AB0873-HPR EFFECTIVENESS AND COST-EFFECTIVENESS OF LONGSTANDING EXERCISE THERAPY VERSUS USUAL CARE IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS OR RHEUMATOID ARTHRITIS: THE PROTOCOLS OF TWO PARALLEL RANDOMIZED CONTROLLED TRIALS
Authors: M. A. T. van Wissen, M. Teuwen, C. Van den Ende, T. P. M. Vliet Vlieland, A. Den Broeder, W. Van den Hout, W. Peter, D. Van Schaardenburg, A. Van Tubergen, M. G. J. Gademan, S. Van Weely
Journal: Annals of the Rheumatic Diseases (2021)

Background: Axial SpondyloArthritis (axSpA) and Rheumatoid Arthritis (RA) are chronic rheumatic diseases with an often progressive course, defined by chronic inflammation. With respect to exercise therapy, in axSpA and RA, multiple systematic reviews concluded that supervised exercise therapy is an effective and safe treatment option, resulting in small to modest improvements in pain, disease activity, functional ability and axial mobility. In general, most of the studies included in these reviews concerned programs of a relatively short duration (&lt;12 weeks) and the studies mostly concerned patients with stable disease, without co-morbid conditions and relatively favorable functional ability (1-5). The group of patients with active disease, irreversible joint damage, multiple joint replacements and/or severe comorbidity hampering participation in exercise therapy programs and in need for individualized, longstanding therapy is therefore likely to be underrepresented in research so far. Consequently, cost-effectiveness studies on longstanding physical therapy are also lacking in these specific subgroups. Objectives: 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 (Figure 1). 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. Figure 1. Study flowchart Results: 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. References: [1]Mewes J, de Bekker P, Bossen D, Steuten L. 2016. Systematic review of supervised physical exercise therapy for patients with rheumatoid arthritis. Panaxea. [2]Mewes J, de Bekker P, Bossen D, Steuten L. 2016. Systematic review of supervised phyiscal exercise therapy for patients with ankylosing spondylitis. Panaxea. [3]Swardh E, Brodin N. 2016. Effects of aerobic and muscle strengthening exercise in adults with rheumatoid arthritis: a narrative review summarising a chapter in Physical activity in the prevention and treatment of disease (FYSS 2016). Br J Sports Med 50: 362-7. [4]Sveaas SH, Smedslund G, Hagen KB, Dagfinrud H. 2017. Effect of cardiorespiratory and strength exercises on disease activity in patients with inflammatory rheumatic diseases: a systematic review and meta-analysis. Br J Sports Med 51: 1065-72. [5]Regel A, Sepriano A, Baraliakos X, van der Heijde D, Braun J, Landewe R, Van den Bosch F, Falzon L, Ramiro S. 2017. Efficacy and safety of non-pharmacological and non-biological pharmacological treatment: a systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis. RMD Open 3: e000397. Disclosure of Interests: None declared