[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"frailty-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:frailty-syndrome":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,49,84,112,139,171,198,227,253,283,305,332,355,375,406,435,462,487,511,531,561,584,604,633,661],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100628162","comparson-of-the-effcacy-of-conventonal-exercse-and-plates-n-pre-fral-and-fral-older-adults-100628162",false,"NCT07458048","Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults","Inclusion Criteria:\n\n* Age 60 years and older Classified as prefrail or frail according to the FRAIL Scale A score of 24 or higher on the Mini-Mental State Examination (MMSE) Provided written informed consent after being informed about the study\n\nExclusion Criteria:\n\nPresence of unstable cardiovascular disease Having received physical therapy and rehabilitation within the past 6 months History of severe neurological disorders History of major surgery affecting mobility within the past 6-12 months Severe musculoskeletal or orthopedic conditions that limit or preventt independent mobility.\n\n\\-","ALL","60 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","Brief Summary\n\nThis clinical study aims to compare the effects of a conventional exercise program and a Pilates exercise program in prefrail and frail older adults. A total of 40 participants aged 60 years and older who are classified as prefrail or frail according to the FRAIL Scale will be included in the study.\n\nParticipants will be randomly assigned to either the conventional exercise group or the Pilates group. Both exercise programs will be conducted twice weekly for 6 weeks. The interventions will focus on stretching exercises, balance and perturbation training, and strength exercises targeting major muscle groups.\n\nPrimary outcomes will include changes in frailty status assessed before and after the intervention. Secondary outcomes will include functional mobility and balance assessed by the Timed Up and Go Test, dynamic balance assessed by the Functional Reach Test, lower extremity strength assessed by the 30-Second Sit-to-Stand Test, gait speed assessed by the 10-Meter Walk Test, depressive symptoms and psychological well-being assessed by the Yesavage Geriatric Depression Scale, independence in daily activities assessed by the Lawton Instrumental Activities of Daily Living Scale, cognitive status assessed by the Mini-Mental State Examination, and fatigue assessed by the Modified Borg Scale. Frailty status will be evaluated using the FRAIL Scale.\n\nThroughout the study, participant safety will be monitored, and any adverse events, such as injuries or discomfort occurring during exercise sessions, will be recorded and managed appropriately.\n\nThis study is expected to provide valuable clinical evidence regarding the effectiveness of conventional exercise and Pilates programs in improving physical health and reducing frailty in prefrail and frail older adults, thereby contributing to the identification of best practice approaches for the management of this vulnerable population.",[26,27,28,29],"Frailty Syndrome","Prefrail Elderly","Frail Elderly","Geriatric",[31,32,33,34,35,36],"Pilates","geriatric","conventional","frailty","exercises","prefrail","NOT_YET_RECRUITING","2026-06-20",{"date":40,"type":41},"2026-06-25","ACTUAL",{"date":43,"type":20},"2026-06-22",{"date":45,"type":20},"2027-02",{"name":47,"class":48},"Istanbul University - Cerrahpasa","OTHER",{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100563058","optimizing-prevention-of-hospital-acquired-disability-through-multidomain-interventions-100563058","NCT06611228","Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions","Optimizing Prevention of Hospital-acquired Disability Through Integrated Multidomain Interventions: the Age-IT Project","OPTIMAge-IT","Inclusion Criteria:\n\n* Age \\>70 years;\n* Mild to moderate frailty, defined by a panel of tools agreed upon by the group of researchers involved in the study (Primary Care Frailty Index \\[PC-FI\\] between 0.07 and 0.21, Clinical Frailty Scale \\[CFS\\] 4-6);\n* Ability to walk with or without assistance\n* Ability to communicate and cooperate with the research team;\n* Ability to sign informed consent.\n\nExclusion Criteria:\n\n* Expected hospital stay duration \\<3 days;\n* Estimated prognosis quoad vitam \\<12 months;\n* Persistent clinical instability, indicated by a NEWS2 score \\>5 (assessed within 48 hours of admission) and\u002For the presence of delirium (4AT \\>4);\n* History of schizophrenia, major depression, bipolar disorder, or psychosis;\n* Severe sensory deficits (visual and auditory);\n* Presence of a nasogastric tube or percutaneous endoscopic gastrostomy (PEG);\n* Severe cardiac conduction disorder (e.g., third-degree atrioventricular block), uncontrolled arrhythmia, new Q wave in the past six months, or ST segment depression (\\>3 mm) on the electrocardiogram;\n* Terminal stage oncological or organic disease (e.g., Child-Pugh C cirrhosis, stage V renal disease, GOLD stage D chronic obstructive pulmonary disease, end-stage heart failure);\n* Residence in a nursing home before hospital admission;\n* Presence of dissected aortic aneurysm, severe aortic stenosis, acute endocarditis\u002Fpericarditis, acute thromboembolism, uncontrolled hypertension (\\>180\u002F100 mmHg) or postural hypotension, uncontrolled hypoglycemia, recent fracture within the last month, or any other medical condition that hinders the execution of physical activity according to clinical judgment;\n* Any condition that prevents safe participation in the intervention and\u002For cooperation with the study;\n* Concurrent participation in other clinical studies;\n* Clinical conditions or situations significantly different from the condition under study, which in the investigator's opinion could interfere with the study or prevent optimal participation;\n* Participants refusal to participate in the study.","70 Years",{"count":59,"type":20},288,[23],"The aim of this study is to assess whether a multidomain, multidisciplinary intervention (MDI), enhanced by technological solutions, effectively improves the functional and cognitive status of older hospitalized patients at risk of disability or worsening frailty. Additionally, the study will evaluate the feasibility and acceptability of delivering these interventions remotely via technology after hospital discharge.\n\nParticipants will:\n\n* Receive an MDI during their hospital stay and continue with remote at-home support for 3 months, or receive usual care.\n* Attend outpatient clinics for follow-up assessment at 3 and 6 months.",[26,63],"Aging",[65,26,66,67,68,69,70,71,72],"Hospital Acquired Disability","Comprehensive Geriatric Assessment","Prevention","Integrated Multidomain Interventions","Telemedicine","Telemonitoring","Outcomes","Hospital","RECRUITING","2026-05-22",{"date":76,"type":41},"2026-05-28",{"date":78,"type":41},"2024-12-01",{"date":80,"type":20},"2027-01-01",{"name":82,"class":48},"University of Milano Bicocca",1,{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":16,"minAge":92,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":83},"100446300","translation-and-cultural-adaptation-of-the-groningen-frailty-indicator-gfi-in-patients-with-hip-fracture-100446300","NCT05091645","Translation and Cultural Adaptation of the Groningen Frailty Indicator (GFI) in Patients With Hip Fracture","Translation and Cultural Adaptation of the Greek Version of the Groningen Frailty Indicator (GFI) in Patients With Hip Fracture; a Prospective Cohort Study","Gr-GFI","Inclusion Criteria:\n\n* adult patients over 65 years old with hip fractures undergoing surgery\n* an ASA (American Society of Anesthesiologists) PS (physical status) I to III\n* non-institutionalized\n* able to communicate orally or in writing\n* consent to participate\n\nExclusion Criteria:\n\n* refused to participate\n* pathological hip fractures\n* institutionalized\n* patients with hip fracture treated conservatively\n* patients with severe cognitive dysfunction\n* patients with insufficient knowledge of the Greek language","65 Years",{"count":94,"type":20},89,"OBSERVATIONAL","This study attempts to the translation and the cultural adaptation of the Groningen Frailty Indicator (GFI) questionnaire in the Greek population in patients suffering from hip fracture.",[26,98],"Hip Fractures",[26,100,101,102],"Hip fractures","Cultural adaptation","Translation","2026-05-03",{"date":105,"type":41},"2026-05-07",{"date":107,"type":41},"2022-02-25",{"date":109,"type":20},"2026-11-15",{"name":111,"class":48},"University of Thessaly",{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":16,"minAge":92,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":83},"100640906","feasibility-and-effects-of-inspiratory-muscle-training-combined-with-blood-flow-restriction-for-frail-older-adults-100640906","NCT07573995","Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults","Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Community-dwelling adults aged 65 years and older who are classified as at least \"vulnerable\" using the Clinical Frailty Scale (score ≥4).\n* Participants must have no cognitive impairment and be able to follow commands, as assessed by the Mini-Mental State Examination (MMSE).