Short and long-term clinical effectiveness and cost-effectiveness of a late-phase community-based balance and gait exercise program following hip fracture. The EVA-Hip Randomised Controlled Trial


Autoři: Kristin Taraldsen aff001;  Pernille Thingstad aff001;  Øystein Døhl aff002;  Turid Follestad aff003;  Jorunn L. Helbostad aff001;  Sarah E. Lamb aff004;  Ingvild Saltvedt aff001;  Olav Sletvold aff001;  Vidar Halsteinli aff003
Působiště autorů: Department of Neuromedicine and Movement Science, NTNU, Faculty of Medicine and Health Sciences, Trondheim, Norway aff001;  Trondheim Municipality, Trondheim, Norway aff002;  Department of Public Health and Nursing, Faculty of Medicine and Health Science, NTNU, Trondheim, Norway aff003;  Oxford University, Oxford, United Kingdom aff004;  Department of Geriatrics, St.Olavs University Hospital, Trondheim, Norway aff005;  Regional Center for Health Care Improvement, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway aff006
Vyšlo v časopise: PLoS ONE 14(11)
Kategorie: Research Article
doi: 10.1371/journal.pone.0224971

Souhrn

The aim of this trial was to evaluate the clinical effectiveness and cost-effectiveness of a home-based exercise program delivered four months following hip-fracture surgery. In the two-armed randomized, single blinded clinical trial we included persons who lived in the catchment area, were 70 years or older, and community-dwelling at time of the fracture. We excluded persons who were unable to walk ten meters prior to the fracture, and those who were bedridden or had medical contraindications for exercise at baseline (ie. four months after the fracture). All participants underwent routine treatment and rehabilitation. The intervention group received additional 20 sessions (10 weeks) structured, home exercise targeting gait and balance, delivered by physiotherapists in primary health care. Gait speed was the primary outcome. Secondary outcomes included physical activity, gait characteristics, cognitive function, activities of daily living, health-related quality of life, and health care costs extracted from hospital and municipality records. In total, 223 participants were included. Four months post surgery 143 were randomized for the exercise trial (70% women, mean age 83.4 (SD 6.1) years, mean gait speed 0.6 (SD 0.2) m/sec). Estimated between group difference in gait speed was 0.09 m/sec (95% CI: 0.04 to 0.14, p<0.001) at posttest and 0.07 m/sec (95% CI: 0.02 to 0.12, p = 0.009) 12 months post surgery. The mean between-group QALY difference was -0.009 (95% CI: -0.061 to 0.038). The mean between-group total cost difference was +242.9 EUR (95% CI: -8397 to 8584). Our findings suggest that gait recovery after hip fracture can be improved by introducing a home-based balance and gait exercise program four months post surgery, without increasing total health care costs. Future research should focus on how to implement gait and balance exercise in comprehensive interventions that increase adherence among the most vulnerable persons and have an effect on daily life activities and patient-centred outcomes.

Trial registration: ClinicalTrials.gov NCT01379456.

Klíčová slova:

Activities of daily living – Allied health care professionals – Cost-effectiveness analysis – Exercise – Hip – Nursing homes – Strength training – Walking


Zdroje

1. Ziden L, Scherman MH, Wenestam CG. The break remains—elderly people's experiences of a hip fracture 1 year after discharge. Disabil Rehabil. 2010;32(2):103–13. doi: 10.3109/09638280903009263 19562584

2. Ziden L, Wenestam CG, Hansson-Scherman M. A life-breaking event: early experiences of the consequences of a hip fracture for elderly people. Clin Rehabil. 2008;22(9):801–11. doi: 10.1177/0269215508090204 18728133

3. Hektoen LF, Saltvedt I, Sletvold O, Helbostad JL, Luras H, Halsteinli V. One-year health and care costs after hip fracture for home-dwelling elderly patients in Norway: Results from the Trondheim Hip Fracture Trial. Scand J Public Health. 2016;44(8):791–8. doi: 10.1177/1403494816674162 28929932

4. Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int. 2006;17(12):1726–33. doi: 10.1007/s00198-006-0172-4 16983459

5. Dyer SM, Crotty M, Fairhall N, Magaziner J, Beaupre LA, Cameron ID, et al. A critical review of the long-term disability outcomes following hip fracture. BMC Geriatr. 2016;16:158. doi: 10.1186/s12877-016-0332-0 27590604

6. Thingstad P, Taraldsen K, Saltvedt I, Sletvold O, Vereijken B, Lamb SE, et al. The long-term effect of comprehensive geriatric care on gait after hip fracture: the Trondheim Hip Fracture Trial—a randomised controlled trial. Osteoporos Int. 2016;27(3):933–42. doi: 10.1007/s00198-015-3313-9 26370827

7. Gill TM, Murphy TE, Gahbauer EA, Allore HG. The course of disability before and after a serious fall injury. JAMA Intern Med. 2013;173(19):1780–6. doi: 10.1001/jamainternmed.2013.9063 23958741

