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

Mat complBackground: 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).The 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-Herrer

Correction: 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

Correction: BMC Geriatrics 22, 612 (2022)After publication of this article [1], the authors reported that the statement in the Funding information section was incorrectly given as ’The present study is funded by a grant from the Spanish Ministry of Science and Innovation and the Instituto de Salud Carlos III (PI20/01546).’ and should have read ’The present study is funded by a grant from the Spanish Ministry of Science and Innovation and the Instituto de Salud Carlos III (PI20/01546), co-financed by FEDER funding’. The original article [1] has been corrected.1 págin