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Can exercise programs delivered at a later stage (>2 months) after total knee replacement improve the functional limitations that persist after surgery?
In this randomized clinical trial of 240 individuals at a later stage after knee replacement, all arms (physical therapy, community, and control) improved physical function. There were no differences between arms in the primary outcome of patient-reported physical function, whereas the secondary outcome of performance-based physical function demonstrated greater improvement in the physical therapy arm.
While the primary outcome suggests no benefit of later-stage exercise programs, the secondary outcomes suggest beneficial effects of physical therapy but require confirmation.
Several functional limitations persist after total knee replacement (TKR). Intensive exercise programs could resolve these limitations but are not well tolerated by many patients until a later stage (>2 months) after surgery. Evidence for exercise at a later stage after TKR is limited.
To compare the effectiveness of later-stage exercise programs after TKR and to explore heterogeneity of treatment effects.
Design, Setting, and Participants
Three-arm single-blind randomized clinical trial (January 7, 2015, to November 9, 2017) using an intent-to-treat approach with follow-ups at 3 months and 6 months. The setting was Allegheny County, Pennsylvania (an outpatient physical therapy clinic and 4 community centers). Participants had primary TKR performed more than 2 months previously, were 60 years or older, experienced moderate functional limitations, and were medically cleared to exercise.
Clinic-based physical therapy exercise (physical therapy arm), community-based group exercise (community arm), and usual care (control arm). The control arm continued their usual care, whereas the exercise arms participated in supervised exercise programs lasting 12 weeks.
Main Outcomes and Measures
The primary outcome was arm differences in the Western Ontario and McMaster Universities Osteoarthritis Index–Physical Function (WOMAC-PF) at 3 months. The secondary outcomes included performance-based tests germane to knee replacement and additional surveys of physical function. Data were analyzed by linear mixed models and responder analysis.
A total of 240 participants (mean [SD] age, 70  years; 61.7% female) were allocated to physical therapy (n = 96), community exercise (n = 96), or control (n = 48). All 3 arms demonstrated clinically important improvement. At 3 months, between-arm analyses for the WOMAC-PF demonstrated no differences between physical therapy and community (−2.2; 98.3% CI, −4.5 to 0.1), physical therapy and control (−2.1; 98.3% CI, −4.9 to 0.7), and community and control (0.1; 98.3% CI, −2.7 to 2.9). Performance-based tests demonstrated greater improvement in the physical therapy arm compared with both the community (0.1 z score units; 98.3% CI, 0.0-0.2) and control (0.3 z score units; 98.3% CI, 0.1-0.4) arms and the community arm compared with the control arm (0.2 z score units; 98.3% CI, 0.0-0.3). The physical therapy arm had more than 17.7% responders than the community arm and more than 19.0% responders than the control arm. There was no difference in responder rates between the community and control arms.
Conclusions and Relevance
Based on the primary outcome, participation in late-stage exercise programs after TKR offered no benefit over usual care. The benefits of physical therapy identified by the secondary outcomes and responder analysis require confirmation.
ClinicalTrials.gov Identifier: NCT02237911
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Accepted for Publication: December 21, 2018.
Published: February 22, 2019. doi:10.1001/jamanetworkopen.2019.0018
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2019 Piva SR et al. JAMA Network Open.
Corresponding Author: Sara R. Piva, PT, PhD, OCS, Department of Physical Therapy, University of Pittsburgh, 100 Technology Dr, Bridgeside Point 1, Ste 480, Pittsburgh, PA 15219 (firstname.lastname@example.org).
Author Contributions: Drs Piva and Moore had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Dr Piva was the primary investigator, and Dr Moore was the biostatistician.
Concept and design: Piva, Schneider, Almeida, Sowa, Irrgang.
Acquisition, analysis, or interpretation of data: Piva, Schneider, Moore, Catelani, Gil, Klatt, DiGioia, Almeida, Khoja, Irrgang.
Drafting of the manuscript: Piva, Schneider, Moore, Gil.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Moore.
Obtained funding: Piva.
Administrative, technical, or material support: Piva, Schneider, Catelani, Gil, Klatt, DiGioia, Almeida, Khoja, Sowa.
Supervision: Piva, Gil, Klatt, Almeida.
Conflict of Interest Disclosures: Dr Piva reported receiving grants from the Patient-Centered Outcomes Research Institute (PCORI). Dr Schneider reported receiving grants from PCORI, being a member of the National Chiropractic Mutual Insurance Company speaker’s bureau, and conducting medicolegal consulting for State Farm Insurance. Dr Moore reported receiving grants from PCORI. Ms Catelani reported receiving grants from the University of Pittsburgh. Dr Klatt reported receiving grants from the University of Pittsburgh, receiving royalties from SLACK Orthopedics and from Elsevier, reported serving on the editorial board for The Journal of Arthroplasty, and serving as a reviewer for Clinical Orthopaedics and Related Research and Journal of the American Academy of Orthopaedic Surgeons. Dr Irrgang reported receiving grants from PCORI. No other disclosures were reported.
Funding/Support: This research was funded through a Patient-Centered Outcomes Research Institute award (CER-1310-06994) (Dr Piva, principal investigator).
Role of the Funder/Sponsor: The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The views in this article are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute, its board of governors, or the methodology committee.
Data Sharing Statement: See Supplement 3.
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