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Aging Clinical and Experimental Research

, Volume 29, Issue 1, pp 89–100 | Cite as

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

  • Francesco LandiEmail author
  • Matteo Cesari
  • Riccardo Calvani
  • Antonio Cherubini
  • Mauro Di Bari
  • Raphael Bejuit
  • Jerome Mshid
  • Sandrine Andrieu
  • Alan J. Sinclair
  • Cornel C. Sieber
  • Bruno Vellas
  • Eva Topinkova
  • Timo Strandberg
  • Leocadio Rodriguez-Manas
  • Fabrizia Lattanzio
  • Marco Pahor
  • Ronenn Roubenoff
  • Alfonso J. Cruz-Jentoft
  • Roberto Bernabei
  • Emanuele MarzettiEmail author
  • on behalf of the SPRINTT Consortium
Original Article

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.

Keywords

Disability Functional impairment Physical activity Nutrition Prevention Unmet needs 

Notes

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.).

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

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

Informed consent

For this type of study, informed consent is not required.

References

  1. 1.
    Bien B, McKee KJ, Dohner H, Triantafillou J, Lamura G, Doroszkiewicz H, Krevers B, Kofahl C (2013) Disabled older people’s use of health and social care services and their unmet care needs in six European countries. Eur J Public Health 23:1032–1038. doi: 10.1093/eurpub/cks190 CrossRefPubMedGoogle Scholar
  2. 2.
    Mander T (2014) Longevity and healthy ageing—will healthcare be drowned by the grey Tsunami or sunk by the demographic iceberg? Post Reprod Health (Lond) 20:8–10. doi: 10.1177/1754045313515208 CrossRefGoogle Scholar
  3. 3.
    Beswick AD, Rees K, Dieppe P, Ayis S, Gooberman-Hill R, Horwood J, Ebrahim S (2008) Complex interventions to improve physical function and maintain independent living in elderly people: a systematic review and meta-analysis. Lancet 371:725–735. doi: 10.1016/S0140-6736(08)60342-6 CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Pahor M, Guralnik JM, Ambrosius WT, Blair S, Bonds DE, Church TS, Espeland MA, Fielding RA, Gill TM, Groessl EJ, King AC, Kritchevsky SB, Manini TM, McDermott MM, Miller ME, Newman AB, Rejeski WJ, Sink KM, Williamson JD, LIFE study investigators (2014) Effect of structured physical activity on prevention of major mobility disability in older adults: the LIFE study randomized clinical trial. JAMA 311:2387–2396. doi: 10.1001/jama.2014.5616 CrossRefPubMedPubMedCentralGoogle Scholar
  5. 5.
    Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB (1994) A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol 49:M85–M94. doi: 10.1093/geronj/49.2.M85 CrossRefPubMedGoogle Scholar
  6. 6.
    Simonsick EM, Montgomery PS, Newman AB, Bauer DC, Harris T (2001) Measuring fitness in healthy older adults: the health ABC long distance corridor walk. J Am Geriatr Soc 49:1544–1548. doi: 10.1046/j.1532-5415.2001.4911247.x CrossRefPubMedGoogle Scholar
  7. 7.
    Stott DJ, Langhorne P, Knight PV (2008) Multidisciplinary care for elderly people in the community. Lancet 371:699–700. doi: 10.1016/S0140-6736(08)60317-7 CrossRefPubMedGoogle Scholar
  8. 8.
    Marzetti E, Calvani R, Landi F, Hoogendijk EO, Fougère B, Vellas B, Pahor M, Bernabei R, Cesari M, SPRINTT Consortium (2015) Innovative Medicines Initiative: The SPRINTT Project. J Frailty Aging 4:207–208. doi: 10.14283/jfa.2015.69 Google Scholar
  9. 9.
    Landi F, Calvani R, Cesari M, Tosato M, Martone AM, Bernabei R, Onder G, Marzetti E (2015) Sarcopenia as the biological substrate of physical frailty. Clin Geriatr Med 31:367–374. doi: 10.1016/j.cger.2015.04.005 CrossRefPubMedGoogle Scholar
  10. 10.
    Cesari M, Landi F, Calvani R, Cherubini A, Di Bari M, Kortebein P, Del Signore A, Le Lain R, Vellas B, Pahor M, Roubenoff R, Bernabei R, Marzetti E, for the SPRINTT Consortium (2016) Rationale for the operational definition of physical frailty and sarcopenia in the SPRINTT trial. Aging Clin Exp Res. doi: 10.1007/s40520-016-0716-1
