[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100423260":3},{"organization":4,"outcomesModule":7,"designInfo":82,"detailedDescription":81,"studyPopulation":85,"armGroups":86,"interventions":98,"overallOfficials":129,"centralContacts":133,"locations":138,"responsibleParty":154,"collaborators":156,"id":159,"slug":81,"hasResults":160,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":81,"eligibilityCriteria":164,"healthyVolunteers":160,"sex":165,"minAge":166,"maxAge":81,"enrollmentInfo":167,"targetDuration":81,"studyType":170,"phases":81,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":141,"whyStopped":81,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"Fondazione Don Carlo Gnocchi Onlus","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":81},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change from admission in muscle mass at decannulation time","Measurement of muscle mass with Bioelectrical Impedance Analysis (BIA).","Respiratory Rehabilitation Unit admission (T0) and decannulation time (T1), an average of 10 days",{"measure":14,"description":15,"timeFrame":16},"Change from admission in hangrip strenght at decannulation time","Measurement of handgrip strenght with a handheld dynamometer. Male cut-off: \\\u003C27 Kg Female cut-off: \\\u003C16 Kg","Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days",[18,21,24,27,30,33,36,39,42,45,48,51,54,57,60,63,66,69,72,75,78],{"measure":19,"description":20,"timeFrame":16},"Change from admission in Body Mass Index (BMI) score at decannulation time","Measurement of height and weight to get a BMI score (weight\u002F(height\\^2). BMI \\\u003C18.5 Kg\u002Fm\\^2: underweight BMI 18.5-24.9 Kg\u002Fm\\^2: normal range BMI 25.0-29.9 Kg\u002Fm\\^2: overweight BMI 30.0-34.9 Kg\u002Fm\\^2 obese class I BMI 35.0-39.9 Kg\u002Fm\\^2 obese class II BMI \\>= 40 Kg\u002Fm\\^2 obese class III",{"measure":22,"description":23,"timeFrame":16},"Change from admission in Malnutrition Universal Screening Tool (MUST) score at decannulation time","MUST is a screening tool to identify adults who are malnourished, at risk of malnutrition or obese.\n\nscore 0: low risk score 1: medium risk score 2 or more: high risk",{"measure":25,"description":26,"timeFrame":16},"Change from admission in nutritional status at decannulation time","Global Leadership Initiative on Malnutrition (GLIM) criteria are 5 diagnostic criteria to assess malnutrition that include 3 phenotypic (weight loss, low body mass index and reduced muscle mass) and 2 etiologic (reduced food intake\u002Fassimilation, and inflammation\u002Fdisease burden) criteria.\n\nTo diagnose malnutrition at least 1 phenotypic criterion and 1 etiologic criterion should be present.",{"measure":28,"description":29,"timeFrame":16},"Change from admission in Gut Microbiota (GM) composition at decannulation time","Gut Microbiota (GM) composition",{"measure":31,"description":32,"timeFrame":16},"Protein C reactive (PCR)","Change from admission in Protein C reactive (PCR) at decannulation time",{"measure":34,"description":35,"timeFrame":16},"Lymphocyte count","Change from admission in lymphocyte count at decannulation time",{"measure":37,"description":38,"timeFrame":16},"Creatinine","Change from admission in creatinine at decannulation time",{"measure":40,"description":41,"timeFrame":16},"Creatine Poshokinase","Change from admission in creatine poshokinase at decannulation time",{"measure":43,"description":44,"timeFrame":16},"Total serum protein","Change from admission in total serum protein at decannulation time",{"measure":46,"description":47,"timeFrame":16},"Albumin","Change from admission in albumin at decannulation time",{"measure":49,"description":50,"timeFrame":16},"Vitamin (25OH) D","Change from admission in vitamin (25OH) D at decannulation time",{"measure":52,"description":53,"timeFrame":16},"Selenium","Change from admission in selenium at decannulation time",{"measure":55,"description":56,"timeFrame":16},"Leptin","Change from admission in leptin at decannulation time",{"measure":58,"description":59,"timeFrame":16},"Uric Acid","Change from admission in uric acid at