\n\nExclusion Criteria:\n\n* (1) are unable to participate in exercise (e.g., due to severe musculoskeletal disorders)\n* (2) have high-risk factors for exercise, such as uncontrolled hypertension (\\>150 mmHg systolic blood pressure (SBP) \u002F \\>90 mmHg diastolic blood pressure (DBP), coagulation disorders, and deep venous thrombosis\n* (3) have hematological disorders or are using hematology related-medications\n* (4) have significant comorbidities, including a history of stroke, diabetes with severe complications, or cardiovascular diseases\n* (5) chronic lung conditions (e.g., obstructive pulmonary disease, asthma), and\n* (6) have participated in a structured exercise training program within the past 3 months at a frequency exceeding three sessions per week.",{"count":120,"type":20},30,[23],"This randomized controlled trial study aims to evaluate the feasibility and preliminary efficacy of a combined inspiratory muscle training (IMT) and blood flow restriction (BFR) intervention in frail older adults. Outcomes of interest include feasibility, physical function, respiratory muscle strength, handgrip strength, five-times sit-to-stand performance, body composition, frailty level, fall efficacy, blood pressure, and adverse events.",[26,124,125,126],"Older Adults","Blood Flow Restriction (BFR) Training Effects","Inspiratory Muscle Training",[34,128,129,130],"older adults","blood flow restriction","inspiratory muscle training","2026-05-01",{"date":105,"type":41},{"date":134,"type":20},"2026-05",{"date":136,"type":20},"2026-10",{"name":138,"class":48},"Taipei Medical University",{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":149,"conditions":150,"keywords":156,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":83},"100619531","the-effect-of-volunteer-engaged-lifestyle-optimisation-via-icope-on-sarcopenia-in-older-adults-velo-s-100619531","NCT07345832","The Effect of Volunteer-Engaged Lifestyle Optimisation Via ICOPE on Sarcopenia in Older Adults (VELO-S)","The Effect of Volunteer-Engaged Lifestyle Optimisation Via ICOPE on Sarcopenia in Older Adults (VELO-S): A Randomised Controlled Trial","Inclusion Criteria:\n\n1. aged 60 or above\n2. Pseudo-Sarcopenia as indicated by a score on SARC-CaIF ≥11, OR sarcopenia according relative BIA-based appendicular skeletal mass\u002F height (Men: \\\u003C7 kg\u002Fm2; women: \\\u003C5.7 kg\u002Fm2), OR handgrip strength on dominant hand (male \\\u003C28 kg, female \\\u003C18 kg) (Chen et al., 2025)\n3. the ability to use a smartphone, electronic tablet, or computer\n4. consent to participate\n\nExclusion Criteria:\n\n1. having medical conditions contradictory to physical activity including unstable cardiovascular and orthopaedic conditions\n2. engaging in other structured health promotion program involving physical activity and nutritional enhancement",{"count":147,"type":20},200,[23],"Sarcopenia prevention and management are highly prioritised goals in the Healthy Ageing agenda. The study aims to: 1) evaluate the effects of the digital-enhanced, volunteer-engaged collaborative care pathway to improve sarcopenia, reduce fall risk, and increase health-related quality of life (HRQL) among community-dwelling older adults with risk of, or diagnosed with, sarcopenia; 2) evaluate whether the volunteers who received health coach capacity training and supported the intervention experienced health benefits across time; 3) explore the engagement experiences and perceived effects of elderly participants with sarcopenia during the program; 4) evaluate the intervention implementation process and effects from the perspectives of social care workers.",[151,152,153,26,154,155],"Sarcopenia","Sarcopenia in Elderly","Fall Prevention in Healthy Aging","Malnutrition Elderly","Frailty",[157,158,34,159,160,161,162],"sarcopenia","elderly","fall prevention","malnutrition","health-related quality of life","digital intervention","2026-04-30",{"date":105,"type":41},{"date":166,"type":20},"2026-06-01",{"date":168,"type":20},"2027-09-30",{"name":170,"class":48},"The University of Hong Kong",{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":178,"sex":16,"minAge":179,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":182,"conditions":183,"keywords":187,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":4},"100635727","longitudinal-assessment-of-lung-function-and-respiratory-muscle-strength-following-training-of-the-inspiratory-muscles-in-frail-older-adults-imt-3-100635727","NCT07556445","Longitudinal Assessment of Lung Function and Respiratory Muscle Strength Following Training of the Inspiratory Muscles in Frail Older Adults (IMT-3)","Longitudinal Assessment of Lung Function and Respiratory Muscle Strength Following Training of the Inspiratory Muscles in Frail Older Adults: A Randomized, Double-Blind, Sham-Controlled Trial","Inclusion Criteria:\n\n* Adults aged 80 years or older.\n* Clinical diagnosis of frailty, defined by a Short Physical Performance\n* Battery (SPPB) score \\\u003C 9.\n* Ability to stand and walk with or without assistive devices.\n* Ability to understand and follow instructions for inspiratory muscle training.\n* Stable medical condition for at least 3 months prior to enrollment.\n* Capacity to provide informed consent or availability of a legal\n\nExclusion Criteria:\n\n* Severe cognitive impairment that prevents understanding the procedures.\n* Diagnosis of neuromuscular diseases affecting respiratory muscles (e.g., ALS, myopathies).\n* Severe or uncontrolled hypertension (≥180\u002F110 mmHg).\n* Recent thoracic or abdominal surgery (\\\u003C3 months).\n* Severe musculoskeletal disorders limiting participation in training.\n* History of recurrent syncope, severe dizziness, or intolerance to respiratory maneuvers.\n* Any condition judged by the research team to compromise safety or participation.",true,"80 Years",{"count":120,"type":20},[23],"This study aims to evaluate the effects of an 8-week inspiratory muscle training program on lung function and respiratory muscle strength in frail older adults aged 80 years and above. Frailty is associated with reduced physical capacity, declines in functional performance, impaired respiratory performance, and a higher risk of disability. Inspiratory muscle training is a simple, low-cost intervention that may improve breathing function, inspiratory muscle strength, and overall health in very old adults, but evidence in this age group remains limited. Participants will be randomly assigned to one of two groups: a high-load inspiratory muscle training group or a low-load sham training group. Both groups will use a threshold device and perform 30 breaths once per day, five days per week, for eight weeks. The experimental group will train with progressively increasing resistance (50% to 80% of maximal inspiratory pressure), while the sham group will use a minimal and non-progressive load (15% of maximal inspiratory pressure). All sessions will be supervised and monitored for safety. The main goal of the study is to determine whether inspiratory muscle training improves maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP) and lung function. These outcomes will allow the evaluation of the clinical relevance of improvements in respiratory muscle strength in this population.\n\nAssessments will be performed before the intervention, immediately after the 8-week program, and again at one and three months after the end of the intervention to examine both immediate and short-term effects. This study may contribute valuable evidence regarding the safety, feasibility, and clinical benefits of inspiratory muscle training in frail very old adults, particularly its impact on respiratory muscle strength and lung function, supporting its potential implementation in rehabilitation and geriatric care.",[26,184,185,186],"Geriatric Health","Respiratory Muscle Weakness","Age-Related Frailty",[126,124,188,189],"Lung Function","Respiratory Muscle Strength","2026-04-29",{"date":163,"type":41},{"date":193,"type":20},"2026-05-20",{"date":195,"type":20},"2026-12-01",{"name":197,"class":48},"Universidad Francisco de Vitoria",{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":21,"phases":207,"briefSummary":208,"conditions":209,"keywords":213,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":83},"100628708","multimodal-prehabilitation-of-frail-patients-undergoing-elective-knee-or-hip-replacement-100628708","NCT07465159","Multimodal Prehabilitation of Frail Patients Undergoing Elective Knee or Hip Replacement","Multimodal Prehabilitation of Frail Patients 70 Years and Older Undergoing Elective Knee or Hip Replacement: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged 70 years or older assigned to undergo hip\u002Fknee replacement at Landspítali University Hospital.\n* Inclusion will be offered to patients who have previously presented at the outpatient orthopedic department and been scheduled for an elective (with a waiting period ≥2 months before surgery) hip\u002Fknee replacement.\n* Patients who are willing to participate and sign informed consent and are willing to be randomized to the control or intervention arm.\n\nExclusion Criteria:\n\n* Patients who screen negative for all frailty tools will be excluded from the study.\n* Patients who are already in active physiotherapy, meeting with a physiotherapist \\>1 every month, will also be excluded.\n* In addition, those who do not undergo planned surgery, are undergoing redo hip\u002Fknee prosthesis replacement will be excluded",{"count":206,"type":20},50,[23],"Background: Frailty is a geriatric syndrome of reduced physiologic reserve that increases surgical risk and is common among older adults undergoing hip or knee replacement. While prehabilitation has shown promise in enhancing outcomes, evidence from randomized controlled trials (RCTs) in frail orthopedic patients is limited.\n\nObjective: This study aims to evaluate the feasibility and preliminary data on the effectiveness of a multimodal prehabilitation program for frail patients undergoing elective hip or knee arthroplasty.\n\nMethods: A pilot RCT will be conducted at Landspítali-University Hospital. Patients ≥70 years scheduled for surgery with ≥2 months waiting time will be screened for frailty using PRISMA-7, the Clock Drawing Test, and Timed Up \\& Go. Patients screening positive for any of the three screening tools will be randomized to multimodal prehabilitation or standard of care. The intervention includes comprehensive geriatric assessment, medication review, tailored physiotherapy using the Otago Exercise Programme, and nutritional counseling if at risk of malnutrition. We will conduct an external pilot for feasibility measures (overall enrollment, recruitment, retention, adherence). Secondary outcomes include physical performance, postoperative complications, patient-reported health status (WOMAC scale) and quality of life (EQ-5D-5L ), length of primary hospital stay, discharge location, falls postoperatively, 180-day readmission and 180-day mortality.