8. Ortiz-Alonso FJ, Vidan-Astiz M, Alonso-Armesto M, Toledano-Iglesias M, Alvarez-Nebreda L, Branas-Baztan F, et al. The pattern of recovery of ambulation after hip fracture differs with age in elderly patients. J Gerontol A Biol Sci Med Sci. 2012;67(6):690–7. doi: 10.1093/gerona/glr231 22219518

9. Latham NK, Jette DU, Warren RL, Wirtalla C. Pattern of functional change during rehabilitation of patients with hip fracture. Arch Phys Med Rehabil. 2006;87(1):111–6. doi: 10.1016/j.apmr.2005.08.121 16401448

10. Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013;381(9868):752–62. doi: 10.1016/S0140-6736(12)62167-9 23395245

11. Chen KW, Chang SF, Lin PL. Frailty as a Predictor of Future Fracture in Older Adults: A Systematic Review and Meta-Analysis. Worldviews Evid Based Nurs. 2017;14(4):282–93. doi: 10.1111/wvn.12222 28449266

12. Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, et al. Gait speed and survival in older adults. JAMA. 2011;305(1):50–8. doi: 10.1001/jama.2010.1923 21205966

13. Abellan van Kan G, Rolland Y, Bergman H, Morley JE, Kritchevsky SB, Vellas B. The I.A.N.A Task Force on frailty assessment of older people in clinical practice. J Nutr Health Aging. 2008;12(1):29–37. doi: 10.1007/bf02982161 18165842

14. Cummings SR, Studenski S, Ferrucci L. A diagnosis of dismobility—giving mobility clinical visibility: a Mobility Working Group recommendation. JAMA. 2014;311(20):2061–2. doi: 10.1001/jama.2014.3033 24763978

15. Griffiths F, Mason V, Boardman F, Dennick K, Haywood K, Achten J, et al. Evaluating recovery following hip fracture: a qualitative interview study of what is important to patients. BMJ Open. 2015;5(1):e005406. doi: 10.1136/bmjopen-2014-005406 25564138

16. Magaziner J, Hawkes W, Hebel JR, Zimmerman SI, Fox KM, Dolan M, et al. Recovery from hip fracture in eight areas of function. J Gerontol A Biol Sci Med Sci. 2000;55(9):M498–507. doi: 10.1093/gerona/55.9.m498 10995047

17. Auais MA, Eilayyan O, Mayo NE. Extended exercise rehabilitation after hip fracture improves patients' physical function: a systematic review and meta-analysis. Phys Ther. 2012;92(11):1437–51. doi: 10.2522/ptj.20110274 22822235

18. Diong J, Allen N, Sherrington C. Structured exercise improves mobility after hip fracture: a meta-analysis with meta-regression. Br J Sports Med. 2016;50(6):346–55. doi: 10.1136/bjsports-2014-094465 26036676

19. Latham NK, Harris BA, Bean JF, Heeren T, Goodyear C, Zawacki S, et al. Effect of a home-based exercise program on functional recovery following rehabilitation after hip fracture: a randomized clinical trial. JAMA. 2014;311(7):700–8. doi: 10.1001/jama.2014.469 24549550

20. Sylliaas H, Brovold T, Wyller TB, Bergland A. Progressive strength training in older patients after hip fracture: a randomised controlled trial. Age Ageing. 2011;40(2):221–7. doi: 10.1093/ageing/afq167 21247887

21. Sylliaas H, Brovold T, Wyller TB, Bergland A. Prolonged strength training in older patients after hip fracture: a randomised controlled trial. Age Ageing. 2012;41(2):206–12. doi: 10.1093/ageing/afr164 22198639

22. Binder EF, Brown M, Sinacore DR, Steger-May K, Yarasheski KE, Schechtman KB. Effects of extended outpatient rehabilitation after hip fracture: a randomized controlled trial. JAMA. 2004;292(7):837–46. doi: 10.1001/jama.292.7.837 15315998

23. Seitz DP, Adunuri N, Gill SS, Rochon PA. Prevalence of dementia and cognitive impairment among older adults with hip fractures. J Am Med Dir Assoc. 2011;12(8):556–64. doi: 10.1016/j.jamda.2010.12.001 21450227

24. Holmes JD, House AO. Psychiatric illness in hip fracture. Age Ageing. 2000;29(6):537–46. doi: 10.1093/ageing/29.6.537 11191247

25. Voshaar RC, Banerjee S, Horan M, Baldwin R, Pendleton N, Proctor R, et al. Predictors of incident depression after hip fracture surgery. Am J Geriatr Psychiatry. 2007;15(9):807–14. doi: 10.1097/JGP.0b013e318098610c 17698601

26. Taylor NF, Barelli C, Harding KE. Community ambulation before and after hip fracture: a qualitative analysis. Disabil Rehabil. 2010;32(15):1281–90. doi: 10.3109/09638280903483869 20156052

27. Thingstad P, Taraldsen K, Hagen G, Sand S, Saltvedt I, Sletvold O, et al. Effectiveness of task specific gait and balance exercise 4 months after hip fracture: protocol of a randomized controlled trial—the Eva-hip study. Physiother Res Int. 2015;20(2):87–99. doi: 10.1002/pri.1599 24996117

28. Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, et al. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994;49(2):M85–94. doi: 10.1093/geronj/49.2.m85 8126356

