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Brain Injury Therapy of Exercise and Enriched Environment

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03256643
Acronym
BITEEE
Enrollment
42
Registered
2017-08-22
Start date
2016-05-01
Completion date
2020-12-01
Last updated
2020-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries

Keywords

traumatic brain injury, brain contusion, craniocerebral trauma, exercise therapy, chronic brain injury, environment impact, cognitive therapy, health facility environment

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.

Interventions

BEHAVIORALExercise

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.

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

BEHAVIORALExercise 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.

Sponsors

Wayne State University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Trail Making Part BChange 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

MeasureTime frameDescription
Quality of Life in Brain Injury QuestionnaireChange 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

MeasureTime frameDescription
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 WalkChange 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 TestChange 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 StatusChange from Baseline at 9 weeks.is a measure of immediate memory, visuospatial/constructional skills, language, attention, and delayed memory.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026