage, and/or cortical contusion
Glasgow outcome scale extended of 4 to 8
speaks English
Beck Depression Inventory -II score between 14 and 28
sedentary life style

Key exclusion criteria (5 listed)

prior history of brain process (example, stroke, brain tumor)
aphasia
psychosis, mania, bipolar disorder, schizophrenia
pregnancy
inability to exercise via cycles or treadmill

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 exercisethe active arm will be asked to perform 60% of maximum heart rate	Other	aerobic exercise group
stretching and flexibility programstretching and flexibility program for the Placebo Comparator Arm	Other	stretching-flexibility

Primary outcome

completion of exercise protocol
Time frame: 12 weeks
The primary aim is to measure the rate of completion of the exercise protocol.

5 secondary outcomes

neuropsychological testing
Time frame: pre and post intervention, week zero and week 13
mood assessment
Time frame: week 0, week 13, and weekly during 12 week intervention
Columbia-Suicide Severity Rating Scale
Time frame: week 0, week 13, and weekly during 12 week intervention
magnetic resonance imaging
Time frame: week 0, week 13
biochemical assays
Time frame: week 0, week 13

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
Background: PubMed 12392873Dunn AL, Trivedi MH, Kampert JB, Clark CG, Chambliss HO. The DOSE study: a clinical trial to examine efficacy and dose response of exercise as treatment for depression. Control Clin Trials. 2002 Oct;23(5):584-603. doi: 10.1016/s0197-2456(02)00226-x.
Background: PubMed 15626549Dunn AL, Trivedi MH, Kampert JB, Clark CG, Chambliss HO. Exercise treatment for depression: efficacy and dose response. Am J Prev Med. 2005 Jan;28(1):1-8. doi: 10.1016/j.amepre.2004.09.003.
Background: PubMed 21310594Hudak A, Warner M, Marquez de la Plata C, Moore C, Harper C, Diaz-Arrastia R. Brain morphometry changes and depressive symptoms after traumatic brain injury. Psychiatry Res. 2011 Mar 31;191(3):160-5. doi: 10.1016/j.pscychresns.2010.10.003.
Background: PubMed 8509524Jorge RE, Robinson RG, Arndt SV, Starkstein SE, Forrester AW, Geisler F. Depression following traumatic brain injury: a 1 year longitudinal study. J Affect Disord. 1993 Apr;27(4):233-43. doi: 10.1016/0165-0327(93)90047-n.
Background: PubMed 7573589Fann JR, Katon WJ, Uomoto JM, Esselman PC. Psychiatric disorders and functional disability in outpatients with traumatic brain injuries. Am J Psychiatry. 1995 Oct;152(10):1493-9. doi: 10.1176/ajp.152.10.1493.
Background: PubMed 8735663van Reekum R, Bolago I, Finlayson MA, Garner S, Links PS. Psychiatric disorders after traumatic brain injury. Brain Inj. 1996 May;10(5):319-27. doi: 10.1080/026990596124340.
Background: PubMed 9421985Gomez-Hernandez R, Max JE, Kosier T, Paradiso S, Robinson RG. Social impairment and depression after traumatic brain injury. Arch Phys Med Rehabil. 1997 Dec;78(12):1321-6. doi: 10.1016/s0003-9993(97)90304-x.
Background: PubMed 16504305Rapoport MJ, Kiss A, Feinstein A. The impact of major depression on outcome following mild-to-moderate traumatic brain injury in older adults. J Affect Disord. 2006 Jun;92(2-3):273-6. doi: 10.1016/j.jad.2005.05.022. Epub 2006 Feb 28.
Background: PubMed 12813115Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.
Background: PubMed 11689092Silver JM, Kramer R, Greenwald S, Weissman M. The association between head injuries and psychiatric disorders: findings from the New Haven NIMH Epidemiologic Catchment Area Study. Brain Inj. 2001 Nov;15(11):935-45. doi: 10.1080/02699050110065295.
Background: PubMed 12102383Simpson G, Tate R. Suicidality after traumatic brain injury: demographic, injury and clinical correlates. Psychol Med. 2002 May;32(4):687-97. doi: 10.1017/s0033291702005561.
Background: PubMed 11561024Teasdale TW, Engberg AW. Suicide after traumatic brain injury: a population study. J Neurol Neurosurg Psychiatry. 2001 Oct;71(4):436-40. doi: 10.1136/jnnp.71.4.436.
Arhinoula A. Martinos Center for Biomedical Imaging, Charlestown, Massachusetts freely available onlineLink provided by the sponsor.

Related trials for Depression

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

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.

Anne Hudak, MD principal investigator

Virginia Commonwealth University

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 stretching and flexibility program in people with Depression and Traumatic Brain Injury, run by Virginia Commonwealth University 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 6 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: withdrawn, as of the sponsor's last update on 21 Dec 2015. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.

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?

completion of exercise protocol (time frame: 12 weeks). 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 NCT01805479, which also lists 129 linked publications.

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 21 Dec 2015.