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Brain Injury Therapy of Exercise and Enriched Environment (BITEEE)

Primary Purpose

Brain Injuries

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Delayed Exercise
Exercise and enrichment
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring traumatic brain injury, brain contusion, craniocerebral trauma, exercise therapy, chronic brain injury, environment impact, cognitive therapy, health facility environment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oakwood Heritage

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Exercise

Delayed Exercise

Exercise and Enrichment

Arm Description

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

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.

Exercise and Enrichment Group is the intervention. The group will be tested at the beginning and end of their exercise/enrichment program.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 9, 2014
Last Updated
March 25, 2020
Sponsor
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT03256643
Brief Title
Brain Injury Therapy of Exercise and Enriched Environment
Acronym
BITEEE
Official Title
Cognitive and Physical Effects of Exercise or Exercise With Enrichment on People With TBI
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
Keywords
traumatic brain injury, brain contusion, craniocerebral trauma, exercise therapy, chronic brain injury, environment impact, cognitive therapy, health facility environment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Exercise is the intervention. People be tested before the start of, and after the end of the eight (8) week exercise program.
Arm Title
Delayed Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise and Enrichment
Arm Type
Experimental
Arm Description
Exercise and Enrichment Group is the intervention. The group will be tested at the beginning and end of their exercise/enrichment program.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Delayed Exercise
Intervention Description
People will be tested up to 40 weeks after beginning the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Exercise and enrichment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Trail Making Part B
Description
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.
Secondary Outcome Measure Information:
Title
Quality of Life in Brain Injury Questionnaire
Description
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.
Other Pre-specified Outcome Measures:
Title
Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT)
Description
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.
Title
Ten Minute Walk
Description
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.
Title
NIH Toolbox Standing Balance Test
Description
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.
Title
Repeatable Battery for the Assessment of Neuropsychological Status
Description
is a measure of immediate memory, visuospatial/constructional skills, language, attention, and delayed memory.
Time Frame
Change from Baseline at 9 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Peduzzi-Nelson, Ph.D.
Organizational Affiliation
Wayne State University I
Official's Role
Study Director
Facility Information:
Facility Name
Oakwood Heritage
City
Taylor
State/Province
Michigan
ZIP/Postal Code
48180
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25228861
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.
Results Reference
background
PubMed Identifier
24555571
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.
Results Reference
background
PubMed Identifier
17591227
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.
Results Reference
background
PubMed Identifier
23720292
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.
Results Reference
background
PubMed Identifier
23313314
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.
Results Reference
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Brain Injury Therapy of Exercise and Enriched Environment

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