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Enrolling by invitation NCT05786729

Aerobic Exercise After Traumatic Brain Injury

Phase I / Phase II Interventional Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aerobic Exercise (AER), Rehabilitation.
Who it may be relevant to
Registry conditions: Traumatic Brain Injury. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at baseline [Time frame: Baseline]
  • Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 4 [Time frame: Week 4]
  • Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 8 [Time frame: Week 8]
  • Aerobic Exercise Induced Changes in Cardio Pulmonary (CPET) at Week 12 [Time frame: Week 12]
Secondary outcome measures (12)
  • Aerobic Exercise Induced Changes in Cognitive Function at baseline [Time frame: Baseline]
  • Aerobic Exercise Induced Changes in Cognitive Function at Week 4 [Time frame: Week 4]
  • Aerobic Exercise Induced Changes in Cognitive Function at Week 8 [Time frame: Week 8]
  • Aerobic Exercise Induced Changes in Cognitive Function at Week 12 [Time frame: Week 12]
  • Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at baseline [Time frame: Baseline]
  • Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 4 [Time frame: Week 4]
  • Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 8 [Time frame: Week 8]
  • Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 12 [Time frame: Week 12]
  • Quality of Life Measured by the NeuroQOL at baseline [Time frame: Baseline]
  • Quality of Life Measured by the NeuroQOL at Week 4 [Time frame: Week 4]
  • Quality of Life Measured by the NeuroQOL at Week 8 [Time frame: Week 8]
  • Quality of Life Measured by the NeuroQOL at Week 12 [Time frame: Week 12]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Centre for Neuro Skills — Bakersfield

Publications

  • 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

Identifiers

NCT: NCT05786729 · Pro00016168

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