[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627107":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":31,"locations":25,"responsibleParty":37,"collaborators":41,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":25,"eligibilityCriteria":50,"healthyVolunteers":47,"sex":51,"minAge":25,"maxAge":25,"enrollmentInfo":52,"targetDuration":25,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":25},{"fullName":5,"class":6},"Columbia University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Home Aerobic Training on Omaveloxolone","EXPERIMENTAL","Participants will be given a recumbent exercise bike (Marcy ME-709 Adjustable Recumbent Exercise Bike, Pomona, CA) for home use. They will be instructed to exercise five times a week. The regimen will include 5-minute warm up, 30 minutes of exercise at target heart rate, and 5 minutes of cool down.",[13,14],"Behavioral: Aerobic Exercise","Drug: Omeveloxolone",{"label":16,"type":17,"description":11,"interventionNames":18},"Home Aerobic Training off Omaveloxolone","ACTIVE_COMPARATOR",[13],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Aerobic Exercise","Both groups will receive aerobic training. The difference will be whether individuals are on or off omaveloxolone.",[16,9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DRUG","Omeveloxolone","Standard of care treatment for Friedreich's Ataxia",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Scott Barbuto, MD PhD","CONTACT","12123054818","sb3779@cumc.columbia.edu",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Scott Barbuto","Assistant Professor at Columbia University Medical Center",[42],{"name":43,"class":44},"Biogen","INDUSTRY","100627107","cardiac-output-and-fatigue-in-friedreichs-ataxia-100627107",false,"NCT07444333","Cardiac Output and Fatigue in Friedreich's Ataxia","Inclusion Criteria:\n\n1. Genetically confirmed FRDA\n2. Ability to safely ride a stationary bicycle (mFARS sitting posture sub-score \\\u003C2)\n\nExclusion Criteria:\n\n1. Beck depression score \\>19, a score that precludes ability to exercise.30,31\n2. Montreal Cognitive Assessment (MoCA) score \\\u003C23\u002F30.32\n3. Disorders that interfere with ability to perform endurance exercise (e.g., stroke, respiratory problems, traumatic brain injury, or neuromuscular disease).\n4. Regular participation in vigorous endurance exercise (defined as \\>2 days\u002Fweek for at least the past 4 months at max HR\\>65%).\n5. Evidence of serious arrhythmias or ischemic heart disease.","ALL",{"count":53,"type":54},30,"ESTIMATED","INTERVENTIONAL",[57],"NA","AIM 1: Acceptability and Feasibility of Home Aerobic Exercise. Individuals with other types of ataxia have been able to train at the above levels safely. We hypothesize that there will be no serious adverse events related to aerobic training, and there will be an acceptable number of minor adverse events. We further hypothesize that drop-out from the trial will be less than 25%.\n\nAIM 2: Impact of Omaveloxolone on VO2max. Omaveloxolone works by activating and preventing the degradation of Nuclear factor-like 2 (Nrf2), which helps prevent oxidative damage within the mitochondria of individuals with FRDA. Improved mitochondrial function should significantly enhance VO2max by increasing ATP production and improving the rate of oxygen consumption. Thus, we hypothesize that individuals on omaveloxolone will have a significantly larger increase in VO2max after the aerobic training when compared to individuals who are not on omaveloxolone.\n\nAIM 3: Impact of Aerobic Training + Omaveloxolone on Fatigue. Omaveloxolone has been shown to cause a transient (12-week) increase in fatigue. Aerobic training, on the other hand, is known to improve fatigue in individuals with other hereditary ataxias. For this aim, the primary outcome measure will be the Fatigue Severity Scale (FSS) with secondary measures of Fatigue Impact Scale (FIS) and 6-minute walk test (6MWT). We hypothesize improved fatigue with the incorporation of aerobic training and that individuals in the omaveloxolone group will have less fatigue than those not on omaveloxolone.",[60],"Friedreich's Ataxia",[62,63,64,65,66],"Friedreich's ataxia","Aerobic exercise","Omaveloxolone","Fatigue","Cardiac Output","NOT_YET_RECRUITING","2026-02-26",{"date":70,"type":71},"2026-03-02","ACTUAL",{"date":73,"type":54},"2026-04-01",{"date":75,"type":54},"2028-04-01",{"name":39,"class":6}]