Better before-better after: efficacy of prehabilitation for older patients with osteoarthritis awaiting total hip replacement-a study protocol for a randomised controlled trial in South-Eastern Norway

Odd-Einar Svinøy, Astrid Bergland, May Arna Risberg, Are Hugo Pripp, Gunvor Hilde, Odd-Einar Svinøy, Astrid Bergland, May Arna Risberg, Are Hugo Pripp, Gunvor Hilde

Abstract

Introduction: Health professions need to prepare for the increase of older patients with osteoarthritis requiring health services including those requiring total joint arthroplasty (TJA). The primary objective of this study is to assess the effect of a tailored prehabilitation programme of older patients awaiting primary surgery for total hip replacement on physical function measured by walking speed within 1 week after intervention as well as 6 weeks and 3 months after TJA surgery.

Methods and analysis: This is a single-blinded randomised controlled trial. The participants are 70 years or older, scheduled for primary total hip replacement due to late stage osteoarthritis. The intervention group will receive patient education and exercise for 6-12 weeks. The control group will receive care as usual. The primary outcome is gait speed. Secondary outcomes are lower body strength, mobility, aerobic capacity, activity of daily living, length of stay at the hospital, referral to an inpatient rehabilitation clinic, pain, quality of life and cost-effectiveness. Estimated sample size is 150 participants randomised into the two arms. The data will be analysed following the intention-to-treat principle with methods for repeated measurements.

Ethics and dissemination: The project proposal has been approved by The Regional Committee for Medical Research Ethics in South Norway (ref no. 2018/503). The results will be published in peer-reviewed articles.

Trial registration number: NCT03602105.

Keywords: arthritis; elderly; exercise; gait speed; joint arthroplasty; prehabilitation.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Planned flow of participants in the study.

