Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.
Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands.
Physiother Res Int. 2022 Jan;27(1):e1933. doi: 10.1002/pri.1933. Epub 2021 Nov 15.
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.
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.
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.
针对患有中轴型脊柱关节炎（axSpA）或类风湿关节炎（RA）的患者，长期运动疗法的有效性和成本效益研究较为匮乏，且主要关注健康状况相对较好的患者。本研究旨在评估长期运动疗法相较于常规护理，在功能严重受限的 axSpA 或 RA 患者亚组中的有效性和成本效益。
在两项独立的平行随机对照试验中，我们将评估长期、主动运动疗法（52 周）与常规护理（1:1）相比的有效性和成本效益。长期、主动运动疗法将侧重于改善个体日常活动和参与的局限性，并由附近的受过培训的物理治疗师提供。对于每种诊断，将纳入 215 名活动和参与受限严重的患者。评估在基线、12、26 和 52 周进行。有效性的主要测量指标是患者特定抱怨量表（Patient-Specific Complaints instrument）在 52 周时的个体功能水平（活动和参与）。对于成本效益分析，将使用 EuroQol（EQ-5D-5L）量表和医疗保健使用及生产力问卷进行评估。经济评估将从社会角度进行成本效用分析。在 52 周后，常规护理组的患者也将接受长期、主动的运动疗法。在 104、156 和 208 周进行随访评估。
这些研究的结果将提供关于长期运动疗法在功能严重受限的 axSpA 和 RA 患者亚组中的有效性和成本效益的见解。
