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Clinical Trials/NCT03256643
NCT03256643
Unknown
Not Applicable

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

Wayne State University1 site in 1 country42 target enrollmentMay 1, 2016
ConditionsBrain Injuries

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Injuries
Sponsor
Wayne State University
Enrollment
42
Locations
1
Primary Endpoint
Trail Making Part B
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2016
End Date
December 1, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jay M Meythaler

Professor of Medicine with Tenure

Wayne State University

Eligibility Criteria

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Trail Making Part B

Time Frame: 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 Outcomes

  • Quality of Life in Brain Injury Questionnaire(Change from Baseline at 9 weeks.)

Study Sites (1)

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