[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632893":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":32,"studyPopulation":24,"armGroups":33,"interventions":46,"overallOfficials":56,"centralContacts":64,"locations":69,"responsibleParty":88,"collaborators":24,"id":90,"slug":24,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":24,"enrollmentInfo":98,"targetDuration":24,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":72,"whyStopped":24,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"National Geriatric Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Short Physical Performance Battery (SPPB) score","The Short Physical Performance Battery (SPPB) assesses lower extremity function including balance, gait speed, and chair stand. Scores range from 0 to 12, with higher scores indicating better physical performance.","baseline to 6 months",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Change in frailty status assessed by Fried frail","Frailty status will be assessed using the Fried frailty phenotype, which includes five components: unintentional weight loss (≥5% body weight in the past year), self-reported exhaustion (assessed by standardized questionnaire), low physical activity level, slowness (measured by gait speed over a 4-meter walk), and weakness (assessed by handgrip strength using a calibrated dynamometer).\n\nEach component is scored as present or absent. Participants meeting 3 or more criteria are classified as frail, those with 1-2 criteria as prefrail, and those with 0 criteria as robust.\n\nChange in frailty status will be defined as the transition between these categories from baseline to 6 months.","Baseline to 6 months",{"measure":19,"description":20,"timeFrame":12},"Change in handgrip strength (kg)","Handgrip strength is assessed using a calibrated handheld dynamometer. The best value of three attempts for the dominant hand is recorded in kilograms (kg). Higher values indicate greater muscle strength",{"measure":22,"description":23,"timeFrame":17},"Change in COPD Assessment Test (CAT) score","The COPD Assessment Test (CAT) evaluates health-related quality of life in patients with COPD. Scores range from 0 to 40, with higher scores indicating worse symptoms.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":28,"primaryPurpose":29,"observationalModel":24,"timePerspective":24,"maskingInfo":30},"RANDOMIZED","PARALLEL","Participants will be assigned to either the intervention group receiving the Vivifrail exercise program or a control group receiving standard care.","TREATMENT",{"masking":31,"maskingDescription":24,"whoMasked":24},"NONE","Frailty is common among older patients with chronic obstructive pulmonary disease (COPD) and is associated with poor functional outcomes and increased health risks. This study aims to determine the prevalence of frailty and to evaluate the effects of the Vivifrail exercise program on physical performance, activities of daily living, and quality of life in older COPD patients at Hospital 198, Ministry of Public Security, Vietnam.\n\nFrailty is a multidimensional geriatric syndrome characterized by decreased physiological reserve and increased vulnerability to adverse health outcomes. It is highly prevalent among older patients with chronic obstructive pulmonary disease (COPD), contributing to functional decline, increased risk of hospitalization, and mortality.\n\nCOPD is a chronic respiratory condition associated with systemic manifestations, including muscle weakness, reduced physical activity, and comorbidities, all of which may accelerate the development of frailty. The coexistence of COPD and frailty leads to worse clinical outcomes and reduced quality of life.\n\nThe Vivifrail exercise program is an evidence-based intervention specifically designed to improve physical function and reduce frailty in older adults through individualized exercise training. Previous studies have demonstrated its effectiveness in improving muscle strength, balance, and functional capacity. However, evidence regarding its effectiveness in older COPD patients, particularly in Vietnam, remains limited.\n\nTherefore, this study aims to assess the prevalence of frailty and evaluate the effects of the Vivifrail exercise program on physical performance, activities of daily living, and quality of life in older patients with COPD.",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"Vivifrail Exersise Group","EXPERIMENTAL","Participants receive the Vivifrail Exercise program",[39],"Behavioral: Vivifrail Exercise program",{"label":41,"type":42,"description":43,"interventionNames":44},"Usual Care Group","ACTIVE_COMPARATOR","Participants receive standard care without structured Exercise",[45],"Other: Usual Care Group",[47,52],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":24},"BEHAVIORAL","Vivifrail Exercise program","The Vivifrail exercise program is a structured, multicomponent intervention designed for older adults. It includes individualized exercises focusing on strength, balance, flexibility, and aerobic capacity based on the participant's functional level. The program is performed regularly under supervision or guidance to improve physical performance, reduce frailty, and enhance quality of life",[35],{"type":53,"name":41,"description":54,"armGroupLabels":55,"otherNames":24},"OTHER","Participants receive standard care without structured exercise intervention",[41],[57,61],{"name":58,"affiliation":59,"role":60},"Diu Thi Vu, MD, MSc","Hanoi Medical University, Vietnam; Hospital 198, Ministry of Puplic Security, Vietnam; National Geriatric Hospital, Vietnam","PRINCIPAL_INVESTIGATOR",{"name":62,"affiliation":63,"role":60},"Huyen Thanh Thi Vu, Associate Prof. PhD","Hanoi Medical University, Vietnam; National Geriatric Hospital, Vietnam",[65],{"name":58,"role":66,"phone":67,"phoneExt":24,"email":68},"CONTACT","+84 912 088 986","vudiu198@gmail.com",[70,84],{"facility":71,"status":72,"city":73,"state":73,"zip":24,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Hospital 198, Ministry of Public Security","RECRUITING","Hanoi","Vietnam","VN",{"type":77,"coordinates":78},"Point",[79,80],105.84117,21.0245,{"lat":80,"lon":79},[83],{"name":58,"role":66,"phone":67,"phoneExt":24,"email":68},{"facility":71,"status":72,"city":73,"state":24,"zip":24,"country":74,"countryCode":75,"cosmosGeoPoint":85,"geoPoint":87,"contacts":24},{"type":77,"coordinates":86},[79,80],{"lat":80,"lon":79},{"type":89,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100632893",false,"NCT07519603","Frailty in Older Adults With Chronic Obstructive Pulmonary Disease (COPD) and Outcomes of the VIVIFRAIL Program","COPD-FRAIL","Inclusion Criteria:\n\n* Age ≥ 60 years\n* Diagnosis of COPD according to GOLD criteria\n* Clinically stable COPD (no exacerbation within the past 4 weeks)\n* Able to participate in exercise training\n* Provide informed consent\n\nExclusion Criteria:\n\n* Acute COPD exacerbation within the past 4 weeks\n* Severe cardiovascular disease limiting exercise\n* Severe cognitive impairment\n* Musculoskeletal disorders preventing exercise\n* Participation in another clinical trial","ALL","60 Years",{"count":99,"type":100},80,"ESTIMATED","INTERVENTIONAL",[103],"NA","Frailty is common among older patients with chronic obstructive pulmonary disease (COPD) and is associated with poor functional outcomes and increased health risks. This study aims to determine the prevalence of frailty and to evaluate the effects of the Vivifrail exercise program on physical performance, activities of daily living, and quality of life in older COPD patients at Hospital 198, Ministry of Public Security, Vietnam.",[106,107],"Chronic Obstructive Pulmonary Disease (COPD)","Frailty",[109,107,110,111,112],"COPD","Older Adults","Vivifrail","Pulmonary Rehabilitation","2026-04-06",{"date":115,"type":116},"2026-04-09","ACTUAL",{"date":118,"type":116},"2026-03-01",{"date":120,"type":100},"2027-01-01",{"name":5,"class":6},2]