protocolSection identificationModule nctId: NCT06271239, orgStudyIdInfo id: U1111-1299-9167, secondaryIdInfos id: 65318722.0.0000.5336, type: OTHER, domain: IRB-Pontifical Catholic University of Rio Grande do Sul, secondaryIdInfos id: RBR-2tq2jky, type: OTHER, domain: The Brazilian Registry of Clinical Trials (ReBEC), briefTitle: Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Pontificia Universidade Católica do Rio Grande do Sul, class: OTHER, collaborators name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., descriptionModule briefSummary: This study employs a randomized, controlled, paired, single-blind clinical trial design. The targeted demographic comprises individuals aged 60 and above. Following the initial assessment, participants will be randomly allocated to two groups: the Intervention Group (ViviFrail) and the Group Suggestions for a Healthy Life (CG), maintaining a 1:1 allocation ratio. Both the ViviFrail group and CG group will exhibit homogeneity in terms of their clinical characteristics and functional performance. The allocation of participants into respective groups will remain concealed from all assessors, ensuring a single-blind approach.In the intervention group (ViviFrail), 25 participants will be instructed to engage in tailored physical exercises outlined in the VIVIFRAIL® protocol within the confines of their homes, with adaptations made according to their clinical conditions and functional performance.Conversely, the Group Suggestions for a Healthy Life (CG) comprising 25 participants will receive exercise suggestions and guidance to maintain a healthy routine for a duration of three months. Subsequently, participants in the CG will undergo the VIVIFRAIL® program intervention for an additional three months., conditionsModule conditions: Frailty, conditions: Aging, conditions: Physical Disability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In the Intervention Group (ViviFrail), participants will perform a six-month VIVIFRAIL® protocol-based exercise, adapted to their clinical profile.The Group Suggestions for a Healthy Life (CG) will receive exercise suggestions and guidance for maintaining a healthy routine for three months. After, they will undergo a three-month intervention using the VIVIFRAIL® protocol.Sample size determination was based on Casas-Herrero et al. (2022). The study assessed the impact of multicomponent training on intrinsic functional capacity, utilizing the Short Physical Performance Battery (SPPB) to gauge balance, gait speed, and lower limb strength on a 0 to 12 scale. Control group: -0.33±1.60 point difference; Treatment group: 1.07±1.52 point difference.Considering a 5% alpha and 80% power, 20 participants per group are required. Anticipating a 25% dropout rate, as observed by Tiecker (2021), we plan to enroll 25 participants per group., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The assessments will be conducted by trained researchers, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Intervention group (ViviFrail), interventions name: Group Suggestions for a Healthy Life (CG), outcomesModule primaryOutcomes measure: Short physical performance battery, secondaryOutcomes measure: Barthel Index, secondaryOutcomes measure: ICOPE questionnaire, secondaryOutcomes measure: Lawton Scale, secondaryOutcomes measure: 4-meter gait speed, secondaryOutcomes measure: Five Times Sit-to-Stand, secondaryOutcomes measure: Balance test in three positions, secondaryOutcomes measure: Self-perceived health, secondaryOutcomes measure: Adverse health outcomes - falls, secondaryOutcomes measure: Adverse health outcomes - hospitalization, secondaryOutcomes measure: Adverse health outcomes - institutionalization, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False