• Marina Petrella, Ivan Aprahamian, Ronei Luciano Mamoni, Carla Fernanda de Vasconcellos Romanini, Natália Almeida Lima, Everson de Cássio Robello, Daniele Lima da Costa, Vinicius Nakajima An, Bianca Nobre Aguirre, Júlia Riccetto Galdeano, Isabela Cunha Fernandes, Salma S Soleman Hernandez, Matteo Cesari, John E Morley, Mikel Izquierdo, and Richard C Oude Voshaar.
• Group of Investigation on Multimorbidity and Mental Health in Aging (GIMMA), Division of Geriatrics, Department of Internal Medicine, Faculty of Medicine of Jundiaí, 250 Francisco Telles st, Jundiaí, 13202-550, Brazil.
• BMC Geriatr. 2021 Jan 29; 21 (1): 83.

BackgroundTo investigate whether an exercise intervention using the VIVIFRAIL© protocol has benefits for inflammatory and functional parameters in different frailty status.Methods/DesignThis is a randomized clinical trial in an outpatient geriatrics clinic including older adults ≥60 years. For each frailty state (frail, pre-frail and robust), forty-four volunteers will be randomly allocated to the control group (n = 22) and the intervention group (n = 22) for 12 weeks. In the control group, participants will have meetings of health education while those in the intervention group will be part of a multicomponent exercise program (VIVIFRAIL©) performed five times a week (two times supervised and 3 times of home-based exercises). The primary outcome is a change in the inflammatory profile (a reduction in inflammatory interleukins [IL-6, TNF- α, IL1beta, IL-17, IL-22, CXCL-8, and IL-27] or an increase in anti-inflammatory mediators [IL-10, IL1RA, IL-4]). Secondary outcomes are change in physical performance using the Short Physical Performance Battery, handgrip strength, fatigue, gait speed, dual-task gait speed, depressive symptoms, FRAIL-BR and SARC-F scores, and quality of life at the 12-week period of intervention and after 3 months of follow-up.DiscussionWe expect a reduction in inflammatory interleukins or an increase in anti-inflammatory mediators in those who performed the VIVIFRAIL© protocol. The results of the study will imply in a better knowledge about the effect of a low-cost intervention that could be easily replicated in outpatient care for the prevention and treatment of frailty, especially regarding the inflammatory and anti-inflammatory pathways involved in its pathophysiology.Trial RegistrationBrazilian Registry of Clinical Trials (RBR-9n5jbw; 01/24/2020). Registred January 2020. http://www.ensaiosclinicos.gov.br/rg/RBR-9n5jbw/ .

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