[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594290":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":38,"centralContacts":42,"locations":52,"responsibleParty":97,"collaborators":100,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":47,"enrollmentInfo":116,"targetDuration":47,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":55,"whyStopped":47,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"University of Chile","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Enhanced or Additional Physical Therapy Group","EXPERIMENTAL","Critically ill patients at risk of developing CIM will receive enhanced (additional) physical therapy consisting of standard physiotherapy plus servo-assisted lower-limb cycling using the Motomed Letto® device. Therapy will be delivered twice daily, 60 minutes per session, for 7 consecutive days during the early ICU stay. Muscle biopsies from the vastus lateralis will be collected for histological and molecular analyses.",[13],"Device: Motomed Letto® servo-assisted cycling + standard physiotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Physical Therapy Group","ACTIVE_COMPARATOR","Critically ill patients at risk of CIM will receive standard physiotherapy delivered according to institutional ICU rehabilitation protocols. The intervention is delivered at the same frequency and clinical stage as the enhanced therapy group.",[19],"Behavioral: Standard physiotherapy",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Motomed Letto® servo-assisted cycling + standard physiotherapy","Servo-assisted cycling using the Motomed Letto® device with a cadence target of 30 revolutions per minute (rpm), performed for 60 minutes twice daily for 7 days. This intervention is administered in addition to standard ICU physiotherapy to critically ill patients at risk of critical illness myopathy (CIM).",[9],[27,28,29],"Motomed Letto®","Additional Physical Therapy","Enhanced Physical Therapy",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"BEHAVIORAL","Standard physiotherapy","Standard physiotherapy including mobilization and passive\u002Factive range-of-motion exercises, delivered during routine ICU care for 7 days.",[15],[36,37],"Conventional physical therapy","routine ICU physiotherapy",[39],{"name":40,"affiliation":5,"role":41},"Paola A Llanos, PhD","STUDY_DIRECTOR",[43,49],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Óscar L Arellano-Pérez, MSc.","CONTACT","+56961479414",null,"oscar.arellano@ug.uchile.cl",{"name":40,"role":45,"phone":50,"phoneExt":47,"email":51},"+56997482044","pllanos@odontologia.uchile.cl",[53,78,92],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Clínica INDISA","RECRUITING","Santiago","Metropolitan Region","7520440","Chile","CL",{"type":62,"coordinates":63},"Point",[64,65],-70.64827,-33.45694,{"lat":65,"lon":64},[68,69,73,75],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},{"name":70,"role":45,"phone":71,"phoneExt":47,"email":72},"Felipe A Castillo, MSc.","+56992246802","felipe.castillo@indisa.cl",{"name":44,"role":74,"phone":47,"phoneExt":47,"email":47},"PRINCIPAL_INVESTIGATOR",{"name":76,"role":77,"phone":47,"phoneExt":47,"email":47},"Felipe A Castillo-Merino, MSc.","SUB_INVESTIGATOR",{"facility":79,"status":55,"city":56,"state":57,"zip":80,"country":59,"countryCode":60,"cosmosGeoPoint":81,"geoPoint":83,"contacts":84},"Hospital de Urgencia Asistencia Pública (HUAP)","8330075",{"type":62,"coordinates":82},[64,65],{"lat":65,"lon":64},[85,89,90,91],{"name":86,"role":45,"phone":87,"phoneExt":47,"email":88},"Iván L Hernández Flores, MSc.","+56 966768137","ivan.hernandezf@redsalud.gob.cl",{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},{"name":44,"role":74,"phone":47,"phoneExt":47,"email":47},{"name":86,"role":77,"phone":47,"phoneExt":47,"email":47},{"facility":5,"status":55,"city":56,"state":57,"zip":93,"country":59,"countryCode":60,"cosmosGeoPoint":94,"geoPoint":96,"contacts":47},"8380453",{"type":62,"coordinates":95},[64,65],{"lat":65,"lon":64},{"type":74,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Oscar Arellano","Principal Investigator, PhD Candidate in Biomedical Sciences, University of Chile",[101,103],{"name":102,"class":6},"Clinica Indisa",{"name":104,"class":105},"Hospital de Urgencia y Asistencia Pública","UNKNOWN","100594290","nlrp3-inflammasome-and-physical-therapy-in-icu-acquired-weakness-100594290",false,"NCT07017517","NLRP3 Inflammasome and Physical Therapy in ICU-Acquired Weakness","Effect of Physical Therapy on NLRP3 Inflammasome Activation and Muscle Atrophy in Critical Illness Myopathy (PT-NLRP3-CIM).","PT-NLRP3-CIM","Inclusion Criteria:\n\n* Medical diagnosis of sepsis upon ICU admission.\n* Receiving invasive mechanical ventilation with a projected requirement ≥7 days.\n* SOFA score ≥8 for three consecutive days within the first five days of ICU admission.\n\nExclusion Criteria:\n\n* Neurocritical illness.\n* Prior malnutrition or cachexia.\n* Pre-existing neuromuscular disease.\n* Coagulopathy (severe liver disease or continuous dialysis).\n* Thrombocytopenia \\\u003C20,000 platelets\u002FμL.\n* Prior Clinical Frailty Scale ≥4.\n* Lower limb amputation or fractures.\n* Ongoing chemotherapy.\n* Pregnancy.\n* BMI \\>35.\n* Uncontrolled epilepsy.\n* Allergy to ultrasound gel.\n* Prior prolonged corticosteroid therapy.\n* Expected ICU stay \\\u003C7 days.\n* Imminent death.\n* Legal guardian refusal to provide informed consent.","ALL","18 Years",{"count":117,"type":118},24,"ESTIMATED","INTERVENTIONAL",[121],"NA","The goal of this clinical trial is to study whether physical therapy can reduce NLRP3 inflammasome activation and muscle atrophy in patients with critical illness myopathy (CIM). It will also explore the role of NLRP3 inflammasome in the pathophysiology of CIM.\n\nThe main questions this study aims to answer are:\n\nIs NLRP3 inflammasome activation associated with muscle atrophy through the upregulation of atrogenes?\n\nDoes physical therapy attenuate NLRP3 inflammasome activation in skeletal muscle, thereby contributing to the prevention or reduction of muscle atrophy in CIM?\n\nResearchers will compare enhanced physical therapy using servo-assisted bed cycling (Motomed Letto®) in critically ill patients at risk of developing CIM during the early phase of ICU stay to conventional physical therapy (standard physiotherapy), to assess whether physical therapy reduces NLRP3 inflammasome activation and muscle degradation.\n\nParticipants will:\n\nBe randomized to receive either conventional physical therapy or enhanced physical therapy (Motomed Letto®) for 7 consecutive days. A control group of patients without CIM will also be included.\n\nUndergo assessments of NLRP3 activity, muscle atrophy markers, and transcriptomic profiles from serum and vastus lateralis muscle biopsies.\n\nBe clinically evaluated using the SOFA scale and muscle ultrasound for CIM diagnosis.\n\nBe followed up for changes in muscle strength and physical functionality.\n\nProvide sociodemographic and clinical information to be recorded throughout the study.",[124],"Critical Illness Myopathy",[126,127,128,129,130],"Critical illness myopathy","Physical therapy","NALP3 inflammasome","Muscle atrophy","ICU-acquired weakness","2026-05-04",{"date":133,"type":134},"2026-05-06","ACTUAL",{"date":136,"type":134},"2026-04-20",{"date":138,"type":118},"2027-05",{"name":5,"class":6},3]