Frailty Intervention Trial (FIT)

Nicola Fairhall, Christina Aggar, Susan E Kurrle, Catherine Sherrington, Stephen Lord, Keri Lockwood, Noeline Monaghan, Ian D Cameron, Nicola Fairhall, Christina Aggar, Susan E Kurrle, Catherine Sherrington, Stephen Lord, Keri Lockwood, Noeline Monaghan, Ian D Cameron

Abstract

Background: Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity). Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty.We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people.

Methods and design: A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period.

Discussion: This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a new approach to the treatment of older people at risk of further functional decline and institutionalisation. The strategies to be examined are readily transferable to routine clinical practice and are applicable broadly in the setting of aged care health services.

Trial registration: Australian New Zealand Clinical Trails Registry: ACTRN12608000250336.

Figures

Figure 1
Figure 1
Overview of the flow of participants through the Frailty Intervention Trial. Adapted from the CONSORT diagram [27,28].

References

    1. Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. Canadian Medical Association Journal. 2005;173:489–495. doi: 10.1503/cmaj.050051.
    1. Walston J, McBurnie M, Newman Tracy RP, Kop WJ, Hirsch CH, Gottdiener J, Fried LP. Frailty and activation of the inflammation and coagulation systems with and without clinical morbidities: Results from the Cardiovascular Health Study. Archives of Internal Medicine. 2002;162:2333–2341. doi: 10.1001/archinte.162.20.2333.
    1. Grenier A. Constructions of frailty in the English language, care practice and the lived experience. Ageing & Society. 2007;27:425–445. doi: 10.1017/S0144686X06005782.
    1. Jones DM, Song X, Rockwood K. Operationalizing a Frailty Index from a Standardized Comprehensive Geriatric Assessment. Journal of the American Geriatrics Society. 2004;52:1929–1933. doi: 10.1111/j.1532-5415.2004.52521.x.
    1. Means R, Richards S, Smith R. Community Care: Policy and Practice. Basingstoke, Hampshire: Palgrave Macmillan; 2003.
    1. Kaufman S. The social construction of frailty: an anthropological perspective. Journal of Aging Studies. 1994;8:45–58. doi: 10.1016/0890-4065(94)90018-3.
    1. Gillick M. Pinning down frailty. Journals of Gerontology Series A-Biological Sciences & Medical Sciences. 2001;56A:M134–M135.
    1. Bortz WM. A conceptual framework of frailty: a review. Journals of Gerontology Series A-Biological Sciences & Medical Sciences. 2002;57A:M283–M288.
    1. Ensrud K, Ewing S, Taylor B, Fink H, Cawthon P, Stone K, Hillier T, Cauley J, Hochberg M, Rodondi N, et al. Comparison of 2 frailty indexes for prediction of falls, disability, fractures, and death in older women. Archives of Internal Medicine. 2008;168:382–389. doi: 10.1001/archinternmed.2007.113.
    1. Morley J, Perry HM, Miller DK. Something about frailty. Journals of Gerontology Series A-Biological Sciences & Medical Sciences. 2002;57A:M698–M704.
    1. Campbell AJ, Buchner DM. Unstable disability and the fluctuations of frailty. Age and Ageing. 1997;26:315–318. doi: 10.1093/ageing/26.4.315.
    1. Rockwood K, Stadnyk K, MacKnight C, McDowell I, Hebert R, Hogan DB. A brief clinical instrument to classify frailty in elderly people. Lancet. 1999;353:205–206. doi: 10.1016/S0140-6736(98)04402-X.
    1. Isaacs B, Gunn J, McKechan A, McMillan I, Neville Y. The concept of pre-death. Lancet. 1971;1:1115–1118. doi: 10.1016/S0140-6736(71)91851-4.
    1. Lunney JR, Lynn J, Foley DJ, Lipson S, Guralnik JM. Patterns of functional decline at the end of life. Journal of the American Medical Association. 2003;289:2387–2392. doi: 10.1001/jama.289.18.2387.
    1. Ory MG, Schechtman KB, Miller P, Hadley EC, Fiatarone MA, Province MA, Arfken CL, Morgan D, Weiss S, Kaplan M. Frailty and injuries in later life: the FICSIT Trials. Journal of the American Geriatrics Society. 1993;41:283–296.
    1. Fried LP, Tangen CM, Walston J, Newman AB, Hirsch CH, Gottdiener J, Seeman T, Tracey R, Kop W, Burke G, et al. Frailty in older adults: evidence for a phenotype. Journals of Gerontology Series A-Biological Sciences & Medical Sciences. 2001;56A:M146–M156.
    1. Leveille SG, Wagner EH, Davis C, Grothaus L, Wallace J, LoGerfo M, Kent D. Preventing disability and managing chronic illness in frail older adults: a randomized trial of a community-based partnership with primary care. Journal of the American Geriatrics Society. 1998;46:1191–1198.
