Authors have no financial or non-financial competing interests to disclose.
SRP- Conceived of the study, designed the study, coordinated and helped to draft the manuscript. CM- Helped to design the study, conceived and drafted the analysis section of the manuscript. JJI- Helped to design the study and draft the manuscript. GJA – Helped to collect relevant preliminary data and draft the manuscript. ABG – Helped to design the study and draft the manuscript. MS- Helped to conceive and design the study, and collaborated to draft the manuscript. All authors read and approved the final manuscript.
Although the outcome of total knee replacement (TKR) is favorable, surgery alone fails to resolve the functional limitations and physical inactivity that existed prior to surgery. Exercise is likely the only intervention capable of improving these persistent limitations, but exercises have to be performed with intensity sufficient to promote significant changes, at levels that cannot be tolerated until later stages post TKR. The current evidence is limited regarding the effectiveness of exercise at a later stage post TKR. To that end, this study aims to compare the outcomes of physical function and physical activity between 3 treatment groups: clinic-based individual outpatient rehabilitative exercise during 12 weeks, community-based group exercise classes during 12 weeks, and usual medical care (wait-listed control group). The secondary aim is to identify baseline predictors of functional recovery for the exercise groups.
This protocol paper describes a comparative effectiveness study, designed as a 3-group single-blind randomized clinical trial. Two hundred and forty older adults who underwent TKR at least 2 months prior will be randomized into one of the three treatment approaches. Data will be collected at baseline, 3 months, and 6 months. The wait-listed control group will be randomized to one of the 2 exercise groups after 6 months of study participation, and will complete a 9-month follow-up. Primary outcome is physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index Physical Function Subscale (WOMAC-PF). Physical function is also measured by performance-based tests. Secondary outcomes include performance-based tests and physical activity assessed by a patient-reported survey and accelerometry-based physical activity monitors. Exploratory outcomes include adherence, co-interventions, attrition, and adverse events including number of falls. Linear mixed models will be fitted to compare the changes in outcome across groups. Logistic regression will identify patient characteristics that predict functional recovery in the exercise groups. Instrumental variable methods will be used to estimate the efficacy of the interventions in the presence of non-compliance.
Results will inform recommendations on exercise programs to improve physical function and activity for patients at the later stage post TKR and help tailor interventions according with patients’ characteristics.
ClinicalTrials.gov Identifier NCT02237911.
Konig A, Walther M, Kirschner S, Gohlke F. Balance sheets of knee and functional scores 5 years after total knee arthroplasty for osteoarthritis: a source for patient information. J Arthroplasty. 2000;15(3):289–94. PubMed
Walsh M, Woodhouse LJ, Thomas SG, Finch E. Physical impairments and functional limitations: A comparison of individuals 1 year after total knee arthroplasty with control subjects. Phys Ther. 1998;78(3):248–58. PubMed
Swanik CB, Lephart SM, Rubash HE. Proprioception, kinesthesia, and balance after total knee arthroplasty with cruciate-retaining and posterior stabilized prostheses. J Bone Joint Surg Am. 2004;86-A(2):328–34. PubMed
Wada M, Kawahara H, Shimada S, Miyazaki T, Baba H. Joint proprioception before and after total knee arthroplasty. Clin Orthop Relat Res. 2002;403:161–7. PubMed
Woolhead GM, Donovan JL, Dieppe PA. Outcomes of total knee replacement: a qualitative study. Rheumatology. 2005;44(8):1032–7. PubMed
Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. PubMedPubMedCentral
Noble PC, Gordon MJ, Weiss JM, Reddix RN, Conditt MA, Mathis KB. Does total knee replacement restore normal knee function? Clin Orthop Relat Res. 2005;431:157–65. PubMed
Minns Lowe CJ, Barker KL, Dewey M, Sackley CM. Effectiveness of physiotherapy exercise after knee arthroplasty for osteoarthritis: systematic review and meta-analysis of randomised controlled trials. BMJ. 2007;335(7624):812. PubMed
Moffet H, Collet JP, Shapiro SH, Paradis G, Marquis F, Roy L. Effectiveness of intensive rehabilitation on functional ability and quality of life after first total knee arthroplasty: A single-blind randomized controlled trial. Arch Phys Med Rehabil. 2004;85(4):546–56. PubMed
Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, Group C. Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med. 2008;148(4):W60–6. PubMed
Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, et al. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007;39(8):1435–45. doi: 10.1249/mss.0b013e3180616aa2. PubMed
Williams MA, Haskell WL, Ades PA, Amsterdam EA, Bittner V, Franklin BA, et al. Resistance exercise in individuals with and without cardiovascular disease: 2007 update: a scientific statement from the American Heart Association Council on Clinical Cardiology and Council on Nutrition, Physical Activity, and Metabolism. Circulation. 2007;116(5):572–84. doi: 10.1161/CIRCULATIONAHA.107.185214. PubMed
Zhao W, Hill MD, Palesch Y. Minimal sufficient balance--a new strategy to balance baseline covariates and preserve randomness of treatment allocation. Stat Methods Med Res. 2012. doi: 10.1177/0962280212436447.