\n\nSignificance: This trial may aid in the design of larger RCT study and provide a signal of the role of multimodal prehabilitation on outcomes, including quality of life and health status among frail arthroplasty patients.",[26,210,211,212],"Prehabilitation","Arthroplasties, Knee Replacement","Arthroplasties, Hip Replacement",[155,214,210,215,216,217],"Arthroplasty","Multimodal prehabilitation","Knee replacement","Hip replacement","2026-04-01",{"date":220,"type":41},"2026-04-07",{"date":222,"type":41},"2026-03-20",{"date":224,"type":20},"2027-12-31",{"name":226,"class":48},"University of Iceland",{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":21,"phases":237,"briefSummary":239,"conditions":240,"keywords":241,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":83},"100628529","phase-1-a-study-to-evaluate-the-safety-and-tolerability-of-intravenous-stemis-in-elderly-subjects-with-mild-to-moderate-frailty-syndrome-100628529","NCT07462819","A Study to Evaluate the Safety and Tolerability of Intravenous Stemis™ in Elderly Subjects With Mild to Moderate Frailty Syndrome","A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-Escalation Study to Evaluate the Safety and Tolerability of Stemis™ Administered Intravenously in Elderly Subjects With Mild to Moderate Frailty Syndrome","Inclusion Criteria:\n\nSubjects will be eligible for enrollment in the study only if they meet all the following criteria at time of Screening:\n\n1. Subjects aged ≥ 60 through ≤ 85 years old.\n2. Subjects with clinical diagnosis of mild to moderate FS as assessed by the Investigator with a CFS score between 4 to 6.\n3. Subjects will not start any new treatment for this condition during the study.\n4. Subjects with body weight between 40 to 90 kg.\n5. Subjects are willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria at time of Screening will be excluded from enrollment:\n\n1. Subjects unwilling or unable to perform any of the assessments required by endpoint analysis.\n2. Subjects who have a diagnosis of any disabling neurologic disorder including, but not limited to: Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, stroke or dementia.\n3. Subjects who have a score on the Mini-Mental State Examination (MMSE) of 24 or below.\n4. Subjects who have a significant comorbid medical condition(s) including, but not limited to:\n\n   * Severe kidney disease requiring hemodialysis or peritoneal dialysis.\n   * Advanced liver diseases such as severe liver cirrhosis.\n   * Severe congestive heart failure (NYHA class 3 and 4).\n   * Severe pulmonary dysfunction, including severe chronic obstructive pulmonary disease stage III or IV (Gold classification)\n5. Subjects who have a history of deep venous thrombosis or pulmonary embolism, known hypercoagulability, or known family history of thromboembolic disease.\n6. Subjects who have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively treated basal cell carcinoma or in situ carcinomas.\n7. Subjects using chronic immunosuppressant therapy, including corticosteroids (\\> 5 mg\u002Fday of prednisone, or equivalent), or TNF-alpha antagonists.\n8. Subjects on chronic immunosuppressive transplant therapy.\n9. Subjects who have participated in another clinical study of new investigational therapies within 6 months prior to screening.\n10. Subjects who have received any other stem cell therapy within 12 months prior to screening.\n11. Subjects with known allergies or hypersensitivity to any component of the formulation and cellular therapies (i.e., penicillin or streptomycin).\n12. Subjects who have a history of drug or alcohol abuse within the past 3 years.\n13. Subjects who are known to be infected with Human Immunodeficiency Virus (HIV).\n14. Subjects are currently hospitalized.\n15. Subjects who have a significant illness as judged by principal investigator (PI) including, but not limited to:\n\n    * Psychiatric illness\n    * Uncontrolled hypertension or hypotension\n    * Unstable cardiac arrhythmia\n    * Active Hepatitis B, Hepatitis C infections\n16. Subjects who have any condition that in the opinion of the PI limits lifespan to \\\u003C 1 year.\n17. Subjects who have any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.\n\n    \\-","85 Years",{"count":236,"type":20},12,[238],"PHASE1","This is a Phase 1 clinical study designed to evaluate the safety and tolerability of an investigational cell therapy product, Stemis™, in older adults with mild to moderate frailty.\n\nFrailty is a condition commonly seen in older adults and may include decreased strength, slower walking speed, and reduced ability to perform daily activities. Currently, there is no specific drug treatment approved for frailty.\n\nStemis™ is an investigational product made from human umbilical cord-derived mesenchymal stem cells. This product has been evaluated for safety in nonclinical studies and in clinical studies for other conditions.\n\nApproximately 12 participants between 60 and 85 years of age who have been assessed as having mild to moderate frailty will take part in this study. Participants will be randomly assigned to receive either Stemis™ or a placebo (saltwater solution). The study is double-blind, meaning that neither the participants nor the study staff will know which treatment is given.\n\nThe study treatment will be administered by intravenous infusion. During the study, participants will be closely monitored for safety, including the occurrence of adverse events, vital signs, laboratory tests, and physical examinations. In addition, assessments such as walking ability, hand grip strength, and quality-of-life questionnaires will be performed as exploratory measures.\n\nThis study is not intended to provide direct medical benefit to participants. The primary purpose of the study is to collect safety information to support future clinical research.",[26],[155,26,242],"MSC","2026-03-17",{"date":245,"type":41},"2026-03-19",{"date":247,"type":20},"2026-04",{"date":249,"type":20},"2028-12",{"name":251,"class":252},"Ji Yan Biomedical Co., Ltd.","INDUSTRY",{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":178,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":260,"targetDuration":262,"studyType":95,"phases":4,"briefSummary":263,"conditions":264,"keywords":269,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":83},"100627717","modified-essential-frailty-toolset-in-older-adults-undergoing-major-elective-surgery-100627717","NCT07452263","Modified Essential Frailty Toolset in Older Adults Undergoing Major Elective Surgery","Modified Essential Frailty Toolset for Predicting Postoperative Complications and Readmission in Older Adults Undergoing Major Elective Surgery","Inclusion Criteria:\n\n* Patients ≥ 70 years who present for preoperative work-up at the admissions department at Landspitali and undergo frailty screening.\n* Patients assigned to undergo major surgery\n\nExclusion Criteria:\n\n* Cardiac surgery\n* Not undergoing planned surgery",{"count":261,"type":20},250,"6 Months","Frailty is a common geriatric syndrome associated with reduced physiological reserve and increased vulnerability to surgical stress. As the population ages, more older adults undergo major elective surgery, yet frailty is often insufficiently assessed in routine practice and no universally accepted screening tool exists.\n\nThe Essential Frailty Toolset (EFT) is a simple validated frailty assessments and has demonstrated strong predictive value for mortality and major postoperative complications, particularly in cardiac surgery populations. EFT incorporates four key domains of cognition, anemia, serum albumin, and physical function capturing both physical and cognitive vulnerability. A modified version (mEFT) has been developed to improve feasibility and applicability in broader surgical settings, requiring minimal training and only a few minutes to administer. Despite its promise, mEFT has not been evaluated in elderly patients undergoing major elective non-cardiac surgery, representing an important gap in the current literature and motivating the present study.\n\nWe therefore propose a modified and simplified frailty screening tool tailored for elderly patients undergoing major elective non-cardiac surgery at our institution. The modified Essential Frailty Toolset (mEFT) is a multi-dimensional assessment designed to address this gap by evaluating physical function, cognition, nutrition, and anemia in just a few minutes. In this version, the tool assigns points based on specific clinical markers: the Timed Up and Go (TUG) test provides one point for a time ≥11.0 seconds and two points for ≥15.0 seconds; the Clock Drawing Test (CDT) provides one point for a score of ≤2 on a 3-point scale; nutritional risk is captured with one point for a BMI \\\u003C22.0 or unintentional weight loss of 5% over the last six months; and anemia provides one point based on hemoglobin levels (below 130g\u002FL for men and 120 g\u002FL for women). These modifications were made to enhance feasibility and clinical relevance in our population. Low serum albumin was rare in our cohort and therefore demonstrated limited discriminatory value as a screening marker. In contrast, low BMI and recent weight loss are well-established risk factors for malnutrition and sarcopenia and are readily obtainable in routine preoperative assessment. Similarly, both the TUG and CDT are quick, inexpensive, and require minimal training, making them well suited for large-scale screening in preoperative clinics.Importantly, the proposed components have been evaluated in a pilot study conducted in our institution.\n\nThis study will evaluate whether a high mEFT score (≥3) is associated with increased postoperative complications and 90-day readmissions among patients aged ≥70 years undergoing major elective surgery. Patients presenting for admission will be included. If mEFT accurately identifies high-risk patients, it may improve preoperative risk stratification, inform shared decision-making, and help identify individuals who could benefit from targeted prehabilitation, supporting broader implementation of frailty screening in surgical care.",[265,26,266,267,268],"Frailty in Adult Surgery","Elective Surgeries","Readmission Rates","Postoperative Complication",[155,270,271,272,273,274],"Postoperative Outcomes","Major elective surgery","Surgical Frailty","Readmission","Complications","2026-03-06",{"date":277,"type":41},"2026-03-10",{"date":279,"type":41},"2025-01-20",{"date":281,"type":20},"2026-12-31",{"name":226,"class":48},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":178,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":290,"targetDuration":292,"studyType":95,"phases":4,"briefSummary":293,"conditions":294,"keywords":296,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":302,"leadSponsor":304,"locationsCount":83},"100621223","validity-of-frailty-screening-tools-as-a-measure-for-postoperative-outcomes-100621223","NCT07367828","Validity of Frailty Screening Tools as a Measure for Postoperative Outcomes","Feasibility and Validity of Frailty Screening Tools as a Measure of Postoperative Outcomes in Older Patients Undergoing Elective Surgery","Inclusion Criteria:\n\n* Patients ≥ 70 years who present for preoperative work-up at the anesthesia department at Landspitali.