Brain Injury Therapy of Exercise and Enriched Environment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2020-12-01

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.

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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.

Conditions

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Brain Injuries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise

Exercise is the intervention. People be tested before the start of, and after the end of the eight (8) week exercise program.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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.

Delayed Exercise

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.

Group Type EXPERIMENTAL

Delayed Exercise

Intervention Type BEHAVIORAL

People will be tested up to 40 weeks after beginning the intervention.

Exercise and Enrichment

Exercise and Enrichment Group is the intervention. The group will be tested at the beginning and end of their exercise/enrichment program.

Group Type EXPERIMENTAL

Exercise and enrichment

Intervention Type BEHAVIORAL

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.

Interventions

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Exercise

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.

Intervention Type BEHAVIORAL

Delayed Exercise

People will be tested up to 40 weeks after beginning the intervention.

Intervention Type BEHAVIORAL

Exercise and enrichment

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.

Intervention Type BEHAVIORAL

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