Clinical trial NCT02276079: The Effect of Exercise on Neurorecovery Following Mild Traumatic Brain Injury
Official title: The Effect of Exercise on Neurorecovery Following Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Concussion
Keywords: Mild Traumatic Brain Injury
Aerobic Exercise
Brain-Derived Neurotrophic Factor
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Clinical & Translational Science Institute
name: American Psychological Foundation
name: American Psychological Association (APA)
First posted: 2014-10-27
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a "proof-of-principle" project to examine the safety and feasibility of implementing a 1-week aerobic exercise program in the post-acute phase after mild traumatic brain injury (mTBI). The study will define the extent to which the exercise program improves recovery from mTBI in terms of relevant functional outcomes (cognition, mood, and physical status) and biomarkers (peripheral brain-derived neurotrophic factor \[BDNF\] concentration).

Detailed description: This is a "proof-of-principle" project for human subjects to examine the safety and feasibility of implementing a 1-week aerobic exercise program in the post-acute phase after mild traumatic brain injury (mTBI). This study will define the extent to which the exercise program improves recovery from mTBI in terms of relevant functional outcomes (cognition, mood, and physical status) and biomarkers (peripheral brain-derived neurotrophic factor \[BDNF\] concentration). This project will also lay the foundation for understanding the relationship between exercise and BDNF in the area of mTBI neurorecovery, thereby allowing future studies to develop best-practice methods for implementing exercise interventions as a treatment option for brain injuries.

Eligibility criteria: Mild traumatic brain injury (mTBI) group:

Inclusion Criteria:

* Meet criteria for mTBI as set forth by the American Congress of Rehabilitation Medicine
* mTBI was sustained 14-25 days before beginning the exercise intervention

Exclusion Criteria:

* comorbid orthopaedic injury that inhibits movement
* history of serious psychiatric disturbance with hospitalization,
* prior history of neurologic disease,
* current or past history of substance abuse disorder,
* diabetes
* previous history of moderate or severe head injury,
* neurological disorder unrelated to TBI (e.g., seizure disorder)
* physician recommendations against exercise
* non-English speakers

Non-injured Group:

Inclusion Criteria:

- Gainesville, Florida community member

Exclusion Criteria:

* History of mTBI or other brain injury in the past year
* comorbid orthopaedic injury that inhibits movement
* history of serious psychiatric disturbance with hospitalization,
* prior history of neurologic disease,
* current or past history of substance abuse disorder,
* diabetes
* previous history of moderate or severe head injury,
* neurological disorder unrelated to TBI (e.g., seizure disorder)
* physician recommendations against exercise
* non-English speakers

