1. 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
-
Carla Fernanda de Vasconcellos Romanini, Natália Almeida Lima, Salma S. Soleman Hernandez, Marina Petrella, Daniele Lima da Costa, Vinicius Nakajima An, Júlia Riccetto Galdeano, Everson de Cássio Robello, John E. Morley, Ronei Luciano Mamoni, Bianca Nobre Aguirre, Richard C. Oude Voshaar, Matteo Cesari, Ivan Aprahamian, Isabela Cunha Fernandes, Mikel Izquierdo, Clinical Cognitive Neuropsychiatry Research Program (CCNP), and Interdisciplinary Centre Psychopathology and Emotion regulation (ICPE)
- Subjects
medicine.medical_specialty ,Frail Elderly ,medicine.medical_treatment ,Physical exercise ,lcsh:Geriatrics ,law.invention ,Study Protocol ,03 medical and health sciences ,Elderly ,0302 clinical medicine ,Randomized controlled trial ,Ambulatory care ,Quality of life ,law ,Humans ,Medicine ,030212 general & internal medicine ,Aged ,Randomized Controlled Trials as Topic ,Inflammation ,Geriatrics ,Rehabilitation ,Hand Strength ,Frailty ,business.industry ,Physical Functional Performance ,Exercise Therapy ,Clinical trial ,lcsh:RC952-954.6 ,Quality of Life ,Physical therapy ,Health education ,Geriatrics and Gerontology ,business ,Brazil ,030217 neurology & neurosurgery - 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/.
- Published
- 2021
- Full Text
- View/download PDF