BITEEE: Brain Injury Therapy of Exercise and Enriched Environment

Sponsor

Wayne State University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03256643

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Injuries	Behavioral: Exercise Behavioral: Delayed Exercise Behavioral: Exercise and enrichment	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Jul 1, 2018

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Exercise is the intervention. People be tested before the start of, and after the end of the eight (8) week exercise program.	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.
Experimental: 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.	Behavioral: Delayed Exercise People will be tested up to 40 weeks after beginning the intervention.
Experimental: 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.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Exercise

Exercise is the intervention. People be tested before the start of, and after the end of the eight (8) week exercise program.

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.

Experimental: 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.

Behavioral: Delayed Exercise

People will be tested up to 40 weeks after beginning the intervention.

Experimental: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) [Change from Baseline at 9 weeks.]
ImPACT is a measure which consists of a word discrimination, design memory, X/O, symbol matching, color matching, and three letter memory tasks.
Ten Minute Walk [Change from Baseline at 9 weeks.]
Ten Meter Walk is a physical measure of balance and gait, consisting of measuring the time it takes for participants to walk.
NIH Toolbox Standing Balance Test [Change from Baseline and at 9 weeks.]
Standing Balance Test measures the detection of spatial orientation, maintenance of posture in static and dynamic conditions.
Repeatable Battery for the Assessment of Neuropsychological Status [Change from Baseline at 9 weeks.]
is a measure of immediate memory, visuospatial/constructional skills, language, attention, and delayed memory.