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

Abstract

Background 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 effectiveness for reducing fall rates, evidence around their putative cumulative effects 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 effectiveness 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 (defined 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 flexibility) 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, effects 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 effectiveness of an individualized multidomain intervention by studying the effect of additive effects 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 effects in the reduction of the incidence of falls and associated adverse outcomes. Trial registration NCT04911179 02/06/2021.

Determinants of physical activity behavior among older adults with subjective cognitive decline based on the capability, opportunity, motivation, and behavior model: mediating and moderating effects

“…This moderating effect emphasizes the necessity for tailored interventions that not only address frailty but also encompass fall prevention strategies for this vulnerable population. For those with a history of falls in the older adults with SCD, intervention programs could be designed to include multifaceted exercise plans ( 44 ). Such plans could serve the dual purpose of increasing PA levels in older adults with SCD while simultaneously reducing the risk of future falls.…”

Eight-year longitudinal falls trajectories and associations with modifiable risk factors: evidence from The Irish Longitudinal Study on Ageing (TILDA)

“…Multicomponent exercise programmes and cognitive stimulation (which target potentially modifiable risk factors of this study) may reduce falls in frail community-dwelling older persons at high risk of falls [ 41 ]. Yet a recent systematic review found few studies investigating exercises interventions for people with mild cognitive impairment and concluded that there was insufficient evidence to inform clinical practice [ 42 ].…”

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

“…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' .…”