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The “Sarcopenia and Physical fRailty IN older people: multi-componenT Treatment strategies” (SPRINTT) randomized controlled trial: design and methods

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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.

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Acknowledgements

The present work was funded by a grant from the Innovative Medicines Initiative—Joint Undertaking (IMI-JU 115621). The work was also partly supported by the “Centro Studi Achille e Linda Lorenzon” (E.M., R.C.), Fondazione Roma (NCDs Call for Proposals 2013; E.M., R.C.), and intramural research grants from the Catholic University of the Sacred Heart (D3.2 2013 and D3.2 2015; E.M., F.L., R.C.).

Author information

Authors and Affiliations

  1. Department of Geriatrics, Neurosciences and Orthopedics, Catholic University of the Sacred Heart School of Medicine, Rome, Italy

    Francesco Landi, Riccardo Calvani, Roberto Bernabei & Emanuele Marzetti

  2. Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Toulouse, France

    Matteo Cesari & Bruno Vellas

  3. Université de Toulouse III Paul Sabatier, Toulouse, France

    Matteo Cesari

  4. Geriatrics and Geriatric Emergency Care, IRCCS-INRCA, Ancona, Italy

    Antonio Cherubini & Fabrizia Lattanzio

  5. Research Unit of Medicine of Aging, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy

    Mauro Di Bari

  6. Division of Geriatric Cardiology and Medicine, Department of Geriatrics and Medicine, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy

    Mauro Di Bari

  7. Sanofi R&D, Paris, Chilly-Mazarin, France

    Raphael Bejuit & Jerome Mshid

  8. INSERM-Toulouse University UMR1027, Toulouse, France

    Sandrine Andrieu

  9. Department of Epidemiology and Public Health, CHU Toulouse, Toulouse, France

    Sandrine Andrieu

  10. Foundation for Diabetes Research in Older People, Diabetes Frail Ltd, Droitwich Spa, UK

    Alan J. Sinclair

  11. Institute for Biomedicine of Aging, Friedrich-Alexander University, Nuremberg, Germany

    Cornel C. Sieber

  12. Department of Geriatrics, First Faculty of Medicine, Charles University, Prague, Czech Republic

    Eva Topinkova

  13. Department of Internal Medicine and Geriatrics, University of Helsinki, Helsinki, Finland

    Timo Strandberg

  14. Clinics of Internal Medicine and Geriatrics, Helsinki University Central Hospital, Helsinki, Finland

    Timo Strandberg

  15. Unit of General Practice, Oulu University Hospital, Oulu, Finland

    Timo Strandberg

  16. Service of Geriatrics, Getafe University Hospital, Madrid, Spain

    Leocadio Rodriguez-Manas

  17. Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA

    Marco Pahor

  18. Global Translational Medicine, Novartis Institutes for Biomedical Research, Basel, Switzerland

    Ronenn Roubenoff

  19. Geriatric Department, University Hospital Ramón y Cajal, Madrid, Spain

    Alfonso J. Cruz-Jentoft

Authors
  1. Francesco Landi
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  2. Matteo Cesari
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  3. Riccardo Calvani
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  4. Antonio Cherubini
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  5. Mauro Di Bari
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  6. Raphael Bejuit
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  7. Jerome Mshid
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  8. Sandrine Andrieu
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  9. Alan J. Sinclair
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  10. Cornel C. Sieber
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  11. Bruno Vellas
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  12. Eva Topinkova
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  13. Timo Strandberg
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  14. Leocadio Rodriguez-Manas
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  15. Fabrizia Lattanzio
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  18. Alfonso J. Cruz-Jentoft
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  19. Roberto Bernabei
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  20. Emanuele Marzetti
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Consortia

on behalf of the SPRINTT Consortium

Corresponding authors

Correspondence to Francesco Landi or Emanuele Marzetti.

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The authors declare that they have no conflict of interest.

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This article does not contain any studies with human participants or animals performed by any of the authors.

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APPENDIX

APPENDIX

SPRINTT study personnel

Università Cattolica del Sacro Cuore (Rome, Italy) Roberto Bernabei (SPRINTT Principal Investigator for the Academia), Claudio Boni, Vincenzo Brandi, Marianna Broccatelli, Riccardo Calvani, Carilia Celesti, Americo Cicchetti, Agnese Collamati, Silvia Coretti, Emanuela D'Angelo, Mariaelena D'Elia, Francesco Landi, Giovanni Landi, Maria Lorenzi, Luca Mariotti, Anna Maria Martone, Emanuele Marzetti, Elena Ortolani, Teodosio Pafundi, Anna Picca, Matteo Ruggeri, Sara Salini, Giulia Savera, Matteo Tosato, Davide L. Vetrano.