\n* Patients assigned to undergo intermediate\u002Fmajor surgery\n\nExclusion Criteria:\n\n* Not undergoing planned surgery",{"count":291,"type":20},350,"1 Year","Frailty is a common geriatric syndrome defined as a clinical state of decreased physiologic reserve resulting in increased vulnerability to stressors. It is associated with several unfavorable postoperative complications independent of age such as readmission, length of hospital stay and mortality. To address these concerns, medical societies have acknowledged a need for routine screening to identify elderly patients who are at high risk for major complications before undergoing surgery.\n\nIn the absence of a golden standard for frailty assessment, there are multiple assessment tools available. However, the challenge with many frailty tools is that they can be time-consuming, and require expertise and clinical training.This poses a challenge for screening a large elderly population before surgery. Some frailty assessment tools, such as PRISMA7 (The Program of Research to Integrate Services for the Maintenance of Autonomy), timed up and go (TUG) and the clock drawing test (CDT), have been demonstrated to be quick, simple and easy to use with minimal training.\n\nThe PRISMA-7 is a frailty screening questionnaire that consists of seven dichotomous items considering age, gender, health problems that affect activities of daily living (ADLs), assistance from others with ADLs, having to count on someone if needed, and the use of mobility aids.\n\nThe TUG test is used for assessing fall risk and frailty in older patients. It is measured by the time it takes an individual to stand up from a seated position, walk three meters and return back to a seated position. There is no standard cut-off for TUG, however, a cut-off of \\> 10 seconds has been used to identify frailty.\n\nCognitive impairment in older surgical patients may predispose patients to executive dysfunction that many elderly patients experience postoperatively and has shown to be a risk factor for surgical complications. Some studies suggest a strong relationship between cognitive impairment and physical frailty resulting in cognitive frailty when evaluating older adults.The CDT has shown to be a valuable screening tool for cognitive concerns. When administering the CDT, a patient receives instructions to draw a clock. Performing the test requires auditory comprehension, planning, sustained attention, visual-spatial skills and executive skills.\n\nThe prevalence of surgical frailty in Iceland has not been researched thoroughly enough to provide an accurate estimate. This is important to reveal the number of senior surgical patients at high risk of adverse postoperative outcomes who could benefit from a preoperative intervention. However, there is a lack of consensus on an optimal frailty assessment to screen patients for identifying frail patients prior to surgery, and more research is needed to evaluate which group of patients would benefit the most from prehabilitation.\n\nThe scientific value of this study is to elucidate the extent of frailty risk and its associated postoperative outcomes in older surgical patients undergoing elective surgery. We opt to find a convenient screening routine prior to surgery to identify patients at risk of frailty. Therefore, the study aims to validate three frailty screening methods and to assess a positive screening result as an independent risk factor for adverse postoperative outcomes in a cohort of elderly surgical patients undergoing elective surgery. We hypothesize that elderly patients at risk of frailty have a higher rate of surgical complications than patients not at risk of frailty.\n\nPatients aged ≥ 70 years who undergo elective surgery will be prospectively examined at the Department of Anesthesiology and Critical Care of Landspítali. The screening assessments to be evaluated are the Program of Research to Integrate Services for the Maintenance of Autonomy (PRISMA-7), a combination of Timed Up \\& Go (TUG), Clock Drawing Test (CDT) and the FRAIL questionnaire, and a combination of PRISMA-7, TUG and CDT. Additional clinical data and outcomes will be obtained from the electronic medical records of Landspítali. The postoperative outcomes measured will be 180-day mortality, surgical complications, 90-day readmission, delirium, non-home discharge and length of hospital stay.\n\nPatients who screen positive on the CDT (≤ 2\u002F3 points) and TUG (≥ 11 seconds) will be considered frail. Those who do not screen positive on both of these tests will be part of the control group (non-frail).",[265,26,295],"Elective Surgery",[155,270,271,272,297],"Intermediate elective surgery","2026-01-19",{"date":300,"type":41},"2026-01-26",{"date":279,"type":41},{"date":303,"type":20},"2026-12-21",{"name":226,"class":48},{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":16,"minAge":312,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":21,"phases":315,"briefSummary":316,"conditions":317,"keywords":319,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":83},"100619704","real-world-evidence-to-assess-the-value-of-a-digital-care-coordination-and-monitoring-program-for-supporting-caregivers-of-adults-discharged-from-the-emergency-department-100619704","NCT07348081","Real World Evidence to Assess the Value of a Digital Care Coordination and Monitoring Program for Supporting Caregivers of Adults Discharged From the Emergency Department.","RW-HOMECARE","Inclusion Criteria:\n\nFOR THE PATIENT\n\n* Person aged 18 or over, treated in the Emergency Department or Emergency Beds\n* Affiliated with Social Security\n* Having an adult non-professional relative helping them with one or more activities of daily living\n* Having a medical decision to return home within the next 72 hours\n* Who has given their free, informed, and express consent FOR THE CAREGIVER\n* Individuals aged 18 or older\n* Who are non-professional caregivers as defined in Article L. 113-1-3 of the Social Action and Families Code, living with or separately from the person being cared for (20)\n* Providing assistance to the patient with one or more activities of daily living, i.e., shopping, medical appointments, coordination of care, administrative tasks, and moral support\n* Access to a cell phone, computer, or tablet with an internet connection\n* Having given their free, informed, and express consent\n\nExclusion Criteria:\n\nFOR THE PATIENT\n\n* Non-French speakers\n* People living in a medical institution or scheduled for institutionalization within the next 3 months\n* People receiving home hospitalization (HAD) or palliative care at home\n* People under legal protection, deprived of their liberty, or under legal guardianship (tutelage or curatelle) FOR THE CAREGIVER\n* Non-French speakers\n* People with cognitive or psychiatric disorders that prevent them from understanding and using the MONKA solution\n* People under legal protection, deprived of their liberty, or under legal guardianship (tutelage or curatelle)","18 Years",{"count":314,"type":20},100,[23],"The RW-HOMECARE study is a prospective, longitudinal, real-world pilot trial designed to assess the impact of proposing the Monka digital solution to non-professional caregivers of patients discharged from emergency or short-stay units. The primary objective is to measure changes in caregiver burden using the ZBI-12 scale at baseline, 30 days, and 90 days. Secondary objectives include evaluating caregivers' physical and mental quality of life (SF-12), patient frailty (Clinical Frailty Scale), and the incidence of adverse events such as emergency visits, unplanned hospitalizations, falls, institutionalization, and death within 90 days. The study also examines the usability, acceptability, and satisfaction with Monka digital solution through standardized questionnaires, the correlation between algorithm-generated vulnerability scores and established measures, and reasons for non-adoption.\n\nEligible dyads (patient and caregiver) are recruited at discharge from emergency or short-stay units. After informed consent, caregivers receive free access to Monka digital solution for 3 months, along with a user guide. Follow-up assessments are conducted by phone at Day 30 and Day 90 (±14 days). All interventions by the coordinating nurse are tracked and analyzed quantitatively and qualitatively.",[26,318],"Caregiver Burden for Those Who Care for Adults With Impaired Functional Status",[320,321,322],"Frailty syndrome","Non-professional caregiver","Burden","2026-01-09",{"date":325,"type":41},"2026-01-16",{"date":327,"type":41},"2025-12-12",{"date":329,"type":20},"2027-03-12",{"name":331,"class":48},"Fondation Hôpital Saint-Joseph",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":16,"minAge":312,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":83},"100619000","physical-performance-assessment-in-kidney-transplant-evaluation-100619000","NCT07338929","Physical Performance Assessment in Kidney Transplant Evaluation","Physical Performance Assessment in Kidney Transplant Evaluation Using the Short Physical Performance Battery (SPPB)","FRAIL-KTx","Inclusion Criteria:\n\n1. Adult patients (≥18 years) undergoing evaluation for kidney transplantation.\n2. Patients on dialysis.\n3. Ability and consent to participate.\n\nExclusion Criteria:\n\n1. Non-adult patients.\n2. Patients unable to provide informed consent.