[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602782":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":64,"collaborators":25,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":25,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":94,"whyStopped":25,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Universidad de La Frontera","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"CONTROL GROUP","Participants of the fourth age (≥80 years old) will receive the standard physical therapy routinely provided during their hospitalization. This intervention involves passive mobilization of the lower limbs, specifically within the ranges of hip flexion, knee flexion and extension, and ankle flexion and extension. One set of 10 bilateral repetitions will be performed while the patient is under sedation in the ICU. Once the patient is awake, the mobilization protocol routinely used in the same unit will be followed.\n\nThis intervention will be carried out twice a day: the first session in the morning (08:00-12:00 hrs) and the second in the afternoon (14:00-18:00 hrs). This corresponds to the standard practice in the ICU of Dr. Hernán Henríquez Aravena Hospital.",[12],"Procedure: Standard physical therapy",{"label":14,"type":15,"description":16,"interventionNames":17},"NMES GROUP","EXPERIMENTAL","The participant will receive standard physical therapy plus medium-frequency NMES.\n\nTwo sessions will be carried out-one in the morning (08:00-12:00 hrs) and another in the afternoon (14:00-18:00 hrs)-always following standard physical therapy.",[18,12],"Device: Medium Frequency Neuromuscular Electrical Stimulation (NMES)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Medium Frequency Neuromuscular Electrical Stimulation (NMES)","The medium-frequency NMES protocol, as reported in previous studies, consists of a carrier frequency of 2,500 Hz, a treatment frequency of 100 Hz, an ON time of 5 seconds (1 second ramp-up, 3 seconds contraction, and 1 second ramp-down), and an OFF time of 10 seconds. This stimulation protocol will be applied for 20 minutes per session (40 minutes of NMES per treatment day).\n\nTwo electrodes will be placed on each thigh, located at the motor point of the quadriceps muscle. Electrode positions will be marked with a semi-permanent marker to ensure consistent placement across sessions.",[14],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"PROCEDURE","Standard physical therapy","Participants of the fourth age (≥80 years old) will receive the standard physical therapy routinely provided during their hospitalization. This intervention involves passive mobilization of the lower limbs, specifically within the ranges of hip flexion, knee flexion and extension, and ankle flexion and extension. One set of 10 bilateral repetitions will be performed while the patient is under sedation in the ICU. Once the patient is awake, the mobilization protocol routinely used in the same unit will be followed.",[9,14],[32],{"name":33,"affiliation":5,"role":34},"Gabriel Nasri Marzuca-Nassr, PhD","STUDY_CHAIR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Ruud S Teppa-Zyl, Master's degree","CONTACT","+56 945259435","ruudteppaz@gmail.com",{"name":33,"role":38,"phone":42,"phoneExt":25,"email":43},"+56 45 2596713","gabriel.marzuca@ufrontera.cl",[45],{"facility":46,"status":25,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Hospital Dr Hernán Henríquez Aravena","Temuco","Araucania","4580000","Chile","CL",{"type":53,"coordinates":54},"Point",[55,56],-72.59738,-38.73628,{"lat":56,"lon":55},[59,62],{"name":60,"role":61,"phone":25,"phoneExt":25,"email":25},"Ruud S Teppa, Master","PRINCIPAL_INVESTIGATOR",{"name":33,"role":63,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"type":61,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Gabriel Nasri Marzuca-Nassr","Associate Professor in the Department of Rehabilitation Sciences, Faculty of Medicine, Universidad de La Frontera, Temuco, Chile.","100602782","neuromuscular-electrical-stimulation-in-critically-ill-patients-aged-80-and-over-100602782",false,"NCT07127991","Neuromuscular Electrical Stimulation in Critically Ill Patients Aged 80 and Over","Impact of Neuromuscular Electrical Stimulation on Muscle Mass, Strength, and Functionality in Critically Ill Oldest Old Patients: a Randomized Controlled Trial","NMES-ICU80","Inclusion Criteria:\n\n* People aged 80 years or older.\n* Hospitalized in the Adult Critical Care Unit of Dr. Hernán Henríquez Aravena Hospital in Temuco.\n* Estimated mechanical ventilation time greater than 72 hours.\n\nExclusion Criteria:\n\n* Patients with prior neurological complications.\n* Patients with severe dependence prior to admission.\n* Patients with difficult-to-manage hemodynamic instability.\n* Patients with accessory elements that limit assessment.\n* Patients with lower limb amputation.\n* Patients in the prone position.\n* Patients with loss of skin integrity.\n* Patients expected to remain in the unit for less than 72 hours.\n\nPatients transferred from other services with a stay of more than 72 hours.","ALL","80 Years",{"count":78,"type":79},30,"ESTIMATED","INTERVENTIONAL",[82],"NA","The aim of this clinical trial is to evaluate the effectiveness of Medium-Frequency Neuromuscular Electrical Stimulation, in combination with standard physical therapy, compared to standard physical therapy alone, on muscle mass, muscle strength, and functionality in critically ill patients aged 80 and over during their hospital stay. The safety of the intervention and the standardization of protocol parameters will also be assessed.\n\nThe main research questions are:\n\n* Does the implementation of a standardized Medium-Frequency Neuromuscular Electrical Stimulation protocol, in combination with standard physical therapy, compared to standard physical therapy alone, help attenuate the loss of skeletal muscle mass, strength, and functionality in critically ill patients aged 80 and over?\n* Is the use of this protocol and its proposed parameters safe for critically ill patients aged 80 and over? The study will consist of applying a standardized Medium-Frequency Neuromuscular Electrical Stimulation protocol to oldest old patients admitted to the Intensive Care Unit of Dr. Hernán Henríquez Aravena Hospital in Temuco, Chile. The sample will consist of oldest old participants (≥80 years), who will be randomly divided into two subgroups: a control group that will receive standard physical therapy typically provided during hospitalization, and an experimental group that will receive the same standard therapy plus Medium-Frequency Neuromuscular Electrical Stimulation, which will begin within the first 48 hours of Intensive Care Unit admission.\n\nThe following variables will be assessed in both groups (control and experimental), from Intensive Care Unit admission to hospital discharge:\n\n* Skeletal muscle mass characteristics and evolution (quadriceps femoris and anterior tibialis muscle thickness), measured by ultrasonography.\n* Handgrip strength, measured using a digital hand dynamometer.\n* Inspiratory muscle strength, assessed using a pimometer.\n* Peripheral muscle strength, evaluated with the Medical Research Council Sum Score (MRC-SS).\n* Functionality, assessed by the Functional Status Score for the Intensive Care Unit (FSS-ICU) .\n* Independence in basic activities of daily living, measured using the Barthel Index.\n* Quality of life, evaluated using the Short Form-36 Health Survey (SF-36).\n* Cognitive impairment, assessed through the Montreal Cognitive Assessment (MoCA).\n* Frailty, measured using the Clinical Frailty Scale (CFS).",[85,86,87],"Intensive Care Units (ICUs)","Muscle Atrophy or Weakness","Old and Very Old People",[89,90,91,92,93],"MUSCLE ATROPHY","FUNCTIONAL STATUS","ICU","OLDER ADULTS","NMES","NOT_YET_RECRUITING","2025-08-13",{"date":97,"type":98},"2025-08-17","ACTUAL",{"date":100,"type":79},"2025-09",{"date":102,"type":79},"2026-12",{"name":5,"class":6},1]