[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472611":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":36,"responsibleParty":83,"collaborators":85,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":18,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":115,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High Dose Exercise","EXPERIMENTAL","The investigators will provide exercise dose recommendations for initial visit until symptom resolution, and revise upon symptom resolution (to use for the subsequent 8 weeks). These include intensity (target HR) and volume (frequency\u002Fduration). Intensity is calculated as 90% of the HR at the end of the exercise test. The volume recommendation is 150 mins\u002Fweek (\\~30 min\u002Fday; 5 days\u002Fweek). The mode of exercise is another consideration. This will be left to participant preference, so that the investigators do not exclude potential participants due to lack of access to specific exercise equipment.",[13],"Behavioral: High Dose Exercise",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard-of-care","NO_INTERVENTION","Participants are instructed to perform activity in line with physician recommendations. This consists of a general recommendation (no specific HR\u002Fvolume) or symptom limited physical activity.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","The investigators will initially test and randomize adolescents ages 13-18 years old ≤14 days post-concussion to high dose aerobic exercise (\\>150 min\u002Fweek, individualized intensity level) or standard-of-care (symptom limited, self-guided physical activity), and re-test upon symptom resolution and 8-weeks post symptom resolution",[9],[25],{"name":26,"affiliation":27,"role":28},"David R Howell, PhD","University of Colorado Denver | Anschutz","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","7207771502","ConcussionResearch@cuanschutz.edu",{"name":35,"role":31,"phone":32,"phoneExt":18,"email":33},"Kelsie Richardson, MS",[37,54,69],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University of Colorado Denver","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-104.83192,39.72943,{"lat":49,"lon":48},[52,53],{"name":26,"role":31,"phone":32,"phoneExt":18,"email":33},{"name":35,"role":31,"phone":32,"phoneExt":18,"email":33},{"facility":55,"status":39,"city":56,"state":57,"zip":58,"country":43,"countryCode":44,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":46,"coordinates":60},[61,62],-71.05977,42.35843,{"lat":62,"lon":61},[65,67],{"name":66,"role":31,"phone":18,"phoneExt":18,"email":18},"Danielle Hunt, MS",{"name":68,"role":28,"phone":18,"phoneExt":18,"email":18},"William P Meehan III, MD",{"facility":70,"status":39,"city":71,"state":57,"zip":72,"country":43,"countryCode":44,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Spaulding Rehabilitation Hospital","Cambridge","02138",{"type":46,"coordinates":74},[75,76],-71.10561,42.3751,{"lat":76,"lon":75},[79,81],{"name":80,"role":31,"phone":18,"phoneExt":18,"email":18},"Andrew Taylor, PhD",{"name":82,"role":28,"phone":18,"phoneExt":18,"email":18},"J Andrew Taylor, PhD",{"type":84,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[86,87,88],{"name":55,"class":6},{"name":70,"class":6},{"name":89,"class":90},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100472611","phase-2-modulating-exercise-dosage-to-improve-concussion-recovery-100472611",false,"NCT05434130","Modulating Exercise Dosage to Improve Concussion Recovery","Modulating Exercise Dosage to Improve Concussion Recovery: A Randomized Clinical Trial","MEDIC","Inclusion Criteria:\n\n* 13-18 years of age\n* Post-Concussion Symptom Scale (PCSS) score \\>10 to ensure participants are not recovered by enrollment\n* Concussion diagnosis by a sports medicine physician\n\nExclusion Criteria:\n\n* Pre-existing neurological disorders\n* Exercise contraindications\n* Concussion \\\u003C6 months before enrollment (excluding the current injury)","ALL","13 Years","18 Years",{"count":103,"type":104},216,"ESTIMATED","INTERVENTIONAL",[107],"PHASE2","Aerobic exercise has emerged as an effective treatment to reduce sport-related concussion symptom severity, yet existing work lacks rigor regarding the precise exercise volume and intensity required to elicit therapeutic effects, how exercise can alter concussion-related pathophysiology, and whether exercise can prevent the development of secondary sequelae. Our objective is to examine if a high dose exercise program (higher volume than currently prescribed at an individualized, safe intensity level) initiated within 14 days of concussion results in faster symptom resolution, altered physiological function, or reduced secondary sequalae. Findings from this research will lead to more rigorous and precise rehabilitation guidelines and improved understanding about how exercise affects neurophysiological function among adolescents with concussion.",[110,111,112,113,114],"Concussion, Brain","Treatment","Aerobic Exercise","Inflammation","Depression, Anxiety",[116,117],"intervention","mild traumatic brain injury","2026-05-04",{"date":120,"type":121},"2026-05-06","ACTUAL",{"date":123,"type":121},"2022-08-05",{"date":125,"type":104},"2027-02-01",{"name":5,"class":6},3]