\n3. Acute medical conditions prohibiting SPPB assessment.",{"count":206,"type":20},"This prospective cohort study investigates physical frailty, assessed by the Short Physical Performance Battery (SPPB), in patients evaluated for kidney transplantation. The study aims to compare SPPB scores before listing, annually during the waiting period, and after transplantation at 6 and 12 months. It also includes a control group of dialysis patients not eligible for transplantation to evaluate differences in physical performance. The goal is to understand how frailty impacts transplant outcomes and patient recovery.",[26],[344,345,34],"kidney transplantation","chronic kidney diseases","2026-01-06",{"date":348,"type":41},"2026-01-14",{"date":350,"type":41},"2025-10-01",{"date":352,"type":20},"2028-10-31",{"name":354,"class":48},"University Hospital, Martin",{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":16,"minAge":179,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":21,"phases":363,"briefSummary":364,"conditions":365,"keywords":366,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":4},"100618185","longitudinal-assessment-of-maximal-inspiratory-pressure-and-functional-capacity-following-inspiratory-muscle-training-in-frail-older-adults-imt-2-100618185","NCT07328334","Longitudinal Assessment of Maximal Inspiratory Pressure and Functional Capacity Following Inspiratory Muscle Training in Frail Older Adults (IMT-2)","Longitudinal Assessment of Maximal Inspiratory Pressure and Functional Capacity Following Inspiratory Muscle Training in Frail Older Adults: A Randomized, Double-Blind, Sham-Controlled Trial","Inclusion Criteria:\n\n* Adults aged 80 years or older.\n* Clinical diagnosis of frailty, defined by a Short Physical Performance Battery (SPPB) score \\\u003C 9.\n* Ability to stand and walk with or without assistive devices.\n* Ability to understand and follow instructions for inspiratory muscle training.\n* Stable medical condition for at least 3 months prior to enrollment.\n* Capacity to provide informed consent or availability of a legal\n\nExclusion Criteria:\n\n* Acute or unstable cardiovascular, respiratory, or metabolic conditions.\n* Severe cognitive impairment that prevents understanding the procedures.\n* Diagnosis of neuromuscular diseases affecting respiratory muscles (e.g., ALS, myopathies).\n* Severe or uncontrolled hypertension (≥180\u002F110 mmHg).\n* Recent thoracic or abdominal surgery (\\\u003C3 months).\n* Severe musculoskeletal disorders limiting participation in training.\n* History of recurrent syncope, severe dizziness, or intolerance to respiratory maneuvers.\n* Any condition judged by the research team to compromise safety or participation.",{"count":120,"type":20},[23],"This study aims to evaluate the effects of an 8-week inspiratory muscle training program on maximal inspiratory pressure and functional capacity in frail older adults aged 80 years and above. Frailty is associated with reduced physical capacity, declines in functional performance, impaired respiratory performance, and a higher risk of disability. Inspiratory muscle training is a simple, low-cost intervention that may improve breathing function, inspiratory muscle strength, and overall health in very old adults, but evidence in this age group remains limited.\n\nParticipants will be randomly assigned to one of two groups: a high-load inspiratory muscle training group or a low-load sham training group. Both groups will use a threshold device and perform 30 breaths once per day, five days per week, for eight weeks. The experimental group will train with progressively increasing resistance (50% to 80% of maximal inspiratory pressure), while the sham group will use a minimal and non-progressive load (15% of maximal inspiratory pressure). All sessions will be supervised and monitored for safety.\n\nThe main goal of the study is to determine whether inspiratory muscle training improves maximal inspiratory pressure (MIP), an established measure of global inspiratory muscle strength. Secondary outcomes include measures of functional capacity, reflecting the ability to perform physical tasks relevant to daily living in very old adults. These outcomes will allow the evaluation of the clinical relevance of improvements in inspiratory muscle strength in this population.\n\nAssessments will be performed before the intervention, immediately after the 8-week program, and again at one and three months after the end of the intervention to examine both immediate and short-term effects. This study may contribute valuable evidence regarding the safety, feasibility, and clinical benefits of inspiratory muscle training in frail very old adults, particularly its impact on inspiratory muscle strength and functional capacity, supporting its potential implementation in rehabilitation and geriatric care.",[26,184,185,186],[126,367,124],"Diaphragm Ultrasound","2026-01-03",{"date":323,"type":41},{"date":371,"type":20},"2026-02-01",{"date":373,"type":20},"2026-09-10",{"name":197,"class":48},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":16,"minAge":312,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":21,"phases":385,"briefSummary":386,"conditions":387,"keywords":392,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":83},"100521415","prehabilitation-in-pancreatic-surgery-100521415","NCT06069297","Prehabilitation in Pancreatic Surgery","Multimodal Prehabilitation in Localized Pancreatic Cancer Patients Undergoing Surgery: a Randomized Controlled Trial","PIPS","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Indication for curative resection for pancreatic or periampullary cancer\n* Signed Informed consent\n\nExclusion Criteria:\n\n* Metastatic or unresectable disease found preoperatively\n* Comorbidities contraindicating prehabilitation regimen (exercise and nutritional intervention) such as orthopedic, cognitive disabilities, chronic renal failure (dialysis or creatinine \\>250 mmol)\n* ASA score 4-5\n* Pregnancy\n* Illiteracy (inability to read and understand Italian language)",{"count":384,"type":20},238,[23],"In patients with pancreatic cancer, older age, multiple comorbidities, frailty, malnutrition and poor functional status are common, especially in individuals receiving neoadjuvant chemotherapy. These characteristics represent potentially modifiable risk factors for poor postoperative outcomes.\n\nThe goal of this clinical randomized controlled trial is to evaluate the extent to which a four-week multimodal prehabilitation program impacts on postoperative morbidity, functional and nutritional status and health-related quality of life in patients with localized pancreatic or periampullary cancer scheduled for curative surgery.\n\nIn addition, the impact of prehabilitation on circulating sarcopenia and cancer cachexia biomarkers in PDAC patients will be explored.\n\nIncluded patients will be randomized (ratio 1:1) and allocated either to the intervention group (Multimodal Prehabilitation), which will receive prehabilitation, or to the control group, which will receive no prehabilitation.",[388,389,26,390,391],"Pancreatic Cancer","Periampullary Cancer","Malnutrition","Perioperative\u002FPostoperative Complications",[210,393,394,395,396],"Physical function","Nutritional status","Functional capacity","Pancreatic cancer","2025-07-29",{"date":399,"type":41},"2025-08-01",{"date":401,"type":41},"2023-07-14",{"date":403,"type":20},"2027-05-31",{"name":405,"class":48},"IRCCS San Raffaele",{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":16,"minAge":92,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":21,"phases":414,"briefSummary":415,"conditions":416,"keywords":418,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":434},"100597606","effectiveness-of-immersive-virtual-reality-combined-with-occupational-therapy-in-reducing-fall-risk-and-frailty-among-older-adults-100597606","NCT07060677","Effectiveness of Immersive Virtual Reality Combined With Occupational Therapy in Reducing Fall Risk and Frailty Among Older Adults","VIRTO-FRAIL","Inclusion Criteria:\n\n* Individuals aged 65 years or older\n* Regularly attending rehabilitation treatment at the Bouco Madrid Ferraz Residence\n* Having the ability to walk with or without assistive devices\n* Presenting sufficient cognitive capacity to understand instructions (score ≥ 24 on the MMSE)\n* Agreeing to participate voluntarily\n* Signing the informed consent form.\n\nExclusion Criteria:\n\n* Having a diagnosis of a severe neurological disease (such as advanced Parkinson's disease or ALS, among others)\n* Having a history of epilepsy or seizures (due to potential adverse effects with VR)\n* Experiencing cardiovascular instability or having a medical contraindication for physical activity\n* Presenting vestibular disorders\n* Participating in other similar intervention programs during the same period\n* Being unable to use virtual reality glasses due to intolerance or dizziness\n* Not agreeing to participate voluntarily in the study and\u002For not signing the informed consent form.",{"count":120,"type":20},[23],"Population aging is a growing global phenomenon that poses significant challenges to healthcare systems, particularly in preventing falls and managing frailty among older adults. Falls remain a leading cause of morbidity and mortality in this population, affecting approximately one-third of individuals over 65 each year. At the same time, frailty syndrome (FS)-a clinical condition marked by progressive decline in physical and cognitive function-significantly increases the risk of falls, disability, and dependency. Pre-frailty, an intermediate and reversible stage, offers a key opportunity for preventive interventions.\n\nScientific evidence supports the effectiveness of interdisciplinary approaches to address frailty and fall prevention. In this context, occupational therapy plays a central role by promoting functional autonomy through meaningful activities. However, traditional approaches may be limited in individuals with low motivation or mild cognitive impairment. Therefore, integrating innovative technologies such as immersive virtual reality (IVR) emerges as a promising therapeutic strategy.