[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595737":3},{"organization":4,"outcomesModule":7,"designInfo":83,"detailedDescription":88,"studyPopulation":88,"armGroups":93,"interventions":105,"overallOfficials":88,"centralContacts":88,"locations":114,"responsibleParty":148,"collaborators":152,"id":170,"slug":88,"hasResults":171,"nctId":172,"briefTitle":173,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":171,"sex":176,"minAge":177,"maxAge":88,"enrollmentInfo":178,"targetDuration":88,"studyType":181,"phases":182,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":117,"whyStopped":88,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},{"fullName":5,"class":6},"Wageningen University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":52},[9],{"measure":10,"description":11,"timeFrame":12},"Physical Functioning","The short physical performance battery (SPPB) is used to assess physcial functioning. This test is a performance test assessing lower extremity function using measures of gait speed (over 4 meter), standing balance, and lower extremity strength.","Physical performance measurements will be performed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.",[14,18,22,25,28,32,36,40,44,48],{"measure":15,"description":16,"timeFrame":17},"Handgrip strength","Handgrip strenght will be measured with a hand dynamometer (kg).","Handgrip strength will be measured at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.",{"measure":19,"description":20,"timeFrame":21},"Muscle mass","Muscle mass will be quantified using dual-energy X-ray absorptiometry (DEXA).","The DEXA scans will be performed at baseline and after 3 months.",{"measure":23,"description":24,"timeFrame":21},"Bone Mineral Density","BMD will be measured at baseline and after 3 months in the hospital. Total hip, femoral neck and total body BMD (g\u002Fcm2) will be measured using DEXA. The unfractured hip will be assessed.",{"measure":23,"description":26,"timeFrame":27},"Quantitative ultrasound (QUS) parameters of the calcaneus will be measured using the portable Achilles EXPII bone ultrasonometer.","The quantitative ultrasound measurements will be performed at baseline and after 3 months.",{"measure":29,"description":30,"timeFrame":31},"Quality of life","Quality of life will be assessed with the EQ5D-5L questionnaire.","Quality of life will be assessed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.",{"measure":33,"description":34,"timeFrame":35},"Blood markers","Blood markers P1NP, IGF-1, PTH and vitamin D will be measured in serum.","Blood markers will be measured at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.",{"measure":37,"description":38,"timeFrame":39},"Inpatient rehabilitation time","Number of days the patient stayed in the rehabilitation centre.","Assessed at discharge from the rehabilitation centre (varies per participant, on average after 1 month).",{"measure":41,"description":42,"timeFrame":43},"Daily life functioning","The Barthel Index of Activities of Daily Living will be used to assess daily life functioning.","Daily life functioning will be assessed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.",{"measure":45,"description":46,"timeFrame":47},"Nutritional Status","The Mini Nutritional Assessment (MNA) will be used to evaluate nutritional status.","This measurement will be performed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.",{"measure":49,"description":50,"timeFrame":51},"Costs","Participants will use a cost diary to keep track of their health care use, out-of-pocket costs, and productivity losses. A health care use questionnaire based on the iMTA Medical Cost Questionnaire will be used, which includes cost categories that were deemed relevant for older adults (general practitioner, home care, informal care, dietitian, physiotherapist, occupational therapist, hospitalization, residential care, rehabilitation care, outpatient clinic, and medication use). Out-of-pocket costs includes sports club memberships, purchase of sport equipment, and other out-of-pocket payments related to the intervention. Productivity losses will be measured using questions from the Productivity Cost Questionnaire.","This will be assessed after 3 months.",[53,56,59,62,65,69,72,75,79],{"measure":54,"description":55,"timeFrame":47},"Dietary intake","The dietary intake will be observed and recorded over a period of three non-consecutive days.",{"measure":57,"description":58,"timeFrame":47},"Frailty status","Frailty status is assessed with the Fried criteria.",{"measure":60,"description":61,"timeFrame":47},"Body weight","Body weight in kg",{"measure":33,"description":63,"timeFrame":64},"Levels of free vitamin D, folate, vitamin B12 and vitamin C are measured","This measurement will be performed at baseline and after 3 months.",{"measure":66,"description":67,"timeFrame":68},"Physical Activity","The LASA Physical Activity Questionnaire (LAPAQ) is used to measure physical activity levels.","This is assessed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.",{"measure":70,"description":71,"timeFrame":68},"Appetite","The Simplified Nutritional Appetite Questionnaire (SNAQ) is used to assess appetite.",{"measure":73,"description":74,"timeFrame":51},"Fear of falling","Fear of falling will be assessed with the Falls Efficacy Scale International (FES-I).",{"measure":76,"description":77,"timeFrame":78},"Oral health","Questionnaire","This measurement will be performed at baseline.",{"measure":80,"description":81,"timeFrame":82},"Number of and time to new falls and fragility fractures","Number of and time to new falls and fragility fractures is assessed with a questionnaire","This is assessed after 3 months.",{"allocation":84,"interventionModel":85,"interventionModelDescription":86,"primaryPurpose":87,"observationalModel":88,"timePerspective":88,"maskingInfo":89},"RANDOMIZED","PARALLEL","A randomized controlled two-arm parallel