Exercise Reset for Concussion in a Military Environment

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.

NCT Number	NCT05498038
Lead Sponsor	State University of New York at Buffalo Collaborators: United States Department of Defense, Children's Hospital of Philadelphia, University of Pennsylvania, University of North Carolina, Chapel Hill, The Geneva Foundation, Center for Neuroscience and Regenerative Medicine (CNRM), Axon Medical Technologies LLC
Conditions	Brain Concussion
Enrollment	168 participants
Start Date	2024-08-07
Primary Completion	2026-09-30 (estimated)
Study Completion	2026-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-21