[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477520":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":33,"locations":43,"responsibleParty":73,"collaborators":75,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":12,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":12,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":46,"whyStopped":12,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"State University of New York at Buffalo","OTHER",[8,13,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Control Service Members","NO_INTERVENTION","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\u002Fday 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.",null,{"label":14,"type":10,"description":15,"interventionNames":12},"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.",{"label":17,"type":18,"description":19,"interventionNames":20},"Concussed Service Members PRA+Exercise","EXPERIMENTAL","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.",[21],"Behavioral: Aerobic Exercise",[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":12},"BEHAVIORAL","Aerobic Exercise","Participants are asked to complete at least 20 minutes of aerobic exercise every day, excluding clinic visits.",[17],[29],{"name":30,"affiliation":31,"role":32},"John Leddy, MD","University at Buffalo","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":12,"email":38},"John J Leddy, MD","CONTACT","7162043200","leddy@buffalo.edu",{"name":40,"role":36,"phone":37,"phoneExt":41,"email":42},"Haley Chizuk, PhD, ATC","2043","haleychi@buffalo.edu",[44,61],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Fort Liberty","RECRUITING","Fayetteville","North Carolina","28310","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-78.87836,35.05266,{"lat":56,"lon":55},[59],{"name":60,"role":36,"phone":12,"phoneExt":12,"email":12},"Kaleigh Presgraves",{"facility":62,"status":46,"city":63,"state":48,"zip":64,"country":50,"countryCode":51,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Camp LeJeune","Jacksonville","28547",{"type":53,"coordinates":66},[67,68],-77.43024,34.75405,{"lat":68,"lon":67},[71],{"name":72,"role":36,"phone":12,"phoneExt":12,"email":12},"Robert Carlson, MPT",{"type":32,"investigatorFullName":74,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"John J. Leddy MD",[76,79,81,83,85,87,89],{"name":77,"class":78},"United States Department of Defense","FED",{"name":80,"class":6},"Children's Hospital of Philadelphia",{"name":82,"class":6},"University of Pennsylvania",{"name":84,"class":6},"University of North Carolina, Chapel Hill",{"name":86,"class":6},"The Geneva Foundation",{"name":88,"class":78},"Center for Neuroscience and Regenerative Medicine (CNRM)",{"name":90,"class":91},"Axon Medical Technologies LLC","INDUSTRY","100477520","exercise-reset-for-concussion-in-a-military-environment-100477520",false,"NCT05498038","Exercise Reset for Concussion in a Military Environment","Exercise Reset for Concussion- Modifying the Buffalo Concussion Protocol for Application in a Military Environment","Inclusion Criteria (Participants):\n\nFor the CSM Group:\n\n* Active-duty service member\n* Aged 18-40 years\n* Injury occurred within 9 days of injury\n* Diagnosed with concussion by an experienced clinician using standard international criteria\n\nFor the HC Group:\n\n* Active-duty service member\n* Ages 18-40\n\nExclusion Criteria (Participants):\n\nFor the CSM group:\n\n* Moderate or severe TBI as indicated by a GCS score \\\u003C13, lesion on CT\u002FMRI, and\u002For focal neurologic sign consistent with intracerebral lesion\n* Injury involving loss of consciousness for \\>30 minutes or post-traumatic amnesia \\>24 hours\n* Inability to exercise because of lower-extremity orthopedic injury, clinically significant vestibular or visual dysfunction, or increased cardiac risk\n* Pre-existing conditions that prevent participation in active testing and\u002For rehabilitation\n* Active substance abuse\u002Fdependence\n* Unwillingness to perform intervention\n* Limited English proficiency\n* Confirmed pregnancy\n\nFor the HC group:\n\n* Has lingering symptoms from a previous concussion or has recovered from a concussion less than 1-month ago\n* On a limited profile or \"chit\" for light duty\n* Active substance abuse\u002Fdependence\n* Unwilling to perform intervention\n* Limited English proficiency\n* Confirmed pregnancy\n\nInclusion Criteria (Providers):\n\n* Active duty\n* Currently active clinician (MD, DO, PT, ATC, OT) involved in concussion management beyond initial emergent diagnosis\n* Willing to participate\n* Able to be contacted by telephone or Zoom\n\nExclusion Criteria (Providers):\n\n* Not active duty\n* Not currently an active clinician (MD, DO, PT, ATC, OT) involved in concussion management\n* Only involved in concussion management at emergent timepoint\n* Unwilling to participate\n* Unable to be contacted by telephone or Zoom",true,"ALL","18 Years","40 Years",{"count":104,"type":105},168,"ESTIMATED","INTERVENTIONAL",[108],"NA","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.",[111],"Brain Concussion",[113,114,115,116,117],"concussion","military","aerobic exercise","recovery","return to duty","2026-01-16",{"date":120,"type":121},"2026-01-21","ACTUAL",{"date":123,"type":121},"2024-08-07",{"date":125,"type":105},"2026-09-30",{"name":5,"class":6},2]