Exercise Reset for Concussion in a Military Environment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorState University of New York at Buffalo

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Aerobic Exercise

Treatment groups

168 Participants
are divided into 3 treatment groups

Sponsors and collaborators

State University of New York at Buffalo

Lead sponsor

United States Department of Defense

Collaborator

Children's Hospital of Philadelphia

Collaborator

University of Pennsylvania

Collaborator

University of North Carolina, Chapel Hill

Collaborator

The Geneva Foundation

Collaborator

Center for Neuroscience and Regenerative Medicine (CNRM)

Collaborator

Axon Medical Technologies LLC

Collaborator