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Exercise for Traumatic Brain Injury (BITEEE Trial)

N/A
Waitlist Available
Research Sponsored by Wayne State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 9 weeks.
Awards & highlights

BITEEE Trial 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.

Eligible Conditions
  • Traumatic Brain Injury

BITEEE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 9 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 9 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Trail Making Part B
Secondary outcome measures
Quality of Life in Brain Injury Questionnaire
Other outcome measures
Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT)
NIH Toolbox Standing Balance Test
Repeatable Battery for the Assessment of Neuropsychological Status
+1 more

BITEEE Trial Design

3Treatment groups
Experimental Treatment
Group I: Exercise and EnrichmentExperimental Treatment1 Intervention
Exercise and Enrichment Group is the intervention. The group will be tested at the beginning and end of their exercise/enrichment program.
Group II: ExerciseExperimental Treatment1 Intervention
Exercise is the intervention. People be tested before the start of, and after the end of the eight (8) week exercise program.
Group III: Delayed ExerciseExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~760

Find a Location

Who is running the clinical trial?

Wayne State UniversityLead Sponsor
307 Previous Clinical Trials
108,441 Total Patients Enrolled
Jean Peduzzi-Nelson, Ph.D.Study DirectorWayne State University I

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Neurobiology of DiseaseJournal
Late Exercise Reduces Neuroinflammation and Cognitive Dysfunction After Traumatic Brain Injury
Piao, Chun-Shu, Bogdan A. Stoica, Junfang Wu, Boris Sabirzhanov, Zaorui Zhao, Rainier Cabatbat, David J. Loane, and Alan I. Faden. 2013. “Late Exercise Reduces Neuroinflammation and Cognitive Dysfunction After Traumatic Brain Injury”. Neurobiology of Disease. Elsevier BV. doi:10.1016/j.nbd.2012.12.017.
clinicaltrials.govStudy
Brain Injury Therapy of Exercise and Enriched Environment
Jay M Meythaler 2016. "Brain Injury Therapy of Exercise and Enriched Environment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03256643.
All > Brain Injury
~5 spots leftby Apr 2025
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