[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501443":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":63,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":23,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":23,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":45,"whyStopped":23,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Baylor College of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Exercise Intervention Group","EXPERIMENTAL","Group of up to 50 patients will randomly allocated into an experimental group at a 4:1 ratio intervention to controls. The experimental group will receive all of the preliminary outcome measure testing (cardiovascular, musculoskeletal, and psychological screening) in addition to exercise intervention education, demonstration, and follow up to ensure compliance and safety.",[13],"Other: Exercise Intervention Group",{"label":15,"type":6,"description":16,"interventionNames":17},"Control Group","Control group will be randomly allocated at a 4:1 ratio, intervention to controls.. The control group will receive all of the preliminary outcome measure testing (cardiovascular, musculoskeletal, and psychological screening) and will be instructed to continue with baseline physical activities. They will be asked to return for a reassessment of all baseline procedures (cardiovascular, musculoskeletal, and psychological screening).",[18],"Other: Control Group",[20,24],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"Patients will be educated on methods of self-evaluating exertion and cardiovascular effort by assessing respiratory rate and perceived exertion. Next, patients will be given options for cardiovascular activities and complete at a moderate level of activity for a minimum of 150 minutes per week. Patients will perform a combination of exercises under the supervision of a physical therapist until a mod intensity level is reached and sustained. Patients will be taught to use the activity tracker to record their heart rate, activity, and PES. Patients will have a phone call every week to assess status, answer questions, and provide guidance on progressing intensity or duration of exercise. At the end of 12 weeks all patients will return for re-assessment.",[9],null,{"type":6,"name":15,"description":25,"armGroupLabels":26,"otherNames":27},"Patients in the control group will be instructed to continue with baseline physical activities over the duration of the study and be given instructions on the use of the activity tracker. At the end of 12 weeks all patients will return for re-assessment.",[15],[28],"No Intervention",[30],{"name":31,"affiliation":5,"role":32},"Shaine A Morris, MD, MPH","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":23,"email":37},"CONTACT","832-826-5692","shainem@bcm.edu",{"name":39,"role":35,"phone":40,"phoneExt":23,"email":41},"Jennifer Bogardus, PT, MPT, PhD","713-794-2070","jennifer.bogardus@utah.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Texas Children's Hospital","RECRUITING","Houston","Texas","77030","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-95.36327,29.76328,{"lat":55,"lon":54},[58,61],{"name":59,"role":35,"phone":60,"phoneExt":23,"email":37},"Shaine A Morris, MD MPH","832-826-5682",{"name":39,"role":35,"phone":40,"phoneExt":23,"email":62},"jbogardus@twu.edu",{"type":32,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Shaine Morris","Associate Professor, Pediatrics-Cardiology",[67],{"name":68,"class":69},"Southern Star Research","INDUSTRY","100501443","marfan-syndrome-moderate-exercise-trial-ii-100501443",false,"NCT05809323","Marfan Syndrome Moderate Exercise Trial II","Clinical Trial On The Effects Of Moderate Physical Activity On Health And Well-Being In Adolescents And Young Adults With Marfan Syndrome","Inclusion Criteria:\n\n* Male and female patients diagnosed with Marfan syndrome (defined by Ghent criteria and either a pathogenic variant in FBN1 or ectopia lentis)\n* Age 10-25 years at enrollment\n\nExclusion Criteria:\n\n1. History of aortic surgery\n2. History of spinal surgery with implanted materials that may negatively impact MRI safety or imaging quality.\n3. Diagnosis of major congenital heart disease (ASD, VSD, bicuspid aortic valve, and mitral valve prolapse will not qualify as exclusion criteria)\n4. Condition limiting the ability to perform moderate exercise.\n5. Major concurrent diagnosis that may confound the interpretation of the effect of the proposed intervention on the proposed outcome measures.\n6. Aortic dilation meeting threshold for prophylactic aortic surgical intervention (\\>\u002F= 4.5 cm in diameter)","ALL","10 Years","25 Years",{"count":81,"type":82},50,"ESTIMATED","INTERVENTIONAL",[85],"NA","Marfan syndrome (MFS) is a distinctive connective tissue disorder that affects multiple organ systems including the heart, bones, ligaments, and eyes, and is associated with significant risk of aortic dissection. Given limited evidence from in-vitro studies, and theoretical concerns, the majority of patients with MFS are restricted from certain physical activities. The lack of exercise and deconditioning have detrimental effects including increasing weakness, joint pain, decreased endurance, and depressive symptoms. Given the significant paucity of data currently existing on the effects of exercise in humans with MFS, and the recent, optimistic findings in rodent models, this pilot trial was established to assess the effects of moderated dynamic exercise in adolescents and young adults with MFS.",[88],"Marfan Syndrome",[90,91,92],"Cardiovascular","Moderate Exercise","Physical Therapy","2024-01-23",{"date":95,"type":96},"2024-01-24","ACTUAL",{"date":98,"type":96},"2023-09-01",{"date":100,"type":82},"2027-07-01",{"name":5,"class":6},1]