Development of Continuous Assessment of Muscle Quality and Frailty in Older Patients Using Multiparametric Combinations of Ultrasound and Blood Biomarkers: Protocol for the ECOFRAIL Study.

Autor:	Virto N; Department of Physical Activity and Sport Science, Faculty of Education and Sport, University of Deusto, Bilbao, Spain., Río X; Department of Physical Activity and Sport Science, Faculty of Education and Sport, University of Deusto, Bilbao, Spain., Angulo-Garay G; Department of Physical Activity and Sport Science, Faculty of Education and Sport, University of Deusto, Bilbao, Spain., García Molina R; Department of Geriatrics, Complejo Hospitalario Universitario de Albacete, Albacete, Spain.; Center for Biomedical Research Network on Fragility and Healthy Aging (CIBERfes), Instituto de Salud Carlos III, Madrid, Spain., Avendaño Céspedes A; Department of Geriatrics, Complejo Hospitalario Universitario de Albacete, Albacete, Spain.; Center for Biomedical Research Network on Fragility and Healthy Aging (CIBERfes), Instituto de Salud Carlos III, Madrid, Spain.; Facultad de Enfermería de Albacete, Universidad de Castilla-La Mancha, Albacete, Spain., Cortés Zamora EB; Department of Geriatrics, Complejo Hospitalario Universitario de Albacete, Albacete, Spain.; Center for Biomedical Research Network on Fragility and Healthy Aging (CIBERfes), Instituto de Salud Carlos III, Madrid, Spain., Gómez Jiménez E; Department of Geriatrics, Complejo Hospitalario Universitario de Albacete, Albacete, Spain., Alcantud Córcoles R; Department of Geriatrics, Complejo Hospitalario Universitario de Albacete, Albacete, Spain.; Center for Biomedical Research Network on Fragility and Healthy Aging (CIBERfes), Instituto de Salud Carlos III, Madrid, Spain., Rodriguez Mañas L; Center for Biomedical Research Network on Fragility and Healthy Aging (CIBERfes), Instituto de Salud Carlos III, Madrid, Spain.; Geriatrics Department, University Hospital of Getafe, Getafe, Spain., Costa-Grille A; Geriatrics Department, University Hospital of Getafe, Getafe, Spain., Matheu A; Center for Biomedical Research Network on Fragility and Healthy Aging (CIBERfes), Instituto de Salud Carlos III, Madrid, Spain.; Biodonostia, Health Research Institute, Donostia, Spain.; IKERBASQUE, Basque Foundation for Science, Bilbao, Spain., Marcos-Pérez D; Department of Geriatrics, Complejo Hospitalario Universitario de Albacete, Albacete, Spain., Lazcano U; Biodonostia, Health Research Institute, Donostia, Spain., Vergara I; Biodonostia, Health Research Institute, Donostia, Spain.; IKERBASQUE, Basque Foundation for Science, Bilbao, Spain.; Osakidetza, Health Care Department, Research Unit APOSIs, Gipuzkoa, Spain.; Research Network in Chronicity, Primary Care and Health Promotion (RICAPPS), Barakaldo, Spain., Arjona L; Deusto Institute of Technology, University of Deusto, Bilbao, Spain., Saeteros M; Deusto Institute of Technology, University of Deusto, Bilbao, Spain., Lopez-de-Ipiña D; Deusto Institute of Technology, University of Deusto, Bilbao, Spain., Coca A; Department of Physical Activity and Sports Sciences, Faculty of Health Sciences, Euneiz University, Vitoria-Gasteiz, Spain., Abizanda Soler P; Department of Geriatrics, Complejo Hospitalario Universitario de Albacete, Albacete, Spain.; Center for Biomedical Research Network on Fragility and Healthy Aging (CIBERfes), Instituto de Salud Carlos III, Madrid, Spain.; Facultad de Medicina de Albacete, Universidad de Castilla-La Mancha, Albacete, Spain., Sanabria SJ; IKERBASQUE, Basque Foundation for Science, Bilbao, Spain.; Deusto Institute of Technology, University of Deusto, Bilbao, Spain.; Department of Radiology, Stanford University, Palo Alto, CA, United States.
Jazyk:	angličtina
Zdroj:	JMIR research protocols [JMIR Res Protoc] 2024 Feb 23; Vol. 13, pp. e50325. Date of Electronic Publication: 2024 Feb 23.
DOI:	10.2196/50325
Abstrakt:	Background: Frailty resulting from the loss of muscle quality can potentially be delayed through early detection and physical exercise interventions. There is a demand for cost-effective tools for the objective evaluation of muscle quality, in both cross-sectional and longitudinal assessments. Literature suggests that quantitative analysis of ultrasound data captures morphometric, compositional, and microstructural muscle properties, while biological assays derived from blood samples are associated with functional information. Objective: This study aims to assess multiparametric combinations of ultrasound and blood-based biomarkers to offer a cross-sectional evaluation of the patient frailty phenotype and to track changes in muscle quality associated with supervised exercise programs. Methods: This prospective observational multicenter study will include patients aged 70 years and older who are capable of providing informed consent. We aim to recruit 100 patients from hospital environments and 100 from primary care facilities. Each patient will undergo at least two examinations (baseline and follow-up), totaling a minimum of 400 examinations. In hospital environments, 50 patients will be measured before/after a 16-week individualized and supervised exercise program, while another 50 patients will be followed up after the same period without intervention. Primary care patients will undergo a 1-year follow-up evaluation. The primary objective is to compare cross-sectional evaluations of physical performance, functional capacity, body composition, and derived scales of sarcopenia and frailty with biomarker combinations obtained from muscle ultrasound and blood-based assays. We will analyze ultrasound raw data obtained with a point-of-care device, along with a set of biomarkers previously associated with frailty, using quantitative real-time polymerase chain reaction and enzyme-linked immunosorbent assay. Additionally, we will examine the sensitivity of these biomarkers to detect short-term muscle quality changes and functional improvement after a supervised exercise intervention compared with usual care. Results: At the time of manuscript submission, the enrollment of volunteers is ongoing. Recruitment started on March 1, 2022, and ends on June 30, 2024. Conclusions: The outlined study protocol will integrate portable technologies, using quantitative muscle ultrasound and blood biomarkers, to facilitate an objective cross-sectional assessment of muscle quality in both hospital and primary care settings. The primary objective is to generate data that can be used to explore associations between biomarker combinations and the cross-sectional clinical assessment of frailty and sarcopenia. Additionally, the study aims to investigate musculoskeletal changes following multicomponent physical exercise programs. Trial Registration: ClinicalTrials.gov NCT05294757; https://clinicaltrials.gov/ct2/show/NCT05294757. International Registered Report Identifier (irrid): DERR1-10.2196/50325. (©Naiara Virto, Xabier Río, Garazi Angulo-Garay, Rafael García Molina, Almudena Avendaño Céspedes, Elisa Belen Cortés Zamora, Elena Gómez Jiménez, Ruben Alcantud Córcoles, Leocadio Rodriguez Mañas, Alba Costa-Grille, Ander Matheu, Diego Marcos-Pérez, Uxue Lazcano, Itziar Vergara, Laura Arjona, Morelva Saeteros, Diego Lopez-de-Ipiña, Aitor Coca, Pedro Abizanda Soler, Sergio J Sanabria. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 23.02.2024.)
Databáze:	MEDLINE
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