  11. 11.
    Studenski SA, Peters KW, Alley DE, Cawthon PM, McLean RR, Harris TB, Ferrucci L, Guralnik JM, Fragala MS, Kenny AM, Kiel DP, Kritchevsky SB, Shardell MD, Dam TT, Vassileva MT (2014) The FNIH sarcopenia project: rationale, study description, conference recommendations, and final estimates. J Gerontol A Biol Sci Med Sci 69:547–558. doi: 10.1093/gerona/glu010 CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    Cesari M, Vellas B, Hsu FC, Newman AB, Doss H, King AC, Manini TM, Church T, Gill TM, Miller ME, Pahor M (2015) A physical activity intervention to treat the frailty syndrome in older persons-results from the LIFE-P study. J Gerontol A Biol Sci Med Sci 70:216–222. doi: 10.1093/gerona/glu099 CrossRefPubMedGoogle Scholar
  13. 13.
    Fielding RA, Rejeski WJ, Blair S, Church T, Espeland MA, Gill TM, Guralnik JM, Hsu FC, Katula J, King AC, Kritchevsky SB, McDermott MM, Miller ME, Nayfield S, Newman AB, Williamson JD, Bonds D, Romashkan S, Hadley E, Pahor M (2011) The Lifestyle Interventions and Independence for Elders Study: design and methods. J Gerontol A Biol Sci Med Sci 66:1226–1237. doi: 10.1093/gerona/glr123 CrossRefPubMedGoogle Scholar
  14. 14.
    King AC, Rejeski WJ, Buchner DM (1998) Physical activity interventions targeting older adults. A critical review and recommendations. Am J Prev Med 15:316–333. doi: 10.1016/S0749-3797(98)00085-3 CrossRefPubMedGoogle Scholar
  15. 15.
    Borg G (1970) Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med 2:92–98PubMedGoogle Scholar
  16. 16.
    American College of Sports Medicine, Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS (2009) Exercise and physical activity for older adults. Med Sci Sports Exerc 41:1510-1530. doi: 10.1249/MSS.0b013e3181a0c95c CrossRefGoogle Scholar
  17. 17.
    Ettinger WH Jr, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, Shumaker S, Berry MJ, O’Toole M, Monu J, Craven T (1997) A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The fitness arthritis and seniors trial (FAST). JAMA 277:25–31. doi: 10.1001/jama.1997.03540250033028 CrossRefPubMedGoogle Scholar
  18. 18.
    Nelson ME, Layne JE, Bernstein MJ, Nuernberger A, Castaneda C, Kaliton D, Hausdorff J, Judge JO, Buchner DM, Roubenoff R, Fiatarone Singh MA (2004) The effects of multidimensional home-based exercise on functional performance in elderly people. J Gerontol A Biol Sci Med Sci 59:154–160. doi: 10.1093/gerona/59.2.M154 CrossRefPubMedGoogle Scholar
  19. 19.
    Pahor M, Blair SN, Espeland M, Fielding R, Gill TM, Guralnik JM, Hadley EC, King AC, Kritchevsky SB, Maraldi C, Miller ME, Newman AB, Rejeski WJ, Romashkan S, Studenski S (2006) Effects of a physical activity intervention on measures of physical performance: Results of the lifestyle interventions and independence for Elders Pilot (LIFE-P) study. J Gerontol A Biol Sci Med Sci 61:1157–1165CrossRefPubMedGoogle Scholar
  20. 20.
    Calvani R, Miccheli A, Landi F, Bossola M, Cesari M, Leeuwenburgh C, Sieber CC, Bernabei R, Marzetti E (2013) Current nutritional recommendations and novel dietary strategies to manage sarcopenia. J Frailty Aging 2:38–53PubMedPubMedCentralGoogle Scholar
  21. 21.
    Michel JP, Cruz-Jentoft AJ, Cederholm T (2015) Frailty, exercise and nutrition. Clin Geriatr Med 31:375–387. doi: 10.1016/j.cger.2015.04.006 CrossRefPubMedGoogle Scholar
  22. 22.
    Abellan van Kan G, Rolland Y, Houles M, Gillette-Guyonnet S, Soto M, Vellas B (2010) The assessment of frailty in older adults. Clin Geriatr Med 26:275–286. doi: 10.1016/j.cger.2010.02.002 CrossRefPubMedGoogle Scholar
  23. 23.
    Landi F, Calvani R, Tosato M, Martone AM, Ortolani E, Savera G, D’Angelo E, Sisto A, Marzetti E (2016) Protein intake and muscle health in old age: From biological plausibility to clinical evidence. Nutrients 8:295. doi: 10.3390/nu8050295 CrossRefPubMedCentralGoogle Scholar
