Actively Recruiting
Exercise Reset for Concussion in a Military Environment
Led by State University of New York at Buffalo · Updated on 2026-01-21
168
Participants Needed
2
Research Sites
112 weeks
Total Duration
On this page
Sponsors
S
State University of New York at Buffalo
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exercise Reset for Concussion in a Military Environment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Active-duty service member
- Aged 18 to 40 years
- Injury occurred within 9 days of concussion
- Diagnosed with concussion by an experienced clinician using standard international criteria
- For healthy controls: active-duty service member aged 18 to 40 years
- For providers: active duty clinician involved in concussion management beyond initial diagnosis, willing to participate, contactable by phone or Zoom
You will not qualify if you...
- Moderate or severe traumatic brain injury indicated by Glasgow Coma Scale score below 13, brain lesion on imaging, or focal neurologic signs
- Loss of consciousness over 30 minutes or post-traumatic amnesia over 24 hours
- Unable to exercise due to lower-extremity injury, significant vestibular or visual dysfunction, or increased cardiac risk
- Pre-existing conditions preventing active testing or rehabilitation
- Active substance abuse or dependence
- Unwillingness to perform the intervention
- Limited English proficiency
- Confirmed pregnancy
- For healthy controls: lingering concussion symptoms or concussion recovery less than 1 month ago
- Healthy controls on limited duty or "chit" for light duty
- Providers not active duty or not involved in concussion management beyond emergent diagnosis
- Providers unwilling to participate or unreachable by phone or Zoom
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Fort Liberty
Fayetteville, North Carolina, United States, 28310
Actively Recruiting
2
Camp LeJeune
Jacksonville, North Carolina, United States, 28547
Actively Recruiting
Research Team
J
John J Leddy, MD
CONTACT
H
Haley Chizuk, PhD, ATC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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