[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567051":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":18,"responsibleParty":39,"collaborators":41,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":18,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":18,"enrollmentInfo":53,"targetDuration":18,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":18,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":18},{"fullName":5,"class":6},"Keralty SAS. Colombia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","Education Component: Lectures and workshops aimed at enhancing awareness and personal growth through knowledge and emotional reflection.\n\nCognitive Component: One-hour sessions divided into introduction (15 min), cognitive stimulation activities (35 min), and closure with reflection and a brief survey.\n\nPhysical Activity Component: A 10-minute warm-up, followed by 30 minutes of guided exercises for balance, coordination, and strength, ending with a 10-minute cool-down.\n\nNutrition Component: Practical workshops focused on healthy eating, including menu planning and food preparation.\n\nSocio-Community and Occupational Component: Encourages community integration and social networking, with gardening activities for growing herbs and vegetables.\n\nAutonomous Activities: Participants implement physical activity recommendations in daily life, with weekly follow-ups by the research team using the RedCap platform for monitoring.",[13],"Behavioral: health intervention with a socio-community approach",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","The control group will maintain the usual care provided by their healthcare service provider.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","health intervention with a socio-community approach","The intervention consists of five components, including education, cognitive stimulation, physical activity, nutrition, and socio-community aspects. The duration of the intervention will be 6 months and will be conducted in either in-person or virtual format, individually or in groups, depending on the nature of each component. Mode of Delivery:\n\nThe intervention will be offered in both in-person and synchronous virtual formats. Participants who are unable to attend in person or who face difficulties doing so on any occasion will have the option to join the sessions through a real-time videoconferencing platform. In both modalities, the professionals in charge will supervise and guide the activities, ensuring proper execution and adherence to the study's objectives. The research team will maintain a detailed record of attendance and participation using the RedCap platform for appropriate tracking.",[9],[26],{"name":27,"affiliation":28,"role":29},"Lina Sofía Morón-Duarte, PhD","keralty","STUDY_CHAIR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Nancy Yomayusa Gonzalez, Dr","CONTACT","+57 601 4871920","igek@keralty.com",{"name":37,"role":33,"phone":18,"phoneExt":18,"email":38},"Kelly Rocio Chacón-Acevedo, Msc","krchacon@keralty.com",{"type":40,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[42],{"name":43,"class":6},"Inter-American Development Bank","100567051","effectiveness-of-a-socio-community-health-intervention-on-pre-frailty-in-older-adults-100567051",false,"NCT06663150","Effectiveness of a Socio-Community Health Intervention on Pre-Frailty in Older Adults","Effectiveness of a Health Intervention With a Socio-community Approach on Frailty in Older Adults With Pre-frailty","Inclusion Criteria:\n\n* Individuals ≥ 60 years old classified as pre-frail in the last 3 months and documented in their medical history.\n* Individuals who meet the requirements and provide voluntary informed consent for their participation.\n* Individuals available to remain in Bogotá D.C. during the study period.\n\nExclusion Criteria:\n\n* Individuals receiving care at community-focused medical centers.\n* Individuals attending community dining programs, physical activity programs, community groups, care blocks, volunteering, or other related activities.\n* Individuals who have experienced falls in the last 6 months with clinical consequences (hospitalization, fractures, traumatic brain injury).\n* Individuals with a clinical history of moderate cognitive impairment, neurodegenerative diseases (e.g., Parkinson's disease), and\u002For neuro-musculoskeletal disorders, active cancer, end-stage renal disease, unstable ischemic heart disease, uncontrolled arrhythmias, severe aortic stenosis, uncontrolled hypertension (\\>180\u002F100 mmHg), or advanced heart failure, exacerbation of chronic diseases (COPD, heart failure), unrehabilitated severe hearing loss, deafness, or blindness with communication limitations.\n* Acute conditions requiring hospitalization, such as acute myocardial infarction or urinary tract infections.\n* Bone fractures in the last 3 months.\n* Individuals unable to follow instructions or with behavioral changes that hinder their participation in the study.\n* Individuals with severe psychiatric illness that, in the physician's judgment, prevents proper adherence to the study intervention.\n* Institutionalized individuals in long-term care facilities.","ALL","60 Years",{"count":54,"type":55},160,"ESTIMATED","INTERVENTIONAL",[58],"NA","The objective of this study is: To evaluate the effectiveness of a health intervention with a socio-community approach on frailty in older adults with pre-frailty.\n\nSpecific Objectives:\n\nTo characterize the study population according to sociodemographic and clinical variables.\n\nTo evaluate the effect of the intervention on the functionality domain at 3 and 6 months.\n\nTo evaluate the effect of the intervention on the cognitive-emotional domain at 3 and 6 months.\n\nTo evaluate the effect of the intervention on the socio-community domain at 3 and 6 months.\n\nTo evaluate the effect of the intervention on frailty in older adults. To determine the proportion of participants hospitalized during the study period.\n\nTo determine the proportion of participants who visited the emergency room during the study period.\n\nTo determine the proportion of participants in long-term care facilities. To determine the proportion of adverse events associated with the intervention.\n\nStudy Hypothesis\n\nThe mean frailty score pre-intervention is equal to the mean frailty score post-intervention.\n\nThe mean frailty score pre-intervention is different from the mean frailty score post-intervention.",[61],"Frail Elderly Syndrome",[63,64,65],"Prefrailty","Frailty","Older Adults","NOT_YET_RECRUITING","2024-10-28",{"date":69,"type":70},"2024-10-29","ACTUAL",{"date":72,"type":55},"2024-11-15",{"date":74,"type":55},"2026-11-30",{"name":5,"class":6}]