[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658506":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":54,"studyPopulation":58,"armGroups":59,"interventions":54,"overallOfficials":54,"centralContacts":62,"locations":68,"responsibleParty":92,"collaborators":54,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":54,"enrollmentInfo":107,"targetDuration":110,"studyType":111,"phases":54,"briefSummary":112,"conditions":113,"keywords":119,"overallStatus":71,"whyStopped":54,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"ASST Sette Laghi","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":54},[9],{"measure":10,"description":11,"timeFrame":12},"10% improvement from baseline at 6-minutes-walking-test-distance","The primary outcome of this study is to evaluate whether prehabilitation translates into an improvement in quality of life before surgery, assessed in terms of functional status. This objective is assessed using the 6-minute walking distance test. A significant improvement is considered to be a positive delta in the six-minute walking test of ≥10% obtained at the assessment performed on the day of admission compared to the value recorded during the first assessment.","From enrollment to the date of surgery",[14,17,20,23,26,29,32,36,40,44,47,50],{"measure":15,"description":16,"timeFrame":12},"Increased thickness of the quadriceps femoris muscle","An increase in the thickness of the quadriceps femoris muscle will be assessed via ultrasound as a direct sign of an increase in the number and volume of muscle fibres",{"measure":18,"description":19,"timeFrame":12},"Increased cross-sectional area of the quadriceps femoris muscle","An increase in the cross-sectional area of the quadriceps femoris muscle will be assessed via ultrasound as a direct sign of an increase in the number and volume of muscle fibres",{"measure":21,"description":22,"timeFrame":12},"Increased pennation angle of the quadriceps femoris muscle","An increase in the pennation angle of the quadriceps femoris muscle, assessed by ultrasound, is a direct sign of increased contractility of the muscle itself, and therefore an indirect index of an increase in muscle strength.",{"measure":24,"description":25,"timeFrame":12},"Change in Pulmonary Function Parameters","Change in pulmonary volumes including Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), and Tiffeneau Index (FEV1\u002FFVC ratio) measured through spirometry at baseline and after completion of prehabilitation.",{"measure":27,"description":28,"timeFrame":12},"Improvement in Functional Performance Tests","Change in performance at Handgrip Strength test (Newton), and Maximal Isometric Strength test (Newton), assessed at baseline and after the prehabilitation program. An increase in the value indicates an improvement in functional capacity.",{"measure":30,"description":31,"timeFrame":12},"Change in Diaphragmatic Excursion","Variation in diaphragmatic movement amplitude assessed by ultrasound before and after the prehabilitation period.",{"measure":33,"description":34,"timeFrame":35},"Change in Health-Related Quality of Life (EQ-5D-5L Index)","Variation in patient-reported quality of life as assessed by the EQ-5D-5L questionnaire. The index score will be compared between baseline and preoperative assessment after prehabilitation and also at 30 days and 180days after discharge","From enrollment to 180 days after discharge",{"measure":37,"description":38,"timeFrame":39},"Incidence of Postoperative Delirium in the Intensive Care Unit","Occurrence of postoperative delirium evaluated daily during ICU stay using the Confusion Assessment Method for the ICU (CAM-ICU).","Perioperative\u002FPeriprocedural",{"measure":41,"description":42,"timeFrame":43},"Change in Nutritional and Biochemical Markers","Variation in nutritional status indicators assessed through blood biochemical parameters (albumin, prealbumin, total protein, lymphocyte count, iron, transferrin, vitamin B12, folic acid, hemoglobin,) before the prehabilitation program, after the prehabilitation program and at 30 days after discharge","From enrollment to 30 days after discharge",{"measure":45,"description":46,"timeFrame":39},"Length of Stay in Intensive Care Unit","Duration of ICU stay (in days) from postoperative admission to ICU discharge.",{"measure":48,"description":49,"timeFrame":39},"Total Hospital Length of Stay","Total duration of hospitalization (in days) from admission for surgery to hospital discharge.",{"measure":51,"description":52,"timeFrame":53},"180-Day Mortality","All-cause mortality evaluated at 180 days after surgery.","From discharge to 180 days after surgery",null,{"allocation":54,"interventionModel":54,"interventionModelDescription":54,"primaryPurpose":54,"observationalModel":56,"timePerspective":57,"maskingInfo":54},"CASE_ONLY","PROSPECTIVE","This prospective, observational, single-center study will enroll approximately 50 adult patients (≥18 years old) undergoing elective cardiac or major abdominal surgery at Ospedale di Circolo e Fondazione Macchi, Varese, Italy. Eligible patients for abdominal surgery must have ASA I-III and PS ECOG ≤2. Key exclusion criteria include emergency surgery, unstable angina, malignant arrhythmias, severe or very severe COPD, dementia, pregnancy, or inability to provide informed consent. Participants will be screened by the surgical team and followed during a personalized prehabilitation program starting about one month before surgery.",[60],{"label":61,"type":54,"description":54,"interventionNames":54},"Eligible patients for major surgery",[63],{"name":64,"role":65,"phone":66,"phoneExt":54,"email":67},"Massimo Stella, MD","CONTACT","0039 0332393447","maxstella95@gmail.com",[69,86],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Ospedale di Circolo","RECRUITING","Varese","VA","21052","Italy","IT",{"type":78,"coordinates":79},"Point",[80,81],8.82511,45.82058,{"lat":81,"lon":80},[84],{"name":64,"role":65,"phone":85,"phoneExt":54,"email":67},"+39 0332 393447",{"facility":5,"status":87,"city":72,"state":54,"zip":88,"country":75,"countryCode":76,"cosmosGeoPoint":89,"geoPoint":91,"contacts":54},"ACTIVE_NOT_RECRUITING","21100",{"type":78,"coordinates":90},[80,81],{"lat":81,"lon":80},{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":96,"oldNameTitle":54,"oldOrganization":54},"PRINCIPAL_INVESTIGATOR","Luca Guzzetti","Principal Investigator","Ospedale di Circolo - Fondazione Macchi","100658506","proposal-for-a-preoperative-functional-optimization-pathway-for-patients-candidate-for-major-surgery-cardiac-and-abdominal-oncology-100658506",false,"NCT07851350","PROPOSAL FOR A PREOPERATIVE FUNCTIONAL OPTIMIZATION PATHWAY FOR PATIENTS CANDIDATE FOR MAJOR SURGERY (CARDIAC AND ABDOMINAL ONCOLOGY)","PRehabilitation With Integrated and Multimodal Evaluation in Cardiac and Abdominal majoR surgEry (PRIME CARE) A Proposed Pathway for Preoperative Functional Optimization in Candidates for Major Surgery","PRIME CARE","Inclusion Criteria:\n\n* Elective major abdominal surgery or elective cardio surgery\n* American Society of Anaesthesiologists Physical Status Classification ≤ 3\n* Performance Status according to ECOG Scale ≤ 2\n\nExclusion Criteria:\n\n* Emergency surgery\n* Unstable angina\n* Malignant arrythmias\n* Severe\u002F very severe COPD\n* Dementia\n* Pregnancy\n* Inability to provide informed consent","ALL","18 Years",{"count":108,"type":109},50,"ESTIMATED","1 Year","OBSERVATIONAL","The study aims to evaluate a prehabilitation protocol for patients undergoing cardiac and abdominal surgery. The project for a preparation program for cardiac surgery was developed within the framework of ERAS (Enhanced Recovery After Surgery), which aims to ensure optimal recovery after surgery and a Surgery), which aims to ensure optimal recovery after surgery and an early and safe return to daily activities.\n\nThe study focuses on the preoperative phase, with the introduction of the concept of prehabilitation, i.e., a program to enhance the functional abilities of individuals in preparation for major surgery. The study focuses on the preoperative phase, introducing the concept of prehabilitation, i.e., a program to enhance the functional abilities of individuals in preparation for major surgery, such as cardiac surgery, on an elective basis.\n\nThis program, which currently represents best clinical practice, lasts four weeks and addresses several areas: strengthening respiratory and muscular functions, optimizing nutrition, and cognitive stimulation. Patients will be assessed at enrollment and up to 180 days post-surgery to evaluate their clinical status compared to pre-surgery on these four aspects mentioned above.",[114,115,116,117,118],"Prehabilitation","Major Abdominal Surgeries","Cardiac Surgery","Multimodal and Integrated Program","Major Surgery in Adult Patients",[114,120,121,122,123],"Multimodal and Integrated program","Cardiac surgery","Abdominal Oncology Surgery","Major surgery","2026-09-25",{"date":126,"type":127},"2026-10-01","ACTUAL",{"date":129,"type":127},"2026-07-29",{"date":131,"type":109},"2028-11-30",{"name":5,"class":6},2]