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Effect of a multicomponent exercise program and cognitive stimulation (VIVIFRAIL-COGN) on falls in frail community older persons with high risk of falls: study protocol for a randomized multicenter control trial

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dc.contributor.authorSánchez Sánchez, Juan Luis
dc.contributor.authorUdina, Cristina
dc.contributor.authorMedina Rincón, Almudena
dc.contributor.authorEsbrí Victor, Mariano
dc.contributor.authorBartolomé Martín, Irene
dc.contributor.authorMoral Cuesta, Débora
dc.contributor.authorMarín Epelde, Itxaso
dc.contributor.authorRamón Espinoza, Fernanda
dc.contributor.authorSánchez Latorre, Marina
dc.contributor.authorIdoate, Fernando
dc.contributor.authorGoñi-Sarriés, Adriana
dc.contributor.authorMartínez Martínez, Blanca
dc.contributor.authorEscudero Bonet, Raquel
dc.contributor.authorLibrero, Julián
dc.contributor.authorCasas Herrero, Álvaro
dc.contributor.departmentCiencias de la Saludes_ES
dc.contributor.departmentOsasun Zientziakeu
dc.date.accessioned2022-11-23T18:09:53Z
dc.date.available2022-11-23T18:09:53Z
dc.date.issued2022
dc.date.updated2022-11-18T09:21:02Z
dc.descriptionMat comples_ES
dc.description.abstractBackground: Falls represent important drivers of intrinsic capacity losses, functional limitations and reduced quality of life in the growing older adult’s population, especially among those presenting with frailty. Despite exercise- and cognitive training-based interventions have shown efectiveness for reducing fall rates, evidence around their puta‑ tive cumulative efects on falls and fall-related complications (such as fractures, reduced quality of life and functional limitations) in frail individuals remains scarce. The main aim of this study is to explore the efectiveness program combining an individualized exercise program and an executive function-based cognitive training (VIVIFRAIL-COGN) compared to usual care in the prevention of falls and fall-related outcomes over a 1-year follow-up. Methods: This study is designed as a four-center randomized clinical trial with a 12-week intervention period and an additional 1-year follow-up. Three hundred twenty frail or pre-frail (≥1 criteria of the Frailty Phenotype) older adults (≥75 years) with high risk of falling (defned by fall history and gait performance) will be recruited in the Falls Units of the participating centers. They will be randomized in a 1:1 ratio to the intervention group (IG) or the control group (CG). The IG will participate in a home-based intervention combining the individualized Vivifrail multicomponent (aerobic, resistance, gait and balance and fexibility) exercise program and a personalized executive function-based cognitive training (VIVIFRAIL-COGN). The CG group will receive usual care delivered in the Falls Units, including the Otago Exercise Program. Primary outcome will be the incidence of falls (event rate/year) and will be ascertained by self-report during three visits (at baseline, and 6 and 12 weeks) and telephone-based contacts at 6, 9 and 12 months after randomization. Secondarily, efects on measures of physical and cognitive function, quality of life, nutritional, muscle quality and psychological status will be evaluated. Discussion: This trial will provide new evidence about the efectiveness of an individualized multidomain interven‑ tion by studying the efect of additive efects of cognitive training and physical exercise to prevent falls in older frail persons with high risk of falling. Compared to usual care, the combined intervention is expected to show additive efects in the reduction of the incidence of falls and associated adverse outcomes. Trial registration: NCT04911179 02/06/2021. © 2022, The Author(s).en
dc.description.sponsorshipThe present study is funded by a grant from the Spanish Ministry of Science and Innovation and the Instituto de Salud Carlos III (PI20/01546). Instituto de Salud Carlos III, PI20/01546, Alvaro Casas-Herreroes_ES
dc.format.mimetypeapplication/pdfen
dc.identifier.citationSánchez-Sánchez, J. L., Udina, C., Medina-Rincón, A., Esbrí-Victor, M., Bartolomé-Martín, I., Moral-Cuesta, D., Marín-Epelde, I., Ramon-Espinoza, F., Latorre, M. S.-, Idoate, F., Goñi-Sarriés, A., Martínez-Martínez, B., Bonet, R. E., Librero, J., & Casas-Herrero, Á. (2022). Effect of a multicomponent exercise program and cognitive stimulation (Vivifrail-cogn) on falls in frail community older persons with high risk of falls: Study protocol for a randomized multicenter control trial. BMC Geriatrics, 22(1), 612.en
dc.identifier.doi10.1186/s12877-022-03214-0
dc.identifier.issn1471-2318
dc.identifier.urihttps://academica-e.unavarra.es/handle/2454/44393
dc.language.isoengen
dc.publisherBMCen
dc.relation.ispartofBmc Geriatrics, 2022, 22 (1),0-0en
dc.relation.projectIDinfo:eu-repo/grantAgreement/ISCIII/Plan Estatal de Investigación Científica y Técnica y de Innovación 2017-2020 (ISCIII)/PI20%2F01546/ES/en
dc.relation.publisherversionhttps://doi.org/10.1186/s12877-022-03214-0
dc.rights© The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.en
dc.rights.accessRightsinfo:eu-repo/semantics/openAccess
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectCognitive functionen
dc.subjectFallsen
dc.subjectFracturesen
dc.subjectFrailtyen
dc.subjectPhysical exerciseen
dc.titleEffect of a multicomponent exercise program and cognitive stimulation (VIVIFRAIL-COGN) on falls in frail community older persons with high risk of falls: study protocol for a randomized multicenter control trialen
dc.typeinfo:eu-repo/semantics/article
dc.type.versionVersión publicada / Argitaratu den bertsioaes
dc.type.versioninfo:eu-repo/semantics/publishedVersionen
dspace.entity.typePublication
relation.isAuthorOfPublicationed9d4f53-b734-4d6e-b1b9-188a148f9a13
relation.isAuthorOfPublication67dfcd6b-a693-478c-98be-f4b7c5bed42d
relation.isAuthorOfPublication.latestForDiscoveryed9d4f53-b734-4d6e-b1b9-188a148f9a13

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