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- 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.
- Authors
Petrella, Marina; Aprahamian, Ivan; Mamoni, Ronei Luciano; de Vasconcellos Romanini, Carla Fernanda; Lima, Natália Almeida; de Cássio Robello, Everson; da Costa, Daniele Lima; An, Vinicius Nakajima; Aguirre, Bianca Nobre; Galdeano, Júlia Riccetto; Fernandes, Isabela Cunha; Soleman Hernandez, Salma S.; Cesari, Matteo; Morley, John E.; Izquierdo, Mikel; Oude Voshaar, Richard C.
- Abstract
<bold>Background: </bold>To investigate whether an exercise intervention using the VIVIFRAIL© protocol has benefits for inflammatory and functional parameters in different frailty status.<bold>Methods/design: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>Brazilian Registry of Clinical Trials (RBR-9n5jbw; 01/24/2020). Registred January 2020. http://www.ensaiosclinicos.gov.br/rg/RBR-9n5jbw/ .
- Subjects
PHYSICAL mobility; OLDER people; RANDOMIZED controlled trials; WALKING speed; HEALTH education; CANCER fatigue
- Publication
BMC Geriatrics, 2021, Vol 21, Issue 1, p1
- ISSN
1471-2318
- Publication type
journal article
- DOI
10.1186/s12877-021-02030-2