Abstract

Background

To investigate whether an exercise intervention using the VIVIFRAIL© 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©) 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.

Discussion

We 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 registration

Brazilian Registry of Clinical Trials (RBR-9n5jbw; 01/24/2020). Registred January 2020. http://www.ensaiosclinicos.gov.br/rg/RBR-9n5jbw/.

Details

Title
The effect of a multicomponent exercise protocol (VIVIFRAIL©) on inflammatory profile and physical performance of older adults with different frailty status: study protocol for a randomized controlled trial
Author
Petrella, Marina; Aprahamian, Ivan  VIAFID ORCID Logo  ; 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; Soleman Hernandez, Salma S; Cesari, Matteo; Morley, John E; Izquierdo, Mikel; Oude Voshaar, Richard C
Pages
1-11
Section
Study protocol
Publication year
2021
Publication date
2021
Publisher
BioMed Central
e-ISSN
14712318
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s12877-021-02030-2
ProQuest document ID
2491031541
Copyright
© 2021. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.