Aerobic Exercise After Traumatic Brain Injury

Официальное название

Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury

Обзор

The purpose of this study is to examine the effects of individualized aerobic exercise regimen on recovery after traumatic brain injury (TBI).Investigators will determine if exercise facilitates recovery by facilitating neuroplasticity and decreasing neuroinflammation.

Подробное описание

Exercise-based therapies can promote recovery of function and are easily implemented in the clinical rehabilitation setting. This study will determine if exercise facilitates recovery by improving markers of neuroplasticity and decreasing neuroinflammatory responses. The investigators will also determine if variations in genes involved in neuroplasticity, and inflammation influence the responsiveness to exercise and rehabilitation. Recovery will be determined by assessing cognitive function, life quality and balance.

Вмешательства

• Другое Aerobic Exercise (AER)
  Aerobic exercise will be performed by utilizing aerobic exercise equipment 3 times per week.
• Другое 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.

Первичные конечные точки

• Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at baseline [Срок оценки: Baseline]
• Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 4 [Срок оценки: Week 4]
• Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 8 [Срок оценки: Week 8]
• Aerobic Exercise Induced Changes in Cardio Pulmonary (CPET) at Week 12 [Срок оценки: Week 12]

Вторичные конечные точки (12)

• Aerobic Exercise Induced Changes in Cognitive Function at baseline [Срок оценки: Baseline]
• Aerobic Exercise Induced Changes in Cognitive Function at Week 4 [Срок оценки: Week 4]
• Aerobic Exercise Induced Changes in Cognitive Function at Week 8 [Срок оценки: Week 8]
• Aerobic Exercise Induced Changes in Cognitive Function at Week 12 [Срок оценки: Week 12]
• Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at baseline [Срок оценки: Baseline]
• Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 4 [Срок оценки: Week 4]
• Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 8 [Срок оценки: Week 8]
• Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 12 [Срок оценки: Week 12]
• Quality of Life Measured by the NeuroQOL at baseline [Срок оценки: Baseline]
• Quality of Life Measured by the NeuroQOL at Week 4 [Срок оценки: Week 4]
• Quality of Life Measured by the NeuroQOL at Week 8 [Срок оценки: Week 8]
• Quality of Life Measured by the NeuroQOL at Week 12 [Срок оценки: Week 12]

Критерии участия

Критерии включения

• All participants will provide informed consent and have to comply with the procedures of the study.
• 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

Критерии исключения

• Current diagnosis of degenerative neurological disease.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Centre for Neuro Skills — Bakersfield

Публикации

• Ashman TA, Gordon WA, Cantor JB, Hibbard MR. Neurobehavioral consequences of traumatic brain injury. Mt Sinai J Med. 2006 Nov;73(7):999-1005. PMID 17195886
• 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. PMID 14584829
• 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. PMID 15051152
• 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. PMID 19555673
• 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. PMID 19923361
• 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. PMID 22285252
• 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. PMID 8780803
• 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. PMID 11323547

Идентификаторы

NCT: NCT05786729 · Pro00016168

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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