References

    1. Grotle M, Hagen KB, Natvig B, et al. . Prevalence and burden of osteoarthritis: results from a population survey in Norway. J Rheumatol 2008;35:677–84.
    1. Wallace IJ, Worthington S, Felson DT, et al. . Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A 2017.
    1. Bitton R. The economic burden of osteoarthritis. Am J Manag Care 2009;15:S230–5.
    1. Cross M, Smith E, Hoy D, et al. . The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis 2014;73:1323–30. 10.1136/annrheumdis-2013-204763
    1. Castell MV, van der Pas S, Otero A, et al. . Osteoarthritis and frailty in elderly individuals across six European countries: results from the European project on osteoarthritis (EPOSA). BMC Musculoskelet Disord 2015;16:359 10.1186/s12891-015-0807-8
    1. Salaffi F, Carotti M, Stancati A, et al. . Health-Related quality of life in older adults with symptomatic hip and knee osteoarthritis: a comparison with matched healthy controls. Aging Clin Exp Res 2005;17:255–63. 10.1007/BF03324607
    1. Slatkowsky-Christensen B, Grotle M. Artrose I Norge. Norsk Epidemiologi 2008.
    1. Pina MF, Ribeiro AI, Santos C. Epidemiology and variability of orthopaedic procedures worldwide. Berlin, Heidelberg: Springer, 2019: 1–19.
    1. Furnes O, Gjertsen J, Hallan G, et al. . Raport Juni 2018: Nasjonal Kompetansetjeneste for Leddproteser OG Hoftebrudd 2018.
    1. Bumpass DB, Nunley RM. Assessing the value of a total joint replacement. Curr Rev Musculoskelet Med 2012;5:274–82. 10.1007/s12178-012-9139-6
    1. Muniesa JM, Marco E, Tejero M, et al. . Analysis of the expectations of elderly patients before undergoing total knee replacement. Arch Gerontol Geriatr 2010;51:e83–7. 10.1016/j.archger.2010.01.003
    1. Nilsdotter AK, Toksvig-Larsen S, Roos EM. Knee arthroplasty: are patients' expectations fulfilled? A prospective study of pain and function in 102 patients with 5-year follow-up. Acta Orthop 2009;80:55–61. 10.1080/17453670902805007
    1. Scott CEH, Bugler KE, Clement ND, et al. . Patient expectations of arthroplasty of the hip and knee. J Bone Joint Surg Br 2012;94:974–81. 10.1302/0301-620X.94B7.28219
    1. Beswick AD, Wylde V, Gooberman-Hill R, et al. . What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open 2012;2:e000435 10.1136/bmjopen-2011-000435
    1. Elings J, van der Sluis G, Goldbohm RA, et al. . Development of a risk stratification model for delayed inpatient recovery of physical activities in patients undergoing total hip replacement. J Orthop Sports Phys Ther 2016;46:135–43. 10.2519/jospt.2016.6124
    1. Gill TM, Beavers DP, Guralnik JM, et al. . The effect of intervening hospitalizations on the benefit of structured physical activity in promoting independent mobility among community-living older persons: secondary analysis of a randomized controlled trial. BMC Med 2017;15:65 10.1186/s12916-017-0824-6
    1. Topp R, Ditmyer M, King K, et al. . The effect of bed rest and potential of prehabilitation on patients in the intensive care unit. AACN Clin Issues 2002;13:263–76. 10.1097/00044067-200205000-00011
    1. Kwok IHY, Paton B, Haddad FS. Does pre-operative physiotherapy improve outcomes in primary total knee arthroplasty? — a systematic review. J Arthroplasty 2015;30:1657–63. 10.1016/j.arth.2015.04.013
    1. Wallis JA, Taylor NF. Pre-operative interventions (non-surgical and non-pharmacological) for patients with hip or knee osteoarthritis awaiting joint replacement surgery--a systematic review and meta-analysis. Osteoarthritis Cartilage 2011;19:1381–95. 10.1016/j.joca.2011.09.001
    1. Hoogeboom TJ, Oosting E, Vriezekolk JE, et al. . Therapeutic validity and effectiveness of preoperative exercise on functional recovery after joint replacement: a systematic review and meta-analysis. PLoS One 2012;7:e38031 10.1371/journal.pone.0038031
    1. Gill SD, McBurney H. Does exercise reduce pain and improve physical function before hip or knee replacement surgery? A systematic review and meta-analysis of randomized controlled trials. Arch Phys Med Rehabil 2013;94:164–76. 10.1016/j.apmr.2012.08.211
    1. Skoffer B, Dalgas U, Mechlenburg I. Progressive resistance training before and after total hip and knee arthroplasty: a systematic review. Clin Rehabil 2015;29:14–29. 10.1177/0269215514537093
    1. Wang L, Lee M, Zhang Z, et al. . Does preoperative rehabilitation for patients planning to undergo joint replacement surgery improve outcomes? A systematic review and meta-analysis of randomised controlled trials. BMJ Open 2016;6:e009857 10.1136/bmjopen-2015-009857
