Exercise Reset for Concussion in a Military Environment

Part of paid clinical trials in Fayetteville, North Carolina.

Sponsor
State University of New York at Buffalo
Study ID
NCT05498038
Status
Recruiting
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Conditions

  • Brain Concussion

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Aerobic Exercise — BEHAVIORAL
    Participants are asked to complete at least 20 minutes of aerobic exercise every day, excluding clinic visits.

Study Details

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.

Key Dates

Start date
Aug 7, 2024
Status verified
Jan 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Persistent Post Concussive Symptoms (PPCS) (Yes/No) [ Time Frame: 28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Fort LibertyFayettevilleNorth Carolina28310
Kaleigh Presgraves
Camp LeJeuneJacksonvilleNorth Carolina28547
Robert Carlson, MPT

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By research site
Fort Liberty· Fayetteville, NCCamp LeJeune· Jacksonville, NC

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