[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595037":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":46,"locations":53,"responsibleParty":72,"collaborators":75,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":51,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":51,"enrollmentInfo":87,"targetDuration":51,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":100,"overallStatus":107,"whyStopped":51,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Royal College of Surgeons, Ireland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual Care","ACTIVE_COMPARATOR","This arm will assess all aspects of usual postoperative hip fracture care which will include multidisciplinary team assessment which include physiotherapists, occupational therapists, dieticians as well as specialist nurses and doctors working as part of the orthogeriatric team (falls and bone health assessment). They will receive daily physiotherapy training starting on the first postoperative day which will include mobility, balance, strength and gait training. This group will also receive additional protein supplementation in the form of a nutritional supplement twice daily as part of usual postoperative hip fracture care.\n\nAll patients will undergo baseline assessments including assessment of level of frailty, pre-fracture level of mobility \\& function, postoperative mobility, nutritional status\u002F screening, grip strength and level of pain.\n\nAll patients will be asked to maintain a three-day food diary to monitor their protein intake.",[13],"Other: Usual Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Exercise and Nutritional Intervention","EXPERIMENTAL","This arm will include and exercise and nutritional intervention in addition to usual postoperative hip fracture care.\n\nThe exercise program will be delivered 3-5 times per week, each session lasting between 20-30 minutes depending on patient tolerance. The program will be progressed gradually between sessions and be guided by patient tolerance. The program will involve bed\u002F chair-based aerobic and resistance training (using an arm crank ergometer, resistance bands and ankle weights). The program will be delivered over the entire length of a patient's hospital stay up to a duration of 6 weeks for prolonged stays.\n\nThe nutritional intervention will take the form of a protein fortified evening snack administered by nursing staff (additional 20g of protein).\n\nAll patients will undergo baseline assessments including assessment of level of frailty, pre-fracture level of mobility \\& function, postoperative mobility, nutritional status\u002F screening, grip strength and level of pain.",[19,20],"Behavioral: Exercise Intervention","Dietary Supplement: Nutritional Intervention",[22,30,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BEHAVIORAL","Exercise Intervention","This arm will include and exercise and nutritional intervention in addition to usual postoperative hip fracture care.\n\nThe exercise program will be delivered 3-5 times per week, each session lasting between 20-30 minutes depending on patient tolerance. The program will be progressed gradually between sessions and be guided by patient tolerance. The program will involve bed\u002F chair-based aerobic and resistance training (using an arm crank ergometer, resistance bands and ankle weights). The program will be delivered over the entire length of a patient's hospital stay up to a duration of 6 weeks for prolonged stays.\n\nAll patients will undergo baseline assessments including assessment of level of frailty, pre-fracture level of mobility \\& function, postoperative mobility, nutritional status\u002F screening, grip strength and level of pain.",[15],[28,29],"Strength and Resistance Training","Aerobic Training",{"type":6,"name":9,"description":11,"armGroupLabels":31,"otherNames":32},[9],[33],"Usual Postoperative Hip Fracture Care",{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DIETARY_SUPPLEMENT","Nutritional Intervention","The nutritional intervention will take the form of a protein fortified evening snack administered by nursing staff (additional 20g of protein).",[15],[40],"Protein Supplementation",[42],{"name":43,"affiliation":44,"role":45},"Niamh O'Regan, MB BCh BAO, B Med Sci, FRCPI","University Hospital Waterford","PRINCIPAL_INVESTIGATOR",[47],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Arveen Jeyaseelan, MB BCh BAO","CONTACT","+35351847557",null,"arveenjeyaseelan20@rcsi.com",[54],{"facility":44,"status":51,"city":55,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Waterford","X91ER8E","Ireland","IE",{"type":60,"coordinates":61},"Point",[62,63],-7.11194,52.25833,{"lat":63,"lon":62},[66,69,70],{"name":43,"role":49,"phone":67,"phoneExt":51,"email":68},"+35351848736","Niamh.ORegan5@hse.ie",{"name":43,"role":45,"phone":51,"phoneExt":51,"email":51},{"name":48,"role":71,"phone":51,"phoneExt":51,"email":51},"SUB_INVESTIGATOR",{"type":45,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"Arveen Jeyaseelan","Co-Investigator",[76],{"name":77,"class":6},"Health Service