decannulation time",{"measure":61,"description":62,"timeFrame":16},"Magnesium","Change from admission in magnesium at decannulation time",{"measure":64,"description":65,"timeFrame":16},"Growth Hormone (GH)","Change from admission in growth hormone at decannulation time",{"measure":67,"description":68,"timeFrame":16},"Insuline-like Growth Factor-1 (IGF-1)","Change from admission in Insuline-like Growth Factor-1 (IGF-1) at decannulation time",{"measure":70,"description":71,"timeFrame":16},"Dehydroepiandrosterone (DHEA)","Change from admission in dehydroepiandrosterone (DHEA) at decannulation time",{"measure":73,"description":74,"timeFrame":16},"Testosterone","Change from admission in testosterone at decannulation time",{"measure":76,"description":77,"timeFrame":16},"Pro-inflammatory cytokine interleukin IL-6","Change from admission in pro-inflammatory cytokine interleukinIL-6 at decannulation time",{"measure":79,"description":80,"timeFrame":16},"Tumor Necrosis Factor-α (TNF-α)","Change from admission in Tumor Necrosis Factor-α (TNF-α) at decannulation time",null,{"allocation":81,"interventionModel":81,"interventionModelDescription":81,"primaryPurpose":81,"observationalModel":83,"timePerspective":84,"maskingInfo":81},"COHORT","PROSPECTIVE","Patients who underwent tracheostomy before admission, attending a rehabilitation program",[87],{"label":88,"type":81,"description":89,"interventionNames":90},"Patients with trachestomy","Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation",[91,92,93,94,95,96,97],"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",[99,104,108,112,116,121,125],{"type":100,"name":101,"description":102,"armGroupLabels":103,"otherNames":81},"DIAGNOSTIC_TEST","handgrip strenght","Muscle strenght measured with a handheld dynamometer, at admission (T0) and at decannulation time (T1)",[88],{"type":100,"name":105,"description":106,"armGroupLabels":107,"otherNames":81},"Bioelectrical Impedance Analysis (BIA)","Muscle mass evaluated by Bioelectrical Impedance Analysis (BIA), at admission (T0) and at decannulation time (T1)",[88],{"type":100,"name":109,"description":110,"armGroupLabels":111,"otherNames":81},"MUST","Malnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1)",[88],{"type":100,"name":113,"description":114,"armGroupLabels":115,"otherNames":81},"GLIM","Malnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1)",[88],{"type":117,"name":118,"description":119,"armGroupLabels":120,"otherNames":81},"BIOLOGICAL","Gut microbiota","A fecal sample obtained at admission (T0) and at decannulation time (T1)",[88],{"type":117,"name":122,"description":123,"armGroupLabels":124,"otherNames":81},"Blood Sample","A Blood sample obtained at admission (T0) and at decannulation time (T1)",[88],{"type":6,"name":126,"description":127,"armGroupLabels":128,"otherNames":81},"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)",[88],[130],{"name":131,"affiliation":5,"role":132},"Chiara F Gheri, MD","PRINCIPAL_INVESTIGATOR",[134],{"name":131,"role":135,"phone":136,"phoneExt":81,"email":137},"CONTACT","00390557393612","cgheri@dongnocchi.it",[139],{"facility":140,"status":141,"city":142,"state":143,"zip":144,"country":143,"countryCode":145,"cosmosGeoPoint":146,"geoPoint":151,"contacts":152},"Fondazione Don Carlo Gnocchi","RECRUITING","Florence","Italy","50143","IT",{"type":147,"coordinates":148},"Point",[149,150],11.24626,43.77925,{"lat":150,"lon":149},[153],{"name":131,"role":135,"phone":136,"phoneExt":81,"email":137},{"type":155,"investigatorFullName":81,"investigatorTitle":81,"investigatorAffiliation":81,"oldNameTitle":81,"oldOrganization":81},"SPONSOR",[157],{"name":158,"class":6},"University of Florence","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":168,"type":169},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.",[173],"Sarcopenia",[101,175,176,177,178,179,109],"bioelectrical impedance analysis (BIA)","respiratory rehabilitation","tracheostomy decannulation","gut microbiota","GLIM criteria","2025-08-21",{"date":182,"type":183},"2025-08-28","ACTUAL",{"date":185,"type":183},"2021-06-09",{"date":187,"type":169},"2025-12-31",{"name":5,"class":6},1]