[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100423260":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":51,"centralContacts":55,"locations":60,"responsibleParty":76,"collaborators":78,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":10,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":10,"enrollmentInfo":90,"targetDuration":10,"studyType":93,"phases":10,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":63,"whyStopped":10,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Fondazione Don Carlo Gnocchi Onlus","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with trachestomy",null,"Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation",[13,14,15,16,17,18,19],"Diagnostic Test: handgrip strenght","Diagnostic Test: Bioelectrical Impedance Analysis (BIA)","Diagnostic Test: MUST","Diagnostic Test: GLIM","Biological: Gut microbiota","Biological: Blood Sample","Other: Anthropometric measures",[21,26,30,34,38,43,47],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DIAGNOSTIC_TEST","handgrip strenght","Muscle strenght measured with a handheld dynamometer, at admission (T0) and at decannulation time (T1)",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"Bioelectrical Impedance Analysis (BIA)","Muscle mass evaluated by Bioelectrical Impedance Analysis (BIA), at admission (T0) and at decannulation time (T1)",[9],{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"MUST","Malnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1)",[9],{"type":22,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"GLIM","Malnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1)",[9],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":10},"BIOLOGICAL","Gut microbiota","A fecal sample obtained at admission (T0) and at decannulation time (T1)",[9],{"type":39,"name":44,"description":45,"armGroupLabels":46,"otherNames":10},"Blood Sample","A Blood sample obtained at admission (T0) and at decannulation time (T1)",[9],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":10},"Anthropometric measures","Measurement of weight and height (assessed only at admission) to calculate the Body Mass Index (BMI), at admission (T0) and at decannulation time (T1)",[9],[52],{"name":53,"affiliation":5,"role":54},"Chiara F Gheri, MD","PRINCIPAL_INVESTIGATOR",[56],{"name":53,"role":57,"phone":58,"phoneExt":10,"email":59},"CONTACT","00390557393612","cgheri@dongnocchi.it",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":65,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Fondazione Don Carlo Gnocchi","RECRUITING","Florence","Italy","50143","IT",{"type":69,"coordinates":70},"Point",[71,72],11.24626,43.77925,{"lat":72,"lon":71},[75],{"name":53,"role":57,"phone":58,"phoneExt":10,"email":59},{"type":77,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[79],{"name":80,"class":6},"University of Florence","100423260","sarcopenia-and-nutritional-status-in-a-rehabilitation-setting-100423260",false,"NCT04791540","Sarcopenia and Nutritional Status in a Rehabilitation Setting","Observational Pilot Study in Patients Who Underwent Tracheostomy: Sarcopenia Assessment by Handgrip Strenght and BIA. Association to Malnutrion Risk, Nutritional Status, Gut Microbioma and Decannulation Time.","Inclusion Criteria:\n\n* Signed informed consent from patients or legal guardians for patients unfit to plead\n* Presence of tracheostomy at admission\n\nExclusion Criteria:\n\n* Refusal\n* Pregnancy\n* Pace maker\u002Fimplantable cardioverter\n* No legal guardians for patients unfit to plead","ALL","18 Years",{"count":91,"type":92},30,"ESTIMATED","OBSERVATIONAL","In this pilot observational study the primary outcome is to assess, in a Respiratory Rehabilitation Unit, if there is an association between sarcopenia, assessed by handgrip strenght and BIA, and a delayed decannulation time in patients who underwent tracheostomy.\n\nSecondary outcomes are to assess if there is an association between an increased malnutrition risk (assessed by MUST), a poor nutritional status (assessed by GLIM criteria) and a delayed decannulation time and the gut microbiota composition.",[96],"Sarcopenia",[23,98,99,100,101,102,31],"bioelectrical impedance analysis (BIA)","respiratory rehabilitation","tracheostomy decannulation","gut microbiota","GLIM criteria","2025-08-21",{"date":105,"type":106},"2025-08-28","ACTUAL",{"date":108,"type":106},"2021-06-09",{"date":110,"type":92},"2025-12-31",{"name":5,"class":6},1]