Primary outcomes:
measure: Change in Symptom Score on the Sport Concussion Assessment Tool (SCAT3)
timeFrame: Baseline and up to day 8
measure: Change in Symptom Severity on the Sport Concussion Assessment Tool (SCAT3)
timeFrame: Baseline and up to day 8
measure: Change in sleep quality
timeFrame: Baseline and up to day 8
measure: Change in postural stability
timeFrame: Baseline and up to day 8
measure: Change in verbal learning and memory
timeFrame: Baseline and up to day 8
measure: Change in auditory-linguistic memory
timeFrame: Baseline and up to day 8
measure: Change in word-fluency
timeFrame: Baseline and up to day 8
measure: Change in semantic fluency
timeFrame: Baseline and up to day 8
measure: Change in psychomotor/executive functioning
timeFrame: Baseline and up to day 8
measure: Change in problem solving and abstract reasoning
timeFrame: Baseline and up to day 8
measure: Change in attention
timeFrame: Baseline and up to day 8
measure: Change in processing speed
timeFrame: Baseline and up to day 8
measure: Change in visual memory
timeFrame: Baseline and up to day 8
measure: Change in sustained and selective attention
timeFrame: Baseline and up to day 8
measure: Change in working memory and attention
timeFrame: Baseline and up to day 8
measure: Change in depression symptoms
timeFrame: Baseline and up to day 8
measure: Change in anxiety symptoms
timeFrame: Baseline and up to day 8
Secondary outcomes:
measure: Change in functional neuroimaging activation
timeFrame: Baseline and up to day 8
measure: Change in Symptom Score on the Sport Concussion Assessment Tool (SCAT3)
timeFrame: Baseline and up to day 70
measure: Change in Symptom Severity on the Sport Concussion Assessment Tool (SCAT3)
timeFrame: Baseline and up to day 70
measure: Change in sleep quality
timeFrame: Baseline and up to day 70
measure: Change in postural stability
timeFrame: Baseline and up to day 70
measure: Change in depression symptoms
timeFrame: Baseline and up to day 70
measure: Change in anxiety symptoms
timeFrame: Baseline and up to day 70
Other outcomes:
measure: Change in aerobic fitness
timeFrame: Baseline and up to day 8
measure: Change in body weight
timeFrame: Baseline and up to day 8
measure: Minutes of physical activity outside of exercise program
timeFrame: Day 7 of exercise program
Locations:
city: Gainesville
country: United States
facility: University of Florida Health Science Center
state: Florida
Study officials:
affiliation: University of Florida
name: Russell M. Bauer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Aliyah R. Snyder, M.S.
role: STUDY_DIRECTOR
References:
citation: Cassidy JD, Carroll LJ, Peloso PM, Borg J, von Holst H, Holm L, Kraus J, Coronado VG; WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. Incidence, risk factors and prevention of mild traumatic brain injury: results of the WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. J Rehabil Med. 2004 Feb;(43 Suppl):28-60. doi: 10.1080/16501960410023732.
citation: Barkhoudarian G, Hovda DA, Giza CC. The molecular pathophysiology of concussive brain injury. Clin Sports Med. 2011 Jan;30(1):33-48, vii-iii. doi: 10.1016/j.csm.2010.09.001.
citation: Prins ML, Alexander D, Giza CC, Hovda DA. Repeated mild traumatic brain injury: mechanisms of cerebral vulnerability. J Neurotrauma. 2013 Jan 1;30(1):30-8. doi: 10.1089/neu.2012.2399.
citation: Griesbach GS, Gomez-Pinilla F, Hovda DA. Time window for voluntary exercise-induced increases in hippocampal neuroplasticity molecules after traumatic brain injury is severity dependent. J Neurotrauma. 2007 Jul;24(7):1161-71. doi: 10.1089/neu.2006.0255.
citation: Bigler ED. Neuropsychology and clinical neuroscience of persistent post-concussive syndrome. J Int Neuropsychol Soc. 2008 Jan;14(1):1-22. doi: 10.1017/S135561770808017X.
citation: 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.
citation: Coelho FG, Gobbi S, Andreatto CA, Corazza DI, Pedroso RV, Santos-Galduroz RF. Physical exercise modulates peripheral levels of brain-derived neurotrophic factor (BDNF): a systematic review of experimental studies in the elderly. Arch Gerontol Geriatr. 2013 Jan-Feb;56(1):10-5. doi: 10.1016/j.archger.2012.06.003. Epub 2012 Jun 29.
citation: Tanaka H, Monahan KD, Seals DR. Age-predicted maximal heart rate revisited. J Am Coll Cardiol. 2001 Jan;37(1):153-6. doi: 10.1016/s0735-1097(00)01054-8.
citation: Dunn AL, Trivedi MH, Kampert JB, Clark CG, Chambliss HO. The DOSE study: a clinical trial to examine efficacy and dose response of exercise as treatment for depression. Control Clin Trials. 2002 Oct;23(5):584-603. doi: 10.1016/s0197-2456(02)00226-x.
citation: Efird J. Blocked randomization with randomly selected block sizes. Int J Environ Res Public Health. 2011 Jan;8(1):15-20. doi: 10.3390/ijerph8010015. Epub 2010 Dec 23.
citation: Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
citation: Riemann BL, Guskiewicz KM. Effects of mild head injury on postural stability as measured through clinical balance testing. J Athl Train. 2000 Jan;35(1):19-25.