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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Effect of cycle ergometer and conventional exercises on rehabilitation of older patients with total hip arthroplasty: study protocol for randomized controlled trial

Authors: Mariana Kátia Rampazo-Lacativa, Maria José D’Elboux

Published in: Trials | Issue 1/2015

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Abstract

Background

Total hip arthroplasty (THA) is an increasingly common treatment for older patients with hip osteoarthritis. The best strategy for a physiotherapy intervention for older people after THA is not clear in the literature. The purpose of this protocol study is to test the feasibility of undertaking a full trial clinical to evaluate the effect of ergometer cycling-associated conventional exercises on functional results and health-related quality of life (HRQOL) of older patients with THA.

Methods/Design

This study protocol is a prospective, single center, randomized controlled pilot clinical trial. Older patients (≥60 years) in the postoperative phase after primary unilateral THA for hip osteoarthritis will be consecutively recruited for this study and randomly allocated to 2 treatment groups. Group I will perform cycle ergometer and conventional exercises, and group II will perform only conventional exercises. The sessions will be conducted twice a week for 8 weeks. Assessments will be made at baseline (2 weeks postoperatively: the moment that the patients receive a referral for physical therapy, which will start after suture removal), after intervention (10 weeks postoperatively), and at 6 months of follow-up (24 weeks postoperatively). The primary outcomes are the function, evaluated using the Harris Hip Score (HHS) and the Short Physical Performance Battery (SPPB). The secondary outcome is HRQOL, measured using 2 evaluation instruments: the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Data collectors will be blinded and will not have contact with participants during the interventions.

Discussion

This randomized controlled trial will provide evidence regarding the effect of this exercise therapy on physical function and quality of life in older patients after THA. If our hypothesis is correct, both interventions will be effective, but the exercises on the cycle ergometer conferring better results in function, physical performance and quality of life. The study follows Consolidated Standards of Reporting Trials (CONSORT) guidelines, and the approval of the local ethics committee has been obtained.

