Designing pharmaceutical trials for sarcopenia in frail older adults: EU/US task force recommendations

Journal of Nutrition, Health and Aging

Volumn 17, Issue 7, 2013, Pages 612-618

  Vellas, B ^a,b,c   Pahor, M ^d   Manini, T ^d   Rooks, D ^e   Guralnik, J M ^f   Morley, J ^g   Studenski, S ^h   Evans, W ⁱ   Asbrand, C ^j   Fariello, R ^k   Pereira, S ^l   Rolland, Y ^a,b,c   Abellan Van Kan, G ^c   Cesari, M ^a,b,c   Chumlea, W M C ^m   Fielding, R ⁿ  

^a INSERM   (France)

^b UNIVERSITÉ PAUL SABATIER   (France)

^c TOULOUSE UNIVERSITY HOSPITAL   (France)

^d UNIVERSITY OF FLORIDA   (United States)

^e NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH   (United States)

^f UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^g SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h UNIVERSITY OF PITTSBURGH   (United States)

ⁱ GLAXOSMITHKLINE   (United States)

^j SANOFI AVENTIS DEUTSCHLAND GMBH   (Germany)

^k NEUROTUNE AG   (Switzerland)

^l ABBOTT LABORATORIES   (United States)

^m WRIGHT STATE UNIVERSITY   (United States)

ⁿ TUFTS UNIVERSITY   (United States)

more..

Author keywords

clinical trial; frailty; intervention; Sarcopenia; skeletal muscle

Indexed keywords

BIOLOGICAL MARKER;

ARTICLE; FRAIL ELDERLY; HUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; SARCOPENIA;

ADVISORY COMMITTEES; AGED; AGED, 80 AND OVER; CONGRESSES AS TOPIC; EUROPEAN UNION; FRAIL ELDERLY; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SARCOPENIA; UNITED STATES;

EID: 84887992393     PISSN: 12797707     EISSN: 17604788     Source Type: Journal    
DOI: 10.1007/s12603-013-0362-7     Document Type: Article

References (51)

