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
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