Trial registration

ClinicalTrials.gov: NCT01622465 (14 June 2012)
Literature
1.
Wood GCA, McLauchlan FRCS. Outcome assessment in the elderly after total hip arthroplasty. J Arthroplasty. 2006;21:398–404.CrossRefPubMed
2.
Ritterman S, Rubin LE. Rehabilitation for total joint arthroplasty. R I Med J. 2013;96(5):19–22.
3.
Bagarié I, Sarac H, Borovac JA, Vlak T, Bekavac J, Hebrang A. Primary total hip arthroplasty: health related quality of life outcomes. Int Orthop. First Published Online: 20 November 2013. doi: 10.1007/s00264-013-2142-2148.
4.
Naylor J, Harmer A, Fransen M, Crosbie J, Innes L. Status of physiotherapy rehabilitation after total knee replacement in Australia. Physiother Res Int. 2006;11:35–47.CrossRefPubMed
5.
Di Monaco M, Vallero F, Tappero R, Cavanna A. Rehabilitation after total hip arthroplasty: a systematic review of controlled trials on physical exercise programs. Eur J Phys Rehabil Med. 2009;45:303–17.PubMed
6.
Minns Lowe CJ, Barker KL, Dewey ME, Sackley CM. Effectiveness of physiotherapy exercise following hip arthroplasty for osteoarthritis: a systematic review of clinical trials. BMC Musculoskelet Disord. 2009;10:1–14.CrossRef
7.
Reardon K, Galea M, Dennett X, Choong P, Byrne E. Quadriceps muscle wasting persists 5 months after total hip arthroplasty for osteoarthritis of the hip: a pilot study. Intern Med J. 2001;31:7–14.CrossRefPubMed
8.
Rampazo MK, D’Elboux MJ. The influence of sociodemographic, clinical and functional variables on the quality of life of elderly people with total hip arthroplasty. Rev Bras Fisioter. 2010;14:244–51.CrossRefPubMed
9.
Arokoski MH, Arokoski JP, Haara M, Kankaanpää M, Vesterinen M, Niemitukia LH, et al. Hip muscle strength and muscle cross sectional area in men with and without hip osteoarthritis. J Rheumatol. 2002;29:2185–95.PubMed
10.
Giaquinto S, Ciotola E, Dall’armi V, Margutti F. Hydrotherapy after total hip arthroplasty: a follow-up study. Arch Gerontol Geriatr. 2010;50:92–5.CrossRefPubMed
11.
Gremeaux V, Renault J, Pardon L, Deley G, Lepers R, Casillas JM. Low-frequency electric muscle stimulation combined with physical therapy after total hip arthroplasty for hip osteoarthritis in elderly patients: a randomized controlled trial. Arch Phys Med Rehabil. 2008;89:2265–73.CrossRefPubMed
12.
Maire J, Dugu B, Faillenet-Maire AF, Smolander J, Tordi N, Parratte B, et al. Influence of a 6-week arm exercise program on walking ability and health status after hip arthroplasty: a 1-year follow-up pilot study. J Rehabil Res Dev. 2006;43:445–50.CrossRefPubMed
13.
Liebs TR, Herzberg W, Röther W, Haasters J, Russlies M, Hassenpflug J. Ergometer cycling after hip or knee replacement surgery: a randomized controlled trial. J Bone Joint Surg Am. 2010;92:814–22.CrossRefPubMed
14.
Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309.CrossRefPubMed
15.
Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. J Bone Joint Surg. 1969;51(4):737–55.PubMed
16.
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;49:85–94.CrossRef
17.
Söderman P, Malchau H. Is the Harris Hip Score System useful to study the outcome of total hip replacement? Clin Orthop Relat Res. 2001;384:189–97.CrossRefPubMed
18.
Guimarães RP, Alves DPL, Silva BS, Bittar ST, Ono NK, Honda E, et al. Translation and transcultural adaptation of Harris Hip Score into Portuguese. Acta Ortop Bras. 2010;18:142–7.
19.
Nakano MM. Versão brasileira da Short Physical Performance Battery - SPPB: adaptação cultural e estudo da confiabilidade. Dissertação de Mestrado. UNICAMP: Campinas, São Paulo; 2007.
20.
Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Marcel E, Salive MPH, et al. Lower-extremity function in persons over the age of 70 years as predictor of subsequent disability. N Engl J Med. 1995;332:556–61.CrossRefPubMed
21.
Ferruci L, Penninx BWJH, Leveille SG, Corti MC, Pahor M, Wallace R, et al. Characteristics of nondisabled older persons who perform poorly in objective tests of lower extremity function. J Am Geriatr Soc. 1992;48:1102–10.CrossRef
22.
Penninx BWJH, Ferrucci L, Leveille SG, Rantanen T, Pahor M, Guralnik JM. Lower extremity performance in nondisabled older persons as a predictor of subsequent hospitalization. J Gerontol. 2000;55(11):691–7.CrossRef
23.
Ware JEJ, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). Conceptual framework and item selection. Med Care. 1992;30:473–83.CrossRefPubMed
24.
Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15:1833–40.PubMed
25.
Ciconelli RM, Ferraz MB, Santos W, Meinao I, Quaresma MR. Tradução para a língua portuguesa e validação do questionário genérico de avaliação de qualidade de vida SF-36 (Brasil SF-36). Rev Bras Reumatol. 1999;39:143–50.
26.
Quintana JM, Escobar A, Bilbao A, Arostegui I, Lafuente I, Vidaurreta I. Responsiveness and clinically important differences for the WOMAC and SF-36 after hip joint replacement. Osteoarthritis Cartilage. 2005;13:1076–83.CrossRefPubMed
27.
Fernandes MI. Translation and validation of the quality of life questionnaire specific to osteoarthritis (WOMAC) for Portuguese. Rev Paulista Reumatol. 2003;1:7.
28.
Matsudo SM, Matsudo VKR, Barros Neto TL. The impact of aging on anthropometric, neuromotor, and metabolic variables of physical fitness. R Bras Ci e Mov. 2000;8(4):21–32.
29.
Arden N, Nevitt MC. Osteoarthritis: epidemiology. Best Pract Res Clin Rheumatol. 2006;20(1):3–25.CrossRefPubMed
30.
Gordon M, Paulsen A, Overgaard S, Garellick G, Pedersen AB, Rolfs O. Factors influencing health-related quality of life after total hip replacement - a comparison of data from the Swedish and Danish hip arthroplasty registers. BMC Musculoskelet Disord. 2013;14:316–21.CrossRefPubMedPubMedCentral
31.
Mariconda M, Galasso O, Costa GG, Recano P, Cerbasi S. Quality of life and functionality after total hip arthroplasty: a long-term follow-up study. BMC Musculoskelet Disord. 2011;12:222–33.CrossRefPubMedPubMedCentral
32.
Roberts D, Ageberg E, Andersson G, Fridén T. Effects of short-term cycling on knee joint proprioception in ACL-deficient patients. Knee Surg Sports Traumatol Arthrosc. 2004;12:357–63.CrossRefPubMed
33.
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;55:916–21.CrossRefPubMed
34.
Cesari M, Onder G, Russo A, Zamboni V, Barillaro C, Ferrucci L, et al. Comorbidity and physical function: results from the Aging and Longevity Study in the Sirente Geographic Área (ilSIRENTE Study). Gerontology. 2006;52:24–32.CrossRefPubMed
35.
Guyatt GH, Naylor D, Juniper E, Heyland DK, Jaeschke R, Cook DJ. Users’ guides to medical literature. XII How to use article about related quality of life Evidence-based medicine working group. JAMA. 1997;277(15):1232–7.CrossRefPubMed
36.
Ware JE. Measuring patients’ views: the optimum outcome measure. SF-36: a valid, reliable assessment of health form the patient’s point of view. BMJ. 1993;306(6890):1429–30.CrossRefPubMedPubMedCentral
Metadata
Title
Effect of cycle ergometer and conventional exercises on rehabilitation of older patients with total hip arthroplasty: study protocol for randomized controlled trial
Authors
Mariana Kátia Rampazo-Lacativa
Maria José D’Elboux
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0647-8

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