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Randomized Controlled Trial
. 2022 Jan;27(1):e1933.
doi: 10.1002/pri.1933. Epub 2021 Nov 15.

Effectiveness and cost-effectiveness of longstanding exercise therapy versus usual care in patients with axial spondyloarthritis or rheumatoid arthritis and severe limitations: The protocols of two parallel randomized controlled trials

Maria A T van Wissen  1 , Max M H Teuwen  1 , Cornelia H M van den Ende  2   3 , Thea P M Vliet Vlieland  1 , Alfons A den Broeder  2   3 , Wilbert B van den Hout  4 , Wilfred F Peter  1 , Dirkjan van Schaardenburg  5 , Astrid M van Tubergen  6   7 , Maaike G J Gademan  1   8 , Salima F E van Weely  1
Affiliations
Randomized Controlled Trial

Effectiveness and cost-effectiveness of longstanding exercise therapy versus usual care in patients with axial spondyloarthritis or rheumatoid arthritis and severe limitations: The protocols of two parallel randomized controlled trials

Maria A T van Wissen et al. Physiother Res Int. 2022 Jan.

Abstract

Objectives: Research on effectiveness and cost-effectiveness of longstanding exercise therapy in patients with axial SpondyloArthritis (axSpA) or Rheumatoid Arthritis (RA) is scarce, and mainly concerned patients with a relatively favorable health status. We aim to evaluate the effectiveness and cost-effectiveness of longstanding exercise therapy compared to usual care in the subgroup of patients with axSpA or RA and severe limitations in functioning.

Methods: In two separate, parallel randomized controlled trials the effectiveness and cost-effectiveness of longstanding, active exercise therapy (52 weeks) compared with usual care (1:1) will be evaluated. The longstanding, active exercise therapy will focus on improving individual limitations in daily activities and participation and will be given by a trained physical therapist in the vicinity of the participant. For each diagnosis, 215 patients with severe limitations in activities and participation will be included. Assessments are performed at baseline, 12, 26, and 52 weeks. The primary outcome measure of effectiveness is the individual level of functioning (activities and participation), as measured with the Patient-Specific Complaints instrument at 52 weeks. For cost-effectiveness analyses, the EuroQol (EQ-5D-5L) and questionnaires on healthcare use and productivity will be administered. The economic evaluation will be a cost-utility analysis from a societal perspective. After 52 weeks, the patients in the usual care group are offered longstanding, active exercise therapy as well. Follow-up assessments are done at 104, 156, and 208 weeks.

Conclusion: The results of these studies will provide insights in the effectiveness and cost-effectiveness of longstanding exercise therapy in the subgroup of axSpA and RA patients with severe functional limitations.

Keywords: axial spondyloarthritis; exercise therapy; physical therapy; randomized controlled trial; rheumatoid arthritis.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

FIGURE 1
FIGURE 1
Study flowchart of two parallel studies for long‐term exercise therapy in axial SpondyloArthritis (axSpA) and Rheumatoid Arthritis (RA) patients
See this image and copyright information in PMC

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