    1. Hoogeboom TJ, Dronkers JJ, Hulzebos EHJ, et al. . Merits of exercise therapy before and after major surgery. Curr Opin Anaesthesiol 2014;27:161–6. 10.1097/ACO.0000000000000062
    1. Fernandes L, Hagen KB, Bijlsma JWJ, et al. . EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis 2013;72:1125–35. 10.1136/annrheumdis-2012-202745
    1. Conaghan PG, Dickson J, Grant RL. Care and management of osteoarthritis in adults: summary of NICE guidance. BMJ 2008;336:502–3. 10.1136/
    1. Zhang W, Nuki G, Moskowitz RW, et al. . OARSI recommendations for the management of hip and knee osteoarthritis: Part III: changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage 2010;18:476–99. 10.1016/j.joca.2010.01.013
    1. Brosseau L, Wells GA, Pugh AG, et al. . Ottawa panel evidence-based clinical practice guidelines for therapeutic exercise in the management of hip osteoarthritis. Clin Rehabil 2016;30:935–46. 10.1177/0269215515606198
    1. American College of Sports Medicine American College of sports medicine position stand. progression models in resistance training for healthy adults. Med Sci Sports Exerc 2009;41:687–708. 10.1249/MSS.0b013e3181915670
    1. Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, et al. . American College of sports medicine position stand. exercise and physical activity for older adults. Med Sci Sports Exerc 2009;41:1510–30. 10.1249/MSS.0b013e3181a0c95c
    1. Haskell WL, Lee I-M, Pate RR, et al. . Physical activity and public health: updated recommendation for adults from the American College of sports medicine and the American heart association. Med Sci Sports Exerc 2007;39:1423–34. 10.1249/mss.0b013e3180616b27
    1. Hermann A, Holsgaard-Larsen A, Zerahn B, et al. . Preoperative progressive explosive-type resistance training is feasible and effective in patients with hip osteoarthritis scheduled for total hip arthroplasty--a randomized controlled trial. Osteoarthritis Cartilage 2016;24:91–8. 10.1016/j.joca.2015.07.030
    1. Chou C-H, Hwang C-L, Wu Y-T. Effect of exercise on physical function, daily living activities, and quality of life in the frail older adults: a meta-analysis. Arch Phys Med Rehabil 2012;93:237–44. 10.1016/j.apmr.2011.08.042
    1. Moseng T, Dagfinrud H, Smedslund G, et al. . The importance of dose in land-based supervised exercise for people with hip osteoarthritis. A systematic review and meta-analysis. Osteoarthritis Cartilage 2017;25:1563–76. 10.1016/j.joca.2017.06.004
    1. Morri M, Natali E, Tosarelli D. At discharge gait speed and independence of patients provides a challenges for rehabilitation after total joint arthroplasty: an observational study. Arch Physiother 2016;6 10.1186/s40945-016-0020-6
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Pandis N, Chung B, Scherer RW, et al. . Consort 2010 statement: extension checklist for reporting within person randomised trials. BMJ 2017;357 10.1136/bmj.j2835
    1. Nilsdotter A, Bremander A. Measures of hip function and symptoms: Harris hip score (HHS), hip disability and osteoarthritis outcome score (HOOS), Oxford hip score (OHS), Lequesne index of severity for osteoarthritis of the hip (LISOH), and American Academy of orthopedic surgeons (a. Arthritis Care Res 2011;63:S200–7. 10.1002/acr.20549
    1. Wondrasch B, Arøen A, Røtterud JH, et al. . The feasibility of a 3-month active rehabilitation program for patients with knee full-thickness articular cartilage lesions: the Oslo cartilage active rehabilitation and education study. J Orthop Sports Phys Ther 2013;43:310–24. 10.2519/jospt.2013.4354
    1. Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc 1982;14:377–81. 10.1249/00005768-198205000-00012
    1. Hoogeboom TJ, Dronkers JJ, van den Ende CHM, et al. . Preoperative therapeutic exercise in frail elderly scheduled for total hip replacement: a randomized pilot trial. Clin Rehabil 2010;24:901–10. 10.1177/0269215510371427
    1. Hoogeboom TJ, Stukstette MJPM, de Bie RA, et al. . Non-Pharmacological care for patients with generalized osteoarthritis: design of a randomized clinical trial. BMC Musculoskelet Disord 2010;11:142 10.1186/1471-2474-11-142
    1. Villadsen A, Overgaard S, Holsgaard-Larsen A, et al. . Postoperative effects of neuromuscular exercise prior to hip or knee arthroplasty: a randomised controlled trial. Ann Rheum Dis 2014;73:1130–7. 10.1136/annrheumdis-2012-203135
    1. Perera S, Patel KV, Rosano C, et al. . Gait speed predicts incident disability: a pooled analysis. GERONA 2016;71:63–71. 10.1093/gerona/glv126
    1. Dobson F, Hinman RS, Roos EM, et al. . OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage 2013;21:1042–52. 10.1016/j.joca.2013.05.002