  24. 24.
    Correia MI, Hegazi RA, Higashiguchi T, Michel JP, Reddy BR, Tappenden KA, Uyar M, Muscaritoli M (2014) Evidence-based recommendations for addressing malnutrition in health care: an updated strategy from the feedM.E. Global Study Group. J Am Med Dir Assoc 15:544–550. doi: 10.1016/j.jamda.2014.05.011 CrossRefPubMedGoogle Scholar
  25. 25.
    Bauer J, Biolo G, Cederholm T, Cesari M, Cruz-Jentoft AJ, Morley JE, Phillips S, Sieber C, Stehle P, Teta D, Visvanathan R, Volpi E, Boirie Y (2013) Evidence-based recommendations for optimal dietary protein intake in older people: a position paper from the PROT-AGE Study Group. J Am Med Dir Assoc 14:542–559. doi: 10.1016/j.jamda.2013.05.021 CrossRefPubMedGoogle Scholar
  26. 26.
    American Geriatrics Society Workgroup on Vitamin D Supplementation for Older Adults (2014) Recommendations abstracted from the American geriatrics society consensus statement on vitamin D for prevention of falls and their consequences. J Am Geriatr Soc 62:147–152. doi: 10.1111/jgs.12631 CrossRefGoogle Scholar
  27. 27.
    Bandinelli S, Lauretani F, Boscherini V, Gandi F, Pozzi M, Corsi AM, Bartali B, Lova RM, Guralnik JM, Ferrucci L (2006) A randomized, controlled trial of disability prevention in frail older patients screened in primary care: the FRASI study. Design and baseline evaluation. Aging Clin Exp Res 18:359–366. doi: 10.1111/jgs.12631 CrossRefPubMedPubMedCentralGoogle Scholar
  28. 28.
    Metzelthin SF, van RE, de Witte LP, Ambergen AW, Hobma SO, Sipers W, Kempen GI (2013) Effectiveness of interdisciplinary primary care approach to reduce disability in community dwelling frail older people: cluster randomised controlled trial. BMJ 347:f5264. doi: 10.1136/bmj.f5264 CrossRefPubMedPubMedCentralGoogle Scholar
  29. 29.
    Cesari M, Demougeot L, Boccalon H, Guyonnet S, Vellas B, Andrieu S (2014) The multidomain intervention to prevent disability in elders (MINDED) project: rationale and study design of a pilot study. Contemp Clin Trials 38:145–154. doi: 10.1016/j.cct.2014.04.006 CrossRefPubMedGoogle Scholar
  30. 30.
    Rejeski WJ, Ip EH, Marsh AP, Miller ME, Farmer DF (2008) Measuring disability in older adults: the international classification system of functioning, disability and health (ICF) framework. Geriatr Gerontol Int 8:48–54. doi: 10.1111/j.1447-0594.2008.00446.x CrossRefPubMedPubMedCentralGoogle Scholar
  31. 31.
    Katz S, Ford AB, Moskowitz RW, Jackson BA, Jaffe MW (1963) Studies of illness in the aged. The index of ADL: a standardized measure of biological and psychosocial function. JAMA 185:914–919. doi: 10.1001/jama.1963.03060120024016 CrossRefPubMedGoogle Scholar
  32. 32.
    Lawton MP, Brody EM (1969) Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist 9:179–186. doi: 10.1093/geront/9.3_Part_1.179 CrossRefPubMedGoogle Scholar
  33. 33.
    Rubenstein LZ, Harker JO, Salva A, Guigoz Y, Vellas B (2001) Screening for undernutrition in geriatric practice: developing the short-form mini-nutritional assessment (MNA-SF). J Gerontol A Biol Sci Med Sci 56:M366–M372. doi: 10.1093/gerona/56.6.M366 CrossRefPubMedGoogle Scholar
  34. 34.
    Folstein MF, Folstein SE, McHugh PR (1975) “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 12:189–198. doi: 10.1016/0022-3956(75)90026-6 CrossRefPubMedGoogle Scholar
  35. 35.
    Tombaugh TN (2004) Trail making test A and B: normative data stratified by age and education. Arch Clin Neuropsychol 19:203–214. doi: 10.1016/S0887-6177(03)00039-8 CrossRefPubMedGoogle Scholar
  36. 36.
    Radloff LS (1977) The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas 1:385–401. doi: 10.1177/014662167700100306 CrossRefGoogle Scholar
  37. 37.
    EuroQol Group (1990) EuroQol–a new facility for the measurement of health-related quality of life. Health Policy 16:199–208. doi: 10.1016/0168-8510(90)90421-9 CrossRefGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2017

