Abstract
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/.
Highlights
To investigate whether an exercise intervention using the VIVIFRAIL© protocol has benefits for inflammatory and functional parameters in different frailty status
The results of the study will imply in a better knowledge about the effect of a low-cost intervention that could be replicated in outpatient care for the prevention and treatment of frailty, especially regarding the inflammatory and anti-inflammatory pathways involved in its pathophysiology
Different functional capacity levels will be determined based on the scores obtained from the Short Physical Performance Battery (SPPB) and the 6-m gait velocity test, with each leading to the recommendation of a certain customized multicomponent physical exercise program (Program A, B, C1, C2 or D)
Summary
Immune dysregulation is underlying frailty, interacting with neuroendocrine dysregulation and neuromuscular dysfunction. In the future this project offers the opportunity to test and disseminate “in the real life” a novel prescription exercise tool (VIVIFRAIL©) [16, 30] with regard to the modification of low-grade chronic inflammation and in physical functional parameters of frail and pre-frail older outpatients It will yield direct information about the effects of a specific and individualized designed exercise program in those geriatric conditions. It is expected that the results of the present study will assist in advancing the use of inflammatory biomarkers and physical functional measures to monitor chronic low-grade inflammation in frail and pre-frail older persons included in programs of prevention and rehabilitation of frailty Another important expected result in our project is to stimulate the prescription of exercise in this population in order to prevent disability. Abbreviations 10-CS: 10-point cognitive screening instrument; 6 m-GVT: 6 m gait velocity test; BMI: Body mass index; CES-D: Center for Epidemiological Studies Depression; CRP: C-reactive protein; GDS: Geriatric Depressive Scale; IL: Interleukin; Kgf: Kilogram-force; MET: Metabolic equivalent of the task; PBMCs: Peripheral blood mononuclear cells; PMNs: Polymorphonuclear cells; REBEC: Brazilian Registry of Clinical Trials; SPPB: Short Physical Performance Battery; TNF-α: Tumor necrosis factor alpha
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