Open Access
Effect of a multicomponent exercise programme (VIVIFRAIL) on functional capacity in frail community elders with cognitive decline: study protocol for a randomized multicentre control trial
(BioMed Central, 2019) Casas Herrero, Álvaro; Antón Rodrigo, Iván; Zambom Ferraresi, Fabrício; López Sáez de Asteasu, Mikel; Martínez Velilla, Nicolás; Elexpuru Estomba, Jaione; Marín Epelde, Itxaso; Ramón Espinoza, Fernanda; Petidier Torregrosa, Roberto; Sánchez Sánchez, Juan Luis; Ibáñez Beroiz, Berta; Izquierdo Redín, Mikel; Ciencias de la Salud; Osasun Zientziak; Gobierno de Navarra / Nafarroako Gobernua
Background: The benefit of physical exercise in ageing and particularly in frailty has been the aim of recent research. Moreover, physical activity in the elderly is associated with a decreased risk of mortality, of common chronic illnesses (i.e. cardiovascular disease or osteoarthritis) and of institutionalization as well as with a delay in functional decline. Additionally, very recent research has shown that, despite its limitations, physical exercise is associated with a reduced risk of dementia, Alzheimer disease or mild cognitive decline. Nevertheless, the effect of physical exercise as a systematic, structured and repetitive type of physical activity, in the reduction of risk of cognitive decline in the elderly, is not very clear. The purpose of this study aims to examine whether an innovative multicomponent exercise programme called VIVIFRAIL has benefits for functional and cognitive status among pre-frail/frail patients with mild cognitive impairment or dementia. Methods/design: This study is a multicentre randomized clinical trial to be conducted in the outpatient geriatrics clinics of three tertiary hospitals in Spain. Altogether, 240 patients aged 75 years or older being capable of and willing to provide informed consent, with a Barthel Index ≥ 60 and mild cognitive impairment or mild dementia, pre-frail or frail and having someone to help to supervise them when conducting the exercises will be randomly assigned to the intervention or control group. Participants randomly assigned to the usual care group will receive normal outpatient care, including physical rehabilitation when needed. The VIVIFRAIL multicomponent exercise intervention programme consists of resistance training, gait re-training and balance training, which appear to be the best strategy for improving gait, balance and strength, as well as reducing the rate of falls in older individuals and consequently maintaining their functional capacity during ageing. The primary endpoint is the change in functional capacity, assessed with the Short Physical Performance Battery (1 point as clinically significant). Secondary endpoints are changes in cognitive and mood status, quality of life (EQ-5D), 6-m gait velocity and changes in gait parameters (i.e. gait velocity and gait variability) while performing a dual-task test (verbal and counting), handgrip, maximal strength and power of the lower limbs as well as Barthel Index of independence (5 points as clinically significant) at baseline and at the 1-month and 3-month follow-up. Discussion: Frailty and cognitive impairment are two very common geriatric syndromes in elderly patients and are frequently related and overlapped. Functional decline and disability are major adverse outcomes of these conditions. Exercise is a potential intervention for both syndromes. If our hypothesis is correct, the relevance of this project is that the results can contribute to understanding that an individualized multicomponent exercise programme (VIVIFRAIL) for frail elderly patients with cognitive impairment is more effective in reducing functional and cognitive impairment than conventional care. Moreover, our study may be able to show that an innovative individualized multicomponent exercise prescription for these high-risk populations is plausible, having at least similar therapeutic effects to other pharmacological and medical prescriptions.
