Op0143-HPR Effectiveness of Longstanding Exercise Therapy Versus Usual Care in People With Axial Spondyloarthritis and Severe Functional Limitations: A Randomized Controlled Trial (L-Exspa)

Background: Exercise therapy is a proven effective and safe treatment for people with axial spondyloarthritis (axSpA) to improve physical function and performance of daily activities. Nonetheless, previous studies have predominantly included patients with a relatively favorable health status. Individuals with sustained disease activity, severe ankylosis or deformities of the spine, and/or significant comorbidities remain under-represented in research. In particular these patients may be in need of longstanding treatment, tailored to their individual functional limitations that may fluctuate over time. Objectives: To evaluate the effectiveness of longstanding (>52 weeks) personalized, supervised exercise therapy compared with usual care (UC) in people with axSpA and severe functional limitations in daily activities. Methods: L-EXSPA was a nation-wide, single-blinded, randomized controlled trial (Netherlands Trial Register NL8238). Adults with axSpA and severe limitations in basic activities of daily living (e.g., limited in self-care, transfers and/or walking distance) were randomized 1:1 to the intervention or UC (1). The intervention consisted of longstanding (>52 weeks; first three months two times a week, thereafter one time per week) supervised exercise therapy tailored to individual goals, comprising active exercises (focused on strength, range of motion, endurance and functional activities), education and self-management support to increase the level of physical activity. Specifically trained, primary care physical therapists delivered the intervention. The primary endpoint was the change in the Patient-Specific Complaint activity ranked 1 (PSC1 Numeric Rating Scale (NRS, 0-10)) at 52 weeks. Secondary endpoints were the PSC activities ranked 2 and 3, the Bath Ankylosing Spondylitis Functional Index questionnaire (BASFI), 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 scale (SF-36, PCS and MCS). (Serious) Adverse events ((S)AEs) were recorded. The mean changes between baseline and 52 weeks were compared between the intervention and UC groups with the unpaired Student's t-test or linear mixed models, where appropriate. All analyses were based on intention-to-treat. In addition, between group effect sizes (ES) were calculated. Results: Of the 426 people that were screened, 215 were enrolled, with 1 patient excluded later because a diagnosis other than axSpA. The 214 included axSpA patients (49% female, age 52 (SD 12) years), of whom 41% had five or more comorbidities and 67% had active disease according to a Bath Ankylosing Spondylitis Disease Activity Index ≥4, were randomized to the intervention (n=110) and UC (N=104) groups. Baseline characteristics are shown in Table 1. In the intervention group 93% (n=102) participants started with the intervention, using on average 41 treatment sessions (SD 15). Table 2 shows the results at 52 weeks. The improvement of the PSC1 in the intervention group was statistically significantly greater compared to the UC group (mean difference 95% CI; -1.8 -2.4 to -1.2; ES 0.8). The intervention group also showed statistically greater improvements in all secondary outcomes at 52 weeks compared to the UC group (ES ranging 0.4-0.7), except for the SF-36 MCS (ES 0.1). No (S)AE occurred during the intervention period. Conclusion: Longstanding, personalized, supervised exercise therapy was more effective than UC after 52 weeks of treatment in people with axSpA and severe functional limitations. Improvements were consistently observed in all outcomes on both physical functioning and physical quality of life. REFERENCES: 1 van Wissen MAT, et al. Physiother Res Int. 2021;e1933. Acknowledgements: Funding: This project is financially supported by the Netherlands Organization for Health Research and Development (ZonMw; 852004019), 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). Disclosure of Interests: M.A.T. van Wissen: None declared, C.H.M. van den Ende: None declared, M.G.J. Gademan: None declared, M.M.H. Teuwen: None declared, W.F. Peter: None declared, E.A.M. Mahler: None declared, D. van Schaardenburg: None declared, F. A. van Gaalen Abbvie, ASAS, BMS, Galapagos, Janssen, Lilly, Novartis, Pfizer, UCB, but not applicable for this study., J.P.L Spoorenberg Pfizer, Abbvie, Novartis, UCB, Lilly, Galapagos, but not applicable for this study, Pfizer, Abbvie, Novartis, but not applicable for this study, W.B. van den Hout: None declared, Astrid van Tubergen: None declared, T.P.M. Vliet Vlieland: None declared, S.F.E. van Weely: None declared.