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Aerobic Exercise for Concussion

N/A
Recruiting
Led By John Leddy, MD
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-40 years
Be between 18 and 65 years old
Must not have
Moderate or severe TBI as indicated by a GCS score <13, lesion on CT/MRI, and/or focal neurologic sign consistent with intracerebral lesion
Inability to exercise because of lower-extremity orthopedic injury, clinically significant vestibular or visual dysfunction, or increased cardiac risk
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Summary

This trial aims to prove that starting personalized aerobic exercise early can help improve recovery from concussions, speed up return to duty, and reduce ongoing symptoms in military personnel. Additionally, the trial will look into

Who is the study for?
This trial is for military personnel aged 18-40 who have been diagnosed with a concussion within the past 9 days. Participants must be diagnosed by a clinician using international standards.
What is being tested?
The study tests whether personalized aerobic exercise can help improve recovery from concussion, speed up return to duty (RTD), and reduce long-term symptoms in combat service members.
What are the potential side effects?
While not explicitly stated, potential side effects of aerobic exercise may include muscle soreness, fatigue, dizziness or exacerbation of existing symptoms temporarily during the recovery period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a serious brain injury confirmed by a scan or specific symptoms.
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I cannot exercise due to a leg injury, balance or vision problems, or heart risk.
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I am taking medication for ADHD or mood stabilization.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Days until Recovery
Persistent Post Concussive Symptoms (PPCS) (Yes/No)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Concussed Service Members PRA+ExerciseExperimental Treatment1 Intervention
CSM allocated to this group will complete PRA protocols/ will receive treatment as usual and will receive an exercise program in addition to PRA.
Group II: Healthy Control Service MembersActive Control1 Intervention
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. They will not be given intervention.
Group III: Concussed Service Members PRAActive Control1 Intervention
CSM allocated to this group will complete PRA protocols/ will receive treatment as usual.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Exercise
2013
Completed Early Phase 1
~1350

Find a Location

Who is running the clinical trial?

Axon Medical Technologies LLCIndustry Sponsor
The Geneva FoundationOTHER
35 Previous Clinical Trials
12,893 Total Patients Enrolled
State University of New York at BuffaloLead Sponsor
264 Previous Clinical Trials
51,932 Total Patients Enrolled
~112 spots leftby Mar 2026