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Recruiting NCT05498038

Exercise Reset for Concussion in a Military Environment

Trial Parameters

Condition Brain Concussion
Sponsor State University of New York at Buffalo
Study Type INTERVENTIONAL
Phase N/A
Enrollment 168
Sex ALL
Min Age 18 Years
Max Age 40 Years
Start Date 2024-08-07
Completion 2026-09-30
Interventions
Aerobic Exercise

Brief Summary

Our primary objective is to show that early, personalized aerobic exercise treatment safely improves concussion recovery, speeds RTD, and reduces persistent symptoms in CSM. Our secondary objectives include demonstrating the clinical utility of our March-in-place test and determining fundamental mechanisms for the effect of exercise rehabilitation on concussion recovery. We will conduct a prospective four-year multicenter mechanistic treatment (Phase 3) RCT in CSM of personalized sub-threshold aerobic exercise added to the PRA compared with the PRA alone. Non-concussed, age-matched SM will serve as a healthy control group (HC) for comparing CSM to normal physiology and to control for the effect of time and of aerobic exercise.

Eligibility Criteria

Inclusion Criteria (Participants): For the CSM Group: * Active-duty service member * Aged 18-40 years * Injury occurred within 9 days of injury * Diagnosed with concussion by an experienced clinician using standard international criteria For the HC Group: * Active-duty service member * Ages 18-40 Exclusion Criteria (Participants): For the CSM group: * Moderate or severe TBI as indicated by a GCS score \<13, lesion on CT/MRI, and/or focal neurologic sign consistent with intracerebral lesion * Injury involving loss of consciousness for \>30 minutes or post-traumatic amnesia \>24 hours * Inability to exercise because of lower-extremity orthopedic injury, clinically significant vestibular or visual dysfunction, or increased cardiac risk * Pre-existing conditions that prevent participation in active testing and/or rehabilitation * Active substance abuse/dependence * Unwillingness to perform intervention * Limited English proficiency * Confirmed pregnancy For the HC group: * Has lingering sy

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