1. Rolland Y, Czerwinski S, Abellan Van Kan G, Morley JE, Cesari M, Onder G, Woo J, Baumgartner R, Pillard F, Boirie Y, et al: Sarcopenia: its assessment, etiology, pathogenesis, consequences and future perspectives. J Nutr Health Aging 2008, 12:433-450.
2. von Haehling S, Morley JE, Anker SD: An overview of sarcopenia: facts and numbers on prevalence and clinical impact. J Cachexia Sarcopenia Muscle 2011, 1:129-133.
3. Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, et al: Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing 2010, 39:412-423.
4. Fielding RA, Vellas B, Evans WJ, Bhasin S, Morley JE, Newman AB, Abellan van Kan G, Andrieu S, Bauer J, Breuille D, et al: Sarcopenia: an undiagnosed condition in older adults. Current consensus definition: prevalence, etiology, and consequences. International working group on sarcopenia. J Am Med Dir Assoc 2011, 12:249-256.
5. Morley JE, Abbatecola AM, Argiles JM, Baracos V, Bauer J, Bhasin S, Cederholm T, Coats AJ, Cummings SR, Evans WJ, et al: Sarcopenia with limited mobility: an international consensus. J Am Med Dir Assoc 2011, 12:403-409.
6. Muscaritoli M, Anker SD, Argiles J, Aversa Z, Bauer JM, Biolo G, Boirie Y, Bosaeus I, Cederholm T, Costelli P, et al: Consensus definition of sarcopenia, cachexia and pre-cachexia: joint document elaborated by Special Interest Groups (SIG) "cachexia-anorexia in chronic wasting diseases" and "nutrition in geriatrics". Clin Nutr 2010, 29:154-159.
7. Roman D, Mahoney K, Mohamadi A: Sarcopenia: What's in a Name? J Am Med Dir Assoc 2012.
8. Evans WJ, Paolisso G, Abbatecola AM, Corsonello A, Bustacchini S, Strollo F, Lattanzio F: Frailty and muscle metabolism dysregulation in the elderly. Biogerontology 2010, 11:527-536.
9. Subra J, Gillette-Guyonnet S, Cesari M, Oustric S, Vellas B: The integration of frailty into clinical practice: preliminary results from the Gerontopole. J Nutr Health Aging 2012, 16:714-720.
10. Anton MM, Spirduso WW, Tanaka H: Age-related declines in anaerobic muscular performance: weightlifting and powerlifting. Med Sci Sports Exerc 2004, 36:143-147.
11. The DJ, Ploutz-Snyder L: Age, body mass, and gender as predictors of masters olympic weightlifting performance. Med Sci Sports Exerc 2003, 35:1216-1224.
12. Fiatarone MA, O'Neill EF, Ryan ND, Clements KM, Solares GR, Nelson ME, Roberts SB, Kehayias JJ, Lipsitz LA, Evans WJ: Exercise training and nutritional supplementation for physical frailty in very elderly people. N Engl J Med 1994, 330:1769-1775.
13. Kosek DJ, Kim JS, Petrella JK, Cross JM, Bamman MM: Efficacy of 3 days/wk resistance training on myofiber hypertrophy and myogenic mechanisms in young vs. older adults. J Appl Physiol 2006, 101:531-544.
14. Verdijk LB, Jonkers RA, Gleeson BG, Beelen M, Meijer K, Savelberg HH, Wodzig WK, Dendale P, van Loon LJ: Protein supplementation before and after exercise does not further augment skeletal muscle hypertrophy after resistance training in elderly men. Am J Clin Nutr 2009, 89:608-616.
15. Goodpaster BH, Chomentowski P, Ward BK, Rossi A, Glynn NW, Delmonico MJ, Kritchevsky SB, Pahor M, Newman AB: Effects of physical activity on strength and skeletal muscle fat infiltration in older adults: a randomized controlled trial. J Appl Physiol 2008, 105:1498-1503.
16. Singh NA, Quine S, Clemson LM, Williams EJ, Williamson DA, Stavrinos TM, Grady JN, Perry TJ, Lloyd BD, Smith EU, Singh MA: Effects of high-intensity progressive resistance training and targeted multidisciplinary treatment of frailty on mortality and nursing home admissions after hip fracture: a randomized controlled trial. J Am Med Dir Assoc 2012, 13:24-30.
17. Abe T, Kearns CF, Sato Y: Muscle size and strength are increased following walk training with restricted venous blood flow from the leg muscle, Kaatsu-walk training. J Appl Physiol 2006, 100:1460-1466.
18. Nielsen JL, Aagaard P, Bech RD, Nygaard T, Hvid LG, Wernbom M, Suetta C, Frandsen U: Proliferation of myogenic stem cells in human skeletal muscle in response to low-load resistance training with blood flow restriction. J Physiol 2012, 590:4351-4361.
19. Liu CJ, Latham N: Can progressive resistance strength training reduce physical disability in older adults? A meta-analysis study. Disabil Rehabil 2011, 33:87-97.
20. Pahor M, Blair SN, Espeland M, Fielding R, Gill TM, Guralnik JM, Hadley EC, King AC, Kritchevsky SB, Maraldi C, et al: 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 2006, 61:1157-1165.
21. Rejeski WJ, Marsh AP, Chmelo E, Prescott AJ, Dobrosielski M, Walkup MP, Espeland M, Miller ME, Kritchevsky S: The Lifestyle Interventions and Independence for Elders Pilot (LIFE-P): 2-year follow-up. J Gerontol A Biol Sci Med Sci 2009, 64:462-467.
22. Alley DE, Chang VW: The changing relationship of obesity and disability, 1988-2004. JAMA 2007, 298:2020-2027.
23. Hulens M, Vansant G, Lysens R, Claessens AL, Muls E, Brumagne S: Study of differences in peripheral muscle strength of lean versus obese women: an allometric approach. Int J Obes Relat Metab Disord 2001, 25:676-681.
24. Manini TM, Newman AB, Fielding R, Blair SN, Perri MG, Anton SD, Goodpaster BC, Katula JA, Rejeski WJ, Kritchevsky SB, et al: Effects of exercise on mobility in obese and nonobese older adults. Obesity (Silver Spring) 2010, 18:1168-1175.