Executive, Ireland","100595037","frailty-intervention-in-postoperative-hip-fracture-inpatients-100595037",false,"NCT07027241","Frailty Intervention in Postoperative Hip Fracture Inpatients","Multicomponent Exercise and Nutrition Based Frailty Intervention in Postoperative Hip Fracture Inpatients","Inclusion Criteria:\n\n* Older adults \\>\u002F= 65\n* Clinical Frailty Score 4-6 (This includes patients with very mild, mild and moderate frailty. This would be in keeping with literature quoting frailty interventions where patients who are 'pre-frail' and frail are included)\n* Post fragility hip fracture (including subtrochanteric fracture)\n* Post hip fracture surgery (all types including total hip replacement, hemiarthroplasty, IM nailing)\n* Medically stable postoperatively\n* No weightbearing restriction\n* Mobile pre-admission (including aids and max assist of 1 person)\n\nExclusion Criteria:\n\n* Medically unstable (NEWS \\>3, unless a higher cutoff is stipulated by the primary medical researcher)\n* Non fragility hip fracture (fracture from non osteoporotic aetiology, pathologic fracture)\n* Hip surgery for other aetiology (prosthetic joint infection, arthritis, implant loosening, avascular necrosis, periprosthetic fracture)\n* Polytrauma\n* Delirium or severe cognitive impairment (as defined by inability to follow instructions and unable to provide informed consent)\n* Pre-existing neurologic or cardiovascular disorders that would affect participation\u002F compliance with exercise intervention\n* Open hip fracture\n* Other lower limb orthopaedic disorders that affect participation\u002F compliance with exercise intervention\n* Terminal illness with \\\u003C\u002F= 6 months to live\n* Active treatment for cancer (systemic chemotherapy or radiotherapy, patients on oral chemotherapeutic agents\u002F checkpoint inhibitors will be eligible for inclusion)\n* Nursing Home Resident\n* Severe lower limb pain post-op\n* Severe skin issues\u002F ulcers in non-operated lower limb that would preclude utilisation of ankle weights\n* Swallowing disorders\u002F difficulty\n* Renal impairment with eGFR \\\u003C30\n* Hepatic failure\n* Patients with a dairy\u002F soy allergy","ALL","65 Years",{"count":88,"type":89},50,"ESTIMATED","INTERVENTIONAL",[92],"NA","Hip fracture is a big health concern in older adults, and can lead to increased risk of death, reduced level of independence \\& mobility, reduced quality of life, and higher likelihood of admission to nursing homes. Frailty is a medical condition associated with ageing that results in a reduced ability to do daily tasks. A frail older adult is also less able to recover well from conditions that may affect their wellbeing (for example, infections, falls resulting in injuries or hospital admissions). Frailty is common in older adults with hip fractures.\n\nThere has been increasing research showing that frailty can be slowed down and improved by a combination of nutritional supplementation and exercise. However, most of the research in this area has been in frail older adults living at home or in nursing homes. The exercise or nutritional programs in these studies tend to be carried out over weeks or months. There are very few studies looking at older adults in hospital and how exercise and nutrition help with frailty over shorter periods of time, even more so in patients who have sustained an injury.\n\nThere is, however, very little research in hospital based frailty programs in older patients who have suffered major trauma. It is well known that standing up and starting to walk soon after a hip fracture improves time to recovery, reduces hospital length of stay and death. Hence, physiotherapy on the first day after hip fracture surgery is now recommended. However, there needs to be more research to aid in developing physiotherapy and exercise programs that are safe and doable in the care of hip fracture patients despite limited resources in our healthcare system.\n\nSimilarly, although malnutrition is common in frail older adults with hip fractures, the benefits of nutritional supplementation in these patients is not fully understood. It is known that having a hip fracture puts a person at risk of muscle breakdown and increasing protein intake is recommended to help reduce this risk. Research on exercise and nutrition based frailty programs specific to hip fracture patients is strongly needed, specifically the development of that are doable and safe in the hospital setting that can help improve outcomes in hip fracture patients after surgery.\n\nThe investigators believe that a multicomponent exercise and nutrition based frailty program will be safe, doable and acceptable in frail older adults after hip fracture surgery.",[95,96,97,98,99,40],"Hip Fractures (ICD-10 72.01-72.2)","Frailty at Older Adults","Strength Training","Resistance Training","Exercise Training",[101,102,103,104,105,106],"Hip fracture","Exercise","Nutrition","Protein supplementation","Strength and resistance training","Frailty","NOT_YET_RECRUITING","2025-06-16",{"date":110,"type":111},"2025-06-18","ACTUAL",{"date":113,"type":89},"2025-08-01",{"date":115,"type":89},"2026-02",{"name":5,"class":6},1]