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Effectiveness of longstanding exercise therapy compared with usual care for people with rheumatoid arthritis and severe functional limitations: a randomised controlled trial
  1. Max M H Teuwen1,
  2. Salima F E van Weely1,
  3. Thea P M Vliet Vlieland1,
  4. Maria A T van Wissen1,
  5. Wilfred F Peter1,
  6. Alfons A den Broeder2,
  7. Dirkjan van Schaardenburg3,
  8. Wilbert B van den Hout4,
  9. Cornelia H M Van den Ende5,6,
  10. Maaike G J Gademan1,7
  1. 1 Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands
  2. 2 Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands
  3. 3 Center for Rehabilitation and Rheumatology, Reade, Amsterdam, The Netherlands
  4. 4 Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands
  5. 5 Department of Research, Sint Maartenskliniek, Nijmegen, The Netherlands
  6. 6 Rheumatology, Radboudumc, Nijmegen, The Netherlands
  7. 7 Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
  1. Correspondence to Max M H Teuwen, Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, 2300 RC, The Netherlands; m.m.h.teuwen{at}


Objectives To compare the effectiveness of longstanding (>52 weeks), supervised exercise therapy with usual care in adults with rheumatoid arthritis (RA) and severe functional limitations.

Methods Participants were randomised 1:1 to the intervention (individualised goal-setting, active exercises, education and self-management regarding physical activity) or usual care. Primary endpoint was the change in the Patient-Specific Complaints activity ranked 1 (PSC1, 0–10) at 52 weeks. Secondary endpoints included the PSC activities ranked 2 and 3 (PSC2, PSC3), Health Assessment Questionnaire-Disability Index (HAQ-DI), Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL), 6-minute walk test (6MWT), Patient Reported Outcome Measurement Information System Physical Function-10 (PROMIS PF-10) and the Short Form-36 Physical and Mental Component Summary Scales (SF-36 PCS and MCS). (Serious) Adverse events (AEs) were recorded. Measurements were done by blinded assessors. Analyses at 52 weeks were based on the intention-to-treat principle.

Results In total, 217 people (90% female, age 58.8 (SD 12.9) years) were randomised (n=104 intervention, n=98 usual care available for analyses). At 52 weeks, the improvement of the PSC1 was significantly larger in the intervention group (mean difference (95% CI) −1.7 (−2.4, –1.0)). Except for the SF-36 MCS, all secondary outcomes showed significantly greater improvements favouring the intervention (PSC2 −1.8 (−2.4, –1.1), PSC3 −1.7 (−2.4, −1.0), PROMIS PF-10 +3.09 (1.80, 4.38), HAQ-DI −0.17 (−0.29, –0.06), RAQoL −2.03 (−3.39, –0.69), SF-36 PCS +3.83 (1.49, 6.17) and 6MWT +56 (38, 75) m). One mild, transient AE occurred in the intervention group.

Conclusion Longstanding, supervised exercise therapy was more effective than usual care in people with RA and severe functional limitations.

Trial registration number Netherlands Trial Register (NL8235), included in the International Clinical Trial Registry Platform (

  • Rheumatoid Arthritis
  • Physical Therapy Modalities
  • Patient Reported Outcome Measures

Data availability statement

Data are available upon reasonable request.

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Data availability statement

Data are available upon reasonable request.

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  • Handling editor Josef S Smolen

  • Contributors SFEvW, TPMVV, WFP, AAdB, DvS, WBvdH, CHMVdE and MGJG made substantial contributions to the conception and design of the study. WFP and SFEvW performed the randomisation, recruitment and training of physical therapists and administrative procedures. MMHT and MATvW had a substantial role in the acquisition of data. The analyses and the interpretation of the data were conducted by MMHT, TPMVV, SFEvW, MATvW, CHMVdE and MGJG. All authors were involved in drafting the work or revising it critically for important intellectual content. All authors approved the final version to be published and agreed to be accountable for all aspects of the work. TPMVV is the guarantor, she accepts full responsibility for the work and/or the conduct of the study, had access to the data and controlled the decision to publish.

  • Funding This project is financially supported by the Netherlands Organization for Health Research and Development (ZonMw; 852004018), Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport), the Royal Dutch Society for Physical Therapy (KNGF) and the Dutch Arthritis Society (ReumaNederland).

  • Competing interests None declared.

  • 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.