Aerobic Exercise After Traumatic Brain Injury

NCT05786729 | Enrolling By Invitation Phase 1

• 1 other identifier: Pro00016168
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (4)

• Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at baseline

  CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.

  Baseline

• Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 4

  CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.

  Week 4

• Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 8

  CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.

  Week 8

• Aerobic Exercise Induced Changes in Cardio Pulmonary (CPET) at Week 12

  CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.

  Week 12

Secondary Outcomes (92)

• Aerobic Exercise Induced Changes in Cognitive Function at baseline

  Baseline

• Aerobic Exercise Induced Changes in Cognitive Function at Week 4

  Week 4

• Aerobic Exercise Induced Changes in Cognitive Function at Week 8

  Week 8

• Aerobic Exercise Induced Changes in Cognitive Function at Week 12

  Week 12

• Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at baseline

  Baseline

Study Arms (3)

Intervention Aerobic Exercise (AER)

EXPERIMENTAL

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.

Other: Aerobic Exercise (AER)

Rehabilitation (R)

ACTIVE COMPARATOR

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.

Other: Rehabilitation

Control (C)

NO INTERVENTION

Healthy volunteers' responsiveness to exercise will be compared to TBI responsiveness.

Interventions

Aerobic Exercise (AER) OTHER

Aerobic exercise will be performed by utilizing aerobic exercise equipment 3 times per week.

Intervention Aerobic Exercise (AER)

Rehabilitation OTHER

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.

Rehabilitation (R)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Neuro Skills: lead
• University of Pittsburgh: collaborator

Study Sites (1)

Centre for Neuro Skills

Bakersfield, California, 93313, United States

Location

Related Publications (14)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 15858047 BACKGROUND

• 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.

  PMID: 23313314 BACKGROUND

• 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.

  PMID: 25445485 BACKGROUND

• Gurley JM, Hujsak BD, Kelly JL. Vestibular rehabilitation following mild traumatic brain injury. NeuroRehabilitation. 2013;32(3):519-28. doi: 10.3233/NRE-130874.

  PMID: 23648606 BACKGROUND

• 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.

  PMID: 16801204 BACKGROUND

• 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.

  PMID: 21561297 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Exercise; Rehabilitation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Grace S Griesbach, PhD

  Centre for Neuro Skills

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Director of Clinical Research

Model Details: Intervention will consist of aerobic exercise sessions at predetermined heart rate range.

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 28, 2023
• Study Start: January 18, 2022
• Primary Completion (Estimated): January 18, 2027
• Study Completion (Estimated): January 18, 2028
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)