Efficacy of pre-operative quadriceps strength training on knee-extensor strength before and shortly following total knee arthroplasty: protocol for a randomized, dose-response trial (The QUADX-1 trial)

Rasmus Skov Husted, Anders Troelsen, Kristian Thorborg, Michael Skovdal Rathleff, Henrik Husted, Thomas Bandholm, Rasmus Skov Husted, Anders Troelsen, Kristian Thorborg, Michael Skovdal Rathleff, Henrik Husted, Thomas Bandholm

Abstract

Background: Patients with knee osteoarthritis (OA) report knee pain, limitation in physical activities and low quality of life. The two primary treatments for knee OA are non-surgical treatment (e.g., exercise) and surgery (total knee arthroplasty (TKA)); however, national guidelines recommend non-surgical treatment to be tried prior to surgical procedures. Patients with knee OA are characterized by decreased muscle strength, particularly in the knee-extensor muscles. Correspondingly, decreased knee-extensor strength is found to be associated with an increased risk of development, progression and severity of knee OA symptoms. Recent trials suggest a positive effect of pre-operative exercise on pre- and post-operative outcome; however, the most effective pre-operative knee-extensor strength exercise dosage is not known. The purpose of the present trial is to investigate the efficacy of three different exercise dosages of pre-operative, home-based, knee-extensor strength exercise on knee-extensor strength before and shortly after surgery in patients eligible for TKA due to end-stage knee OA.

Methods: In this randomized dose-response trial with a three-arm parallel design, 140 patients with end-stage knee OA (candidates for TKA) are randomized to one of three exercise dosages (two, four or six session/week) of knee-extensor strength exercise (three sets, 12 repetitions at 12 RM, per exercise session) for 12 weeks. The knee-extensor strength exercise is home-based (unsupervised) and performed with an elastic exercise band following an initial exercise instruction. Adherence is objectively quantified using a sensor attached to the exercise band. The primary outcome will be the change in knee-extensor strength. Following the 12-week exercise period, the need for TKA surgery is re-assessed by an orthopedic surgeon.

Discussion: Decreased knee-extensor strength is a major challenge in patients with knee OA. Exercise programs focusing on knee-extensor strength are found to be more effective in relieving knee OA pain and symptoms compared to more general exercise programs. However, the optimal exercise dosage for knee-extensor strength deficits in patients with knee OA is inconclusive. Knowledge on the dose-response relationship for knee-extensor strength exercise in patients with knee OA will help guide future non-surgical treatment in this patient population.

Trial registration: ClinicalTrials.gov, ID: NCT02931058 . Pre-registered on 10 October 2016.

Keywords: Dose-response; Exercise therapy; Knee osteoarthritis; Knee-extensor exercise; Strength training; Total knee arthroplasty.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval has been granted by the Ethical Committee of the Capital Region Denmark. ID: H-16025136. Confirmation received 13 September 2016. Informed consent will be obtained from all participants of the trial.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of enrollment, randomization, treatment and follow-up
Fig. 2
Fig. 2
Schedule for enrollment, intervention and outcome assessments (Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT))
Fig. 3
Fig. 3
The home-based, knee-extensor strength exercise
Fig. 4
Fig. 4
Objective quantification of exercise adherence for a full exercise session comprising three sets of 12 repetitions
Fig. 5
Fig. 5
Objective quantification of exercise adherence for a single exercise set of 12 repetitions
Fig. 6
Fig. 6
A hypothetical presentation of group changes from baseline to the primary endpoint (after 12 weeks of exercise) for the primary outcome, knee-extensor strength
Fig. 7
Fig. 7
A hypothetical presentation of group changes in knee-extensor strength over the whole trial period. NB, control data are from the academic literature [11] and so are the healthy, age-matched, control data (age 66.8 years (6.5 SD)) [7]
Fig. 8
Fig. 8
A hypothetical simple regression model with the change in isometric knee-extensor strength (Nm/kg) at the primary endpoint and time-under-tension (TUT)
Fig. 9
Fig. 9
Elastic exercise band fixation to an immoveable object (e.g., an elastic exercise band anchor behind a closed door) and placement around the ankle of the exercise leg

