title: The "Sarcopenia and Physical fRailty IN older people: multi-componenT Treatment strategies" (SPRINTT) randomized controlled trial: design and methods.
abstract: The sustainability of health and social care systems is threatened by a growing population of older persons with heterogeneous needs related to multimorbidity, frailty, and increased risk of functional impairment. Since disability is difficult to reverse in old age and is extremely burdensome for individuals and society, novel strategies should be devised to preserve adequate levels of function and independence in late life. The development of mobility disability, an early event in the disablement process, precedes and predicts more severe forms of inability. Its prevention is, therefore, critical to impede the transition to overt disability. For this reason, the Sarcopenia and Physical fRailty IN older people: multi-componenT Treatment strategies (SPRINTT) project is conducting a randomized controlled trial (RCT) to test a multicomponent intervention (MCI) specifically designed to prevent mobility disability in high-risk older persons. SPRINTT is a phase III, multicenter RCT aimed at comparing the efficacy of a MCI, based on long-term structured physical activity, nutritional counseling/dietary intervention, and an information and communication technology intervention, versus a healthy aging lifestyle education program designed to prevent mobility disability in 1500 older persons with physical frailty and sarcopenia who will be followed for up to 36 months. The primary outcome of the SPRINTT trial is mobility disability, operationalized as the inability to walk for 400 m within 15 min, without sitting, help of another person, or the use of a walker. Secondary outcomes include changes in muscle mass and strength, persistent mobility disability, falls and injurious falls, disability in activities of daily living, nutritional status, cognition, mood, the use of healthcare resources, cost-effectiveness analysis, quality of life, and mortality rate. SPRINTT results are expected to promote significant advancements in the management of frail older persons at high risk of disability from both clinical and regulatory perspectives. The findings are also projected to pave the way for major investments in the field of disability prevention in old age.
authors.affiliation: Department of Geriatrics, Neurosciences and Orthopedics, Catholic University of the Sacred Heart School of Medicine, Rome, Italy. francesco.landi@rm.unicatt.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Landi
authors.affiliation: Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.|Université de Toulouse III Paul Sabatier, Toulouse, France.
authors.forename: Matteo
authors.initials: M
authors.lastname: Cesari
authors.affiliation: Department of Geriatrics, Neurosciences and Orthopedics, Catholic University of the Sacred Heart School of Medicine, Rome, Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Calvani
authors.affiliation: Geriatrics and Geriatric Emergency Care, IRCCS-INRCA, Ancona, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Cherubini
authors.affiliation: Research Unit of Medicine of Aging, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.|Division of Geriatric Cardiology and Medicine, Department of Geriatrics and Medicine, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Di Bari
authors.affiliation: Sanofi R&D, Paris, Chilly-Mazarin, France.
authors.forename: Raphael
authors.initials: R
authors.lastname: Bejuit
authors.affiliation: Sanofi R&D, Paris, Chilly-Mazarin, France.
authors.forename: Jerome
authors.initials: J
authors.lastname: Mshid
authors.affiliation: INSERM-Toulouse University UMR1027, Toulouse, France.|Department of Epidemiology and Public Health, CHU Toulouse, Toulouse, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Andrieu
authors.affiliation: Foundation for Diabetes Research in Older People, Diabetes Frail Ltd, Droitwich Spa, UK.
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Sinclair
authors.affiliation: Institute for Biomedicine of Aging, Friedrich-Alexander University, Nuremberg, Germany.
authors.forename: Cornel C
authors.initials: CC
authors.lastname: Sieber
authors.affiliation: Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Vellas
authors.affiliation: Department of Geriatrics, First Faculty of Medicine, Charles University, Prague, Czech Republic.
authors.forename: Eva
authors.initials: E
authors.lastname: Topinkova
authors.affiliation: Department of Internal Medicine and Geriatrics, University of Helsinki, Helsinki, Finland.|Clinics of Internal Medicine and Geriatrics, Helsinki University Central Hospital, Helsinki, Finland.|Unit of General Practice, Oulu University Hospital, Oulu, Finland.
authors.forename: Timo
authors.initials: T
authors.lastname: Strandberg
authors.affiliation: Service of Geriatrics, Getafe University Hospital, Madrid, Spain.
authors.forename: Leocadio
authors.initials: L
authors.lastname: Rodriguez-Manas
authors.affiliation: Geriatrics and Geriatric Emergency Care, IRCCS-INRCA, Ancona, Italy.
authors.forename: Fabrizia
authors.initials: F
authors.lastname: Lattanzio
authors.affiliation: Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.
authors.forename: Marco
authors.initials: M
authors.lastname: Pahor
authors.affiliation: Global Translational Medicine, Novartis Institutes for Biomedical Research, Basel, Switzerland.
authors.forename: Ronenn
authors.initials: R
authors.lastname: Roubenoff
authors.affiliation: Geriatric Department, University Hospital Ramón y Cajal, Madrid, Spain.
authors.forename: Alfonso J
authors.initials: AJ
authors.lastname: Cruz-Jentoft
authors.affiliation: Department of Geriatrics, Neurosciences and Orthopedics, Catholic University of the Sacred Heart School of Medicine, Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Bernabei
authors.affiliation: Department of Geriatrics, Neurosciences and Orthopedics, Catholic University of the Sacred Heart School of Medicine, Rome, Italy. emarzetti@live.com.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Marzetti
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D003362:Cost-Benefit Analysis; D015444:Exercise; D016330:Frail Elderly; D006801:Humans; D051346:Mobility Limitation; D011788:Quality of Life; D012107:Research Design; D055948:Sarcopenia / Q000517:prevention & control* / Q000628:therapy
keywords: Disability; Functional impairment; Nutrition; Physical activity; Prevention; Unmet needs