Exercise and Rehabilitation After Traumatic Brain Injury
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- Aerobic Exercise Induced Changes in Inflammatory responses to exercise [4 to 30 weeks depending on the duration of rehabilitation coverage.]
Selected analytes will be evaluated from serum.
- Aerobic Exercise Induced Changes in Cognitive Function [5 years]
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.
- Aerobic Exercise Induced Changes in Cardio Pulmonary Fitness [4 to 30 weeks depending on the duration of rehabilitation coverage.]
Ventilatory Threshold (aerobic capacity)
- Aerobic Exercise Induced Changes in Neuroplasticity responses to exercise [4 to 30 weeks depending on the duration of rehabilitation coverage.]
Selected analytes will be evaluated from serum.
Secondary Outcome Measures
- Genetic polymorphisms involved in Inflammatory and neuroplasticity responses to aerobic exercise. [4 to 30 weeks depending on the duration of rehabilitation coverage.]
Genetic material will be obtained.
- Aerobic Exercise Induced Changes in Depression Symptoms [4 to 30 weeks depending on the duration of rehabilitation coverage.]
Beck Depression Inventory
Other Outcome Measures
- Verbal Memory [4 to 30 weeks depending on the duration of rehabilitation coverage.]
California Verbal Learning Test (CVLT II).
- Visual Search/Processing Speed [4 to 30 weeks depending on the duration of rehabilitation coverage.]
Trail Making
- Quality of Life [4 to 30 weeks depending on the duration of rehabilitation coverage.]
Quality of Life in Neurological Disorders (Neuro-QoL)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre for Neuro Skills | Encino | California | United States | 91436 |
Sponsors and Collaborators
- Centre for Neuro Skills
Investigators
- Principal Investigator: Grace S Griesbach, PhD, Centre for Neuro Skills
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- Chandrasekhar SS. The assessment of balance and dizziness in the TBI patient. NeuroRehabilitation. 2013;32(3):445-54. doi: 10.3233/NRE-130867. Review.
- 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.
- 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.
- 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.
- 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.
- AER-TBI1