Recruiting

Exercise Reset

Sponsor:

State University of New York at Buffalo

Code:

NCT05498038

Conditions

Brain Concussion

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Aerobic Exercise

Study Details

Brief 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

Study ID

NCT05498038

Start date

Aug 7, 2024

Status verified date

Jan, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria (Participants):

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

Exclusion Criteria (Participants):

For the CSM group:

  • Moderate or severe TBI as indicated by a GCS score <13, lesion on CT/MRI, and/or focal neurologic sign consistent with intracerebral lesion
  • Injury involving loss of consciousness for >30 minutes or post-traumatic amnesia >24 hours
  • Inability to exercise because of lower-extremity orthopedic injury, clinically significant vestibular or visual dysfunction, or increased cardiac risk
  • Pre-existing conditions that prevent participation in active testing and/or rehabilitation
  • Active substance abuse/dependence
  • Unwillingness to perform intervention
  • Limited English proficiency
  • Confirmed pregnancy

For the HC group:

  • Has lingering symptoms from a previous concussion or has recovered from a concussion less than 1-month ago
  • On a limited profile or "chit" for light duty
  • Active substance abuse/dependence
  • Unwilling to perform intervention
  • Limited English proficiency
  • Confirmed pregnancy

Inclusion Criteria (Providers):

  • 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

Exclusion Criteria (Providers):

  • Not active duty
  • Not currently an active clinician (MD, DO, PT, ATC, OT) involved in concussion management
  • Only involved in concussion management at emergent timepoint
  • Unwilling to participate
  • Unable to be contacted by telephone or Zoom

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Aerobic Exercise

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

Primary outcome measure

  • Persistent Post Concussive Symptoms (PPCS) (Yes/No) [ Time Frame: 28 days ]
  • Days until Recovery [ Time Frame: 3 months ]
  • Neurobehaviorial Symptom Inventory-22 (NSI) [ Time Frame: 4 years ]
  • Average weekly Physical Activity time [ Time Frame: 4 years ]
  • Buffalo Concussion March-in-place Test (BCMT) [ Time Frame: 4 years ]
  • Daily Symptom Score Severity [ Time Frame: 4 years ]
  • Average Nightly Sleep Quality [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

John J Leddy, MD

7162043200leddy@buffalo.edu

Haley Chizuk, PhD, ATC

7162043200haleychi@buffalo.edu

Locations

Fort Liberty

Recruiting

Fayetteville, North Carolina, United States, 28310

Camp LeJeune

Recruiting

Jacksonville, North Carolina, United States, 28547

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

  • concussion
  • military
  • aerobic exercise
  • recovery
  • return to duty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-01-21.