An interventional study of Exercise and Delayed Exercise in Brain Injuries, sponsored by Wayne State University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by Wayne State University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria
Exercise is the intervention. People be tested before the start of, and after the end of the eight (8) week exercise program.
Behavioral: 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.
Behavioral: Delayed Exercise
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
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.
People will be tested up to 40 weeks after beginning the intervention.
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.
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.
Time frame: Change from Baseline at 9 weeks.
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.
Time frame: Change from Baseline at 9 weeks.
Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT)
ImPACT is a measure which consists of a word discrimination, design memory, X/O, symbol matching, color matching, and three letter memory tasks.
Time frame: Change from Baseline at 9 weeks.
Ten Minute Walk
Ten Meter Walk is a physical measure of balance and gait, consisting of measuring the time it takes for participants to walk.
Time frame: Change from Baseline at 9 weeks.
NIH Toolbox Standing Balance Test
Standing Balance Test measures the detection of spatial orientation, maintenance of posture in static and dynamic conditions.
Time frame: Change from Baseline and at 9 weeks.
Repeatable Battery for the Assessment of Neuropsychological Status
is a measure of immediate memory, visuospatial/constructional skills, language, attention, and delayed memory.
Time frame: Change from Baseline at 9 weeks.
Plan to share: No
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Wayne State University