Exercise and Rehabilitation After Traumatic Brain Injury

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.

Official Title
-----------------
Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Other: Aerobic Exercise (AER)
* Other: Rehabilitation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention will consist of aerobic exercise sessions at predetermined heart rate range.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention aerobic exercise (AER)<br>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)<br>* 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.<br>Other: Rehabilitation<br>* 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.<br>|
| Active Comparator: rehabilitation (R)<br>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<br>* 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.<br>|
| No Intervention: control (C)<br>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. |