Study Results
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Basic Information
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ENROLLING_BY_INVITATION
PHASE1/PHASE2
190 participants
INTERVENTIONAL
2022-01-18
2028-01-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Aerobic Exercise (AER)
Consented participants will be randomly assigned to aerobic exercise regimen (AER) + Standard Rehabilitation(R+AER) or Standard Rehabilitation only (R) group. In order to determine the necessary time window for AER exercise treatment, TBI subjects will partake in supervised AER sessions for a period of 12 weeks. After a baseline evaluations follow-ups will take place at take place at weeks 4, 8 and 12. Thus each participants will be evaluated 4 times.
Aerobic Exercise (AER)
Aerobic exercise will be performed by utilizing aerobic exercise equipment 3 times per week.
Rehabilitation (R)
Participants with traumatic brain injury that are enrolled in a comprehensive rehabilitation program. These participants will receive standard rehabilitation. Given that the duration of the rehabilitative program is variable the duration of participation will be no less than 4 weeks and will not exceed 12 weeks. Activity levels will be monitored.
Rehabilitation
Rehabilitative program is focused on completion of activities of daily living, initiation, appropriate behavior and community integration for five days per week at the Centre for Neuro Skills.
Control (C)
Healthy volunteers' responsiveness to exercise will be compared to TBI responsiveness.
No interventions assigned to this group
Interventions
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Aerobic Exercise (AER)
Aerobic exercise will be performed by utilizing aerobic exercise equipment 3 times per week.
Rehabilitation
Rehabilitative program is focused on completion of activities of daily living, initiation, appropriate behavior and community integration for five days per week at the Centre for Neuro Skills.
Eligibility Criteria
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Inclusion Criteria
* Age will range from 18 to 60 years.
* Except for the non-injured control group, subjects will be required to have experienced TBI.
* All participants should be fluent in English or Spanish.
* All participants should have the ability to comply with the research protocol.
* Capable of exercising in aerobic exercise equipment (with or without trunk support).
* Able to walk independently with or without a device
Exclusion Criteria
* A history of cerebral vascular accidents.
* A history of major psychosis as defined by DSM-IV.
* Subjects receiving physical therapy in a location that is not CNS.
* Pregnancy.
* A history of previous TBI requiring hospitalization.
* Inability to cooperate
* Orthopedic impairment that compromises exercise performance
* Any cardiovascular or respiratory condition that jeopardizes patient health during exercise.
18 Years
60 Years
ALL
Yes
Sponsors
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University of Pittsburgh
OTHER
Centre for Neuro Skills
INDUSTRY
Responsible Party
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Grace S. Griesbach
National Director of Clinical Research
Principal Investigators
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Grace S Griesbach, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Neuro Skills
Locations
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Centre for Neuro Skills
Bakersfield, California, United States
Countries
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References
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Ashman TA, Gordon WA, Cantor JB, Hibbard MR. Neurobehavioral consequences of traumatic brain injury. Mt Sinai J Med. 2006 Nov;73(7):999-1005.
Kleim JA, Jones TA, Schallert T. Motor enrichment and the induction of plasticity before or after brain injury. Neurochem Res. 2003 Nov;28(11):1757-69. doi: 10.1023/a:1026025408742.
Griesbach GS, Hovda DA, Molteni R, Wu A, Gomez-Pinilla F. Voluntary exercise following traumatic brain injury: brain-derived neurotrophic factor upregulation and recovery of function. Neuroscience. 2004;125(1):129-39. doi: 10.1016/j.neuroscience.2004.01.030.
Griesbach GS, Hovda DA, Gomez-Pinilla F. Exercise-induced improvement in cognitive performance after traumatic brain injury in rats is dependent on BDNF activation. Brain Res. 2009 Sep 8;1288:105-15. doi: 10.1016/j.brainres.2009.06.045. Epub 2009 Jun 23.
Seifert T, Brassard P, Wissenberg M, Rasmussen P, Nordby P, Stallknecht B, Adser H, Jakobsen AH, Pilegaard H, Nielsen HB, Secher NH. Endurance training enhances BDNF release from the human brain. Am J Physiol Regul Integr Comp Physiol. 2010 Feb;298(2):R372-7. doi: 10.1152/ajpregu.00525.2009. Epub 2009 Nov 18.
Johnson VE, Stewart W, Smith DH. Axonal pathology in traumatic brain injury. Exp Neurol. 2013 Aug;246:35-43. doi: 10.1016/j.expneurol.2012.01.013. Epub 2012 Jan 20.
Povlishock JT, Pettus EH. Traumatically induced axonal damage: evidence for enduring changes in axolemmal permeability with associated cytoskeletal change. Acta Neurochir Suppl. 1996;66:81-6. doi: 10.1007/978-3-7091-9465-2_15.
Schuit AJ, Feskens EJ, Launer LJ, Kromhout D. Physical activity and cognitive decline, the role of the apolipoprotein e4 allele. Med Sci Sports Exerc. 2001 May;33(5):772-7. doi: 10.1097/00005768-200105000-00015.
Adlard PA, Perreau VM, Pop V, Cotman CW. Voluntary exercise decreases amyloid load in a transgenic model of Alzheimer's disease. J Neurosci. 2005 Apr 27;25(17):4217-21. doi: 10.1523/JNEUROSCI.0496-05.2005.
Piao CS, Stoica BA, Wu J, Sabirzhanov B, Zhao Z, Cabatbat R, Loane DJ, Faden AI. Late exercise reduces neuroinflammation and cognitive dysfunction after traumatic brain injury. Neurobiol Dis. 2013 Jun;54:252-63. doi: 10.1016/j.nbd.2012.12.017. Epub 2013 Jan 8.
Norden DM, Muccigrosso MM, Godbout JP. Microglial priming and enhanced reactivity to secondary insult in aging, and traumatic CNS injury, and neurodegenerative disease. Neuropharmacology. 2015 Sep;96(Pt A):29-41. doi: 10.1016/j.neuropharm.2014.10.028. Epub 2014 Nov 13.
Gurley JM, Hujsak BD, Kelly JL. Vestibular rehabilitation following mild traumatic brain injury. NeuroRehabilitation. 2013;32(3):519-28. doi: 10.3233/NRE-130874.
Rinne MB, Pasanen ME, Vartiainen MV, Lehto TM, Sarajuuri JM, Alaranta HT. Motor performance in physically well-recovered men with traumatic brain injury. J Rehabil Med. 2006 Jul;38(4):224-9. doi: 10.1080/16501970600582989.
Bland DC, Zampieri C, Damiano DL. Effectiveness of physical therapy for improving gait and balance in individuals with traumatic brain injury: a systematic review. Brain Inj. 2011;25(7-8):664-79. doi: 10.3109/02699052.2011.576306. Epub 2011 May 11.
Other Identifiers
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Pro00016168
Identifier Type: -
Identifier Source: org_study_id
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