[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100439449":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":34,"responsibleParty":53,"collaborators":18,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":36,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Complejo Hospitalario Universitario de Albacete","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group multicomponent physical exercise program, nutritional intervention and Frailty training","EXPERIMENTAL","Group multicomponent physical exercise program, nutritional intervention program and Primary Care training in Frailty.\n\nThe exercise program will be delivered by trained experts in groups of 6 participants, and will be based on the recommendations presented in the Spanish Healthcare Ministry document updated 2022. This program includes balance, flexibility, and strength and power exercises. The program will be realized twice a week, during 45 minutes time, for 12 weeks, twice, with a discontinuation period of 2 months. Nutritional recommendations will de presented by a nutritionist at the beginning of the intervention to the Primary Care physicians. Primary Care Physicians will have the opportunity of referring high risk participants to their Geriatrics Department Participants when appropriate, following Healthcare Ministry algorithm",[13],"Other: Multicomponent physical exercise program and a nutritional intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Control group will receive usual care by their Primary Care Physicians. Healthy lifestyle recommendations including exercise and nutritional recommendations will be offered",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Multicomponent physical exercise program and a nutritional intervention","The exercise program will be delivered by trained experts in groups of 6 participants, and will be based on the recommendations presented in the Spanish Healthcare Ministry document. This program includes balance, flexibility, and strength and power exercises. The program will be realized twice a week, during 45 minutes time, for 16 weeks, twice a year. Nutritional intervention will be based on the results of MNA-SF. If the results of this instrument show normal nutrition status, general nutritional recommendations will de presented by a nutritionist twice a year before the physical exercise program. If MNA-SF shows nutritional risk or malnutrition, oral nutritional supplementation will be offered. Primary Care Physicians will have the opportunity of referring high risk participants to their Geriatrics Department Participants when appropriate, following Healthcare Ministry algorithm",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Pedro Abizanda Soler, MD,PhD","CONTACT","+34636557437","pabizanda@sescam.jccm.es",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Almudena Avendaño Céspedes, RN, PhD","+34967597684","aavendanoc@sescam.jccm.es",[35],{"facility":5,"status":36,"city":37,"state":18,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Albacete","02006","Spain","ES",{"type":42,"coordinates":43},"Point",[44,45],-1.85643,38.99424,{"lat":45,"lon":44},[48,49,50],{"name":26,"role":27,"phone":32,"phoneExt":18,"email":29},{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},{"name":51,"role":52,"phone":18,"phoneExt":18,"email":18},"Pedro Abizanda Soler, Head Geriatrics Department","PRINCIPAL_INVESTIGATOR",{"type":52,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Pedro Abizanda","Principal Investigator","100439449","rct-to-analyze-the-efficacy-of-a-spanish-healthcare-ministry-based-in-intervention-to-reduce-frailty-status-in-prefrail-older-adults-100439449",false,"NCT05002439","RCT to Analyze the Efficacy of a Spanish Healthcare ministRy Based In InTervention to Reduce Frailty Status in Prefrail Older Adults","Multicenter Randomized Clinical Trial to Analyze the Efficacy of a Spanish Healthcare ministRy Based In InTervention to Reduce Frailty Status in Prefrail Older Adults (FRAILMERIT)","FRAILMERIT","Inclusion Criteria:\n\n* Community-dwelling adults with age equal or greater than 70 years.\n* Barthel index \\> 85\n* Gait speed \\\u003C 0.8 m\u002Fs OR frailty \u002Fprefrailty using the frailty phenotype\n* Ability to realize the physical exercise program\n* Capacity to understand the procedures and interventions of the trial\n* Capacity to understand and sign the informed consent\n\nExclusion Criteria:\n\n* Major contraindications for exercise: Severe aortic valve stenosis, myocardial infarction in the previous 6 weeks, Venous thromboembolic disease in the previous 6 weeks.\n* Inability to conduct the physical tests of the trial\n* Inability to understand the procedures of the trial\n* Active solid organ or hematologic neoplasm other than basocellular skin neoplasm, or life expectancy lower than one year.\n* Surgical intervention programmed that could interfere with the physical exercise program.","ALL","70 Years","100 Years",{"count":68,"type":69},273,"ESTIMATED","INTERVENTIONAL",[72],"NA","Objectives: The main objective is to analyze the efficacy of an intervention based on the algorithm proposed by the Spanish Healtcare Ministry (see figure in annex 1) at Primary Care level to reduce Frailty status or Physical Function in community-dwelling older adults. Secondary objectives are: 1. To analyze if the intervention is cost-effective; 2. To analyze if the intervention reduces hospitalizations and emergency department visits, incident disability, falls, institutionalization, mortality, Primary Care visits and Drug use, and improves quality of life.\n\nMethodology: Multicentric Randomized Clinical Trial in 273 Prefrail or Frail or with a gait speed lower that 0.8 m\u002Fs community-dwelling women and men with an age equal or greater to 70 years, attended in selected Primary Care centers of Spain (Albacete, Hellín, Barcelona, Madrid, La Carlota, and Tacoronte). Randomization will be made by clusters, being every cluster a different Primary Care center in order to avoid contamination. Randomization on a 1:1 relationship between groups. The main outcome variable will be Frailty status or Physical function change (main composite outcome) at 8-month follow-up measured with the Frailty Phenotype and the Short Physical Performance Battery (SPPB) respectively. All instrumentation will follow the guidelines of the Spanish Healthcare Ministry algorithm for frailty updated 2022. Intervention will consist on a groupal multicomponent physical exercise program, a nutritional intervention program and a training in Frailty to Primary Care centers. The intervention will be delivered by trained experts in groups of 6 participants, and will be based on the recommendations of the Spanish Healthcare Ministry document, updated in 2022.",[75,76,77],"Frailty","Aged","Exercise",[75,76,79],"Multimodal training","2025-03-14",{"date":82,"type":83},"2025-03-18","ACTUAL",{"date":85,"type":83},"2020-01-01",{"date":87,"type":69},"2025-03-31",{"name":5,"class":6},1]