Brain Injury Therapy of Exercise and Enriched Environment (BITEEE)

March 25, 2020 updated by: Jay M Meythaler, Wayne State University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Taylor, Michigan, United States, 48180
        • Oakwood Heritage

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline at 9 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life in Brain Injury Questionnaire
Time Frame: 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.
Change from Baseline at 9 weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT)
Time Frame: 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.
Change from Baseline at 9 weeks.
Ten Minute Walk
Time Frame: 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.
Change from Baseline at 9 weeks.
NIH Toolbox Standing Balance Test
Time Frame: Change from Baseline and at 9 weeks.
Standing Balance Test measures the detection of spatial orientation, maintenance of posture in static and dynamic conditions.
Change from Baseline and at 9 weeks.
Repeatable Battery for the Assessment of Neuropsychological Status
Time Frame: Change from Baseline at 9 weeks.
is a measure of immediate memory, visuospatial/constructional skills, language, attention, and delayed memory.
Change from Baseline at 9 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Investigators

  • Study Director: Jean Peduzzi-Nelson, Ph.D., Wayne State University I

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

December 9, 2014

First Submitted That Met QC Criteria

August 19, 2017

First Posted (Actual)

August 22, 2017

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123 (Giresun University Scientific Research Project)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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