The effect of targeted exercise on knee-muscle function in patients with persistent hamstring deficiency following ACL reconstruction - study protocol for a randomized controlled trial

Bo Bregenhof, Uffe Jørgensen, Per Aagaard, Nis Nissen, Mark W Creaby, Jonas Bloch Thorlund, Carsten Jensen, Trine Torfing, Anders Holsgaard-Larsen, Bo Bregenhof, Uffe Jørgensen, Per Aagaard, Nis Nissen, Mark W Creaby, Jonas Bloch Thorlund, Carsten Jensen, Trine Torfing, Anders Holsgaard-Larsen

Abstract

Background: Anterior cruciate ligament (ACL) reconstruction, using hamstring auto-graft is a common surgical procedure, which often leads to persistent hamstring muscle-strength deficiency and reduced function. The purpose of this randomized controlled trial (RCT) is to investigate the effect of a combined, progressive, strength and neuromuscular exercise intervention on knee muscle strength, functional capacity and hamstring muscle-tendon morphology in ACL-reconstructed patients with persistent hamstring muscle-strength deficiency compared with controls.

Methods/design: The study is designed as a multicenter, parallel-group RCT with balanced randomization (1:1) and blinded outcome assessments (level of evidence: II) and will be reported in accordance with the CONSORT Statement. Fifty ACL-reconstructed patients (hamstring auto-graft) with persistent limb-to-limb knee-flexor muscle-strength asymmetry at 12-24 months' post surgery, will be recruited through outpatient clinics and advertisements. Patients will be randomized to a 12-week progressive, strength and neuromuscular exercise group (SNG) with supervised training twice weekly or a control intervention (CON) consisting of a home-based, low-intensity exercise program. Outcome measures include between-group change in maximal isometric knee-flexor strength (primary outcome) and knee-extensor muscle strength, hamstring-to-quadriceps strength ratios of the leg that has been operated on and Knee injury and Osteoarthritis Outcome Score (KOOS) (secondary outcomes). In addition, several explorative outcomes will be investigated: The International Knee Documentation Committee Subjective Knee Form (IKDC), the Tegner Activity Score, rate of force development (RFD) for the knee flexors and extensors, tendon regeneration and potential muscle hypertrophy at graft harvest site evaluated by magnetic resonance imaging (MRI), postural control, kinetic/kinematic gait characteristics and knee-related functional capacity.

Discussion: This RCT is designed to investigate the effect of combined, progressive-resistance and neuromuscular exercises on knee-flexor/extensor strength, in the late rehabilitation phase following ACL reconstruction. Reduced hamstring strength represents a potential risk factor for secondary ACL rupture and accelerated progression of osteoarthritis. If deemed effective, the intervention paradigm introduced in this study may help to improve current treatment strategies in ACL-reconstructed patients.

Trial registration: ClinicalTrials.gov, ID: NCT02939677 (recruiting). Registered on 20 October 2016.

Keywords: ACL reconstruction; Exercise; Muscle strength; Physical function; Rehabilitation.

Conflict of interest statement

Ethics approval and consent to participate

Ethics Committee of the Region of Southern Denmark (ID: S-20160034).

All participants have been given written and oral information before entering enrollment. Written consent to participation and publication, have been, and will be, obtained from all participants, in this study (enrollment is currently still in progress). The consent form is held by the corresponding authors’ institution and is available for review by the Editor-in-Chief upon request.

Consent for publication

The corresponding authors confirm that informed written and oral consent has been received for publication of the manuscript, additional files and supplementary figures. Written informed consent has been obtained from the participants and authors, for publication of their individual details in this manuscript, although no individual participant details will be published in this study protocol article. The consent form is held by the corresponding authors’ institution and is available for review by the Editor-in-Chief upon request. The study results will be released to the participating physicians, referring physicians, participants and the general medical community, Furthermore, all participants will be invited to participate in a presentation, reviewing the process and results produced throughout the study period.

