The effect of a multicomponent exercise protocol (VIVIFRAIL (c)) on inflammatory profile and physical performance of older adults with different frailty status: study protocol for a randomized controlled trial

Author(s):Show less -

Petrella, Marina ^[1] ; Aprahamian, Ivan ^{[2, 1]} ; Mamoni, Ronei Luciano ^[1] ; de Vasconcellos Romanini, Carla Fernanda ^[1] ; Lima, Natalia Almeida ^[1] ; de Cassio Robello, Everson ^[1] ; da Costa, Daniele Lima ^[1] ; An, Vinicius Nakajima ^[1] ; Aguirre, Bianca Nobre ^[1] ; Galdeano, Julia Riccetto ^[1] ; Fernandes, Isabela Cunha ^[1] ; Soleman Hernandez, Salma S. ^[1] ; Cesari, Matteo ^[3] ; Morley, John E. ^[4] ; Izquierdo, Mikel ^{[5, 6, 7]} ; Oude Voshaar, Richard C. ^[2]

Affiliation

^[1] Fac Med Jundiai, Div Geriatr, Dept Internal Med, Grp Invest Multimorbid & Mental Hlth Aging GIMMA, 250 Francisco Telles St, BR-13202550 Jundiai - Brazil

^[2] Univ Groningen, Univ Med Ctr Groningen, Dept Psychiat, Groningen - Netherlands

^[3] Univ Milan, Fdn IRCCS Ca Granda Osped Maggiore Policlin, Geriatr Unit, Milan - Italy

^[4] St Louis Univ, Med Sch, Div Geriatr, St Louis, MO 63103 - USA

^[5] Univ Publ Navarra UPNA, IdiSNA, Complejo Hosp Navarra CHN, Navarrabiomed, Pamplona - Spain

^[6] Inst Salud Carlos III, CIBER Frailty & Hlth Aging CIBERFES, Madrid - Spain

^[7] Univ Santo Tomas, Grp GICAEDS, Programa Cultura Fis Deporte & Recreac, Bogota 110311 - Colombia

• Document type: Journal article
• Source: BMC GERIATRICS; v. 21, n. 1 JAN 29 2021.
• Web of Science Citations: 0

Abstract

Background: To investigate whether an exercise intervention using the VIVIFRAIL (c) protocol has benefits for inflammatory and functional parameters in different frailty status. Methods/design: This 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 (c)) 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- alpha, 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. Discussion: We expect a reduction in inflammatory interleukins or an increase in anti-inflammatory mediators in those who performed the VIVIFRAIL (c) 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 registration: Brazilian Registry of Clinical Trials (RBR-9n5jbw; 01/24/2020). Registred January 2020. http://www.ensaiosclinicos.gov.br/rg/RBR-9n5jbw/. (AU)

• FAPESP's process: 19/27618-0 - Inflammatory and anti-inflammatory biomarkers in frailty elderly and the association with sarcopenia
• Grantee: Ivan Aprahamian
• Support Opportunities: Regular Research Grants