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Published in: BMC Public Health 1/2016

Open Access 01-12-2016 | Study protocol

Effectiveness and efficiency of an 11-week exercise intervention for patients with hip or knee osteoarthritis: a protocol for a controlled study in the context of health services research

Authors: Inga Krauss, Gerhard Mueller, Georg Haupt, Benjamin Steinhilber, Pia Janssen, Nicola Jentner, Peter Martus

Published in: BMC Public Health | Issue 1/2016

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Abstract

Background

Osteoarthritis is the most common reason for pain in older adults, and the individual and economic burden of this disease is immense. The chronic character of osteoarthritis requires a long-term therapeutic treatment. In this regard life-style interventions such as physical exercises that can be carried out by the patient himself are recommended as first line treatment. There is evidence for the short-term benefit of exercise therapy in terms of pain reduction and physical functioning. Nonetheless research agendas highlight the need for multifaceted interventions that incorporate exercise strategies into patient care. Studies should be conducted with appropriate sample sizes and should allow statements on long-term effects as well as cost-utility and safety. These open questions are under the scope of this study.

Methods/design

This is a controlled study in the context of health services research. The study population consists of n = 1400 subjects with hip or knee osteoarthritis. The intervention group will be recruited from participants of a country-wide health insurance offer for people with hip or knee osteoarthritis. Potential participants for the control group (ratio 10:1 (control vs. intervention) will be filtered out from the insurance data base according to pre-defined matching criteria and asked by letter for their participation. The final statistical twins from the responders (1:1) will be determined via propensity score matching. The progressive training intervention comprises 8 supervised group sessions, supplemented by home exercises (2/week over 11 weeks). Exercises include mobilization, strengthening and training of postural control. Primary outcomes are pain and function measured with the WOMAC Index immediately after the intervention period. Among other things, health related quality of life, self-efficacy, cost utility and safety will be evaluated as secondary outcomes. Participants will be followed up 6, 12 and 24 month after baseline.

Discussion

Results of this trial will document the effects of clinical as well as economic outcomes in a regular health care setting on the basis of a large sample size. As such, results of this trial might have great impact on future implementations of group- and home-based exercises in hip or knee osteoarthritis.