Competing interests

All the authors declare that they have no competing interests, in accordance with BioMed Central’s guidance on 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
SPIRIT Figure. Template of content for the schedule of enrollment, interventions and assessments
Fig. 2
Fig. 2
Study flowchart. Participant flow through intervention period

References

    1. Chechik O, Amar E, Khashan M, Lador R, Eyal G, Gold A. An international survey on anterior cruciate ligament reconstruction practices. Int Orthop. 2013;37(2):201–206. doi: 10.1007/s00264-012-1611-9.
    1. Duchman KR, Lynch TS, Spindler KP. Graft selection in anterior cruciate ligament surgery: who gets what and why? Clin Sports Med. 2017;36(1):25–33. doi: 10.1016/j.csm.2016.08.013.
    1. Shaerf DA, Pastides PS, Sarraf KM, Willis-Owen CA. Anterior cruciate ligament reconstruction best practice: a review of graft choice. World J Orthop. 2014;5(1):23–29. doi: 10.5312/wjo.v5.i1.23.
    1. Papannagari R, Gill TJ, Defrate LE, Moses JM, Petruska AJ, Li G. In vivo kinematics of the knee after anterior cruciate ligament reconstruction: a clinical and functional evaluation. Am J Sports Med. 2006;34(12):2006–2012. doi: 10.1177/0363546506290403.
    1. Patel RR, Hurwitz DE, Bush-Joseph CA, Bach BR, Jr, Andriacchi TP. Comparison of clinical and dynamic knee function in patients with anterior cruciate ligament deficiency. Am J Sports Med. 2003;31(1):68–74. doi: 10.1177/03635465030310012301.
    1. Lohmander LS, Englund PM, Dahl LL, Roos EM. The long-term consequence of anterior cruciate ligament and meniscus injuries: osteoarthritis. Am J Sports Med. 2007;35(10):1756–1769. doi: 10.1177/0363546507307396.
    1. Pinczewski LA, Lyman J, Salmon LJ, Russell VJ, Roe J, Linklater J. A 10-year comparison of anterior cruciate ligament reconstructions with hamstring tendon and patellar tendon autograft: a controlled, prospective trial. Am J Sports Med. 2007;35(4):564–574. doi: 10.1177/0363546506296042.
    1. Stergiou N, Ristanis S, Moraiti C, Georgoulis AD. Tibial rotation in anterior cruciate ligament (ACL)-deficient and ACL-reconstructed knees: a theoretical proposition for the development of osteoarthritis. Sports Med. 2007;37(7):601–613. doi: 10.2165/00007256-200737070-00004.
    1. Holsgaard-Larsen A, Jensen C, Mortensen NH, Aagaard P. Concurrent assessments of lower limb loading patterns, mechanical muscle strength and functional performance in ACL-patients—a cross-sectional study. Knee. 2014;21(1):66–73. doi: 10.1016/j.knee.2013.06.002.
    1. More RC, Karras BT, Neiman R, Fritschy D, Woo SL, Daniel DM. Hamstrings—an anterior cruciate ligament protagonist. An in vitro study. Am J Sports Med. 1993;21(2):231–237. doi: 10.1177/036354659302100212.
    1. Zebis MK, Andersen LL, Bencke J, Kjaer M, Aagaard P. Identification of athletes at future risk of anterior cruciate ligament ruptures by neuromuscular screening. Am J Sports Med. 2009;37(10):1967–1973. doi: 10.1177/0363546509335000.
    1. Kruse LM, Gray B, Wright RW. Rehabilitation after anterior cruciate ligament reconstruction: a systematic review. J Bone Joint Surg Am. 2012;94(19):1737–1748. doi: 10.2106/JBJS.K.01246.
    1. Smekal D, Kalina R, Urban J. Rehabilitation after arthroscopic anterior cruciate ligament reconstruction. Acta Chir Orthop Traumatol Cech. 2006;73(6):421–428.
    1. Bien DP, Dubuque TJ. Considerations for late stage acl rehabilitation and return to sport to limit re-injury risk and maximize athletic performance. Int J Sports Phys Ther. 2015;10(2):256–271.
    1. Augustsson J. Documentation of strength training for research purposes after ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2013;21(8):1849–1855. doi: 10.1007/s00167-012-2167-3.
