Brain Injury Therapy of Exercise and Enriched Environment

Brain Injuries Clinical Trial

— BITEEE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03256643
• Other study ID #: 123
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2020
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: December 1, 2020
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Wounds and Injuries

Intervention

Behavioral:
• 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.
• Delayed Exercise
People will be tested up to 40 weeks after beginning the intervention.
• 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.

Locations

Country	Name	City	State
United States	Oakwood Heritage	Taylor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Change from Baseline at 9 weeks.
Other	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.	Change from Baseline at 9 weeks.
Other	NIH Toolbox Standing Balance Test	Standing Balance Test measures the detection of spatial orientation, maintenance of posture in static and dynamic conditions.	Change from Baseline and at 9 weeks.
Other	Repeatable Battery for the Assessment of Neuropsychological Status	is a measure of immediate memory, visuospatial/constructional skills, language, attention, and delayed memory.	Change from Baseline at 9 weeks.
Primary	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.	Change from Baseline at 9 weeks.
Secondary	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.	Change from Baseline at 9 weeks.