29. Kressig RW, Beauchet O, European GNG. Guidelines for clinical applications of spatio-temporal gait analysis in older adults. Aging Clin Exp Res. 2006;18(2):174–6. doi: 10.1007/bf03327437 16702791

30. Thingstad P, Egerton T, Ihlen EF, Taraldsen K, Moe-Nilssen R, Helbostad JL. Identification of gait domains and key gait variables following hip fracture. BMC Geriatr. 2015;15:150. doi: 10.1186/s12877-015-0147-4 26581616

31. Taraldsen K, Sletvold O, Thingstad P, Saltvedt I, Granat MH, Lydersen S, et al. Physical behavior and function early after hip fracture surgery in patients receiving comprehensive geriatric care or orthopedic care—a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2014;69(3):338–45. doi: 10.1093/gerona/glt097 23902933

32. Mahoney FI, Barthel DW. Functional Evaluation: The Barthel Index. Md State Med J. 1965;14:61–5.

33. Nouri FM, Lincoln NB. An extended activities of daily living scale for stroke patients. Clin Rehabil. 1987;1:301–5.

34. Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12(3):189–98. doi: 10.1016/0022-3956(75)90026-6 1202204

35. Hughes CP, Berg L, Danziger WL, Coben LA, Martin RL. A new clinical scale for the staging of dementia. Br J Psychiatry. 1982;140:566–72. doi: 10.1192/bjp.140.6.566 7104545

36. Sheikh JI, Yesavage JA. Geriatric Depression Scale (GDS). Recent evidence and development of a shorter version. Clinical Gerontology: A Guide to Assessment and Intervention: NY: The Haworth Press, Inc.; 1986.

37. Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997;35(11):1095–108. doi: 10.1097/00005650-199711000-00002 9366889

38. Helbostad JL, Taraldsen K, Granbo R, Yardley L, Todd CJ, Sletvold O. Validation of the Falls Efficacy Scale-International in fall-prone older persons. Age Ageing. 2010;39(2):259.

39. Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, et al. Development of a fatigue scale. J Psychosom Res. 1993;37(2):147–53. doi: 10.1016/0022-3999(93)90081-p 8463991

40. Sletvold O, Helbostad JL, Thingstad P, Taraldsen K, Prestmo A, Lamb SE, et al. Effect of in-hospital comprehensive geriatric assessment (CGA) in older people with hip fracture. The protocol of the Trondheim Hip Fracture trial. BMC Geriatr. 2011;11:18. doi: 10.1186/1471-2318-11-18 21510886

41. White IR, Horton NJ, Carpenter J, Pocock SJ. Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ. 2011;342:d40. doi: 10.1136/bmj.d40 21300711

42. Liu GF, Lu K, Mogg R, M. M, V. MD. Should baseline be a covariate or dependent variable in analyses of change from baseline in clinical trials? Statistics in Medicine. 2009;28: Pages: 2509–30. doi: 10.1002/sim.3639 19610129

43. Stef van Buuren KG-O. mice: Multivariate Imputation by Chained Equations R Journal of Statistical Software. 2011;45(3):1–67

44. boot: Bootstrap R (S-Plus) Functions. R package In: Ripley ACaB, editor. version 1.3–11. ed: R package version 1.3–11.; 2014.

45. Schwarzer R, Luszczynska A. Predicting Health Behaviours. Health Action Process Approach. In M. Conner PNE, editor. Maidenhead, UK: McGraw Hill Open University Press; 2015.

46. 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(5):743–9. doi: 10.1111/j.1532-5415.2006.00701.x 16696738

47. Alley DE, Hicks GE, Shardell M, Hawkes W, Miller R, Craik RL, et al. Meaningful improvement in gait speed in hip fracture recovery. J Am Geriatr Soc. 2011;59(9):1650–7. doi: 10.1111/j.1532-5415.2011.03560.x 21883109

48. Bohannon RW, Glenney SS. Minimal clinically important difference for change in comfortable gait speed of adults with pathology: a systematic review. J Eval Clin Pract. 2014;20(4):295–300. doi: 10.1111/jep.12158 24798823

49. Middleton A, Fritz SL, Lusardi M. Walking speed: the functional vital sign. J Aging Phys Act. 2015;23(2):314–22. doi: 10.1123/japa.2013-0236 24812254

50. Singh NA, Quine S, Clemson LM, Williams EJ, Williamson DA, Stavrinos TM, et al. 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. Journal of the American Medical Directors Association. 2012;13(1):24–30. doi: 10.1016/j.jamda.2011.08.005 21944168

51. Ziden L, Kreuter M, Frandin K. Long-term effects of home rehabilitation after hip fracture—1-year follow-up of functioning, balance confidence, and health-related quality of life in elderly people. Disabil Rehabil. 2010;32(1):18–32. doi: 10.3109/09638280902980910 19925273

52. Ziden L, Frandin K, Kreuter M. Home rehabilitation after hip fracture. A randomized controlled study on balance confidence, physical function and everyday activities. Clin Rehabil. 2008;22(12):1019–33. doi: 10.1177/0269215508096183 19052241


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