Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Centre for Neuro Skills
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Aerobic Exercise Induced Changes in Inflammatory responses to exercise
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Aerobic Exercise (AER) (Other)
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.
Intervention: Rehabilitation (Other)
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.
Intervention: Rehabilitation (Other)
control (C)
Healthy volunteers' responsiveness to exercise and activity levels will be determined to detect TBI effects.
Outcomes
Primary Outcomes
Aerobic Exercise Induced Changes in Inflammatory responses to exercise
Time Frame: 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
Time Frame: 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
Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Ventilatory Threshold (aerobic capacity)
Aerobic Exercise Induced Changes in Neuroplasticity responses to exercise
Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Selected analytes will be evaluated from serum.
Secondary Outcomes
- Genetic polymorphisms involved in Inflammatory and neuroplasticity responses to aerobic exercise.(4 to 30 weeks depending on the duration of rehabilitation coverage.)
- Aerobic Exercise Induced Changes in Depression Symptoms(4 to 30 weeks depending on the duration of rehabilitation coverage.)
Investigators
Grace S. Griesbach
National Director of Clinical Research
Centre for Neuro Skills