IRCCS-INRCA (Ancona, Italy) Fabrizia Lattanzio (Local Principal Investigator), Renato Baldoni, Serena Bernabei, Anna Rita Bonfigli, Silvia Bustacchini, Barbara Carrieri, Laura Cassetta, Antonio Cherubini, Michela Cucchi, Giacomo Cucchieri, Anna Rita Costantini, Giuseppina Dell’Aquila, Emma Espinosa, Massimiliano Fedecostante, Riccardo Fraternali, Roberta Galeazzi, Antonella Mengarelli, Stefano Piomboni, Elena Posacki, Eddy Severini, Tiziana Tregambe, Fabiana Trotta.

Università di Parma (Parma, Italy) Marcello Maggio (Local Principal Investigator), Fulvio Lauretani, Valeria Buttò, Alberto Fisichella, Chiara Guareschi, Yari Longobucco, Sara Tagliaferri.

Università di Firenze (Florence, Italy) Mauro Di Bari.

Servicio Mardrileno de Salud-Hospital Universitario de Getafe (Getafe, Spain) Leocadio Rodriguez-Manas (Local Principal Investigator), Soledad Alamo, Cristina Alonso Bouzon, Jimmy Gonzales Turin, Olga Laosa Zafra, Andrea Lopez Picazo, Laura Pedraza Sepulveda, Juan Luis Sanchez, Carlos Sanchez Puelles, Myryam Valdés Aragonés.

Servicio Mardrileno de Salud-Hospital Universitario Ramón y Cajal (Madrid, Spain) Alfonso José Cruz-Jentoft (Local Principal Investigator), Juan Alvarez Santos, Loreto Alvarez-Nebreda, Nelén Fernández Jiménez, Jesús Mateos-del Nozal, Beatriz Montero-Errasquín, Beatriz Ponce Moreno, Cristina Roldán-Plaza, Alfonso Romera-de Vicente, Vicente Sánchez-Cadenas, Carmen Sánchez-Castellano, Elisabet Sánchez-García, Mará Nieves Vaquero-Pinto.

Univerzita Karlova v Praze (Prague, Czech Republic) Eva Topinková (Local Principal Investigator), Lucie Bautzka, Kamila Blechová, Terza Gueye, Ilona Juklicková, Terza Klbíková, Jana Křenková, Pavla Mádlová, Helena Mejstriková, Renata Melčova, Helena Michálková.

Salesians Hospital (Opava, Czech Republic) Ingrid Ryznarová (Local Principal Investigator), Ivana Drastichova, Eva Hasaliková, Radim Hucko, Seget Jakub, Monika Janácová, Michaela Kilmková, Martina Parízková, Kristyna Pavelková, Michaela Redrova, Petra Rusková.

Friedrich-Alexander-Universität Erlangen-Nürnberg (Nürnberg, Germany) Cornel C. Sieber (Local Principal Investigator), Tina Auerswald, Christof Engel, Anna Franke, Ellen Freibergen, Ulrike Freiheit, Susann Gotthardt, Karin Kampe, Robert Kob, Christine Kokott, CarolinKraska, Christian Meyer, Veronika Reith, Hanna Rempe, Daniel Schoene, Gabrielle Sieber, Kerstin Zielinski.

Universitätsmedizin Göttingen, Georg-August-Universität (Göttingen, Germany) Stefan D. Anker, Nicole Ebner, Romanus Grütz, Stephan von Haehling.

University of Maastricht (Maastricht, The Netherlands) Annemie M. W. J. Schols (Local Principal Investigator), Harry Gosker, Stephanie Huysmans, Sandy Quaaden, Jos M. Schols, Nick Smeets, Pascal Stevens, Coby van de Bool, Claire Weling.

Helsingin yliopisto (Helsinki, Finland) Timo Strandberg (Local Principal Investigator), Katja Hallikas, Marjatta Herranen, Tiina Huusko, Laura Hytönen, Kirsi Ikonen, Satu Jyväkorpi, Anne Karppi-Sjöblom, Kaisa Karvinen, Maija Käyhty, Tarja Kindsted, Erja Landström, Saana Leirimaa, Hanna Öhman, Kaisu Pitkälä, Anja Punkka, Anne-Mari Saavalainen, Tuulia Salo, Madis Sepa, Katja Sohlberg, Anele Urtamo, Emmi Vaatamoinen, Sirpa Venäläinen, Hannu Vanhanen.

Centre Hospitalier Universitaire de Toulouse (Toulouse, France) Bruno Vellas (Local Principal Investigator), Gabor Abellan Van Kan, Virginie Biville, Lauréane Brigitte, Carole Cervera, Matteo Cesari, Marie Champarnaud, Céline Cluzan, Muriel Croizet, Sophie Dardenne, Marie Dorard, Charlotte Dupuy, Emilie Durand, Catherine Faisant, Bertrand Fougère, Philippe Girard, Sophie Guyonnet, Emiel Hoogendijk, Rémi Mauroux, Agathe Milhet, Sylvie Montel, Pierre-Jean Ousset, Cécile Picauron, Gaelle Soriano, Maturin Tabue Teguo, Bernard Teysseyre.

