[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564779":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":27,"locations":12,"responsibleParty":34,"collaborators":12,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":12,"enrollmentInfo":48,"targetDuration":12,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":62,"whyStopped":12,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":12},{"fullName":5,"class":6},"Singapore General Hospital","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","Participants in the control group (uSEP) will receive the standard PREPARE program provided by the hospital, which includes preoperative physiotherapy education and a home exercise booklet (Supplementary Material: Educational Materials). This unsupervised, home-based programme consists of full-body aerobic, resistance, and respiratory exercises that participants will perform independently at home. Additionally, participants with a Maximal Inspiratory Pressure (MIP) of less than 100 cmH₂O will be given an Inspiratory Muscle Trainer (IMT) to enhance respiratory function.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention","EXPERIMENTAL","Participants in the intervention group (swSEP) will receive standard preoperative physiotherapy education in addition to a Fitbit Aspire 3 wearable device, which will track vital signs such as heart rate, physical activity, and sleep patterns. They will follow a personalised exercise program that is remotely supervised by a physiotherapist via telemedicine twice a week. The exercise regimen will consist of 20-minute sessions, at least three times per week, and will include three core components: strength training, aerobic exercise, and flexibility exercises. Strength training will involve 2-3 sets of full-body exercises, including combinations of upper body, lower body, and abdominal movements. Aerobic exercises will be performed at a minimum intensity of 40% of the participant's maximal heart rate (HRmax) for up to 20 minutes. Flexibility training will include six stretches, each held for 20 seconds and repeated twice, targeting the chest, arms, legs, and trunk.",[18],"Device: Supervised prehabilitation programme",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Supervised prehabilitation programme","Participants will receive standard preoperative physiotherapy education along with a Fitbit Aspire 3 wearable device to track vital signs such as heart rate, physical activity, and sleep patterns. They will follow a personalized exercise program, supervised remotely by a physiotherapist via telemedicine twice a week. The program will include 20-minute sessions at least three times per week, focusing on strength training, aerobic exercises (at 40% of maximal heart rate), and flexibility exercises. Progress will be monitored through vital signs and workout data, with the physiotherapists adjusting the regimen as needed. Participants with low inspiratory pressure (MIP \\<100 cmH₂O) will receive an Inspiratory Muscle Trainer (IMT). Additionally, some participants may be provided with a portable cycle pedometer featuring adjustable resistance. To ensure safety, both participants and caregivers will receive a safety briefing, and a 24-hour emergency hotline.",[14],[26],"swSEP",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Yuhe Ke, MMED (ANES)","CONTACT","+65 6321 4220","+65","ke.yuhe@singhealth.com.sg",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Ke Yuhe","Associate Consultant","100564779","prehabilitation-of-frail-elderly-patients-undergoing-major-surgery-at-home-prepare-home-using-smart-wearables-100564779",false,"NCT06633614","PREhabilitation of Frail Elderly PAtients Undergoing majoR surgEry at HOME (PREPARE-HOME) Using Smart Wearables","PREhabilitation of Frail Elderly PAtients Undergoing majoR surgEry at HOME (PREPARE-HOME) Using Smart Wearables: A Prospective Randomized Controlled Trial","PREPARE@HOME","Inclusion Criteria:\n\n* Frail elderly patients aged 65 years or older.\n* Scheduled to undergo major elective, non-cardiac surgery.\n* Anticipated surgery duration of over two hours or expected blood loss greater than 500 mL.\n* Frailty status with Edmonton Frail Scale (EFS) score of 6 or higher.\n* Capacity to provide informed consent independently.\n* Available at least two weeks before surgery to participate in the prehabilitation program.\n* Ability to follow exercise instructions independently.\n* Ownership of a smartphone with Bluetooth and cellular connectivity.\n\nExclusion Criteria:\n\n* Severe comorbidities that interfere with participation in the exercise program (e.g., unstable angina, severe aortic stenosis, or uncontrolled arrhythmias).\n* Cognitive impairments that prevent understanding or adherence to the intervention.","ALL","65 Years",{"count":49,"type":50},190,"ESTIMATED","INTERVENTIONAL",[53],"NA","The goal of this clinical trial is to evaluate whether a prehabilitation program using wearable technology can improve physical function and postoperative outcomes in elderly patients (65 years or older) undergoing major elective non-cardiac surgery. The main questions it aims to answer are:\n\nDoes the prehabilitation program improve physical function, as measured by the 6-minute walk test (6MWT), from baseline to pre-surgery? Does the prehabilitation program reduce postoperative complications and enhance recovery? Researchers will compare participants who receive the prehabilitation program with wearable technology (intervention group) to those receiving standard preoperative care (control group) to see if the intervention results in greater improvements in physical function and postoperative outcomes.\n\nParticipants will:\n\nFollow a personalized exercise program monitored remotely via telemedicine. Wear a Fitbit Aspire 3 device to track vital signs such as heart rate and physical activity.\n\nUndergo assessments of physical function and quality of life before surgery.",[56],"Frailty Syndrome",[58,59,60,61],"Prehabilitation","Home-based","Perioperative Science","Wearable Technology","NOT_YET_RECRUITING","2025-05-12",{"date":65,"type":66},"2025-05-15","ACTUAL",{"date":68,"type":50},"2025-08-01",{"date":70,"type":50},"2028-01-31",{"name":5,"class":6}]