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RECRUITINGINTERVENTIONAL

Exercise Reset for Concussion in a Military Environment

Exercise Reset for Concussion- Modifying the Buffalo Concussion Protocol for Application in a Military Environment

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 symptoms from a previous concussion or has recovered from a concussion less than 1-month ago - On a limited profile or "chit" for light duty - Active substance abuse/dependence - Unwilling to perform intervention - Limited English proficiency - Confirmed pregnancy Inclusion Criteria (Providers): - Active duty - Currently active clinician (MD, DO, PT, ATC, OT) involved in concussion management beyond initial emergent diagnosis - Willing to participate - Able to be contacted by telephone or Zoom Exclusion Criteria (Providers): - Not active duty - Not currently an active clinician (MD, DO, PT, ATC, OT) involved in concussion management - Only involved in concussion management at emergent timepoint - Unwilling to participate - Unable to be contacted by telephone or Zoom Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 symptoms from a previous concussion or has recovered from a concussion less than 1-month ago * On a limited profile or "chit" for light duty * Active substance abuse/dependence * Unwilling to perform intervention * Limited English proficiency * Confirmed pregnancy Inclusion Criteria (Providers): * Active duty * Currently active clinician (MD, DO, PT, ATC, OT) involved in concussion management beyond initial emergent diagnosis * Willing to participate * Able to be contacted by telephone or Zoom Exclusion Criteria (Providers): * Not active duty * Not currently an active clinician (MD, DO, PT, ATC, OT) involved in concussion management * Only involved in concussion management at emergent timepoint * Unwilling to participate * Unable to be contacted by telephone or Zoom

Treatments Being Tested

BEHAVIORAL

Aerobic Exercise

Participants are asked to complete at least 20 minutes of aerobic exercise every day, excluding clinic visits.

Locations (2)

Fort Liberty
Fayetteville, North Carolina, United States
Camp LeJeune
Jacksonville, North Carolina, United States