INSERM-Toulouse University UMR1027 (Toulouse, France) Sandrine Andrieu (Local Principal Investigator), Alessandro Blasimme, Cedric Dray, Emmanuelle Rial-Sebbag, Philippe Valet.

Centre Hospitalier Universitaire de Limoges (Limoges, France) Thierry Dantoine (Local Principal Investigator), Maxime Billot, Noelle Cardinaud, Muriel Castelli, Marion Charenton-Blavignac, Cecilia Ciccolari-Micaldi, Caroline Gayot, Anael Larreur, Cécilie Laubarie-Mouriet, Delphine Marchesseau, Thomas Mergans, Thai Binh Nguyen, Arnaud Papon, Johann Ribet, Isabelle Saulinier, Achille Tchalla.

Université Paris Descartes (Paris, France) Thomas Rapp (Local Principal Investigator), Nicolas Sirven.

Uniwersytet Jagiellonski (Krakow, Poland) Anna Skalska (Local Principal Investigators), Ewa Blaszcyk, Marcin Cwynar, Joanna Czesak, Paulina Fatyga, Malgorzata Fedyk-Lukasik, Tomasz Grodzicki, Paulina Jamrozik, Zbigniew Janusz, Ewa Klimek, Sylwia Komoniewska, Maria Kret, Maciej Ozog, Agnieszka Parnicka, Kararzyna Petitjean, Anna Pietrzyk, Karolina Piotrowicz, Barbara Skalska-Dulinska, Damian Starzyk, Katarzyna Szczerbinska, Borys Witkiewicz, Anna Wlodarczyk.

Diabetes Frail Ltd (Luton, United Kingdom) Alan Sinclair (Local Principal Investigator), Sital Harris, Allison Ogborne, Sarah Ritchie, Caroline Sinclair, Harriet Sinclair.

Aston University (Birmingham, United Kingdom) Srikanth Bellary (Local Principal Investigator), Sital Harris, Hannah Worthington.

Szpitala Geriatrycznego im Jana Pawla II (Katowice, Polan) Jaroslaw Derejczyk.

Medical University of Graz (Graz, Austria) Regina Roller-Wirnsberger.

University of Iceland (Reykjavík, Iceland) Pálmi Jónsson.

Sanofi-Aventis Research and Development (Chilly Mazarin, France) Philippe Bordes (Local Principal Investigator), Sandrine Arnaud, Christian Asbrand, Raphael Bejuit, Sandrine Durand, Klaus Flechsenhar, Florence Joly, Regis Le Lain, Mathieu Moncharmont, Jerome Msihid, Aurèle Ndja, Brigitte Riche, Anne Caroline Weber, Jiazhao Yuan.

Novartis Pharma AG (Basel, Switzerland) Ronenn Roubenoff (SPRINTT Principal Investigator for EFPIA), Patrick Kortebein, Ram R. Miller.

(Madrid, Spain) Carmen Gorostiaga (Local Principal Investigator), Patricia Belissa-Mathiot, Hao Hu, Laurence Laigle, Itziar Martinez Melchor.

Glaxo Smith Kline Research and Development (Research Triangle Park, NC, USA) Alan Russel (Local Principal Investigator), Mike Bennecky, Tom Haws, Ashish Joshi, Karen Philpott, Anne Walker.

Caretek (Turin, Italy) Gianluca Zia (Local Principal Investigator), Sabina De Giorgi, Luca Feletti, Elisa Marchioro, Francesco Mocci, Maria Grazia Varesio.

EU-Open (Bruxelles, Belgium) Alfredo Cesario (Local Principal Investigator), Barbara Cabin, Willem P. de Boer, Claire Ignaszewski, Ingrid Klingmann.

Roessingh Research and Development (Twente, The Netherlands) Miriam Vollenbroek-Hutten (Local Principal Investigator), Termie Hermens, Stephanie Jansen-Kosterink, Monique Tabak.

Telemedicine Technologies (Boulogne-Billancourt, France) Patrick Blandin, Laure Coutard, Anne-Marie Lenzotti, Hocine Mokhtari, Nicolos Rodon.

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Landi, F., Cesari, M., Calvani, R. et al. The “Sarcopenia and Physical fRailty IN older people: multi-componenT Treatment strategies” (SPRINTT) randomized controlled trial: design and methods. Aging Clin Exp Res 29, 89–100 (2017). https://doi.org/10.1007/s40520-016-0715-2

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  • DOI: https://doi.org/10.1007/s40520-016-0715-2

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