\n\nIVR enables users to interact with simulated three-dimensional environments, enhancing cognitive stimulation, motor training, and treatment adherence. Modern devices like the Meta Quest 3 headsets provide accessible, safe, and adaptable immersive experiences, with reported benefits in balance, gait, attention, and motivation. Nonetheless, no studies to date have specifically evaluated the effectiveness of this technology when combined with conventional occupational therapy to reduce fall risk and frailty in older adults.\n\nThis project proposes a pilot randomized controlled trial (RCT), lasting 5 months, using a single-blind, parallel-group design. It will be conducted at the Bouco Madrid Ferraz Residential Center (Madrid, Spain), following CONSORT 2010 methodological guidelines. The primary aim is to assess the efficacy of a combined intervention using IVR through Meta Quest 3 headsets and occupational therapy, compared to conventional occupational therapy alone, in reducing fall risk, improving frailty status, enhancing quality of life, and increasing rehabilitation motivation in older adults.\n\nThe sample will include 30 participants (15 per group), selected based on specific inclusion and exclusion criteria. Participants will be randomly assigned to a control group (CG), receiving standard occupational therapy, or to an experimental group (EG), receiving a combined intervention of occupational therapy and IVR using the Kinesix XR platform, which is designed to enhance balance.\n\nThe intervention will last 8 weeks, with two one-hour sessions per week. The experimental group will receive 30 minutes of occupational therapy and 30 minutes of IVR per session. Assessments will be conducted at baseline, post-intervention, and at a 3-month follow-up using validated scales to measure fall risk, balance, frailty level, quality of life, and satisfaction.\n\nData will be pseudonymized, statistically analyzed using SPSS, and managed in compliance with the European General Data Protection Regulation (EU 2016\u002F679). The small sample size reflects the exploratory nature of the study, aimed at assessing feasibility, safety, and preliminary outcomes prior to conducting a larger-scale trial.\n\nUltimately, this project aims to provide initial evidence on an innovative intervention for older adults by integrating digital tools with conventional therapeutic approaches. If proven effective, the VIRTO-FRAIL model could lay the groundwork for new strategies in geriatric rehabilitation and fall prevention.",[26,417,153],"Older Adults, Balance",[419,420,421,422,124,423,424],"Inmersive Virtual Reality","Occupational Therapy","Frailty Sindrome","Fall Prevention","Pre-Frailty","Quality of Life","2025-07-10",{"date":427,"type":41},"2025-07-16",{"date":429,"type":20},"2025-09-15",{"date":431,"type":20},"2025-11",{"name":433,"class":48},"Universidad Rey Juan Carlos",2,{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":16,"minAge":92,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":21,"phases":445,"briefSummary":446,"conditions":447,"keywords":450,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":83},"100582963","cognitive-groove-brought-to-you-by-geras-dance-100582963","NCT06870149","Cognitive Groove (Brought to You by GERAS DANCE)","Does Cognitive Groove (Brought to You by GERAS DANCE) Improve Physical Performance in Community-Dwelling Older Adults With Frailty: A Parallel Randomized Controlled Trial","GERAS DANCE","Inclusion Criteria:\n\n* Community-dwelling aged ≥65 years\n* At high risk for mobility disability\u002Ffunctional limitations as assessed by the FRAIL Scale ≥2\n* Able to ambulate independently (25 m) with or without an assistive device\n* Able to follow two-step instructions\n* Medical clearance from referring clinician, or for self-referrals, medical clearance from family physician to safely participate in exercise\n* Can arrange transportation to the YMCA up to 2 times per week\n\nExclusion Criteria:\n\n* Unable to speak or understand English\n* Current regular participation in a structured exercise program or receiving active physical therapy services\n* Severe cardiac or pulmonary disease\n* Unstable angina or heart failure\n* Severe osteoarthritis (e.g., awaiting joint replacement)\n* Parkinson's disease or other progressive neurological disorder\n* Receiving palliative care\n* Travel\u002Fcommitments requiring missing more than two weeks","100 Years",{"count":261,"type":20},[23],"The goal of this clinical trial is to determine the effect of a community-based rehabilitation intervention (Cognitive Groove, Brought to you by GERAS DANCE), compared to usual care, on clinical outcomes in community-dwelling older adults living with frailty. The main questions it aims to answer are:\n\n1. In community-dwelling older adults living with frailty, is Cognitive Groove more effective than usual care in improving functional movement, physical performance and strength?\n2. In community-dwelling older adults living with frailty is Cognitive Groove more effective than usual care in improving frailty status, fear of falling, balance confidence, mood, cognition, grip strength, activities of daily living, life space mobility, loneliness, and quality of life?\n3. As a community-based rehabilitation intervention, is Cognitive Groove a cost-effective intervention embedded within the community for older adults living with frailty after 12-months?\n\nParticipants will participate in Cognitive Groove classes twice per week for 3 months or receive no intervention (usual care).",[155,448,449,26],"Frail Older Adults","Frailty in Aging",[155,451,452],"Rehabilitation","Dance","2025-06-27",{"date":455,"type":41},"2025-07-01",{"date":457,"type":41},"2025-06-10",{"date":459,"type":20},"2027-12",{"name":461,"class":48},"McMaster University",{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":16,"minAge":92,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":21,"phases":472,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":483,"leadSponsor":485,"locationsCount":4},"100564779","prehabilitation-of-frail-elderly-patients-undergoing-major-surgery-at-home-prepare-home-using-smart-wearables-100564779","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.",{"count":471,"type":20},190,[23],"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.",[26],[210,476,477,478],"Home-based","Perioperative Science","Wearable Technology","2025-05-12",{"date":481,"type":41},"2025-05-15",{"date":399,"type":20},{"date":484,"type":20},"2028-01-31",{"name":486,"class":48},"Singapore General Hospital",{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":178,"sex":16,"minAge":92,"maxAge":495,"enrollmentInfo":496,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":498,"conditions":499,"keywords":500,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":83},"100590327","the-cohorfes-a-prospective-study-of-frailty-and-dependence-100590327","NCT06965972","The CohorFES: a Prospective Study of Frailty and Dependence","Prospective Cohort for the Study of Phenotypic Clusters, Progression Paths and Outcomes of Frailty and Dependence: The Spanish CohorFES","COHORFES","Inclusion Criteria:\n\n* women and men 65 years old or above visited in the outpatient clinics of participant centers\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients in a critical situation of end of live or Barthel scale \\\u003C60.","120 Years",{"count":497,"type":20},1500,"Background Frailty has become a major problem for the health system, but also a window of opportunity to fight against disability through preventive strategies focused on the detection and treatment of frailty in all settings. However, no systematic strategies of screening and early detection are available in clinical settings. This project aims to identify clinical and biological phenotypic clusters that drive through the different stages of frailty and to describe the underlying mechanisms of the trajectories leading to disability and the potential for treatment. Moreover, validation of Frailty Trait Scale 5 (FTS5) will be performed as an easy model to be implemented in primary care and hospital scope.\n\nMethods\u002Fdesign A prospective population-based cohort will be stablished for frailty phenotyping (CohorFES). Creation of a CIBERFES Biobank where blood and urine samples from participants of CohortFES are stored for future researches. Demographic and clinical history data, anthropometric measurements, predimed questionnaire, peripheral blood biochemical variables and metabolomics were collected for each participant at baseline and every year until become frailty.\n\nUsing cluster partition models (k-means and hierarchical clustering) will group together individuals with similar deficits and characteristics (frailty phenotypes). Then, by using pre-established criteria (gap and silhouette), the proposed clustering solution (belonging to given clusters) will be evaluated. Further, investigators will assess, in a longitudinal fashion, the appearance and accumulation of deficits during the study period and identifying the clusters subgroups with more rapid progression. Results will be applied to establish and compare clusters and trajectories. Finally, frailty phenotypes and patient clusters will be correlated with health outcomes such as the use of health services (both primary and secondary care), hospital admissions, and mortality.\n\nDiscussion Information about clinical and biological phenotypic clusters that drive through the different stages of frailty can lead to identify potential targets that could improve the therapeutic management of these patients.\n\nIn summary, from a research perspective the project aims to better understanding of the interindividual variability in clinical events that lead to frailty, dependence and finally, to death.",[26],[493,155,501],"FTS5","2025-05-02",{"date":504,"type":41},"2025-05-11",{"date":506,"type":41},"2022-12-01",{"date":508,"type":20},"2035-12-31",{"name":510,"class":48},"Parc de Salut Mar",{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":515,"acronym":516,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":21,"phases":519,"briefSummary":520,"conditions":521,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":4},"100580854","effectiveness-of-post-hospital-discharge-housing-counselling-to-support-geriatric-patients-in-staying-at-home-a-pragmatic-randomised-controlled-trial-100580854","NCT06842719","Effectiveness of Post-Hospital Discharge Housing Counselling to Support Geriatric Patients in Staying At Home: a Pragmatic Randomised Controlled Trial","Frail@Home","Inclusion criteria:\n\n\\- Patients aged 70 and over who have been living at home up to now, with typical geriatric multimorbidity and a Barthel Index \\\u003C 70, who have been admitted to the Wolgast Centre for Geriatric Medicine and whose discharge destination is their own home again. The latter must be in the catchment area of the Wolgast Hospital.