Clinical trial NCT03256643: Brain Injury Therapy of Exercise and Enriched Environment
Official title: Cognitive and Physical Effects of Exercise or Exercise With Enrichment on People With TBI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Injuries
Keywords: traumatic brain injury
brain contusion
craniocerebral trauma
exercise therapy
chronic brain injury
environment impact
cognitive therapy
health facility environment
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Trail Making Part B
timeFrame: Change from Baseline at 9 weeks.
Secondary outcomes:
measure: Quality of Life in Brain Injury Questionnaire
timeFrame: Change from Baseline at 9 weeks.
Other outcomes:
measure: Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT)
timeFrame: Change from Baseline at 9 weeks.
measure: Ten Minute Walk
timeFrame: Change from Baseline at 9 weeks.
measure: NIH Toolbox Standing Balance Test
timeFrame: Change from Baseline and at 9 weeks.
measure: Repeatable Battery for the Assessment of Neuropsychological Status
timeFrame: Change from Baseline at 9 weeks.
Locations:
city: Taylor
country: United States
facility: Oakwood Heritage
state: Michigan
Study officials:
affiliation: Wayne State University I
name: Jean Peduzzi-Nelson, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Alwis DS, Rajan R. Environmental enrichment and the sensory brain: the role of enrichment in remediating brain injury. Front Syst Neurosci. 2014 Sep 2;8:156. doi: 10.3389/fnsys.2014.00156. eCollection 2014.
citation: Bondi CO, Klitsch KC, Leary JB, Kline AE. Environmental enrichment as a viable neurorehabilitation strategy for experimental traumatic brain injury. J Neurotrauma. 2014 May 15;31(10):873-88. doi: 10.1089/neu.2014.3328. Epub 2014 Apr 17.
citation: Fischer FR, Peduzzi JD. Functional recovery in rats with chronic spinal cord injuries after exposure to an enriched environment. J Spinal Cord Med. 2007;30(2):147-55. doi: 10.1080/10790268.2007.11753926.
citation: Gomez-Pinilla F, Hillman C. The influence of exercise on cognitive abilities. Compr Physiol. 2013 Jan;3(1):403-28. doi: 10.1002/cphy.c110063.
citation: Piao CS, Stoica BA, Wu J, Sabirzhanov B, Zhao Z, Cabatbat R, Loane DJ, Faden AI. Late exercise reduces neuroinflammation and cognitive dysfunction after traumatic brain injury. Neurobiol Dis. 2013 Jun;54:252-63. doi: 10.1016/j.nbd.2012.12.017. Epub 2013 Jan 8.