References

    1. Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS)—validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003;1:17. doi: 10.1186/1477-7525-1-17.
    1. Pedersen A, Mehnert, Odgaard A, Schrøder HM. Existing data sources for clinical epidemiology: The Danish Knee Arthroplasty Register. Clin Epidemiol. 2012;125:125-135.
    1. Sundhedsstyrelsen—Knæartrose. Nationale kliniske retningslinjer og faglige visitationsretningslinjer. KBH. 2012;1:1-80.
    1. Svege I, Nordsletten L, Fernandes L, Risberg MA. Exercise therapy may postpone total hip replacement surgery in patients with hip osteoarthritis: a long-term follow-up of a randomised trial. Ann Rheum Dis. 2015;74:164–9. doi: 10.1136/annrheumdis-2013-203628.
    1. Wang L, Lee M, Zhang Z, Moodie J, Cheng D, Martin J. 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. doi: 10.1136/bmjopen-2015-009857.
    1. Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, et al. A randomized, controlled trial of total knee replacement. N Engl J Med. 2015;373:1597–606. doi: 10.1056/NEJMoa1505467.
    1. Bade MJ, Kohrt WM, Stevens-Lapsley JE. Outcomes before and after total knee arthroplasty compared to healthy adults. J Orthop Sports Phys Ther. 2010;40:559–67. doi: 10.2519/jospt.2010.3317.
    1. van der Esch M, Holla JF, van der Leeden M, Knol DL, Lems WF, Roorda LD, et al. Decrease of muscle strength is associated with increase of activity limitations in early knee osteoarthritis: 3-year results from the cohort hip and cohort knee study. Arch Phys Med Rehabil. 2014;95:1962–8. doi: 10.1016/j.apmr.2014.06.007.
    1. Culvenor AG, Ruhdorfer A, Juhl C, Eckstein F, Øiestad BE. Knee extensor strength and risk of structural, symptomatic, and functional decline in knee osteoarthritis: a systematic review and meta-analysis: risk of deterioration in knee OA and Knee Extensor Strength. Arthritis Care Res. 2017;69:649–58. doi: 10.1002/acr.23005.
    1. Øiestad BE, Juhl CB, Eitzen I, Thorlund JB. Knee extensor muscle weakness is a risk factor for development of knee osteoarthritis. A systematic review and meta-analysis. Osteoarthr Cartil. 2015;23:171–7. doi: 10.1016/j.joca.2014.10.008.
    1. Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010;91:1770–6. doi: 10.1016/j.apmr.2010.07.229.
    1. Husted H, Lunn TH, Troelsen A, Gaarn-Larsen L, Kristensen BB, Kehlet H. Why still in hospital after fast-track hip and knee arthroplasty? Acta Orthop. 2011;82:679–84. doi: 10.3109/17453674.2011.636682.
    1. Juhl C, Christensen R, Roos EM, Zhang W, Lund H. Impact of exercise type and dose on pain and disability in knee osteoarthritis: a systematic review and meta-regression analysis of randomized controlled trials: impact of exercise type and dose in knee osteoarthritis. Arthritis Rheum. 2014;66:622–36. doi: 10.1002/art.38290.
    1. McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthr Cartil OARS Osteoarthr Res Soc. 2014;22:363–88. doi: 10.1016/j.joca.2014.01.003.
    1. Calatayud J, Casaña J, Ezzatvar Y, Jakobsen MD, Sundstrup E, Andersen LL. High-intensity preoperative training improves physical and functional recovery in the early post-operative periods after total knee arthroplasty: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2016
    1. Skoffer B, Maribo T, Mechlenburg I, Hansen PM, Søballe K, Dalgas U. Efficacy of pre-operative progressive resistance training on post-operative outcomes in patients undergoing total knee arthroplasty: progressive resistance training before total knee arthroplasty. Arthritis Care Res. 2015;29:14-29.
    1. Ratamess NA, Alvar BA, Evetoch TK, Housh TJ, Kibler WB, Kraemer WJ, et al. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009;41:687–708. doi: 10.1249/MSS.0b013e3181915670.
    1. Borde R, Hortobágyi T, Granacher U. Dose-response relationships of resistance training in healthy old adults: a systematic review and meta-analysis. Sports Med. 2015;45:1693–720. doi: 10.1007/s40279-015-0385-9.