25. Villareal DT, Chode S, Parimi N, Sinacore DR, Hilton T, Armamento-Villareal R, Napoli N, Qualls C, Shah K: Weight loss, exercise, or both and physical function in obese older adults. N Engl J Med 2011, 364:1218-1229.
26. Messier SP, Loeser RF, Miller GD, Morgan TM, Rejeski WJ, Sevick MA, Ettinger WH, Jr., Pahor M, Williamson JD: Exercise and dietary weight loss in overweight and obese older adults with knee osteoarthritis: the Arthritis, Diet, and Activity Promotion Trial. Arthritis Rheum 2004, 50:1501-1510.
27. Morley JE, Malmstrom TK, Miller DK: A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging 2012, 16:601-608.
28. Kanis JA, Johnell O, Oden A, Johansson H, McCloskey E: FRAX and the assessment of fracture probability in men and women from the UK. Osteoporos Int 2008, 19:385-397.
29. Abellan van Kan G, Houles M, Vellas B: Identifying sarcopenia. Curr Opin Clin Nutr Metab Care 2012, 15:436-441.
30. Kortebein P, Ferrando A, Lombeida J, Wolfe R, Evans WJ: Effect of 10 days of bed rest on skeletal muscle in healthy older adults. JAMA 2007, 297:1772-1774.
31. Isenring EA, Banks M, Ferguson M, Bauer JD: Beyond malnutrition screening: appropriate methods to guide nutrition care for aged care residents. J Acad Nutr Diet 2012, 112:376-381.
32. Abellan van Kan G, Cameron Chumlea W, Gillette-Guyonet S, Houles M, Dupuy C, Rolland Y, Vellas B: Clinical trials on sarcopenia: methodological issues regarding phase 3 trials. Clin Geriatr Med 2011, 27:471-482.
33. Seynnes O, Fiatarone Singh MA, Hue O, Pras P, Legros P, Bernard PL: Physiological and functional responses to low-moderate versus high-intensity progressive resistance training in frail elders. J Gerontol A Biol Sci Med Sci 2004, 59:503-509.
34. Callahan D, Phillips E, Carabello R, Frontera WR, Fielding RA: Assessment of lower extremity muscle power in functionally-limited elders. Aging Clin Exp Res 2007, 19:194-199.
35. Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, et al: Gait speed and survival in older adults. JAMA 2011, 305:50-58.
36. Ostir GV, Volpato S, Fried LP, Chaves P, Guralnik JM: Reliability and sensitivity to change assessed for a summary measure of lower body function: results from the Women's Health and Aging Study. J Clin Epidemiol 2002, 55:916-921.
37. Perera S, Mody SH, Woodman RC, Studenski SA: Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc 2006, 54:743-749.
38. Latham NK, Mehta V, Nguyen AM, Jette AM, Olarsch S, Papanicolaou D, Chandler J: Performance-based or self-report measures of physical function: which should be used in clinical trials of hip fracture patients? Arch Phys Med Rehabil 2008, 89:2146-2155.
39. Kwon S, Perera S, Pahor M, Katula JA, King AC, Groessl EJ, Studenski SA: What is a meaningful change in physical performance? Findings from a clinical trial in older adults (the LIFE-P study). J Nutr Health Aging 2009, 13:538-544.
40. Chale A, Cloutier GJ, Hau C, Phillips EM, Dallal GE, Fielding RA: Efficacy of Whey Protein Supplementation on Resistance Exercise-Induced Changes in Lean Mass, Muscle Strength, and Physical Function in Mobility-Limited Older Adults. J Gerontol A Biol Sci Med Sci 2013;68:682-90.
41. Stimpson SA, Turner SM, Clifton LG, Poole JC, Mohammed HA, Shearer TW, Waitt GM, Hagerty LL, Remlinger KS, Hellerstein MK, Evans WJ: Total-body creatine pool size and skeletal muscle mass determination by creatine-(methyl-d3) dilution in rats. J Appl Physiol 2012, 112:1940-1948.
42. Kovacheva EL, Hikim AP, Shen R, Sinha I, Sinha-Hikim I: Testosterone supplementation reverses sarcopenia in aging through regulation of myostatin, c-Jun NH2-terminal kinase, Notch, and Akt signaling pathways. Endocrinology 2010, 151:628-638.
43. Cadilla R, Turnbull P: Selective androgen receptor modulators in drug discovery: medicinal chemistry and therapeutic potential. Curr Top Med Chem 2006, 6:245-270.
44. Butikofer L, Zurlinden A, Bolliger MF, Kunz B, Sonderegger P: Destabilization of the neuromuscular junction by proteolytic cleavage of agrin results in precocious sarcopenia. FASEB J 2011, 25:4378-4393.
45. Drey M, Sieber CC, Bauer JM, Uter W, Dahinden P, Fariello RG, Vrijbloed JW: Cterminal Agrin Fragment as a potential marker for sarcopenia caused by degeneration of the neuromuscular junction. Exp Gerontol 2012, 48:76-80.
46. Ferrando AA, Paddon-Jones D, Hays NP, Kortebein P, Ronsen O, Williams RH, McComb A, Symons TB, Wolfe RR, Evans W: EAA supplementation to increase nitrogen intake improves muscle function during bed rest in the elderly. Clin Nutr 2010, 29:18-23.
47. Deutz NE, Pereira SL, Hays NP, Oliver JS, Edens NK, Evans CM, Wolfe RR: Lean body mass is maintained by β-hydroxy-β-methylbutyrate (HMB) during 10 days of bed rest in older adults. Clin Nutr 2013: in press.
48. Food and Drug Administration: Guidance for Industry: Qualification Process for Drug Development Tools, accessed 12/18/12 http://www.fda.gov/ downloads/Drugs/GuidanceComplicanceRegulatoryInformationi/Guidances/UCM230597. pdf. 2010.
49. Chumlea WC, Cesari M, Evans WJ, Ferrucci L, Fielding RA, Pahor M, Studenski S, Vellas B: Sarcopenia: designing phase IIB trials. J Nutr Health Aging 2011, 15:450-455.
50. Lustgarten MS, Fielding RA: Assessment of analytical methods used to measure changes in body composition in the elderly and recommendations for their use in phase II clinical trials. J Nutr Health Aging 2011, 15:368-375.
51. Cesari M: Frailty and aging. J Frailty Aging 2012, 1:3-6.