DeJong G, Tian W, Smout RJ, Horn SD, Putman K, Smith P, et al. Use of rehabilitation and other health care services by patients with joint replacement after discharge from skilled nursing and inpatient rehabilitation facilities. Arch Phys Med Rehabil. 2009;90(8):1297–305. doi: 10.1016/j.apmr.2008.12.029. PubMed
Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38(6):727–35. PubMed
Hardy SE, Perera S, Roumani YF, Chandler JM, Studenski SA. Improvement in usual gait speed predicts better survival in older adults. J Am Geriatr Soc. 2007;55(11):1727–34. PubMed
Curb JD, Ceria-Ulep CD, Rodriguez BL, Grove J, Guralnik J, Willcox BJ, et al. Performance-based measures of physical function for high-function populations. J Am Geriatr Soc. 2006;54(5):737–42. PubMed
Cesari M, Kritchevsky SB, Newman AB, Simonsick EM, Harris TB, Penninx BW, et al. Added value of physical performance measures in predicting adverse health-related events: results from the Health, Aging And Body Composition Study. J Am Geriatr Soc. 2009;57(2):251–9. doi: 10.1111/j.1532-5415.2008.02126.x. PubMedPubMedCentral
Simonsick EM, Newman AB, Nevitt MC, Kritchevsky SB, Ferrucci L, Guralnik JM, et al. Measuring higher level physical function in well-functioning older adults: expanding familiar approaches in the Health ABC study. J Gerontol A Biol Sci Med Sci. 2001;56(10):M644–9. PubMed
Seeman TE, Charpentier PA, Berkman LF, Tinetti ME, Guralnik JM, Albert M, et al. Predicting changes in physical performance in a high-functioning elderly cohort: MacArthur studies of successful aging. J Gerontol. 1994;49(3):M97–M108. PubMed
de Brito LB, Ricardo DR, de Araujo DS, Ramos PS, Myers J, de Araujo CG. Ability to sit and rise from the floor as a predictor of all-cause mortality. Eur J Prev Cardiol. 2012. doi: 10.1177/2047487312471759.
Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika. 1988;75:800–2.
Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials. 4th ed. New York: Springer Science; 2010.
Bellamy N, Buchanan WW, Goldsmith CH. 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
Bellamy N, Kean WF, Buchanan WW, Gerecz-Simon E, Campbell J. Double blind randomized controlled trial of sodium meclofenamate (Meclomen) and diclofenac sodium (Voltaren): post validation reapplication of the WOMAC Osteoarthritis Index. J Rheumatol. 1992;19(1):153–9. PubMed
Philip B, Roth PL, Buster MA. The Usefulness of Unit Weights in Creating Composite Scores: A Literature Review, Application to Content Validity, and Meta-Analysis. Organ Res Methods. 2007;10:689–709.
Cereda E, Turrini M, Ciapanna D, Marbello L, Pietrobelli A, Corradi E. Assessing energy expenditure in cancer patients: a pilot validation of a new wearable device. JPEN J Parenter Enteral Nutr. 2007;31(6):502–7. PubMed
Brawley LR, Rejeski WJ, King AC. Promoting physical activity for older adults: the challenges for changing behavior. Am J Prev Med. 2003;25(3 Suppl 2):172–83. PubMed
Linn BS, Linn MW, Gurel L. Cumulative illness rating scale. J Am Geriatr Soc. 1968;16(5):622–6. PubMed
Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psych. 1988;56:893–7.
Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989;32:37–44. PubMed
Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994;10(2):77–84. PubMed
Swartzman LC, Gwadry FG, Shapiro AP, Teasell RW. The factor structure of the Coping Strategies Questionnaire. Pain. 1994;57(3):311–6. PubMed
Geisser ME, Robinson ME, Henson CD. The Coping Strategies Questionnaire and chronic pain adjustment: a conceptual and empirical reanalysis. Clin J Pain. 1994;10(2):98–106. PubMed
- A randomized trial to compare exercise treatment methods for patients after total knee replacement: protocol paper
Sara R. Piva
Charity G. Moore
Alexandra B. Gil
Gustavo J. Almeida
James J. Irrgang
- BioMed Central
Neu im Fachgebiet Orthopädie und Unfallchirurgie
Mail Icon II