[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636079":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":41,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":26,"enrollmentInfo":53,"targetDuration":26,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":26},{"fullName":5,"class":6},"University of Salerno","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TELEREHABILITATION","EXPERIMENTAL","Participants assigned to this arm will receive an 8-week individualized sensorimotor and cognitive telerehabilitation program delivered through a synchronous digital platform. The intervention includes motor training and cognitive training tailored to the participant's frailty level, with continuous remote monitoring of vital signs, including ECG, heart rate, oxygen saturation, and blood pressure. Participants and caregivers will receive initial training and technical support.",[13],"Behavioral: Telerehabilitation",{"label":15,"type":16,"description":17,"interventionNames":18},"Caregiver-Supervised Home Exercise","ACTIVE_COMPARATOR","Participants assigned to this arm will receive an 8-week individualized home-based sensorimotor and cognitive exercise program matched to the participant's frailty profile. The program will be explained in person and then continued at home under caregiver or family supervision. Participants will perform the same general categories of motor and cognitive exercises as the intervention group and will record activities in a daily diary, with monitoring of heart rate, oxygen saturation, and blood pressure according to study procedures.",[19],"Behavioral: Caregiver-Supervised Home Exercise Program",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Telerehabilitation","Participants will receive an 8-week individualized sensorimotor and cognitive telerehabilitation program delivered through a synchronous digital platform. The intervention includes motor training and cognitive training tailored to frailty level, with real-time remote supervision by healthcare professionals and continuous monitoring of vital signs, including ECG, heart rate, oxygen saturation, and blood pressure. Participants and caregivers will receive initial training and technical support for use of the telerehabilitation system.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Caregiver-Supervised Home Exercise Program","Participants will receive an 8-week individualized home-based sensorimotor and cognitive exercise program matched to frailty level. The program will be explained in person and then performed at home under caregiver or family supervision. It includes motor and cognitive exercises corresponding to those used in the intervention group, along with activity diary completion and monitoring of heart rate, oxygen saturation, and blood pressure according to study procedures.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Alessia Bramanti, Electronic Engineering","CONTACT","+393483809181","abramanti@unisa.it",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Alessia Bramanti","Associate Professor",[42],{"name":43,"class":6},"Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona","100636079","high-technology-telerehabilitation-for-the-treatment-of-the-fragile-patient-100636079",false,"NCT07561021","High-technology TeleRehabilitation for the Treatment of the FRAgile Patient","TeleRiab4Fra","Inclusion Criteria:\n\n* Age 65 years or older.\n* Diagnosis of chronic heart failure for at least 6 months, on stable optimal medical therapy for at least 1 month, regardless of systolic function classification (HFrEF, HFmrEF, or HFpEF), and in NYHA class I-III.\n* Pre-frailty or frailty documented by validated instruments, defined by at least one of the following: Fried phenotype: pre-frailty (1-2 criteria) or frailty (3 or more criteria); Italian Frailty Index (IFI): score ≥1;\n\nShort Physical Performance Battery (SPPB):\n\ntotal score 5-9\u002F12, consistent with functional frailty; or total score 10\u002F12, consistent with pre-frailty if the reduction is attributable to the sit-to-stand test, as documented in the case report form.\n\n* Ability to provide written informed consent, or availability of a legally authorized representative when applicable.\n* Availability of a caregiver, when required for participation in the rehabilitation program.\n\nExclusion Criteria:\n\n* Age younger than 65 years.\n* NYHA class IV and\u002For high likelihood of heart transplantation or ventricular assist device (VAD) implantation within 6 months after screening.\n* Absence of pre-frailty\u002Ffrailty, defined as:\n\nFried phenotype = 0 criteria, and IFI = 0, and SPPB ≥ 11\u002F12 (or 10\u002F12 without evidence of impairment in the sit-to-stand component according to the predefined criterion).\n\n* Severe renal impairment (estimated glomerular filtration rate eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²) or dialysis.\n* Inability to walk independently, even with assistive devices. SPPB total score \\\u003C5\u002F12, indicating severe functional impairment not compatible with safe execution of the study protocol, regardless of IFI or Fried criteria.\n* Other serious diseases substantially limiting life expectancy (for example, end-stage cancer or end-stage lung disease).\n* Severe visual impairment preventing completion of study procedures even with caregiver support and reasonable accommodations.\n* Current or suspected pregnancy.","ALL","65 Years",{"count":54,"type":55},70,"ESTIMATED","INTERVENTIONAL",[58],"NA","The aim of this randomized controlled clinical trial is to evaluate the efficacy of an 8-week sensorimotor and cognitive telerehabilitation program in frail and pre-frail older adults with stable chronic heart failure. The study will compare a synchronous telerehabilitation intervention with a caregiver-supervised home exercise program. The primary question is whether telerehabilitation improves functional capacity, measured by change in peak oxygen uptake (VO₂peak) on cardiopulmonary exercise testing, more than the control intervention. A key secondary question is whether telerehabilitation improves frailty status, measured by the Italian Frailty Index (IFI), compared with the control group. Secondary outcomes include quality of life, physical performance, cognitive function, treatment adherence, caregiver burden and stress, and selected biomarkers related to heart failure and frailty. Participants will undergo baseline and follow-up clinical, functional, cognitive, and laboratory assessments and will be followed for up to 24 weeks.",[61,62,63],"Heart Failure","Prefrail Elderly","Frail Elderly Syndrome",[65,66,67,68,69,70,71,72,73,74],"Chronic Heart Failure","Cardiac Rehabilitation","Tele-rehabilitation","Telemedicine","Exercise Training","Remote Monitoring","mHealth","Wearable Sensors","Home-based Rehabilitation","Digital Health","NOT_YET_RECRUITING","2026-05-01",{"date":78,"type":79},"2026-05-07","ACTUAL",{"date":81,"type":55},"2026-05-15",{"date":83,"type":55},"2027-03-15",{"name":5,"class":6}]