Aerobic exercise program for concussion recovery in military personnel
Exercise Reset for Concussion- Modifying the Buffalo Concussion Protocol for Application in a Military Environment
This study is testing if a personalized aerobic exercise program can help military personnel recover faster from concussions compared to just following standard recovery guidelines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 2 sites (Fayetteville, North Carolina and 1 other locations) |
| Trial ID | NCT05498038 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of early personalized aerobic exercise in improving recovery from concussions among military service members. It will compare the outcomes of a combined aerobic exercise and the Department of Defense's Progressive Return to Activity protocol against the protocol alone. The study will also assess the utility of a march-in-place test for clinical decision-making and explore the biological mechanisms through which exercise may enhance recovery, including its effects on mental health and autonomic nervous system regulation.
Who should consider this trial
Good fit: Ideal candidates are military service members aged 18-40 who have sustained a concussion within the last 9 days.
Not a fit: Patients with moderate to severe traumatic brain injuries or those unable to participate in exercise due to other medical conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery times and reduce long-term symptoms for service members suffering from concussions.
How similar studies have performed: While the specific combination of aerobic exercise and military concussion protocols is novel, previous studies have shown positive outcomes with exercise interventions in concussion recovery.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fayetteville, North Carolina and 1 other locations
- Fort Liberty — Fayetteville, North Carolina, United States (Recruiting)
- Camp LeJeune — Jacksonville, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: John Leddy, MD — University at Buffalo
- Study coordinator: John J Leddy, MD
- Email: leddy@buffalo.edu
- Phone: 7162043200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.