Exercise Reset for Concussion in a Military Environment
ConditionBrain Concussion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorState University of New York at Buffalo
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Aerobic Exercise
BehavioralParticipants are asked to complete at least 20 minutes of aerobic exercise every day, excluding clinic visits.
Treatment groups
168 Participants
are divided into 3 treatment groupsGroup A: Healthy Control Service MembersNo intervention 0 interventions
Group B: Concussed Service Members PRANo intervention 0 interventions
Group C: Concussed Service Members PRA+ExerciseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Persistent Post Concussive Symptoms (PPCS) (Yes/No)
PPCS is defined as recovery more than 28 days from the day of concussive injury (yes) or before 28 days (no). Recovery is defined as return to baseline symptoms, exercise tolerant and confirmation by independent medical examination.
Time frame
28 days2
Days until Recovery
Determination of clinical recovery will be made by a clinician. Each week we will use a multi-modal assessment to establish clinical recovery, which is defined as return to a pre-injury level of symptoms, a normal physical examination and exercise tolerant on the graded exercise assessment.
Time frame
3 months3
Neurobehaviorial Symptom Inventory-22 (NSI)
To assess ongoing concussion symptoms, one of the main outcomes of the study. The NSI is a 5-minute measure validated in military populations to characterize concussion symptoms, endorsed by VA/DoD as a core TBI outcome measure. We will also use the symptom scale of the NSI to ask CSM about symptoms that existed before the concussion.
Time frame
4 years4
Average weekly Physical Activity time
Average of activity time per day over one week (hours:minutes) - Physical activity is measured using Polar Coach to control for this potential mediator of concussion recovery. Activity time in duration per day (hours:minutes) is tracked and then manually averaged and recorded via a standardized Excel spreadsheet.
Time frame
4 yearsSecondary outcomes
1
Concentration of Salivary BDNF
Concentration of salivary BDNF will be collected and used as a measure to assess enhanced neuroplasticity as a possible mechanism for the effect of aerobic exercise treatment on concussion.
Time frame
4 years2
Salivary miRNA
Concentration of salivary miRNA will be collected and used as a measure to assess enhanced neuroplasticity as a possible mechanism for the effect of aerobic exercise treatment on concussion.
Time frame
4 years3
National Institute of Neurological Disorders Scale (NIHSS)
We will collect brief validated measures of anxiety and depression to assess improved mental health as a potential mechanism for the effect of aerobic exercise treatment on concussion. Low scores indicate no deficit in neurological symptoms; high scores indicate severe deficits in neurological symptoms, and values range from 0 to 42.
Time frame
4 years4
Stroke Patient Reported Outcomes and Measurement Information System (PROMIS) scale
We will collect brief validated measures of anxiety and depression to assess improved mental health as a potential mechanism for the effect of aerobic exercise treatment on concussion. Higher scores compared to the general population via standardized T-Scores indicate impairments, and values range from 20 to 80.
Time frame
4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
State University of New York at Buffalo
Lead sponsor
United States Department of Defense
Collaborator
Children's Hospital of Philadelphia
Collaborator
University of Pennsylvania
Collaborator
University of North Carolina, Chapel Hill
Collaborator
The Geneva Foundation
Collaborator
Center for Neuroscience and Regenerative Medicine (CNRM)
Collaborator
Axon Medical Technologies LLC
Collaborator
Source ClinicalTrials.gov