\n\nExclusion criteria:\n\n* Persons who are not able to understand the purpose of the study or who are not able to conduct business (e.g. severe dementia, delirium)\n* Patients in a palliative state in the terminal stage\n* Patients who are being discharged to a nursing home\n\nT",{"count":147,"type":20},[23],"Hospitalisation is often a disruptive event for older people, especially for geriatric patients with frailty. A critical factor for a successful return to one's own home is the living situation. Unfortunately, a large proportion of homes in Germany are not sufficiently accessible and often do no longer meet the needs of older residents with various health limitations. This can impair residents' functionality, increase the risk of falls, and restrict independence. Through timely housing advice and adaptation, including digital aids, more older people could be enabled to remain in their own homes with a high degree of safety despite their limitations (\"Aging in Place\").\n\nWhilst long-term care insurance provide funding for home environment improvements, this is often not utilised, in part due to a lack of advice. The effectiveness of housing counselling in stabilising the functional level of geriatric patients after hospital discharge and in preventing negative outcomes such as rehospitalisation, falls, nursing home placement or death has not been sufficiently investigated in the German health and social care system. The few available studies show that interventions related to the home environment can have positive effects on activities of daily living, fall risk and mental health. As the functional abilities of older patients are usually worse at the time of discharge than before hospitalisation, this is a good time to assess the home environment and the person-environment fit.\n\nIntegrating professional housing counselling into discharge management could make a significant contribution to increasing safety in the home environment, improving self-help skills and preventing falls and re-hospitalisation. This could improve quality of life and reduce the burden on the healthcare system. The Frail@Home trial is a single-centre, randomised, controlled pragmatic trial (RCT) to test whether housing counselling provided within two to four weeks of hospital discharge increases the chances of older people remaining in their familiar home environment. The intervention group will receive on-site housing counseling, while the control group will receive standard care plus an additional information booklet from the local housing counseling service. The primary endpoint of the study is the number of days spent at home (DSH) in the first 6 and 12 months after discharge from acute geriatric care. The follow-up period will be 12 months. If successful, this study will be the first to show, using RCT methods, that early housing counselling after hospital discharge supports the retention of geriatric patients in their familiar homes.",[26],"2025-02-18",{"date":524,"type":41},"2025-02-24",{"date":526,"type":20},"2025-03-01",{"date":528,"type":20},"2026-08-01",{"name":530,"class":48},"Maximilian König",{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":537,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":16,"minAge":539,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":21,"phases":541,"briefSummary":543,"conditions":544,"keywords":546,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":434},"100532109","phase-2-the-nadage-study-nicotinamide-riboside-replenishment-therapy-against-functional-decline-in-aging-100532109","NCT06208527","The NADage Study: Nicotinamide Riboside Replenishment Therapy Against Functional Decline in Aging","The NADage Study: a Randomized Double-blind Trial of NAD Replenishment Therapy on Aging","NADage","Inclusion Criteria:\n\n* Participant must understand the nature of the study and be able to provide written, informed consent.\n* Male or female aged ≥ 75 years at baseline.\n* Fried Frailty Phenotype score ≥ 3 to identify frail individuals.\n* Montreal Cognitive Assessment (MoCA) at screening adjusted to age, gender, and educational level, with a threshold set at the 10th percentile (z-score ≤ -1.28).\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Does not reside in a facility or institution.\n* Advanced disability, end-stage disease, presence of severe chronic illness and\u002For life expectancy of less than a year.\n* Inability to complete a 6-minute walk test (6MWT) and\u002For contraindications to the procedure (history of unstable angina or myocardial infarction within 30 days prior to the test).\n* Diagnosis of active malignancy in the last 2 years at baseline (exceptions include non-metastatic skin conditions and non-metastatic and\u002For treated prostate cancer with stable prostate-specific antigen (PSA) levels in six months prior to baseline). Specific considerations may apply depending on the type of cancer.\n* Significant neurological or psychiatric disorders, including but not limited to psychotic disorders, severe bipolar or unipolar depression, multiple sclerosis, uncontrolled seizure conditions, and neurodegenerative disorder.\n* A history of cerebrovascular events, excluding transient ischemic attack (TIA) that occurs more than 3 months prior to baseline.\n* Hospitalization or major surgery within 3 months prior to baseline.\n* Significant changes in medications or treatment plans made less than one month prior to baseline, judged by the site investigator to interfere with the subject's participation in the study.\n* Consumption of NAD precursor supplements (e.g., Nicotinamide riboside, nicotinamide mononucleotide or Vitamin B3), or related supplements within 6 months prior to baseline.\n* Elective surgeries scheduled during the study duration.\n* Concurrent participation in other clinical trials with interventions that could affect frailty measures.\n* Any medical history, at the discretion of the investigator, might hinder compliance with study procedures or increase risk to the participant.","75 Years",{"count":314,"type":20},[542],"PHASE2","This clinical study, designed as a double-blind, randomized, placebo-controlled trial, aims to investigate the potential of nicotinamide riboside (NR) to decelerate functional decline in the elderly frail population. In animal studies, NR, which is converted to nicotinamide adenine dinucleotide (NAD), has shown potential as a neuroprotective agent, with indications of protection against amyotrophic lateral sclerosis (ALS), Alzheimer's dementia, and Parkinson's disease. Furthermore, aging is commonly associated with decreased tissue NAD levels, a phenomenon linked to premature aging and a spectrum of age-related disorders, including cardiovascular diseases and cancers. Existing preclinical and clinical research highlights the promise of NAD replenishment through enhanced DNA repair, sirtuin activity, and improved mitochondrial function. The research center has conducted two phase II clinical trials on NR for Parkinson's disease (NAD-PARK and NR-SAFE), administering up to 3000 mg of NR daily. These trials have shown promising results, indicating NR's potential as a treatment that may alter the course of the disease and possibly as neuroprotective treatment in Parkinson's disease.\n\nThe NAD age trial primarily aims to determine:\n\n* The efficacy of NAD therapy in improving clinical symptoms of frailty, evaluated through standardized physical and cognitive function tests.\n* The safety of administering 2000 mg NR daily in an elderly frail population.\n\nThe study will include 100 individuals, classified as frail based on the Fried Frailty Phenotype. Participants will be randomly assigned to receive either 2000 mg of NR daily or a placebo. Over a 52-week period, participants will undergo:\n\n* Clinical evaluations, including actigraphy and questionnaires.\n* Cognitive assessments.\n* Bio sampling.\n* Magnetic resonance imaging (MRI).\n* Positron emission tomography (FDG-PET) scanning.\n\nThe outcomes of this study could potentially demonstrate that NR effectively reduces signs of frailty, offering considerable advantages to the individuals affected, their families, and society as a whole.",[155,545,26,63],"Frail Elderly Syndrome",[155,547,548,549,550,551,63,552],"Nicotinamide Riboside","NR","Nicotinamide adenine dinucleotide","NAD","Frail","Functional decline","2025-01-17",{"date":279,"type":41},{"date":556,"type":20},"2025-01",{"date":558,"type":20},"2030-12",{"name":560,"class":48},"Haukeland University Hospital",{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":16,"minAge":312,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":21,"phases":569,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":83},"100402744","frailty-and-physician-modified-fenestrated-endograft-for-thoracoabdominal-aortic-pathologies-100402744","NCT04524247","Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies","Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts","Inclusion Criteria:\n\n* Patients may be included in the study if the patient has at least one of the following indications and are anatomically appropriate for treatment with fenestrated\u002Fbranched stent grafts.\n\n  1. Pararenal, paravisceral, and type I to IV thoracoabdominal aortic aneurysms or chronic post-dissection aneurysms with a diameter 5cm or 2 times the normal aortic diameter.\n  2. Aneurysm with a history of growth ≥ 0.5cm per year.\n  3. Saccular aneurysms deemed at significant risk for rupture based on physician interpretation.\n  4. Symptomatic aneurysm without hemodynamic instability\n  5. Aneurysms meeting any of the above criteria 1\\~4, above or below the previous endovascular and\u002For open aortic repairs. Previously placed aortic stent graft or open aortic grafts may serve as seal zones.