[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585929":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":51,"collaborators":24,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":24,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"IRCCS San Raffaele Roma","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"supervised exercise in cardiac rehabilitation","EXPERIMENTAL","group 1: patients will perform supervised exercise training in the gym of San Raffaele IRCCS of Rome",[13],"Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION",{"label":15,"type":16,"description":17,"interventionNames":18},"home-based exercise","ACTIVE_COMPARATOR","group 1: patients will be asked to perform not supervised exercise training at home according to european guidelines for people with cardiovascular diseases",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"EXERCISE TRAINING WITH OR WITHOUT MEDICATION","In the first phase of the study all enrolled patients will perform exercise in the context of an in-hospital intesive rehabilitation after the acute event. At discharge they will be randomized in two groups: supervised exercise in the context of a cardiac rehabilitation facility or home-based exercise",[15,9],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Lucia Gatta","CONTACT","+390652253440","lucia.gatta@sanraffaele.it",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"IRCCs San Raffaele","RECRUITING","Rome","RM","00166","Italy","IT",{"type":41,"coordinates":42},"Point",[43,44],12.51133,41.89193,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":49,"phoneExt":24,"email":50},"Prof. Giuseppe Caminiti, MD","0652253440","giuseppe.caminitii@sanraffaele.it",{"type":52,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100585929","risk-of-falling-and-cardiac-rehabilitation-100585929",false,"NCT06908759","Risk of Falling and Cardiac Rehabilitation","Risk of Falling Assessment in a Population of Patients With Cardiovascular Diseases Undergoing Cardiac Rehabilitation","CARDIO-BALANCE","Inclusion Criteria:\n\n\\- Age \\> 65 years\n\nRecent acute cardiac event, including:\n\n1. Cardiac surgery (CABG, aortic and\u002For mitral valve replacement, mitral valvuloplasty, or combined CABG + valve surgery)\n2. Recent myocardial infarction treated with percutaneous revascularization\n3. Episode of acute heart failure\n\nExclusion Criteria:\n\nPersistent clinical instability, defined as:\n\n* Marked hypotension (BP ≤ 95\u002F60 mmHg) or hypertension (BP ≥ 160\u002F100 mmHg)\n* Bradycardia (HR \\\u003C 50 bpm) or tachycardia (HR \\> 115 bpm)\n* Resting dyspnea\n* Signs and symptoms of infection","ALL","65 Years",{"count":64,"type":65},150,"ESTIMATED","INTERVENTIONAL",[68],"NA","Background and Rationale Cardiac rehabilitation (CR) is a key intervention for patients with chronic heart disease or recent acute cardiovascular events. In elderly and frail patients, CR aims not only to improve functional capacity but also to maintain or recover independence in daily activities. Hospitalization following an acute event often leads to bed rest, which-even after just 2-3 days-can cause hypokinetic syndrome, characterized by loss of muscle tone, orthostatic hypotension, decreased mobility, and psychological decline, including depression. Moreover, immobility increases thrombotic risk and vascular complications.\n\nTo mitigate these effects, CR is initiated promptly after clinical stabilization and includes three phases:\n\n1. Phase I - In-hospital rehabilitation\n2. Phase II - Early outpatient rehabilitation\n3. Phase III - Long-term maintenance Elderly patients are particularly vulnerable to falls due to the combined effects of reduced muscle strength, orthostatic hypotension, cognitive decline, and pre-existing sarcopenia-often exacerbated by acute events and immobility. Approximately 60% of cardiac patients hospitalized for acute events present with moderate-to-high fall risk. Fall risk in this population is multifactorial, involving cardiovascular issues (e.g., arrhythmias, orthostatic hypotension), medication effects, and non-cardiac factors such as vision loss, balance impairment, neuromuscular conditions, and cognitive deficits.",[71,72,73],"Risk of Falling","Elderly (People Aged 65 or More)","Cardiovascular Diseases",[75,76],"risk of fall","cardiac rehabilitation","2025-04-02",{"date":79,"type":80},"2025-04-03","ACTUAL",{"date":82,"type":80},"2024-05-31",{"date":84,"type":65},"2025-06-30",{"name":5,"class":6},1]