Authors and Affiliations

  • Francesco Landi
    • 1
    Email author
  • Matteo Cesari
    • 2
    • 3
  • Riccardo Calvani
    • 1
  • Antonio Cherubini
    • 4
  • Mauro Di Bari
    • 5
    • 6
  • Raphael Bejuit
    • 7
  • Jerome Mshid
    • 7
  • Sandrine Andrieu
    • 8
    • 9
  • Alan J. Sinclair
    • 10
  • Cornel C. Sieber
    • 11
  • Bruno Vellas
    • 2
  • Eva Topinkova
    • 12
  • Timo Strandberg
    • 13
    • 14
    • 15
  • Leocadio Rodriguez-Manas
    • 16
  • Fabrizia Lattanzio
    • 4
  • Marco Pahor
    • 17
  • Ronenn Roubenoff
    • 18
  • Alfonso J. Cruz-Jentoft
    • 19
  • Roberto Bernabei
    • 1
  • Emanuele Marzetti
    • 1
    Email author
  • on behalf of the SPRINTT Consortium
  1. 1.Department of Geriatrics, Neurosciences and OrthopedicsCatholic University of the Sacred Heart School of MedicineRomeItaly
  2. 2.GérontopôleCentre Hospitalier Universitaire de ToulouseToulouseFrance
  3. 3.Université de Toulouse III Paul SabatierToulouseFrance
  4. 4.Geriatrics and Geriatric Emergency CareIRCCS-INRCAAnconaItaly
  5. 5.Research Unit of Medicine of Aging, Department of Experimental and Clinical MedicineUniversity of FlorenceFlorenceItaly
  6. 6.Division of Geriatric Cardiology and Medicine, Department of Geriatrics and MedicineAzienda Ospedaliero-Universitaria CareggiFlorenceItaly
  7. 7.Sanofi R&DParisFrance
  8. 8.INSERM-Toulouse University UMR1027ToulouseFrance
  9. 9.Department of Epidemiology and Public HealthCHU ToulouseToulouseFrance
  10. 10.Foundation for Diabetes Research in Older PeopleDiabetes Frail LtdDroitwich SpaUK
  11. 11.Institute for Biomedicine of AgingFriedrich-Alexander UniversityNurembergGermany
  12. 12.Department of Geriatrics, First Faculty of MedicineCharles UniversityPragueCzech Republic
  13. 13.Department of Internal Medicine and GeriatricsUniversity of HelsinkiHelsinkiFinland
  14. 14.Clinics of Internal Medicine and GeriatricsHelsinki University Central HospitalHelsinkiFinland
  15. 15.Unit of General PracticeOulu University HospitalOuluFinland
  16. 16.Service of GeriatricsGetafe University HospitalMadridSpain
  17. 17.Department of Aging and Geriatric ResearchUniversity of FloridaGainesvilleUSA
  18. 18.Global Translational MedicineNovartis Institutes for Biomedical ResearchBaselSwitzerland
  19. 19.Geriatric DepartmentUniversity Hospital Ramón y CajalMadridSpain

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