[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626521":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":43,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":20,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":68,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Andaluz Health Service","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Vivifrail Exercise Program","EXPERIMENTAL","All participants in this single-arm study are assigned to the experimental group. Following a baseline clinical and functional assessment, participants are categorized into specific functional profiles based on their frailty status and fall risk. Participants are monitored over a 12-week period, which includes three in-person visits at the health center (baseline, week 6, and week 12) for functional reassessment, alongside biweekly telephone follow-ups by the research team to monitor adherence, safety, and potential adverse events.",[13],"Other: Behavioral: Vivifrail multicomponent physical exercise program",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"OTHER","Behavioral: Vivifrail multicomponent physical exercise program","The Vivifrail multicomponent physical exercise program is a structured, 12-week home-based regimen. The standardized protocol requires 5 sessions per week: 3 non-consecutive days of 45-60 minute multicomponent training (focusing on upper and lower body strength using household items like water bottles or elastic bands, static\u002Fdynamic balance, and flexibility) and 2 days of 20-40 minute aerobic endurance training (brisk walking). Exercise intensity is prescribed at a moderate rate of perceived exertion (Borg scale 4-6). A systematic progression in exercise load and duration is implemented starting at week 7, strictly adhering to the guidelines of the participant's assigned passport.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Elena Pérez Expósito, MD","CONTACT","+34 950 17 50 50","elena.perez.exposito.sspa@juntadeandalucia.es",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Primary Care Center Virgen del Mar (Centro de Salud Virgen del Mar)","Almería","ALMERÍA","04009","Spain","ES",{"type":36,"coordinates":37},"Point",[38,39],-2.45974,36.83814,{"lat":39,"lon":38},[42],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":44,"investigatorFullName":23,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Family Medicine Resident","100626521","effects-of-vivifrail-program-on-functional-capacity-and-geriatric-syndromes-in-the-elderly-100626521",false,"NCT07436715","Effects of VIVIFRAIL Program on Functional Capacity and Geriatric Syndromes in the Elderly.","Effects of the VIVIFRAIL Multicomponent Physical Exercise Program on Functional Capacity and Geriatric Syndromes in Frail and Pre-frail Older Adults Over 70 Years in Primary Care in Almeria: A Quasi-Experimental Study.","VIVIAL","INCLUSION CRITERIA:\n\nParticipants aged 70 years or older.\n\nClassified as pre-frail or frail according to the FRAIL scale (score ≥ 1).\n\nBarthel Index score ≥ 60 points.\n\nAbility to communicate effectively.\n\nAbility to ambulate, with or without assistive devices.\n\nEXCLUSION CRITERIA:\n\nRecent acute myocardial infarction or unstable angina.\n\nUncontrolled atrial or ventricular arrhythmias.\n\nDissecting aortic aneurysm.\n\nSevere aortic stenosis.\n\nAcute endocarditis or pericarditis.\n\nUncontrolled arterial hypertension.\n\nAcute thromboembolic disease.\n\nSevere acute heart failure.\n\nSevere acute respiratory failure.\n\nUncontrolled orthostatic hypotension.\n\nDiabetes mellitus with acute decompensation or uncontrolled hypoglycemia.\n\nRecent bone fracture within the last month.\n\nInstitutionalization (e.g., nursing home residents).","ALL","70 Years",{"count":57,"type":58},86,"ESTIMATED","INTERVENTIONAL",[61],"NA","The aim of this quasi-experimental, pretest-posttest study is to evaluate the effectiveness of the Vivifrail multicomponent physical exercise program in improving the functional capacity of pre-frail and frail older adults (aged 70 and older) attending the Virgen del Mar Health Center in Almería.\n\nThe main questions it aims to answer are:\n\n* Does functional capacity, as measured by the Short Physical Performance Battery (SPPB), significantly improve after participating in the Vivifrail program?\n* What is the effect of the Vivifrail program on various geriatric syndromes and associated health conditions (e.g., fall risk, sarcopenia, chronic pain, mild cognitive impairment, depression), and what patient profile is most likely to benefit from the intervention?\n* As a single-arm interventional study, there is no parallel comparison group. Researchers will compare each participant's outcomes against their own baseline at three time points (baseline, week 6, and week 12) to assess for significant improvements following the intervention.\n\nParticipants will:\n\n* Complete a 12-week home-based, multicomponent physical exercise program (five sessions per week including strength, balance, flexibility, and aerobic endurance training), tailored to their baseline functional level.\n* Attend three in-person visits at the health center (baseline, a 6-week follow-up, and a final visit at 12 weeks) for the research staff to assess their clinical, functional, and sociodemographic variables.\n* Complete an Activity Diary to record their home-based sessions and perceived rate of exertion in order to monitor adherence.\n* Receive biweekly follow-up phone calls from the research team to reinforce motivation, track adherence, and monitor for any potential adverse events (e.g., falls, pain).",[64],"Fragility",[64,66,67],"Exercise","Primary Care","NOT_YET_RECRUITING","2026-02-22",{"date":71,"type":72},"2026-02-27","ACTUAL",{"date":74,"type":58},"2026-03-16",{"date":76,"type":58},"2026-06-15",{"name":23,"class":6},1]