Open Access
CITA GO-ON study: a community based multidomain lifestyle intervention to prevent cognitive decline: protocol design and recruitment process
(Frontiers Media, 2025-06-16) Tainta, Mikel; Ecay-Torres, Mirian; Barandiaran, Myriam; Estanga, Ainara; López, Carolina; Altuna Azkargorta, Miren; Iriondo, Ane; Saldias, Jon; García-Sebastián, Maite; Cañada, Marta; Arriba, Maria de; Reparaz Escudero, Imanol; López Sáez de Asteasu, Mikel; Izquierdo Redín, Mikel; Balluerka, Nekane; Gorostiaga, Arantxa; Ros, Naia; Soroa, Goretti; Domper, Jara; Gayoso, Lucía; Arrizabalaga-López, María; Etxeberria, Usune; Torres, María Inés; Alberdi, Elena; Capetillo-Zarate, Estibaliz; Mateo-Abad, Maider; Vergara, Itziar; Mar, Javier; Martínez-Lage, Pablo; Ciencias de la Salud; Osasun Zientziak
Introduction: Growing research suggests that dementia is a complex disorder with multiple risk factors and causes. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) demonstrated that lifestyle interventions could confer cognitive benefits. Inspired by this, the GOIZ-ZAINDU (GZ) feasibility study adapted the FINGER approach to the Basque context. Building upon the GZ study, the CITA GO-ON trial aims to enhance and expand the evidence supporting dementia prevention through a multidomain intervention of risk factor management and resilience promotion. Methods: It is a two-year, population-based, randomized controlled trial to prevent cognitive decline in adults aged 60–85 years with Cardiovascular Risk Factors, Aging and Dementia (CAIDE) risk score ≥6, no dementia, and belowthan- expected performance on at least one of three cognitive screening tests. Participants are randomized (1:1) to receive either Regular Health Advice (RHA) or a Multidomain Intervention (MD-Int) that encompasses cognitive training, socio-emotional skills, multicomponent physical exercise, nutritional and culinary intervention, and monitoring for cardiovascular risks, pharmacological drug mismanagement, and comorbidities. The primary outcome is the efficacy of the intervention to reduce the risk of cognitive decline measured by the global composite z-score of the modified Neuropsychological Test Battery over two years. The secondary outcomes measure cost-effectiveness, quality of life, and functional abilities. Blood samples and brain imaging will also be collected to evaluate the effects of the intervention on brain structure and plasma biomarkers. Results: Recruitment has been completed with 1051 participants selected (mean age (standard deviation, SD) of 69.65 (6.36), 58,50 % female, and mean CAIDE (SD) of 7.62 (1.427). The final participant is expected to complete the last study visit by the autumn of 2026. Discussion: The CITA GO-ON Study, as a part of the World-Wide FINGERS network, is designed to validate the efficacy of a multidomain lifestyle intervention for dementia prevention and contribute valuable data to inform public health strategies fostering healthy, active aging.
Open Access
Biomarkers of delirium risk in older adults: a systematic review and meta-analysis
(Frontiers Media, 2023) Lozano Vicario, Lucía; García Hermoso, Antonio; Cedeño Veloz, Bernardo Abel; Fernández Irigoyen, Joaquín; Santamaría Martínez, Enrique; Romero Ortuno, Román; Zambom Ferraresi, Fabrício; López Sáez de Asteasu, Mikel; Muñoz-Vázquez, Ángel Javier; Izquierdo Redín, Mikel; Martínez Velilla, Nicolás; Ciencias de la Salud; Osasun Zientziak
Delirium is a neuropsychiatric syndrome associated with increased morbidity and mortality in older patients. The aim of this study was to review predictive biomarkers of delirium in older patients to gain insights into the pathophysiology of this syndrome and provide guidance for future studies. Two authors independently and systematically searched MEDLINE, Embase, Cochrane Library, Web of Science and Scopus databases up to August 2021. A total of 32 studies were included. Only 6 studies were eligible for the meta-analysis, pooled results showed a significant increase in some serum biomarkers (C-reactive protein [CRP], tumour necrosis factor alpha [TNF-α] and interleukin-6 [IL-6]) among patients with delirium (odds ratio = 1.88, 95% CI 1.01 to 1.637; I2 = 76.75%). Although current evidence does not favour the use of any particular biomarker, serum CRP, TNF-α, and IL-6 were the most consistent biomarkers of delirium in older patients.

López Sáez de Asteasu, Mikel

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