Clinical trial NCT03407924: Exercise and Rehabilitation After Traumatic Brain Injury
Official title: Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Traumatic Brain Injury
Lead sponsor: Centre for Neuro Skills
Sponsor class: INDUSTRY
First posted: 2018-01-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention will consist of aerobic exercise sessions at predetermined heart rate range.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of exercise on recovery after traumatic brain injury. Investigators will determine if exercise enhances rehabilitation by increasing substances (proteins) that can facilitate recovery.

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, memory and inflammation influence the responsiveness to exercise and rehabilitation. Particular genetic polymorphisms involved in neuroplasticity and inflammatory responses will be evaluated. Recovery will be determined by assessing cognitive function, life quality and balance.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of TBI (for R+AER and R groups).
* Fluency in English or Spanish.
* Able to walk with or without a device.

Exclusion Criteria:

* Orthopedic or cardiac conditions that prevent from exercising.
* Current diagnosis of neurological and/or psychiatric diseases.

Unable to be in the Los Angeles CA metropolitan area for the duration of the study

Primary outcomes:
measure: Aerobic Exercise Induced Changes in Inflammatory responses to exercise
timeFrame: 4 to 30 weeks depending on the duration of rehabilitation coverage.
measure: Aerobic Exercise Induced Changes in Cognitive Function
timeFrame: 5 years
measure: Aerobic Exercise Induced Changes in Cardio Pulmonary Fitness
timeFrame: 4 to 30 weeks depending on the duration of rehabilitation coverage.
measure: Aerobic Exercise Induced Changes in Neuroplasticity responses to exercise
timeFrame: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Secondary outcomes:
measure: Genetic polymorphisms involved in Inflammatory and neuroplasticity responses to aerobic exercise.
timeFrame: 4 to 30 weeks depending on the duration of rehabilitation coverage.
measure: Aerobic Exercise Induced Changes in Depression Symptoms
timeFrame: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Other outcomes:
measure: Verbal Memory
timeFrame: 4 to 30 weeks depending on the duration of rehabilitation coverage.
measure: Visual Search/Processing Speed
timeFrame: 4 to 30 weeks depending on the duration of rehabilitation coverage.
measure: Quality of Life
timeFrame: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Locations:
city: Encino
country: United States
facility: Centre for Neuro Skills
state: California
Study officials:
affiliation: Centre for Neuro Skills
name: Grace S Griesbach, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hellawell DJ, Taylor RT, Pentland B. Cognitive and psychosocial outcome following moderate or severe traumatic brain injury. Brain Inj. 1999 Jul;13(7):489-504. doi: 10.1080/026990599121403.
citation: Ashman TA, Gordon WA, Cantor JB, Hibbard MR. Neurobehavioral consequences of traumatic brain injury. Mt Sinai J Med. 2006 Nov;73(7):999-1005.
citation: Alsalaheen BA, Mucha A, Morris LO, Whitney SL, Furman JM, Camiolo-Reddy CE, Collins MW, Lovell MR, Sparto PJ. Vestibular rehabilitation for dizziness and balance disorders after concussion. J Neurol Phys Ther. 2010 Jun;34(2):87-93. doi: 10.1097/NPT.0b013e3181dde568.
citation: Chamelian L, Feinstein A. Outcome after mild to moderate traumatic brain injury: the role of dizziness. Arch Phys Med Rehabil. 2004 Oct;85(10):1662-6. doi: 10.1016/j.apmr.2004.02.012.
citation: Agrawal M, Joshi M. Impact of rehabilitation on functional outcome during the first year of moderate and severe traumatic brain injury. Brain Inj. 2014;28(3):292-7. doi: 10.3109/02699052.2013.865266. Epub 2013 Dec 30.
citation: Griesbach GS, Kreber LA, Harrington D, Ashley MJ. Post-acute traumatic brain injury rehabilitation: effects on outcome measures and life care costs. J Neurotrauma. 2015 May 15;32(10):704-11. doi: 10.1089/neu.2014.3754. Epub 2015 Feb 11.
citation: Chandrasekhar SS. The assessment of balance and dizziness in the TBI patient. NeuroRehabilitation. 2013;32(3):445-54. doi: 10.3233/NRE-130867.
citation: Ridgel AL, Vitek JL, Alberts JL. Forced, not voluntary, exercise improves motor function in Parkinson's disease patients. Neurorehabil Neural Repair. 2009 Jul-Aug;23(6):600-8. doi: 10.1177/1545968308328726. Epub 2009 Jan 8.