Brain Injury Therapy of Exercise and Enriched Environment
- Conditions
- Brain Injuries
- Interventions
- Behavioral: Exercise and enrichmentBehavioral: ExerciseBehavioral: Delayed Exercise
- Registration Number
- NCT03256643
- Lead Sponsor
- Wayne State University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 42
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Exercise and Enrichment 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. Exercise Exercise Exercise is the intervention. People be tested before the start of, and after the end of the eight (8) week exercise program. Delayed Exercise 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.
- Primary Outcome Measures
Name Time Method Trail Making Part B Change from Baseline at 9 weeks. 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.
- Secondary Outcome Measures
Name Time Method Quality of Life in Brain Injury Questionnaire Change from Baseline at 9 weeks. Quality of Life in Brain Injury Questionnaire is a thirty-seven question self-reported measure of overall patient health.
Trial Locations
- Locations (1)
Oakwood Heritage
🇺🇸Taylor, Michigan, United States