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Exercise Training in Depressed Traumatic Brain Injury Survivors

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ClinicalTrials.gov Identifier: NCT01805479
Recruitment Status : Withdrawn (Unable to enroll participants. Sponsor requested study closure.)
First Posted : March 6, 2013
Last Update Posted : December 21, 2015
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Traumatic Brain Injury Other: aerobic exercise Other: stretching and flexibility program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Exercise Training in Depressed Traumatic Brain Injury Survivors
Study Start Date : February 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: stretching-flexibility
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.
Other: stretching and flexibility program
stretching and flexibility program for the Placebo Comparator Arm

Active Comparator: aerobic exercise group
aerobic activity targeting 60% peak heart rate for 12 weeks is the active group.
Other: aerobic exercise
the active arm will be asked to perform 60% of maximum heart rate

Primary Outcome Measures :
  1. completion of exercise protocol [ Time Frame: 12 weeks ]
    The primary aim is to measure the rate of completion of the exercise protocol.

Secondary Outcome Measures :
  1. neuropsychological testing [ Time Frame: pre and post intervention, week zero and week 13 ]
    cognitive testing battery will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects. Administered to both arms.

  2. mood assessment [ Time Frame: week 0, week 13, and weekly during 12 week intervention ]
    depression symptom inventories will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects. Administered to both arms.

  3. Columbia-Suicide Severity Rating Scale [ Time Frame: week 0, week 13, and weekly during 12 week intervention ]
    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.

  4. magnetic resonance imaging [ Time Frame: week 0, week 13 ]
    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.

  5. biochemical assays [ Time Frame: week 0, week 13 ]
    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.

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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805479

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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0568
Sponsors and Collaborators
Virginia Commonwealth University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Anne Hudak, MD Virginia Commonwealth University
Additional Information:
Langlois JA, Rutland-Brown W, Thomas KE. Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths. Atlanta (GA): Centers for Disease Control and Prevention, Nation Center for Injury Prevention and Control. 2006.
Finkelstein E, Corso P, Miller T and associates. The Incidence and Economic Burden of Injuries in the United States. New York (NY): Oxford University Press. 2006.
Beck, Aaron T., Robert A. Steer, and Gregory K. Brown. BDI-II, Beck Depression Inventory: Manual. San Antonio, Tex: Psychological Corp, 1996
Borg, GAV. Physical Performance and Perceived Exertion. Lund, Sweden: Gleerup.
Benton AL, Hamsher KD, Sivan AB. Multilingual Aphasia Examination. Manual of instructions. AJA Associates, Iowa City. 2000.
Reitan RM, Wolfson D. The Halstead-Reitan neuropsychological test battery: Theory and clinical interpretation. Neuropsychology Press, Tucson, AZ. 1993.
Reitan RM Trail Making Test. Manual for administration and scoring. Reitan Neuropsychology Laboratory, Tucson, AZ. 1992.
Wechsler D. Wechsler Adult Intelligence Scale (WAIS-III). The Psychological Corporation, San Antonio, TX. 1997.
Delis DCK, Joel H, Kaplan E, Ober BA. California Verbal Learning Test. PsychCorp, A brand of Harcourt Assessment, Inc. 2000.
Cohen J. Statistical Power Analysis for the Behavioral Sciences, (revised edition). New York. NY: Academic Press, 1977

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01805479    
Other Study ID Numbers: PT107574
7K23HD067553 ( U.S. NIH Grant/Contract )
First Posted: March 6, 2013    Key Record Dates
Last Update Posted: December 21, 2015
Last Verified: December 2015
Keywords provided by Virginia Commonwealth University:
traumatic brain injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System