    1. Kennedy D, Stratford PW, Pagura SMC, et al. . Comparison of gender and group differences in self-report and physical performance measures in total hip and knee arthroplasty candidates. J Arthroplasty 2002;17:70–7. 10.1054/arth.2002.29324
    1. Jones CJ, Rikli RE, Beam WC. A 30-S chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport 1999;70:113–9. 10.1080/02701367.1999.10608028
    1. Troosters T, Gosselink R, Decramer M. Six minute walking distance in healthy elderly subjects. Eur Respir J 1999;14:270–4. 10.1034/j.1399-3003.1999.14b06.x
    1. Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc 1991;39:142–8. 10.1111/j.1532-5415.1991.tb01616.x
    1. Kennedy DM, Stratford PW, Wessel J, et al. . Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord 2005;6:3 10.1186/1471-2474-6-3
    1. Nilsdotter AK, Lohmander LS, Klässbo M, et al. . Hip disability and osteoarthritis outcome score (HOOS)--validity and responsiveness in total hip replacement. BMC Musculoskelet Disord 2003;4:10 10.1186/1471-2474-4-10
    1. Drummond MF, Sculpher MJ, Claxton K, et al. . Methods for the economic evaluation of health care programmes. 4th edn Oxford: Oxford University Press, 2015.
    1. Briggs AH. Handling uncertainty in economic evaluation and presenting the results. Oxford University Press, 2001: 172–214.
    1. Briggs A, Fenn P. Confidence intervals or surfaces? uncertainty on the cost-effectiveness plane. Health Econ 1998;7:723–40. 10.1002/(SICI)1099-1050(199812)7:8<723::AID-HEC392>;2-O
    1. Glick HA, Doshi JA, Sonnad SS, et al. . Economic evaluation in clinical trials. 2nd edn Oxford: Oxford University Press, 2015.
    1. Perera S, Mody SH, Woodman RC, et al. . Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc 2006;54:743–9. 10.1111/j.1532-5415.2006.00701.x
    1. WHO World report on ageing and health, 2015. Available:
    1. Gill TM, Gahbauer EA, Murphy TE, et al. . Risk factors and precipitants of long-term disability in community mobility: a cohort study of older persons. Ann Intern Med 2012;156:131–40.
    1. Stratford PW, Kennedy DM. Performance measures were necessary to obtain a complete picture of osteoarthritic patients. J Clin Epidemiol 2006;59:160–7. 10.1016/j.jclinepi.2005.07.012
    1. Stratford PW, Kennedy DM, Woodhouse LJ. Performance measures provide assessments of pain and function in people with advanced osteoarthritis of the hip or knee. Phys Ther 2006;86:1489–96. 10.2522/ptj.20060002
    1. Guralnik JM, Branch LG, Cummings SR, et al. . Physical performance measures in aging research. J Gerontol 1989;44:M141–6. 10.1093/geronj/44.5.M141
    1. Abellan Van Kan G, Rolland Y, Andrieu S, et al. . Gait speed at usual PACE as a predictor of adverse outcomes in community-dwelling older people an international Academy on nutrition and aging (IANA) Task force. J Nutr Health Aging 2009;13:881–9. 10.1007/s12603-009-0246-z
    1. Bohannon RW, Williams Andrews A. Normal walking speed: a descriptive meta-analysis. Physiotherapy 2011;97:182–9. 10.1016/j.physio.2010.12.004
    1. Deshpande N, Metter EJ, Lauretani F, et al. . Interpreting fear of falling in the elderly: what do we need to consider? J Geriatr Phys Ther 2009;32:91–6. 10.1519/00139143-200932030-00002
    1. Studenski S, et al. Gait speed and survival in older adults. JAMA 2011;305:50–8. 10.1001/jama.2010.1923
    1. Zeni J, Abujaber S, Pozzi F, et al. . Relationship between strength, pain, and different measures of functional ability in patients with end-stage hip osteoarthritis. Arthritis Care Res 2014;66:1506–12. 10.1002/acr.22329
    1. Higgins J, Altman D, Sterne J. Assessing risk of bias in included studies. The Cochrane Collaboration: Cochrane Handbook for Systematic Reviews of Interventions, 2011.
    1. Moher D, Hopewell S, Schulz KF, et al. . Consort 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340 10.1136/bmj.c869
    1. Verhagen AP, de Vet HC, de Bie RA, et al. . The art of quality assessment of RCTs included in systematic reviews. J Clin Epidemiol 2001;54:651–4. 10.1016/S0895-4356(00)00360-7
    1. Slack MK, Draugalis JR. Establishing the internal and external validity of experimental studies. Am J Health Syst Pharm 2001;58:2173–81. 10.1093/ajhp/58.22.2173
    1. Schulz KF. Assessing allocation concealment and blinding in randomised controlled trials: why bother? Evid Based Med 2000;5:36–8. 10.1136/ebm.5.2.36
    1. De Amici D, Klersy C, Ramajoli F, et al. . Impact of the Hawthorne effect in a longitudinal clinical study: the case of anesthesia. Control Clin Trials 2000;21:103–14. 10.1016/s0197-2456(99)00054-9

Source: PubMed

3
Abonner