Exercise and Rehabilitation After Traumatic Brain Injury

Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury

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.

Study Overview

• Status: Unknown
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: Aerobic Exercise (AER); Other: Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Grace S Griesbach, PhD; Phone Number: (818)783-3800; Email: researchcentre@neuroskills.com
• Study Contact Backup: Name: Lisa Kreber, PhD; Phone Number: (661)873-6513; Email: researchcentre@neuroskills.com

Study Locations

• United States
  • California
    • Encino, California, United States, 91436
      • Recruiting
      • Centre for Neuro Skills
      • Contact: Grace Griesbach, PhD; Phone Number: 818-783-3800; Email: researchcentre@neuroskills.com
      • Contact: Charan Singh, MS; Phone Number: (661)872-3408; Email: csingh@neuroskills.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention aerobic exercise (AER); Participants with traumatic brain injury (TBI) that are enrolled in a comprehensive rehabilitation program (R) will be engaged in an aerobic exercise program (AER). These participants will also receive standard rehabilitation which includes exercise within the physical therapy session. Given that the duration of the rehabilitative program is variable the period of AER training will be no less than 4 weeks and will not exceed 30 weeks. Activity levels will be monitored.	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.; 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.
Active Comparator: rehabilitation (R); 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 30 weeks. Activity levels will be monitored.	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.
No Intervention: control (C); Healthy volunteers' responsiveness to exercise and activity levels will be determined to detect TBI effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
Aerobic Exercise Induced Changes in Cardio Pulmonary Fitness	Ventilatory Threshold (aerobic capacity)	4 to 30 weeks depending on the duration of rehabilitation coverage.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Aerobic Exercise Induced Changes in Depression Symptoms	Beck Depression Inventory	4 to 30 weeks depending on the duration of rehabilitation coverage.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal Memory	California Verbal Learning Test (CVLT II).	4 to 30 weeks depending on the duration of rehabilitation coverage.
Visual Search/Processing Speed	Trail Making	4 to 30 weeks depending on the duration of rehabilitation coverage.
Quality of Life	Quality of Life in Neurological Disorders (Neuro-QoL)	4 to 30 weeks depending on the duration of rehabilitation coverage.

Collaborators and Investigators

• Sponsor: Centre for Neuro Skills
• Investigators: Principal Investigator: Grace S Griesbach, PhD, Centre for Neuro Skills

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Ashman TA, Gordon WA, Cantor JB, Hibbard MR. Neurobehavioral consequences of traumatic brain injury. Mt Sinai J Med. 2006 Nov;73(7):999-1005.
• 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.
• 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.
• 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.
• Chandrasekhar SS. The assessment of balance and dizziness in the TBI patient. NeuroRehabilitation. 2013;32(3):445-54. doi: 10.3233/NRE-130867.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: July 9, 2015
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: AER-TBI1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No