Exercise and Rehabilitation After Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03407924
• Other study ID #: AER-TBI1
• Status: Recruiting
• Phase: Phase 1
• First received: July 9, 2015
• Last updated: January 26, 2018
• Start date: June 2016
• Est. completion date: March 2022

Study information

• Verified date: January 2018
• Source: Centre for Neuro Skills
• Contact: Grace S Griesbach, PhD
• Phone: (818)783-3800
• Email: researchcentre[@]neuroskills.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2022
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Aerobic Exercise (AER)
Aerobic exercise will be performed with a treadmill or stationary tandem bike 3 times per week. Each exercise session will take about 30 minutes plus 5 to 10 min of warm-up and cool-down. Participants will wear a safety harness.
• 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.

Locations

Country	Name	City	State
United States	Centre for Neuro Skills	Encino	California

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Neuro Skills

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. Review. — View 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. — View Citation

Chandrasekhar SS. The assessment of balance and dizziness in the TBI patient. NeuroRehabilitation. 2013;32(3):445-54. doi: 10.3233/NRE-130867. Review. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Verbal Memory	California Verbal Learning Test (CVLT II).	4 to 30 weeks depending on the duration of rehabilitation coverage.
Other	Visual Search/Processing Speed	Trail Making	4 to 30 weeks depending on the duration of rehabilitation coverage.
Other	Quality of Life	Quality of Life in Neurological Disorders (Neuro-QoL)	4 to 30 weeks depending on the duration of rehabilitation coverage.
Primary	Aerobic Exercise Induced Changes in Inflammatory responses to exercise	Selected analytes will be evaluated from serum.	4 to 30 weeks depending on the duration of rehabilitation coverage.
Primary	Aerobic Exercise Induced Changes in Cognitive Function	Attention, processing speed, reaction times, memory and nonverbal reasoning are evaluated by CNS Vital Signs. All scores are aggregated to one reported value (Neurocognitive Index). Scoring is by a computer based auto-scored multivariate scoring system developed by the manufacturers.	5 years
Primary	Aerobic Exercise Induced Changes in Cardio Pulmonary Fitness	Ventilatory Threshold (aerobic capacity)	4 to 30 weeks depending on the duration of rehabilitation coverage.
Primary	Aerobic Exercise Induced Changes in Neuroplasticity responses to exercise	Selected analytes will be evaluated from serum.	4 to 30 weeks depending on the duration of rehabilitation coverage.
Secondary	Genetic polymorphisms involved in Inflammatory and neuroplasticity responses to aerobic exercise.	Genetic material will be obtained.	4 to 30 weeks depending on the duration of rehabilitation coverage.
Secondary	Aerobic Exercise Induced Changes in Depression Symptoms	Beck Depression Inventory	4 to 30 weeks depending on the duration of rehabilitation coverage.