    1. Bieler T, Sobol NA, Andersen LL, Kiel P, Lofholm P, Aagaard P, et al. The effects of high-intensity versus low-intensity resistance training on leg extensor power and recovery of knee function after ACL-reconstruction. Biomed Res Int. 2014;2014:278512. doi: 10.1155/2014/278512.
    1. van Grinsven S, van Cingel RE, Holla CJ, van Loon CJ. Evidence-based rehabilitation following anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2010;18(8):1128–1144. doi: 10.1007/s00167-009-1027-2.
    1. Konrath JM, Vertullo CJ, Kennedy BA, Bush HS, Barrett RS, Lloyd DG. Morphologic characteristics and strength of the hamstring muscles remain altered at 2 years after use of a hamstring tendon graft in anterior cruciate ligament reconstruction. Am J Sports Med. 2016;44(10):2589–2598. doi: 10.1177/0363546516651441.
    1. Choi JY, Ha JK, Kim YW, Shim JC, Yang SJ, Kim JG. Relationships among tendon regeneration on MRI, flexor strength, and functional performance after anterior cruciate ligament reconstruction with hamstring autograft. Am J Sports Med. 2012;40(1):152–162. doi: 10.1177/0363546511424134.
    1. Eriksson K, Larsson H, Wredmark T, Hamberg P. Semitendinosus tendon regeneration after harvesting for ACL reconstruction. A prospective MRI study. Knee Surg Sports Traumatol Arthrosc. 1999;7(4):220–225. doi: 10.1007/s001670050152.
    1. Tadokoro K, Matsui N, Yagi M, Kuroda R, Kurosaka M, Yoshiya S. Evaluation of hamstring strength and tendon regrowth after harvesting for anterior cruciate ligament reconstruction. Am J Sports Med. 2004;32(7):1644–1650. doi: 10.1177/0363546504263152.
    1. Rispoli DM, Sanders TG, Miller MD, Morrison WB. Magnetic resonance imaging at different time periods following hamstring harvest for anterior cruciate ligament reconstruction. Arthroscopy. 2001;17(1):2–8. doi: 10.1053/jars.2001.19460.
    1. The Consort Statement. BMJ. 2010;340:c332. .
    1. Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P, Group CN. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017;167(1):40–47.
    1. Ageberg E, Link A, Roos EM. Feasibility of neuromuscular training in patients with severe hip or knee OA: the individualized goal-based NEMEX-TJR training program. BMC Musculoskelet Disord. 2010;11:126. doi: 10.1186/1471-2474-11-126.
    1. Zebis MK, Bencke J, Andersen LL, Dossing S, Alkjaer T, Magnusson SP, et al. The effects of neuromuscular training on knee joint motor control during sidecutting in female elite soccer and handball players. Clin J Sport Med. 2008;18(4):329–337. doi: 10.1097/JSM.0b013e31817f3e35.
    1. Di Stasi S, Myer GD, Hewett TE. Neuromuscular training to target deficits associated with second anterior cruciate ligament injury. J Orthop Sports Phys Ther. 2013;43(11):777–92. a1-11.
    1. Clausen B, Holsgaard-Larsen A, Sondergaard J, Christensen R, Andriacchi TP, Roos EM. The effect on knee-joint load of instruction in analgesic use compared with neuromuscular exercise in patients with knee osteoarthritis: study protocol for a randomized, single-blind, controlled trial (the EXERPHARMA trial) Trials. 2014;15:444. doi: 10.1186/1745-6215-15-444.
    1. Paterno MV, Schmitt LC, Ford KR, Rauh MJ, Hewett TE. Altered postural sway persists after anterior cruciate ligament reconstruction and return to sport. Gait Posture. 2013;38(1):136–140. doi: 10.1016/j.gaitpost.2012.11.001.
    1. Lagally KM, Robertson RJ, Gallagher KI, Gearhart R, Goss FL. Ratings of perceived exertion during low- and high-intensity resistance exercise by young adults. Percept Mot Skills. 2002;94(3 Pt 1):723–731. doi: 10.2466/pms.2002.94.3.723.