    1. Melis R, van Eijken M, Teerenstra S, van Achterberg T, Parker S, Borm G, Lisdonk E van de, Wensing M, Olde Rikkert M. A randomised study of a multidisciplinary program to intervene on geriatric syndromes in vulnerable older people who live at home (Dutch EASYcare Study) Journals of Gerontology Series A: Biological Sciences and Medical Sciences. 2008;63A:283–290.
    1. Cohen H, Feussner J, Weinberger M, Carnes M, Hamdy RC, Hsieh F, Phibbs C, Courtney D, Lyles KW, May C, et al. A controlled trial of inpatient and outpatient geriatric evaluation and management. New England Journal of Medicine. 2002;346:905–912. doi: 10.1056/NEJMsa010285.
    1. Ollonqvist K, Gronlund R, Karppi S, Salmelainen U, Poikkeus L, Hinkka K. A network based rehabilitation model for frail elderly people: development and assessment of a new model. Scandinavian Journal Caring Science. 2007;21:253–261. doi: 10.1111/j.1471-6712.2007.00464.x.
    1. Beswick A, Rees K, Dieppe P, Ayis S, Gooberman-Hill R, Horwood J, Ebrahim S. Complex interventions to improve physical function and maintain independent living in elderly people: a systematic review and meta-analysis. Lancet. 2008;371:725–735. doi: 10.1016/S0140-6736(08)60342-6.
    1. Gill TM, Baker DI, Gottschalk M, Peduzzi PN, Allore H, Byers A. A program to prevent functional decline in physically frail, elderly persons who live at home. The New England Journal of Medicine. 2002;347:1068–1074. doi: 10.1056/NEJMoa020423.
    1. 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. The New England Journal of Medicine. 1994;330:1769–1775. doi: 10.1056/NEJM199406233302501.
    1. Page S, Amory J, Bowman F, Anawalt BD, Matsumoto AM, Bremner WJ, Tenover JL. Exogenous testosterone (T) alone or with Finasteride increases physical performance, grip strength, and lean body mass in older men with low serum T. Journal of Clinical Endocrinology Metabolism. 2005;90:1502–1510. doi: 10.1210/jc.2004-1933.
    1. Percheron G, Hogrel J, Denot-Ledunois S, Fayet G, Forette F, Baulieu EE, Fardeau M, Marini JF. Effect of a 1-year oral administration of dehydroepiandrosterone to 60- to 80-year-old individuals on muscle function and cross sectional area: a double-blinded placebo-controlled trial. Archives of Internal Medicine. 2003;163:720–727. doi: 10.1001/archinte.163.6.720.
    1. Onder G, Penninx B, Balkrishnan R, Fried L, Chaves P, Williamson J, Carter C, Bari M, Guralnik J, Pahor M. Relation between use of angiotensin-converting enzyme inhibitors and muscle strength and physical function in older women: an observational study. Lancet. 2002;359:926–930. doi: 10.1016/S0140-6736(02)08024-8.
    1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357:1191–1194. doi: 10.1016/S0140-6736(00)04337-3.
    1. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gøtzsche PC, Lang T. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134:663–694.
    1. Folstein MF, Folstein SE, McHugh PR. Mini-mental state. "A practical method for grading the cognitive state of patients for the clinician". Journal of Psychiatric Research. 1975;12:189–198. doi: 10.1016/0022-3956(75)90026-6.
    1. Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Applied Psychological Measurement. 1977;1:385–401. doi: 10.1177/014662167700100306.
    1. Cesari M, Kritchevsky S, Penninx B, Nicklas B, Simonsick E, Newman A, Tylavsky F, Brach JP, Satterfield S, Bauer D, et al. Prognostic value of usual gait speed in well-functioning older people-results from the Health, Aging and Body Composition Study. Journal of the American Geriatric Society. 2005;53:1675–1680.
    1. Cesari M, Leeuwenburgh C, Lauretani F, Onder G, Bandinelli S, Maraldi C, Guralnik JM, Pahor M, Ferrucci L. Frailty syndrome and skeletal muscle: results from the Invecchiare in Chianti Study. American Journal of Clinical Nutrition. 2006;83:1142–1148.
    1. Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. New England Journal of Medicine. 1995;332:556–561. doi: 10.1056/NEJM199503023320902.
    1. Mahoney FI, Barthel DW. Functional evaluation: The Barthel Index. Maryland State Medical Journal. 1965;14:61–65.
    1. Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Annals of Medicine. 2001;33:337–343. doi: 10.3109/07853890109002087.
    1. Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. Journal of Psychiatric Research. 1982;17:37–49. doi: 10.1016/0022-3956(82)90033-4.
    1. Lord SR, Menz HB, Tiedemann A. Physiological profile approach to falls risk assessment and prevention. Physical Therapy. 2003;83:237–225.
    1. Hill KD, Bernhardt J, McGann AM, Maltese D, Berkovits D. A new test of dynamic standing balance for stroke patients: reliability, validity and comparison with healthy elderly. Physiotherapy Canada. 1996;48:257–262.
