NCT05498038 · State University of New York at Buffalo
Exercise Reset for Concussion in a Military Environment
What this study 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Aerobic Exercise
Participants are asked to complete at least 20 minutes of aerobic exercise every day, excluding clinic visits.
Primary outcome measures
Persistent Post Concussive Symptoms (PPCS) (Yes/No)
Time frame: 28 days
PPCS is defined as recovery more than 28 days from the day of concussive injury (yes) or before 28 days (no). Recovery is defined as return to baseline symptoms, exercise tolerant and confirmation by independent medical examination.
Days until Recovery
Time frame: 3 months
Determination of clinical recovery will be made by a clinician. Each week we will use a multi-modal assessment to establish clinical recovery, which is defined as return to a pre-injury level of symptoms, a normal physical examination and exercise tolerant on the graded exercise assessment.
Neurobehaviorial Symptom Inventory-22 (NSI)
Time frame: 4 years
To assess ongoing concussion symptoms, one of the main outcomes of the study. The NSI is a 5-minute measure validated in military populations to characterize concussion symptoms, endorsed by VA/DoD as a core TBI outcome measure. We will also use the symptom scale of the NSI to ask CSM about symptoms that existed before the concussion.
Average weekly Physical Activity time
Time frame: 4 years
Average of activity time per day over one week (hours:minutes) - Physical activity is measured using Polar Coach to control for this potential mediator of concussion recovery. Activity time in duration per day (hours:minutes) is tracked and then manually averaged and recorded via a standardized Excel spreadsheet.
Buffalo Concussion March-in-place Test (BCMT)
Time frame: 4 years
Average total steps per day over one week- Physical activity is measured using Polar Coach to control for this potential mediator of concussion recovery. Total steps per day are tracked and then manually averaged and recorded via a standardized Excel spreadsheet.
Daily Symptom Score Severity
Time frame: 4 years
Daily Symptom Score Severity will be measured using Ecological Momentary Assessment (EMA) (RECOUPS) - Measure daily symptoms to control for this potential mediator of concussion recovery. Participants report their symptom score once daily in response to text messages sent to their smartphone.
Average Nightly Sleep Quality
Time frame: 4 years
Measure sleep quality using Polar Coach to control for this potential mediator of concussion recovery. Duration of sleep time, sleep start time, sleep end time, and sleep restlessness score of each sleep session are tracked. Average sleep time per night, average sleep continuity, and average sleep continuity percentages are recorded via a standardized Excel spreadsheet and summated to generate a sleep quality score which will be analzyed.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
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
- Fayetteville, North Carolina
- Jacksonville, North Carolina
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
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 21, 2026 · Source of record for eligibility and locations