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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met