    1. Jensen C, Aagaard P, Overgaard S. Recovery in mechanical muscle strength following resurfacing vs standard total hip arthroplasty—a randomised clinical trial. Osteoarthr Cartil. 2011;19(9):1108–1116. doi: 10.1016/j.joca.2011.06.011.
    1. Izquierdo M, Ibanez J, Gorostiaga E, Garrues M, Zuniga A, Anton A, et al. Maximal strength and power characteristics in isometric and dynamic actions of the upper and lower extremities in middle-aged and older men. Acta Physiol Scand. 1999;167(1):57–68. doi: 10.1046/j.1365-201x.1999.00590.x.
    1. Toonstra J, Mattacola CG. Test-retest reliability and validity of isometric knee-flexion and -extension measurement using 3 methods of assessing muscle strength. J Sport Rehabil. 2013;Technical Notes(7).
    1. Aagaard P, Simonsen EB, Magnusson SP, Larsson B, Dyhre-Poulsen P. A new concept for isokinetic hamstring: quadriceps muscle strength ratio. Am J Sports Med. 1998;26(2):231–237. doi: 10.1177/03635465980260021201.
    1. Zebis MK, Andersen LL, Ellingsgaard H, Aagaard P. Rapid hamstring/quadriceps force capacity in male vs. female elite soccer players. J Strength Cond Res. 2011;25(7):1989–1993. doi: 10.1519/JSC.0b013e3181e501a6.
    1. Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)—development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998;28(2):88–96. doi: 10.2519/jospt.1998.28.2.88.
    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. 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 (Hoboken). 2011;63 Suppl 11:S208–28.
    1. Flosadottir V, Roos EM, Ageberg E. Muscle function is associated with future patient-reported outcomes in young adults with ACL injury. BMJ Open Sport Exerc Med. 2016;2(1):e000154. doi: 10.1136/bmjsem-2016-000154.
    1. Irrgang JJ, Anderson AF, Boland AL, Harner CD, Kurosaka M, Neyret P, et al. Development and validation of the international knee documentation committee subjective knee form. Am J Sports Med. 2001;29(5):600–613. doi: 10.1177/03635465010290051301.
    1. Briggs KK, Kocher MS, Rodkey WG, Steadman JR. Reliability, validity, and responsiveness of the Lysholm knee score and Tegner activity scale for patients with meniscal injury of the knee. J Bone Joint Surg Am. 2006;88(4):698–705.
    1. Aagaard P, Simonsen EB, Andersen JL, Magnusson P, Dyhre-Poulsen P. Increased rate of force development and neural drive of human skeletal muscle following resistance training. J Appl Physiol (1985). 2002;93(4):1318–26.
    1. Maffiuletti NA, Bizzini M, Widler K, Munzinger U. Asymmetry in quadriceps rate of force development as a functional outcome measure in TKA. Clin Orthop Relat Res. 2010;468(1):191–198. doi: 10.1007/s11999-009-0978-4.
    1. Davis RBOS, Tyburski D, Gage JR. A gait analysis data collection and reduction technique. Hum Mov Sci. 1991;10(5):575–587. doi: 10.1016/0167-9457(91)90046-Z.
    1. Holsgaard Larsen A, Caserotti P, Puggaard L, Aagaard P. Reproducibility and relationship of single-joint strength vs multi-joint strength and power in aging individuals. Scand J Med Sci Sports. 2007;17(1):43–53.
    1. Holsgaard-Larsen A, Jensen C, Aagaard P. Subjective vs objective predictors of functional knee joint performance in anterior cruciate ligament-reconstructed patients—do we need both? Knee. 2014;21(6):1139–1144. doi: 10.1016/j.knee.2014.09.004.
    1. Jakobsen MD, Sundstrup E, Krustrup P, Aagaard P. The effect of recreational soccer training and running on postural balance in untrained men. Eur J Appl Physiol. 2011;111(3):521–530. doi: 10.1007/s00421-010-1669-2.
    1. Gustavsson A, Neeter C, Thomee P, Silbernagel KG, Augustsson J, Thomee R, et al. A test battery for evaluating hop performance in patients with an ACL injury and patients who have undergone ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2006;14(8):778–788. doi: 10.1007/s00167-006-0045-6.
