Brain Injury Therapy of Exercise and Enriched Environment

Study Overview
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Brief Summary
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The purpose of this study is to determine whether exercise or exercise with enrichment is beneficial in individuals who previously had a head injury. The enrichment will consist of a cultural educational program that will include ethnic food, music, slides and a talk. A series of tests that measure mental function and balance will be done before and after the exercise or the exercise/enrichment program will be done to measure efficacy.

Detailed Description
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Traumatic brain injury (TBI) results in long-lasting physical and cognitive deficits. The purpose of this study is to determine whether exercise or exercise with enrichment is beneficial in individuals who previously had a head injury. The environmental enrichment will consist of a cultural educational program that will include ethnic food, music, slides and a talk on 8 different cultures. Individuals will be evaluated using neuropsychological and physical tests before and after the intervention. Testing will consist of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Trailmaking Test (TMT), Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Quality of Life in Brain Injury Questionnaire (QOLIBRI), 10 meter walk, and the NIH Toolbox Standing Balance Test. Initial testing will include the Disability Rating Scale to help balance groups (after random assignment) in terms of baseline ability. In rodents, exercise or an enriched environment after TBI improve cognitive function and motor function and the combination results in even greater improvement. The mechanism of cognitive improvement from exercise or environmental enrichment relates to increases in brain derived neurotrophic factor and neurogenesis in the hippocampus. An additional possible mechanism of the positive effects of exercise or enrichment is a reduction in inflammation. Our hypothesis is that exercise or exercise with enrichment will result in better motor performance and improved cognitive ability.

Official Title
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Cognitive and Physical Effects of Exercise or Exercise With Enrichment on People With TBI

Conditions
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Brain Injuries

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Delayed Exercise
* Behavioral: Exercise and enrichment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Traumatic brain injury (TBI) person 1 to 15 year post-TBI Initial Glascow Coma SCale (GCS) of < or = 12 18-75 years old able to perform standardized exercise program Exclusion Criteria Inability to walk independently without assistive aids. Severe cardiovascular limitations limiting exercise of up to 5 metabolic equivalents.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Exercise is the intervention. People be tested before the start of, and after the end of the eight (8) week exercise program. | Behavioral: Exercise<br>* Exercise intervention will consist of 8 exercise classes and exercises at home. A booklet will be given to each person that has a description and photograph of each exercise that designed to work on core strength and balance.<br>|
| Experimental: Delayed Exercise<br>Delayed Exercise Group will have exercise as intervention. People be tested before the start of, and after the end of the eight (8) weeks then after exercise intervention. | Behavioral: Delayed Exercise<br>* People will be tested up to 40 weeks after beginning the intervention.<br>|
| Experimental: Exercise and Enrichment<br>Exercise and Enrichment Group is the intervention. The group will be tested at the beginning and end of their exercise/enrichment program. | Behavioral: Exercise and enrichment<br>* Exercise and enrichment will consist of the same exercise program described for the exercise intervention. The enrichment protocol consisting of cultural educational program will take place during the exercises and breaks for this group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trail Making Part B | Trail Making test is a measure of visual conceptual and visuomotor tracking, attention, and maintenance of cognitive set-shifting that is known to be highly sensitive to brain damage. | Change from Baseline at 9 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life in Brain Injury Questionnaire | Quality of Life in Brain Injury Questionnaire is a thirty-seven question self-reported measure of overall patient health. | Change from Baseline at 9 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic brain injury, brain contusion, craniocerebral trauma, exercise therapy, chronic brain injury, environment impact, cognitive therapy, health facility environment