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  • SUpervised exercise-therapy and Patient Education Rehabilitation (SUPER) versus minimal intervention for young adults at risk of knee osteoarthritis after ACL reconstruction: SUPER-Knee randomised controlled trial protocol

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Sports and exercise medicine
Protocol
SUpervised exercise-therapy and Patient Education Rehabilitation (SUPER) versus minimal intervention for young adults at risk of knee osteoarthritis after ACL reconstruction: SUPER-Knee randomised controlled trial protocol
  1. Adam G Culvenor1,2,
  2. Thomas J West1,2,
  3. Andrea M Bruder1,2,
  4. Mark J Scholes1,2,
  5. Christian J Barton1,2,
  6. Ewa M Roos3,
  7. Edwin Oei4,
  8. Steven M McPhail5,6,
  9. Richard B Souza7,
  10. Jusuk Lee8,
  11. Brooke E Patterson1,2,
  12. Michael A Girdwood1,2,
  13. Jamon L Couch1,2,
  14. Kay M Crossley1,2
  1. 1La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, Victoria, Australia
  2. 2Australian IOC Research Centre, La Trobe University, Bundoora, Victoria, Australia
  3. 3Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark
  4. 4Department of Radiology & Nuclear Medicine, Erasmus MC Rotterdam, Rotterdam, The Netherlands
  5. 5Australian Centre for Health Services Innovation & Centre for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Kelvin Grove, Queensland, Australia
  6. 6Clinical Informatics Directorate, Metro South Health, Woolloongabba, Queensland, Australia
  7. 7Department of Physical Therapy and Rehabilitation Science, University of California San Francisco, San Francisco, California, USA
  8. 8Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, California, USA
  1. Correspondence to Dr Adam G Culvenor; a.culvenor{at}latrobe.edu.au

Abstract

Introduction Anterior cruciate ligament injury and reconstruction (ACLR) is often associated with pain, functional loss, poor quality of life and accelerated knee osteoarthritis development. The effectiveness of interventions to enhance outcomes for those at high risk of early-onset osteoarthritis is unknown. This study will investigate if SUpervised exercise-therapy and Patient Education Rehabilitation (SUPER) is superior to a minimal intervention control for improving pain, function and quality of life in young adults with ongoing symptoms following ACLR.

Methods and analysis The SUPER-Knee Study is a parallel-group, assessor-blinded, randomised controlled trial. Following baseline assessment, 184 participants aged 18–40 years and 9–36 months post-ACLR with ongoing symptoms will be randomly allocated to one of two treatment groups (1:1 ratio). Ongoing symptoms will be defined as a mean score of <80/100 from four Knee injury and Osteoarthritis Outcome Score (KOOS4) subscales covering pain, symptoms, function in sports and recreational activities and knee-related quality of life. Participants randomised to SUPER will receive a 4-month individualised, physiotherapist-supervised strengthening and neuromuscular programme with education. Participants randomised to minimal intervention (ie, control group) will receive a printed best-practice guide for completing neuromuscular and strengthening exercises following ACLR. The primary outcome will be change in the KOOS4 from baseline to 4 months with a secondary endpoint at 12 months. Secondary outcomes include change in individual KOOS subscale scores, patient-perceived improvement, health-related quality of life, kinesiophobia, physical activity, thigh muscle strength, knee function and knee cartilage morphology (ie, lesions, thickness) and composition (T2 mapping) on MRI. Blinded intention-to-treat analyses will be performed. Findings will also inform cost-effectiveness analyses.

Ethics and dissemination This study is approved by the La Trobe University and Alfred Hospital Ethics Committees. Results will be presented in peer-reviewed journals and at international conferences.

Trial registration number ACTRN12620001164987.

  • knee
  • rehabilitation medicine
  • sports medicine
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2022-068279

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    Footnotes

    • AGC and TJW are joint first authors.

    • Twitter @ewa_roos, @Knee_Howells

    • Contributors AC, KC, CB, ER, EO and SMM conceived the study and obtained funding. AC, KC and CB designed the study protocol with input from ER, EO and SMM. SMM provided statistical expertise and will conduct primary statistical analysis. EO, RBS and JL provided imaging expertise and will lead imaging analysis. AC drafted the manuscript with input from TJW, KC, CB, ER, EO, SMM, RBS, JL, AMB, BEP, MG, JLC and MJS. All authors have read and approved the final manuscript.

    • Funding This trial is supported by the National Health and Medical Research Council (NHMRC) of Australia (ID: 1158500). AC is a recipient of an NHMRC Investigator Grant (GNT2008523), CB was a recipient of a Medical Research Future Fund Translating Research Into Practice (MRFF TRIP) Fellowship (ID: 1150439).

    • Disclaimer The funders have no role in the study design and will not have any role in its execution, data management, analysis and interpretation or on the decision to submit the results for publication.

    • Competing interests CB is the owner of a business providing physiotherapy treatment and exercise classes for some participants enrolled in this study. CB will have no role in the decision of which clinic participants attend for study treatment. All other authors declare no competing interests.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.