Actively Recruiting
Exercise Reset for Concussion- Modifying the Buffalo Concussion Protocol for Application in a Military Environment
Led by State University of New York at Buffalo · Updated on 2026-01-21
168
Participants Needed
2
Research Sites
N/A
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
Researchers are studying how early, personalized aerobic exercise can help military service members recover from concussion more safely and quickly. The study aims to see if adding light aerobic exercise to the current Department of Defense Progressive Return to Activity (DoD PRA) protocol improves recovery, speeds return to duty, and reduces long-term post-concussion symptoms. It also explores how a March-in-place test may aid clinical decisions and investigates the biological effects of exercise on concussion recovery. This is a four-year multicenter randomized controlled trial involving concussed service members and healthy controls. Participants are divided into three groups: healthy control service members who will perform daily aerobic exercise; concussed service members following the standard PRA protocol; and concussed service members who receive both the PRA protocol and a personalized aerobic exercise prescription. The exercise group starts their program the day after the first visit and is reminded daily via text messages to complete their prescribed activity and report symptoms. All participants wear activity monitors to track physical activity, heart rate, and sleep continuously until recovery or for four weeks. Throughout the study, participants will undergo various assessments including symptom tracking, physical activity monitoring, sleep quality measurements, and the Buffalo Concussion March-in-place Test. Researchers will measure outcomes such as persistent post-concussive symptoms, days until recovery, neurobehavioral symptoms, and biological markers related to brain health and autonomic function. The study also evaluates mental health and overall suitability of this exercise approach in a military setting, with data collected over four years to understand long-term effects and recovery patterns.
CONDITIONS
Brief 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
- Diagnosed with concussion within 9 days by an experienced clinician using standard criteria (for concussed group)
- Active-duty service member aged 18 to 40 years (for healthy control group)
You will not qualify if you...
- Moderate or severe traumatic brain injury indicated by Glasgow Coma Scale score less than 13, brain lesion, or neurological signs
- Loss of consciousness over 30 minutes or post-traumatic amnesia over 24 hours
- Inability to exercise due to orthopedic injury, significant vestibular or visual dysfunction, or high 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
- Lingering concussion symptoms or recovery less than 1 month ago (for healthy controls)
- Limited clinician involvement or lack of active duty status (for providers)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks or until clinical recovery
Participants complete at least 20 minutes of aerobic exercise daily, in addition to following the Department of Defense Progressive Return to Activity protocol. Exercise intensity is monitored with an activity and heart rate monitor. Participants report symptoms daily via text message and receive daily reminders to complete their assigned activity.
Multiple visits for assessments during the treatment period
Duration - Up to 3 months post-injury
Participants are monitored for recovery and persistent post-concussive symptoms up to 3 months post-injury, including assessments of physical activity, sleep quality, mental health, and biomarker levels.
Periodic visits for outcome assessments
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
H
Haley Chizuk, PhD, ATC
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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