Brain Injury Therapy of Exercise and Enriched Environment (BITEEE)

Wayne State University

Status: Unknown

Conditions: Brain Injuries

Treatments: Behavioral: Delayed Exercise; Behavioral: Exercise and enrichment; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03256643

123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

42 participants in 3 patient groups

Exercise

Experimental group

Description:

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

Treatment:

Behavioral: Exercise

Delayed Exercise

Experimental group

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.

Treatment:

Behavioral: Delayed Exercise

Exercise and Enrichment

Experimental group

Description:

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

Treatment:

Behavioral: Exercise and enrichment