\n\nExclusion Criteria:\n\n* Patients must be excluded from the study if any of the following conditions is true:\n\n  1. Less than 18 years of age.\n  2. Unwilling to comply with the follow-up schedule.\n  3. Inability or refusal to give informed consent by the patient or a legally authorized representative.\n  4. Pregnant or breastfeeding.\n  5. Life-expectancy less than 2 years.\n  6. Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol and performed remotely from the fenestrated procedure (\\>30 days). Examples include remote (\\>30days) participation in a thoracic, or abdominal branch device trial.\n  7. Eligible for treatment with FDA-approved marketed device.\n  8. Eligible and willing to travel to a center with IDE protocol wherein the device is made by a manufacturer.",{"count":314,"type":20},[23],"The primary objective of this single arm, prospective feasibility study, Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts, is to assess the use of the physician-modified fenestrated\u002Fbranched endografts to repair thoracoabdominal and complex aortic aneurysms in subjects having appropriate anatomy, at high risks for open repairs. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 3 months, 6 months, 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).\n\nAdditionally, this study will assess the degree of patient frailty before and after the aneurysm repair, as well as the association between the preoperative baseline frailty and clinical outcomes detailed above. This will help improve subject selection in identification of high risk patients who would not only suffer poor clinical outcomes, but also experience decline in their functional status.",[572,573,574,26],"Thoracoabdominal Aortic Aneurysm","Thoracoabdominal; Aortic, Aneurysm, Dissecting","Pararenal Aneurysm","2024-06-28",{"date":577,"type":41},"2024-07-01",{"date":579,"type":41},"2021-02-23",{"date":581,"type":20},"2032-07-02",{"name":583,"class":48},"University of Southern California",{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":588,"acronym":34,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":16,"minAge":590,"maxAge":4,"enrollmentInfo":591,"targetDuration":292,"studyType":95,"phases":4,"briefSummary":593,"conditions":594,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":83},"100551981","comparison-of-frailty-screening-performance-and-predictive-validity-of-adverse-health-outcomes-in-breast-cancer-patients-using-frailty-screening-tools-100551981","NCT06467149","Comparison of Frailty Screening Performance and Predictive Validity of Adverse Health Outcomes in Breast Cancer Patients Using Frailty Screening Tools","Inclusion Criteria:\n\n* Clinical diagnosis of breast cancer\n* Age ≥50 years old\n* the treatment plan discussed by MDT includes surgery and chemotherapy\n* can walk on their own (with the assistance of walking aids)\n\nExclusion Criteria:\n\n* Communication disorders\n* Mental disorders that can't cooperate normally\n* Combined with other malignant tumours\n* Terminal stage of the disease","50 Years",{"count":592,"type":20},500,"This study uses the Physical Frailty Phenotype (PFP) as the diagnostic criterion for frailty and aims to explore the frailty screening scale FRAIL (The FRAIL Scale), Tilburg Frailty Index (TFI) and geriatric screening. Screening performance of Tool-8 (Geriatric-8, G-8) in breast cancer patients, to compare the predictive validity of different frailty screening scales for adverse health outcomes in breast cancer patients, and to select appropriate frailty screening methods for breast cancer patients in my country Screening scale.",[26],"2024-06-19",{"date":597,"type":41},"2024-06-24",{"date":599,"type":41},"2023-08-12",{"date":601,"type":20},"2025-12-30",{"name":603,"class":48},"Ju Qiu",{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":178,"sex":16,"minAge":92,"maxAge":4,"enrollmentInfo":612,"targetDuration":614,"studyType":95,"phases":4,"briefSummary":615,"conditions":616,"keywords":620,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":631,"locationsCount":83},"100375838","movement-and-behaviours-measurement-study-100375838","NCT04173715","Movement and Behaviours Measurement Study","Validation of Cut-points to Estimate Sedentary Time and Physical Activity Intensities in Older Adults","MOBEMENTS","Inclusion Criteria:\n\n* 65 years and older\n* Non-institutionalized\n* Physical function assessment (SPPB\\>3)\n\nExclusion Criteria:\n\n* Have started an exercise program.\n* Mini-Mental Score \\\u003C 18.\n* Presenting any physical activity contraindication.",{"count":613,"type":20},90,"1 Day","There are few studies that already have validated specific raw accelerometer cut-points for people over 65 years old.\n\nThe purpose of the present study is to validate raw accelerometer cut points for general people over 65 years old and specific raw accelerometer cut points based on the functional status of older adults over 65 years old.\n\nThe study will be carried out with an observational approach. Participants will be divided into 4 groups. First of them will be made grouping all subjects and the rest divided according to their functional status. They will perform different-intensity physical activities while wearing accelerometers attached to their body and wearing a portable gas analyser too. Their intensity will be assessed based on their own Rest Metabolic Rate (RMR). Energy expenditure and accelerations will be matched and, based on that, sedentary behaviour, light physical activity and moderate-to-vigorous physical activity cut-points will be derived.",[63,617,26,618,619],"Physical Function","Physical Disability","Lifestyle, Sedentary",[621,622,623,617,26,624,63],"Cut-Points","Accelerometry","Physical Activity Quantification","Energy Expenditure","2024-05-07",{"date":627,"type":41},"2024-05-08",{"date":629,"type":41},"2019-10-14",{"date":281,"type":20},{"name":632,"class":48},"University of Castilla-La Mancha",{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":642,"conditions":643,"keywords":646,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":83},"100524129","comprehensive-geriatric-assessment-in-kidney-transplantation-100524129","NCT06104696","Comprehensive Geriatric Assessment in Kidney Transplantation","CoGeriaTx","Inclusion Criteria:\n\n* kidney transplant candidates aged 60+ years\n* kidney transplant recipients aged 60+ years\n\nExclusion Criteria:\n\n* kidney transplant candidates aged below 60 years\n* kidney transplant recipients aged below 60 years",{"count":641,"type":20},1000,"This observational study aims to analyze the results of comprehensive geriatric assessment and to monitor the development of functional status in geriatric kidney transplant candidates and recipients.",[644,26,645],"Kidney Transplant; Complications","Depressive Syndrome",[344,32,34,647,648,649,650],"depression","pretransplant evaluation","comprehensive geriatric assessment","posttransplant","2023-10-23",{"date":653,"type":41},"2023-10-27",{"date":655,"type":41},"2020-01-02",{"date":657,"type":20},"2040-01-02",{"name":659,"class":660},"Institute for Clinical and Experimental Medicine","OTHER_GOV",{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":665,"acronym":666,"eligibilityCriteria":667,"healthyVolunteers":12,"sex":16,"minAge":590,"maxAge":4,"enrollmentInfo":668,"targetDuration":4,"studyType":21,"phases":670,"briefSummary":671,"conditions":672,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":83},"100435781","structured-program-of-exercise-for-recipients-of-kidney-transplantation-100435781","NCT04954690","Structured Program of Exercise for Recipients of Kidney Transplantation","SPaRKT","Inclusion Criteria:\n\n* On hemodialysis or peritoneal dialysis\n* Age ≥ 50 years\n* SPPB score ≤ 10\n* Telephone access\n* Internet access\n* Having a living donor kidney\n\nExclusion Criteria:\n\n* Already in an exercise program\n* Non-English speakers",{"count":669,"type":20},136,[23],"Older patients with end- stage kidney disease (ESKD) are at very high risk for functional impairment. Kidney transplantation (KT) has the potential to ameliorate the detrimental effects of ESKD on physical activity and functional status. However, KT alone may not meet the full extent of this potential, particularly for older or more impaired adults. In fact, activity declines immediately post-KT and fails to return to expected levels even 5 years post-KT. Older patients waitlisted for KT (most of whom are on dialysis) are therefore reliant on their pre-KT levels of exercise, which are also predictive of post-KT mortality.\n\n\"Prehabilitation\" has been used in other surgical populations to minimize functional loss, and a structured exercise program may be beneficial in the pre- KT setting. However, few waitlisted patients are able to participate in typical exercise interventions due to barriers such as severe fatigue. Older patients have additional barriers such as further mobility impairment and requiring substantial caregiver support. Therefore for older living donor kidney transplant candidates, it is necessary to address issues such as specifics of coaching, timing, and importantly, incorporate caregiver participation.\n\nThe overall objective of this proposal is to adapt a previously developed 8- week, home- based, structured exercise program among older (≥50 years) dialysis patients awaiting living donor KT, with a focus on caregiver involvement. The investigators will trial the exercise program as compared to usual care. The investigators will then pilot the refined intervention in a total of 72 patient-caregiver dyads, 48 of whom will undergo the proposed intervention (24 with caregiver participation, 24 without). The primary outcomes for the pilot will be change in physical performance and activity from baseline to after the intervention, along with measurements of exploratory quality of life outcomes. In addition, the investigators will measure these same outcomes at 3- months post KT to evaluate for a durable effect of the intervention. An additional post-transplantation outcome of interest will be number of days hospitalized within 3 months of transplantation.",[644,673,618,26],"Dialysis; Complications","2023-10-12",{"date":676,"type":41},"2023-10-16",{"date":678,"type":41},"2022-11-22",{"date":680,"type":20},"2029-07",{"name":682,"class":48},"University of California, San Francisco"]