    1. Rhea MR, Alvar BA, Burkett LN, Ball SD. A meta-analysis to determine the dose response for strength development. Med Sci Sports Exerc. 2003;35:456–64. doi: 10.1249/01.MSS.0000053727.63505.D4.
    1. Farrugia P, Petrisor BA, Farrokhyar F, Bhandari M. Practical tips for surgical research: Research questions, hypotheses and objectives. Can J Surg J Can Chir. 2010;53:278–81.
    1. Bartholdy C, Juhl C, Christensen R, Lund H, Zhang W, Henriksen M. The role of muscle strengthening in exercise therapy for knee osteoarthritis: a systematic review and meta-regression analysis of randomized trials. Semin Arthritis Rheum. 2017
    1. Peer M, Rush R, Gallacher P, Gleeson N. Pre-surgery exercise and post-operative physical function of people undergoing knee replacement surgery: a systematic review and meta-analysis of randomized controlled trials. J Rehabil Med. 2017;49:304–15. doi: 10.2340/16501977-2210.
    1. Bandholm T, Christensen R, Thorborg K, Treweek S, Henriksen M. Preparing for what the reporting checklists will not tell you: the PREPARE Trial guide for planning clinical research to avoid research waste. Br J Sports Med. 2017;51(20):1494–501. doi: 10.1136/bjsports-2017-097527.
    1. Chan A-W, Tetzlaff J, Gøtzsche P, Altman DG, Dickersin K, Hróbjartsson A, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;8:346-388.
    1. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10:28–55. doi: 10.1016/j.ijsu.2011.10.001.
    1. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. doi: 10.1136/bmj.g1687.
    1. Skoffer B, Maribo T, Mechlenburg I, Hansen PM, Søballe K, Dalgas U. Efficacy of preoperative progressive resistance training on postoperative outcomes in patients undergoing total knee arthroplasty: progressive resistance training before TKA. Arthritis Care Res. 2016
    1. Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Postoperative effects of neuromuscular exercise prior to hip or knee arthroplasty: a randomised controlled trial. Ann Rheum Dis. 2014;73:1130–7. doi: 10.1136/annrheumdis-2012-203135.
    1. American Society of Anesthesiologists . ASA Physical Status Classification System. 2014.
    1. The QUADX-1 Trial. Home-based knee-extensor exercise. . Accessed 17 Sept 2017.
    1. Toigo M, Boutellier U. New fundamental resistance exercise determinants of molecular and cellular muscle adaptations. Eur J Appl Physiol. 2006;97:643–63. doi: 10.1007/s00421-006-0238-1.
    1. Smith BE, Hendrick P, Smith TO, Bateman M, Moffatt F, Rathleff MS, et al. Should exercises be painful in the management of chronic musculoskeletal pain? A systematic review and meta-analysis. Br J Sports Med. 2017;51(23):1679–87. doi: 10.1136/bjsports-2016-097383.
    1. Dobson F, Bennell KL, Hinman RS, Abbott JH, Roos EM. Recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Melbourne: OARSI; 2012.
    1. Losina E, Ranstam J, Collins JE, Schnitzer TJ, Katz JN. OARSI Clinical Trials Recommendations: key analytic considerations in design, analysis, and reporting of randomized controlled trials in osteoarthritis. Osteoarthr Cartil. 2015;23:677–85. doi: 10.1016/j.joca.2015.03.011.
    1. Gagnon D, Nadeau S, Gravel D, Robert J, Bélanger D, Hilsenrath M. Reliability and validity of static knee strength measurements obtained with a chair-fixed dynamometer in subjects with hip or knee arthroplasty. Arch Phys Med Rehabil. 2005;86:1998–2008. doi: 10.1016/j.apmr.2005.04.013.
    1. Jakobsen TL, Kehlet H, Bandholm T. Reliability of the 6-min walk test after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2013;21:2625–8. doi: 10.1007/s00167-012-2054-y.
    1. Parent E, Moffet H. Comparative responsiveness of locomotor tests and questionnaires used to follow early recovery after total knee arthroplasty. Arch Phys Med Rehabil. 2002;83:70–80. doi: 10.1053/apmr.2002.27337.
