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Exercise for 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

No Placebo-Only Group

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

Brain Injury

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 9 weeks.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Trail Making Part B

Secondary study objectives

Quality of Life in Brain Injury Questionnaire

Other study objectives

Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT)

NIH Toolbox Standing Balance Test

Repeatable Battery for the Assessment of Neuropsychological Status

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~820

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