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Exercise Reset for Concussion- Modifying the Buffalo Concussion Protocol for Application in a Military Environment

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

⁃ 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

• 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

Locations
United States
North Carolina
Fort Liberty
RECRUITING
Fayetteville
Camp LeJeune
RECRUITING
Jacksonville
Contact Information
Primary
John J Leddy, MD
leddy@buffalo.edu
7162043200
Backup
Haley Chizuk, PhD, ATC
haleychi@buffalo.edu
7162043200
Time Frame
Start Date: 2024-08-07
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 168
Treatments
No_intervention: Healthy Control Service Members
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. All HC participants will be provided with an activity monitor (with GPS tracking disabled) to wear 24 hours/day for measurement of daily physical activity and sleep duration over the time between first and final test sessions. The activity monitor also acts as an HR monitor to record the participants' HR during their prescribed exercise bouts. HC will be asked to exercise each day at approximately 70% of their age-predicted maximum heart rate (from the formula 220 minus age x 0.7 = target HR) for 20 minutes to control for the effect of exercise on the physiological tests.
No_intervention: Concussed Service Members PRA
CSM randomized to PRA alone will receive written instructions on how to follow the PRA protocol. All participants will be provided with an activity monitor (with GPS tracking disabled), and we will record daily physical activity and sleep patterns.
Experimental: Concussed Service Members PRA+Exercise
CSM randomized to aerobic exercise+PRA will receive their individualized aerobic exercise prescription plus written instructions on how to follow the PRA protocol. CSM will start the exercise program the day after the first visit. All participants will be reminded each day by text message to complete their assigned activity (in the case of exercise + PRA participants, to perform their exercise at the prescribed dose \[HR\]) and to report any adverse effects). All participants will also report symptoms once daily in response to a text message to their phone. All participants will wear an activity monitor continuously until clinical recovery or for 4 weeks to measure daily activity and sleep. The activity monitor will also act as an HR monitor and will be worn by participants in the PRA+aerobic exercise group during daily exercise sessions to measure participant adherence to the prescribed exercise dose.
Related Therapeutic Areas
Sponsors
Collaborators: University of North Carolina, Chapel Hill, Axon Medical Technologies LLC, United States Department of Defense, Children's Hospital of Philadelphia, Center for Neuroscience and Regenerative Medicine (CNRM), The Geneva Foundation, University of Pennsylvania
Leads: State University of New York at Buffalo

This content was sourced from clinicaltrials.gov