    1. Itoh H, Kurosaka M, Yoshiya S, Ichihashi N, Mizuno K. Evaluation of functional deficits determined by four different hop tests in patients with anterior cruciate ligament deficiency. Knee Surg Sports Traumatol Arthrosc. 1998;6(4):241–245. doi: 10.1007/s001670050106.
    1. Noyes FR, Barber SD, Mangine RE. Abnormal lower limb symmetry determined by function hop tests after anterior cruciate ligament rupture. Am J Sports Med. 1991;19(5):513–518. doi: 10.1177/036354659101900518.
    1. Rudolph KS, Axe MJ, Snyder-Mackler L. Dynamic stability after ACL injury: who can hop? Knee Surg Sports Traumatol Arthrosc. 2000;8(5):262–269. doi: 10.1007/s001670000130.
    1. Meierbachtol A, Rohman E, Paur E, Bottoms J, Tompkins M. Quantitative improvements in Hop Test scores after a 6-week neuromuscular training program. Sports Health. 2017;9(1):22–29. doi: 10.1177/1941738116667933.
    1. International Committee of Medical Journal Editors []. Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals . 2016. Available from: . (Cited in accordance with ICMJE-website).
    1. Pocock SJ, Assmann SE, Enos LE, Kasten LE. Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med. 2002;21(19):2917–2930. doi: 10.1002/sim.1296.
    1. Helms RW. Precise definitions of some terminology for longitudinal clinical trials: subjects, patient populations, analysis sets, intention to treat, and related terms. Pharm Stat. 2016;15(6):471–485. doi: 10.1002/pst.1767.
    1. ICF WHO. International Classification of Functioning, Disability and Health. 2017. Available from: .
    1. Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA. 1995;273(1):59–65. doi: 10.1001/jama.1995.03520250075037.
    1. Barber SD, Noyes FR, Mangine RE, McCloskey JW, Hartman W. Quantitative assessment of functional limitations in normal and anterior cruciate ligament-deficient knees. Clin Orthop Relat Res. 1990;255:204–214.
    1. Eastlack ME, Axe MJ, Snyder-Mackler L. Laxity, instability, and functional outcome after ACL injury: copers versus noncopers. Med Sci Sports Exerc. 1999;31(2):210–215. doi: 10.1097/00005768-199902000-00002.
    1. Fitzgerald GK, Axe MJ, Snyder-Mackler L. A decision-making scheme for returning patients to high-level activity with nonoperative treatment after anterior cruciate ligament rupture. Knee Surg Sports Traumatol Arthrosc. 2000;8(2):76–82. doi: 10.1007/s001670050190.
    1. Neeter C, Gustavsson A, Thomee P, Augustsson J, Thomee R, Karlsson J. Development of a strength test battery for evaluating leg muscle power after anterior cruciate ligament injury and reconstruction. Knee Surg Sports Traumatol Arthrosc. 2006;14(6):571–580. doi: 10.1007/s00167-006-0040-y.
    1. Petsching R, Baron R, Albrecht M. The relationship between isokinetic quadriceps strength test and Hop Tests for distance and One-legged Vertical Jump Test following anterior cruciate ligament reconstruction. J Orthop Sports Phys Ther. 1998;28(1):23–31. doi: 10.2519/jospt.1998.28.1.23.
    1. Seto JL, Orofino AS, Morrissey MC, Medeiros JM, Mason WJ. Assessment of quadriceps/hamstring strength, knee ligament stability, functional and sports activity levels five years after anterior cruciate ligament reconstruction. Am J Sports Med. 1988;16(2):170–180. doi: 10.1177/036354658801600215.
    1. Aagaard P, Simonsen EB, Trolle M, Bangsbo J, Klausen K. Isokinetic hamstring/quadriceps strength ratio: influence from joint angular velocity, gravity correction and contraction mode. Acta Physiol Scand. 1995;154(4):421–427. doi: 10.1111/j.1748-1716.1995.tb09927.x.

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