Trail registration

German Clinical Trial Register DRKS00009251. Registered 10 September 2015.
Appendix
Available only for authorised users
Literature
1.
Grotle M, Hagen KB, Natvig B, Dahl FA, Kvien TK. Prevalence and burden of osteoarthritis: results from a population survey in Norway24. J Rheumatol. 2008;35(4):677–84.PubMed
2.
Rabenberg M. Arthrose. Berlin: Robert Koch-Institut; 2013.
3.
4.
Conaghan PG, Kloppenburg M, Schett G, Bijlsma JW. Osteoarthritis research priorities: a report from a EULAR ad hoc expert committee. Ann Rheum Dis. 2014;73(8):1442–5.CrossRefPubMed
5.
Sharif B, Kopec J, Bansback N, Rahman MM, Flanagan WM, Wong H, Fines P, Anis A. Projecting the direct cost burden of osteoarthritis in Canada using a microsimulation model. Osteoarthritis Cartilage. 2015;23:1654–63.CrossRefPubMed
6.
American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. Arthritis Rheum. 2000;43(9):1905–15.CrossRef
7.
Roddy E, Zhang W, Doherty M, Arden NK, Barlow J, Birrell F, Carr A, Chakravarty K, Dickson J, Hay E, Hosie G, Hurley M, Jordan KM, McCarthy C, McMurdo M, Mockett S, O'Reilly S, Peat G, Pendleton A, Richards S. Evidence-based recommendations for the role of exercise in the management of osteoarthritis of the hip or knee—the MOVE consensus. Rheumatology (Oxford). 2005;44(1):67–73.CrossRef
8.
Fransen M, McConnell S, Hernandez-Molina G, Reichenbach S. Exercise for osteoarthritis of the hip. Cochrane Database Syst Rev. 2014;4, CD007912.PubMed
9.
Bennell KL, Dobson F, Hinman RS. Exercise in osteoarthritis: moving from prescription to adherence. Best Pract Res Clin Rheumatol. 2014;28(1):93–117.CrossRefPubMed
10.
11.
Fernandes L, Hagen KB, Bijlsma JW, Andreassen O, Christensen P, Conaghan PG, Doherty M, Geenen R, Hammond A, Kjeken I, Lohmander LS, Lund H, Mallen CD, Nava T, Oliver S, Pavelka K, Pitsillidou I, da Silva JA, de la TJ, Zanoli G, Vliet Vlieland TP. EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013;72(7):1125–35.CrossRefPubMed
12.
Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken ). 2012;64(4):465–74.CrossRef
13.
Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16(2):137–62.CrossRefPubMed
14.
15.
Fransen M, McConnell S. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2009;4, CD004376.
16.
Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman R, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. 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(2):476–99.CrossRefPubMed
17.
Krauss I, Steinhilber B, Haupt G, Miller R, Martus P, Janssen P. Exercise therapy in hip osteoarthritis—a randomized controlled trial. Dtsch Arztebl Int. 2014;111(35/36):592–9.PubMedPubMedCentral
18.
Müller G. Bericht zur Evaluationsstudie AOK-Rückenkonzept. 2015. Unpublished work.
19.
Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivar Behav Res. 2011;46(3):399–424.CrossRef
20.
Krauss I, Steinhilber B, Haupt G, Miller R, Grau S, Janssen P. Efficacy of conservative treatment regimes for hip osteoarthritis—evaluation of the therapeutic exercise regime "Hip School": a protocol for a randomised, controlled trial. BMC Musculoskelet Disord. 2011;12:270.CrossRefPubMedPubMedCentral
21.
Haupt G, Janßen P, Krauß I, Steinhilber B. Das Tübinger Hüftkonzept. 1. Auflage ed. Essen: Verlag hellblau; 2014.
22.
23.
Froböse I, Fiehn R. Muskeltraining (Fünf-Stufen-Modell). In: Froböse I, Nellessen G, Wilke C, editors. Training in der Therapie. 2nd ed. München, Jena: Urban & Fischer; 2003. p. 57–79.
24.
Bellamy N. The WOMAC Knee and Hip Osteoarthritis Indices: development, validation, globalization and influence on the development of the AUSCAN Hand Osteoarthritis Indices. Clin Exp Rheumatol. 2005;23(5 Suppl 39):S148–53.PubMed
25.
Pham T, van der Heijde D, Lassere M, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M. Outcome variables for osteoarthritis clinical trials: The OMERACT-OARSI set of responder criteria. J Rheumatol. 2003;30(7):1648–54.PubMed
26.
27.
Schwarzer R, Jerusalem M. Generalized Self-Efficacy scale. In: Weinman J, Wright S, Johnston M, editors. Measures in health psychology: A user's portfolio. Causal and control beliefs. Windsor: NFER-NELSON; 1995. p. 35–7.
28.
Robert K-I, editor. Sportliche Aktivität. Faktenblatt zu GEDA 2012: Ergebnisse der Studie »Gesundheit in Deutschland aktuell 2012. Berlin: Robert Koch Institut; 2014.
29.
Robert K-I, editor. Körperliche Aktivität. Faktenblatt zu GEDA 2012: Ergebnisse der Studie »Gesundheit in Deutschland aktuell 2012. Berlin: Robert Koch Institut; 2014.
30.
Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233–7.CrossRefPubMed
31.
Schmidt J, Lamprecht F, Wittmann WW. Satisfaction with inpatient management. Development of a questionnaire and initial validity studies. Psychother Psychosom Med Psychol. 1989;39(7):248–55.PubMed
32.
Nallamothu BK, Hayward RA, Bates ER. Beyond the randomized clinical trial: the role of effectiveness studies in evaluating cardiovascular therapies. Circulation. 2008;118(12):1294–303.CrossRefPubMed
33.
34.
Mikesky AE, Mazzuca SA, Brandt KD, Perkins SM, Damush T, Lane KA. Effects of strength training on the incidence and progression of knee osteoarthritis. Arthritis Rheum. 2006;55(5):690–9.CrossRefPubMed
35.
Steinhilber B, Haupt G, Miller R, Janssen P, Krauss I. Home-based strengthening exercise therapy in male and female patients with hip osteoarthritis: effects on hip muscle strength and it's relation to physical disability and pain - results a randomized, controlled trial. 2015. Unpublished Work.
36.
Pinto D, Robertson MC, Hansen P, Abbott JH. Cost-effectiveness of nonpharmacologic, nonsurgical interventions for hip and/or knee osteoarthritis: systematic review. Value Health. 2012;15(1):1–12.CrossRefPubMed
37.
Marra CA, Grubisic M, Cibere J, Grindrod KA, Woolcott JC, Gastonguay L, Esdaile JM. Cost-utility analysis of a multidisciplinary strategy to manage osteoarthritis of the knee: economic evaluation of a cluster randomized controlled trial study. Arthritis Care Res (Hoboken ). 2014;66(6):810–6.CrossRef
38.
Pinto D, Robertson MC, Abbott JH, Hansen P, Campbell AJ. Manual therapy, exercise therapy, or both, in addition to usual care, for osteoarthritis of the hip or knee. 2: economic evaluation alongside a randomized controlled trial. Osteoarthritis Cartilage. 2013;21(10):1504–13.CrossRefPubMed
39.
Bennell KL, Rini C, Keefe F, French S, Nelligan R, Kasza J, Forbes A, Dobson F, Haxby AJ, Dalwood A, Vicenzino B, Harris A, Hinman RS. Effects of Adding an Internet-Based Pain Coping Skills Training Protocol to a Standardized Education and Exercise Program for People With Persistent Hip Pain (HOPE Trial): Randomized Controlled Trial Protocol. Phys Ther. 2015;95(10):1408–422.CrossRefPubMedPubMedCentral
40.
Wang C, Iversen MD, McAlindon T, Harvey WF, Wong JB, Fielding RA, Driban JB, Price LL, Rones R, Gamache T, Schmid CH. Assessing the comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial. BMC Complement Altern Med. 2014;14:333.CrossRefPubMedPubMedCentral
41.
Foster NE, Healey EL, Holden MA, Nicholls E, Whitehurst DG, Jowett S, Jinks C, Roddy E, Hay EM. A multicentre, pragmatic, parallel group, randomised controlled trial to compare the clinical and cost-effectiveness of three physiotherapy-led exercise interventions for knee osteoarthritis in older adults: the BEEP trial protocol (ISRCTN: 93634563). BMC Musculoskelet Disord. 2014;15:254.CrossRefPubMedPubMedCentral
42.
Fernandes L, Storheim K, Nordsletten L, Risberg MA. Development of a therapeutic exercise program for patients with osteoarthritis of the hip. Phys Ther. 2010;90(4):592–601.CrossRefPubMed
Metadata
Title
Effectiveness and efficiency of an 11-week exercise intervention for patients with hip or knee osteoarthritis: a protocol for a controlled study in the context of health services research
Authors
Inga Krauss
Gerhard Mueller
Georg Haupt
Benjamin Steinhilber
Pia Janssen
Nicola Jentner
Peter Martus
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2016
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-016-3030-0

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