Exercise Reset for Concussion in a Military Environment

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.

Conditions

• Brain Concussion

Interventions

BEHAVIORAL

Aerobic Exercise

Participants are asked to complete at least 20 minutes of aerobic exercise every day, excluding clinic visits.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Children's Hospital of Philadelphia

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• The Geneva Foundation

  collaborator OTHER

• Center for Neuroscience and Regenerative Medicine (CNRM)

  collaborator FED

• Axon Medical Technologies LLC

  collaborator INDUSTRY

• State University of New York at Buffalo

  lead OTHER

Principal Investigators

• John Leddy, MD · University at Buffalo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-08-07

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• United States

Study Locations