trial","TREATMENT",null,{"masking":90,"maskingDescription":88,"whoMasked":91},"SINGLE",[92],"OUTCOMES_ASSESSOR",[94,101],{"label":95,"type":96,"description":97,"interventionNames":98},"Intervention","EXPERIMENTAL","The intervention group receives a tailor-made protein-enriched diet and an extended progressive resistance training program.",[99,100],"Other: Protein-enriched diet","Other: Progressive resistance exercise",{"label":102,"type":103,"description":104,"interventionNames":88},"Control","NO_INTERVENTION","The control group receives usual care.",[106,110],{"type":6,"name":107,"description":108,"armGroupLabels":109,"otherNames":88},"Protein-enriched diet","A protein intake of 1.5 g\u002Fkg bodyweight\u002Fday. This will be obtained by consuming protein-rich and protein-enriched foods.",[95],{"type":6,"name":111,"description":112,"armGroupLabels":113,"otherNames":88},"Progressive resistance exercise","The intervention group will perform resistance training during three non-consecutive days with a minimum of 48 hours between the sessions. Subjects will continue the resistance training after discharge for 2 times a week, also with a minimum of 48 hours between sessions until the study period of 3 months is completed. All sessions will be supervised by physiotherapists.",[95],[115,134],{"facility":116,"status":117,"city":118,"state":88,"zip":119,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":127,"contacts":128},"Rijnstate Hospital","RECRUITING","Arnhem","6851AD","Netherlands","NL",{"type":123,"coordinates":124},"Point",[125,126],5.91111,51.98,{"lat":126,"lon":125},[129],{"name":130,"role":131,"phone":132,"phoneExt":88,"email":133},"Hugo H Wijnen, MD","CONTACT","0031 88 005 7397","hwijnen@rijnstate.nl",{"facility":135,"status":117,"city":136,"state":88,"zip":137,"country":120,"countryCode":121,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Gelderse Vallei Hospital","Ede","6716RP",{"type":123,"coordinates":139},[140,141],5.65833,52.03333,{"lat":141,"lon":140},[144],{"name":145,"role":131,"phone":146,"phoneExt":88,"email":147},"Nienke Golüke, MD","0031 318 43 5938","ngoluke@zgv.nl",{"type":149,"investigatorFullName":150,"investigatorTitle":151,"investigatorAffiliation":5,"oldNameTitle":88,"oldOrganization":88},"PRINCIPAL_INVESTIGATOR","Lisette de Groot","prof.dr.ir.",[153,154,155,157,160,162,164,166,168],{"name":116,"class":6},{"name":135,"class":6},{"name":156,"class":6},"HAN University of Applied Sciences",{"name":158,"class":159},"Liemerije Revalidatiezorg","UNKNOWN",{"name":161,"class":159},"Opella Revalidatiezorg",{"name":163,"class":159},"Pleyade Revalidatiezorg",{"name":165,"class":159},"Attent Zorg en Behandeling",{"name":167,"class":159},"Alliantie Voeding in de Zorg",{"name":169,"class":159},"Osteoporosis Association","100595737",false,"NCT07036341","Rehabilitation After a Hip Fracture: the Effects of Dietary Protein and Exercise on Bone and Muscle Health and Quality of Life","ProBUS","In order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Age ≥ 65 years\n* Acute hip fracture\n* Able to give written informed consent\n* Mentally competent, as judged by the treating physician\n* Admission to a rehabilitation centre that participates in this research\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Allergic, intolerant or hypersensitive to milk\u002Flactose (self-reported)\n* Not willing to stop using dietary supplements with exception of calcium and vitamin D\n* Pathological fracture or periprosthetic fracture\n* Abnormal hepatic or renal laboratory parameters, such as estimated glomerular filtration rate (eGFR) \\\u003C30 ml\u002Fmin\u002F1,73 m2 (data from hospital)\n* Diagnosis of disorders\u002Fdiseases where a high protein intake can be harmful, such as renal impairment or failure, or liver disease (geriatric care physician has the decisive voice)\n* Diagnosis of bone metabolic disorders such as primary hyperparathyroidism, Paget's disease, or myeloma.\n* Taking medication other than bisphosphonates known to strongly alter bone, calcium or muscle metabolism, such as oestrogen, hormone replacement therapy, corticosteroids, anabolic agents, or calcitonin.\n* Disorders\u002Fdiseases which may affect ability to follow study protocol and which cannot be overcome with help of a caregiver\n* Current participation in other scientific research\n* No permission to request information from the general practitioner\u002F treating specialist(s) about medical history, medication use, liver and kidney values, and details about the broken hip","ALL","65 Years",{"count":179,"type":180},102,"ESTIMATED","INTERVENTIONAL",[183],"NA","Hip fractures often lead to functional limitations, loss of independence, weight loss and decreased well-being. Only half of the patients regain their functional level and 24% die within the following year. Financial consequences are significant due to costly surgery and long-term care. Hip fracture incidence is expected to increase sharply due to the ageing population, reducing accessibility to and quality of rehabilitation care. Therefore, optimizing treatment is essential.\n\nPrevious protein and exercise studies showed improved muscle and bone health in healthy or frail community-dwelling older adults, but effects in older hip fracture patients are not known. Better rehabilitation may improve bone and muscle health, nutritional status, quality of life, lower costs and lower burden for healthcare.\n\nThe overall objective is to investigate the effectiveness, costs and cost-effectiveness of a protein-enriched diet and resistance exercise for 3 months compared to usual care on bone and muscle health, and quality of life in older adults recovering from an acute hip fracture.",[186],"Hip Fractures",[188,189,190,191,192],"Hip fracture patients","Protein","Resistance Exercise","Bone health","Muscle health","2025-06-23",{"date":195,"type":196},"2025-06-25","ACTUAL",{"date":198,"type":196},"2024-09-01",{"date":200,"type":180},"2026-08",{"name":5,"class":6},2]