    1. Almeida GJ, Schroeder CA, Gil AB, Fitzgerald GK, Piva SR. Interrater reliability and validity of the stair ascend/descend test in subjects with total knee arthroplasty. Arch Phys Med Rehabil. 2010;91:932–8. doi: 10.1016/j.apmr.2010.02.003.
    1. Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS) Arthritis Care Res. 2011;63:S208–28. doi: 10.1002/acr.20632.
    1. Collins NJ, Roos EM. Patient-reported outcomes for total hip and knee arthroplasty. Clin Geriatr Med. 2012;28:367–94. doi: 10.1016/j.cger.2012.05.007.
    1. Harris KK, Dawson J, Jones LD, Beard DJ, Price AJ. Extending the use of PROMs in the NHS—using the Oxford Knee Score in patients undergoing non-operative management for knee osteoarthritis: a validation study. BMJ Open. 2013;3:e003365. doi: 10.1136/bmjopen-2013-003365.
    1. Gagliese L, Weizblit N, Ellis W, Chan VWS. The measurement of postoperative pain: a comparison of intensity scales in younger and older surgical patients. Pain. 2005;117:412–20. doi: 10.1016/j.pain.2005.07.004.
    1. Li L, Liu X, Herr K. Postoperative pain intensity assessment: a comparison of four scales in Chinese adults. Pain Med. 2007;8:223–34. doi: 10.1111/j.1526-4637.2007.00296.x.
    1. Sloman R, Wruble AW, Rosen G, Rom M. Determination of clinically meaningful levels of pain reduction in patients experiencing acute postoperative pain. Pain Manag Nurs. 2006;7:153–8. doi: 10.1016/j.pmn.2006.09.001.
    1. Campbell R, Evans M, Tucker M, Quilty B, Dieppe P, Donovan JL. Why don’t patients do their exercises? Understanding non-compliance with physiotherapy in patients with osteoarthritis of the knee. J Epidemiol Community Health. 2001;55:132–8. doi: 10.1136/jech.55.2.132.
    1. McLean SM, Burton M, Bradley L, Littlewood C. Interventions for enhancing adherence with physiotherapy: a systematic review. Man Ther. 2010;15:514–21. doi: 10.1016/j.math.2010.05.012.
    1. Picorelli AMA, Pereira LSM, Pereira DS, Felício D, Sherrington C. Adherence to exercise programs for older people is influenced by program characteristics and personal factors: a systematic review. J Physiother. 2014;60:151–6. doi: 10.1016/j.jphys.2014.06.012.
    1. Ravaud P. Management of osteoarthritis (OA) with an unsupervised home based exercise programme and/or patient administered assessment tools. A cluster randomised controlled trial with a 2x2 factorial design. Ann Rheum Dis. 2004;63:703–8. doi: 10.1136/ard.2003.009803.
    1. Rathleff MS, Bandholm T, Ahrendt P, Olesen JL, Thorborg K. Novel stretch-sensor technology allows quantification of adherence and quality of home-exercises: a validation study. Br J Sports Med. 2014;48:724–8. doi: 10.1136/bjsports-2012-091859.
    1. Rathleff MS, Thorborg K, Rode LA, McGirr KA, Sørensen AS, Bøgild A, et al. Adherence to commonly prescribed, home-based strength training exercises for the lower extremity can be objectively monitored using the Bandcizer. J Strength Cond Res. 2015;29:627–36. doi: 10.1519/JSC.0000000000000675.
    1. Bennell KL, Kyriakides M, Metcalf B, Egerton T, Wrigley TV, Hodges PW, et al. Neuromuscular versus quadriceps strengthening exercise in patients with medial knee osteoarthritis and varus malalignment: a randomized controlled trial: neuromuscular exercise and knee adduction moment. Arthritis Rheumatol. 2014;66:950–9. doi: 10.1002/art.38317.
    1. Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, et al. Editorial-sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors. Ethiop J Health Sci. 2016;26:2–4. doi: 10.4314/ejhs.v26i1.2.
    1. Hoffmann TC, Maher CG, Briffa T, Sherrington C, Bennell K, Alison J, et al. Prescribing exercise interventions for patients with chronic conditions. CMAJ. 2016;188(7):510–8. doi: 10.1503/cmaj.150684.

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