    1. Lord S, Ward J, Williams P. Exercise effect on dynamic stability in older women: a randomized controlled trial. Archives of Physical Medicine and Rehabilitation. 1996;77:232–236. doi: 10.1016/S0003-9993(96)90103-3.
    1. Coster W, Haley S, Jette A. Measuring patient-reported outcomes after discharge from inpatient rehabilitation settings. Journal of Rehabilitation Medicine. 2006;38:237–242. doi: 10.1080/16501970600609774.
    1. Lincoln N, Gladman J. The Extended Activities of Daily Living Scale: a further validation. Disability and Rehabilitation. 1992;14:41–43.
    1. Wood-Dauphinee S, Opzoomer A, Williams J, Marchand B, Spitzer W. Assessment of global function: the Reintegration to Normal Living Index. Archives of Physical Medicine and Rehabilitation. 1988;69:583–590.
    1. Kiresuk TJ, Smith A, Cardillo JE. Goal Attainment Scaling. Hillsdale, NJ: Erlbaum Associates; 1994.
    1. Peel C, Baker P, Roth D, Brown C, Bodner E, Allman R. Assessing mobility in older adults: the UAB Study of Aging Life-Space Assessment. Physical Therapy. 2005;85:1008–1019.
    1. Logan PS, Gladman JRF, Avery A, Walker MF, Dyas J, Groom L. Randomised controlled trial of an occupational therapy intervention to increase outdoor mobility after stroke. British Medical Journal. 2004 doi: 10.1136/bmj.38264.679560.8F. (published 25 November 2004).
    1. Lord SR, Castell S, Corcoran J, Dayhew J, Matters B, Shan A, Williams P. The effect of group exercise on physical functioning and falls in frail older people living in retirement villages: a randomised, controlled trial. Journal of the American Geriatrics Society. 2003;51:1685–1692. doi: 10.1046/j.1532-5415.2003.51551.x.
    1. Beller EM, Gebski V, Keech AC. Randomisation in clinical trails. Medical Journal of Australia. 2002;177:565–567.
    1. Marcus BH, Forsyth LH. Motivating people to be physically active. Champaign, IL:Human Kinetics; 2003.
    1. Marcus BH, Selby VC, Niaura RS, Rossi JS. Self-efficacy and the stages of exercise behavior change. Research Quarterly for Exercise and Sport. 1992;63:60–66.
    1. Sherrington C. Australian Physiotherapy Association Conference Week. Cairns Australia; 2007. Exercise which challenges balance can prevent falls in older people: meta-analysis of RCTs with meta-regression.
    1. Lachlin JM. Statistical considerations in the intent-to-treat principle. Control Clin trials. 2000;21:167–189. doi: 10.1016/S0197-2456(00)00046-5.
    1. Campbell A, Robertson M, La Grow S, Kerse N, Sanderson G, Jacobs R, Sharp D. Randomised controlled trial of prevention of falls in people aged 75 with severe visual impairment: the VIP trial. British Medical Journal. 2005;331:817–925. doi: 10.1136/bmj.38601.447731.55.
    1. Robertson M, Campbell A, Herbison P. Statistical analysis of efficacy in falls prevention trials. Journals of Gerontology Series A-Biological Sciences & Medical Sciences. 2005;60:530–534.
    1. Robertson MC, Gardner MM, Devlin N, Campbell A. Effectiveness and economic evaluation of a nurse-delivered home exercise program to prevent falls. 1: Randomised-control trial. British Medical Journal. 2001;322:697–701. doi: 10.1136/bmj.322.7288.697.
    1. Van Spall HG, Toren A, Kiss A, Fowler RA. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. Journal of the American Medical Association. 2007;297:1233–1240. doi: 10.1001/jama.297.11.1233.
    1. Ellis G, Langhorne P. Comprehensive geriatric assessment for older hospital patients. British Medical Bulletin. 2005;71:45–59. doi: 10.1093/bmb/ldh033.
    1. Chandler JM, Duncan PW, Kochersberger G, Studenski S. Is lower extremity strength gain associated with improvement in physical performance and disability in frail, community-dwelling elders? Archives of Physical Medicine & Rehabilitation. 1998;79:24–30. doi: 10.1016/S0003-9993(98)90202-7.
    1. Shimada H, Uchiyama Y, Kakurai S. Specific effects of balance and gait exercises on physical function among the frail elderly. Clinical Rehabilitation. 2003;17:472–479. doi: 10.1191/0269215503cr638oa.
    1. Milne AC, Potter J, Avenell A. Protein and energy supplementation in elderly people at risk from malnutrition. Cochrane Database of Systematic Reviews. 2005:CD003288.
    1. Bartali B, Frongillo EA, Bandinelli S, Lauretani F, Semba RD, Fried LP, Ferrucci L. Low nutrient intake is an essential component of frailty in older persons. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences. 2006;61:589–593.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi