[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637842":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":55,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Fondazione Don Carlo Gnocchi Onlus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tele-rehabilitation group","EXPERIMENTAL","Participants will undergo a structured, multidimensional cardiac telerehabilitation program with an integrated approach.",[13],"Other: Tele-rehabilitation",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care Group","ACTIVE_COMPARATOR","Participants will continue with usual care, receiving standard outpatient rehabilitative treatment according to current clinical practice guidelines.",[19],"Other: Standard of Care",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Tele-rehabilitation","A structured, multidimensional telerehabilitation program delivered via the Maia Connected Care platform (AB Medica, MDR class IIa), lasting 16 weeks (4 months), in addition to standard post-rehabilitation care. 1. Synchronous sessions (televisits):\n\nWeeks 1-4:\n\n2 sessions\u002Fweek (physiotherapy + psychological support)\n\nWeeks 5-16:\n\n1 session\u002Fweek (alternating physiotherapy and psychological support)\n\n1 session\u002Fmonth (nutritional counseling) 2. Asynchronous rehabilitation program (continuous for 16 weeks): Personalized exercise training (endurance and resistance training) delivered via video-guided modules; Remote monitoring and adaptation by clinicians 3. Cognitive training: Delivered via digital platform (RICORDO-DTx) Multidomain exercises tailored based on baseline MoCA performance\n\n4\\. Nutritional support: Monthly teleconsultations with a dietitian Monitoring using validated tools (MUST, SARC-F, BIA)",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard of Care","Routine clinical care and standard rehabilitative treatment according to current hospital practices.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Anastasia Toccafondi, physioterapist","CONTACT","02-40308570","atoccafondi@dongnocchi.it",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Fondazione Don Carlo Gnocchi ETS","RECRUITING","Milan","Milano","20148","Italy","IT",{"type":46,"coordinates":47},"Point",[48,49],12.59836,42.78235,{"lat":49,"lon":48},[52],{"name":53,"role":33,"phone":54,"phoneExt":25,"email":35},"Anastasia Toccafondi, BcS","02 403081",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Anastasia Toccafondi","physiotherapist","100637842","effectiveness-of-a-structured-multidimensional-tele-rehabilitation-intervention-in-cardiac-patients-with-post-intensive-care-syndrome-cardio-pics-100637842",false,"NCT07599306","Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS)","Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS): Impact on Mortality, Rehospitalization, and Clinical-functional Outcomes.","CARDIO-PICS","Inclusion Criteria:\n\n* Adults aged 30-75 years\n* Previous ICU admission ≥48 hours\n* Presence of Post-Intensive Care Syndrome (PICS), defined as at least one of the following objectively assessed impairments at baseline (T0):\n* Neuromotor impairment, defined as Diagnosis of Critical Illness Myopathy (CIM) or Critical Illness Polyneuropathy (CIP), confirmed by electromyography (EMG)\n* Cognitive impairment, defined as Montreal Cognitive Assessment (MoCA) score \\\u003C 26\n* Psychological impairment, defined as Patient Health Questionnaire-9 (PHQ-9) score ≥ 10\n* Nutritional impairment, defined as the presence of malnutrion according to GLIM criteria, requiring at least one phenotypic criterion (non-volitional weight loss \\>5% within 6 months or \\>10% beyond 6 months; BMI \\\u003C20 kg\u002Fm² if \\\u003C70 years or \\\u003C22 kg\u002Fm² if ≥70 years; reduced muscle mass) and at least one etiologic criterion (reduced food intake or assimilation for \\>1 week, or any acute\u002Fchronic inflammatory burden) and\u002For presence of sarcopenia assessed by calf circumference \\\u003C31 cm and reduced muscle strength measured by handgrip strength\n* Metabolic or bone metabolism disorder, defined as altered bone metabolism markers (Bone Turnover Markers outside reference range)\n\nAbility to provide written informed consent\n\nExclusion Criteria\n\n* Prognostically unfavorable malnutrition defined as: CONUT score ≥5.\n* Delirium present at the time of the enrollment, documented by a positive Confusion Assessment Method (CAM or CAM-ICU)\n* Pre-existing severe cognitive impairment or dementia, defined as:\n\ndocumented diagnosis in the medical record prior to ICU admission\n\n\\- Any clinical condition limiting participation in the rehabilitation program, including: severe orthopedic, neurological, or functional limitations not related to PICS","ALL","30 Years","75 Years",{"count":71,"type":72},326,"ESTIMATED","INTERVENTIONAL",[75],"NA","This two-arm, parallel-group randomized clinical trial investigates the effectiveness of an additional telerehabilitation program compared with standard care in patients with Post-Intensive Care Syndrome (PICS). The post-rehabilitation phase is crucial for consolidating recovery and ensuring continuity of care, with telerehabilitation offering a promising tool to enhance long-term adherence and outcomes.\n\nThe primary objective is to evaluate whether a structured, multidisciplinary remote rehabilitation program can reduce the risk of rehospitalization and mortality while improving clinical, functional, and psychosocial recovery. Approximately 326 patients aged 30-75 years will be enrolled after inpatient rehabilitation and randomly assigned to either a four-month structured telerehabilitation program or standard post-discharge follow-up.\n\nAll participants will undergo assessments at 4 and 12 months to monitor physical, cognitive, psychological, and metabolic recovery, with the ultimate aim of promoting a more complete and sustained rehabilitation after critical illness.",[78,79,80],"Critical Illness","Post Intensive Care Syndrome (PICS)","Cardiopathy",[82,83,84,85,86,87,88,89,90,91],"ICU","PICS","Multimodal rehabilitation","critical illness recovery","Polyneuropathies","Sarcopenia","Nutrition Assessment","Cognitive Dysfunction","Metabolic Diseases","tele-rehabilitation","2026-06-03",{"date":94,"type":95},"2026-06-04","ACTUAL",{"date":97,"type":95},"2026-04-13",{"date":99,"type":72},"2028-12-31",{"name":5,"class":6},1]