NCT05498038 Exercise Reset for Concussion in a Military Environment
| NCT ID | NCT05498038 |
| Status | Recruiting |
| Phase | — |
| Sponsor | State University of New York at Buffalo |
| Condition | Brain Concussion |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2024-08-07 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 168 participants in total. It began in 2024-08-07 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria (Participants): For the CSM Group: * 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 For the HC Group: * Active-duty service member * Ages 18-40 Exclusion Criteria (Participants): For the CSM group: * 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 * Active substance abuse/dependence * Unwillingness to perform intervention * Limited English proficiency * Confirmed pregnancy For the HC group: * Has lingering symptoms from a previous concussion or has recovered from a concussion less than 1-month ago * On a limited profile or "chit" for light duty * Active substance abuse/dependence * Unwilling to perform intervention * Limited English proficiency * Confirmed pregnancy Inclusion Criteria (Providers): * Active duty * Currently active clinician (MD, DO, PT, ATC, OT) involved in concussion management beyond initial emergent diagnosis * Willing to participate * Able to be contacted by telephone or Zoom Exclusion Criteria (Providers): * Not active duty * Not currently an active clinician (MD, DO, PT, ATC, OT) involved in concussion management * Only involved in concussion management at emergent timepoint * Unwilling to participate * Unable to be contacted by telephone or Zoom
Contact & Investigator
John Leddy, MD
PRINCIPAL INVESTIGATOR
University at Buffalo
Frequently Asked Questions
Who can join the NCT05498038 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Brain Concussion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05498038 currently recruiting?
Yes, NCT05498038 is actively recruiting participants. Contact the research team at leddy@buffalo.edu for enrollment information.
Where is the NCT05498038 trial being conducted?
This trial is being conducted at Fayetteville, United States, Jacksonville, United States.
Who is sponsoring the NCT05498038 clinical trial?
NCT05498038 is sponsored by State University of New York at Buffalo. The principal investigator is John Leddy, MD at University at Buffalo. The trial plans to enroll 168 participants.