Association of an app-based intervention with improvements in mobility, trunk muscle strength and patient-reported disease activity in axial spondyloarthritis: a 24-week pre-post study.
Patrick-Pascal Strunz, Marc Schmalzing, Amelie Wüst, Patricia Possler, Tobias Heusinger, Maxime le Maire, Anna Fleischer, Thorsten Bley, Michael Gernert, Hannah Labinsky, Ottar Gadeholt, Robert Leppich, Astrid Schmieder, Ludwig Hammel, Billy Sperlich, Ann-Cathrin Koschker, Hermann Einsele, Matthias Froehlich, Karsten Sebastian Luetkens
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引用次数: 0
Abstract
Background: In a nationwide randomised controlled trial among 200 axial spondyloarthritis (axSpA) patients, the medical app Axia improved patient-reported disease activity scores, functional status and quality of life.
Objective: This companion study aimed to explore Axia's effects on objective parameters such as mobility, strength and imaging.
Design: Single-centre, two-phase pre-post intervention study over 24 weeks.
Methods: Thirty-two patients with axSpA on stable pharmacotherapy underwent 12 weeks of standard care (phase I) followed by 12 weeks of Axia use (phase II). The primary endpoint was Bath Ankylosing Spondylitis Metrology Index (BASMI) at week 24 (W24) versus week 12 (W12) and baseline. Secondary endpoints included muscle strength, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), safety and magnetic resonance imaging (MRI) of the sacroiliac joints.
Results: Twenty-seven (84%) of 32 participants (mean age 49.1 years, 48.1% females and radiographic axSpA, 66.7% biological or targeted synthetic disease-modifying anti-rheumatic drugs therapy) completed the study. During standard care, BASMI (baseline 3.1; W12 3.0; p > 0.05) and BASDAI (baseline 4.7; W12 4.9; p > 0.05) remained unchanged, while median spinal extensor strength declined by 14%. During Axia use, BASMI improved to 2.4 (p < 0.001), BASDAI to 3.7 (p < 0.001) and muscle strength increased by 25% (p < 0.01). BASMI improvement was greater in patients with baseline MRI inflammation. MRI showed no increase or decrease in bone marrow oedema or structural damage. No app-related adverse events occurred.
Conclusion: Axia use was associated with improved spinal mobility, extensor strength and disease activity, without relevant safety concerns.
Trial registration: The study was registered in the German Clinical Trials Register (DRKS00038067).
背景：在一项针对200名轴性脊柱炎（axSpA）患者的全国性随机对照试验中，医疗应用程序Axia改善了患者报告的疾病活动评分、功能状态和生活质量。目的：本研究旨在探讨Axia对运动能力、力量和影像学等客观参数的影响。设计：单中心，干预前后两阶段研究，为期24周。方法：32例接受稳定药物治疗的axSpA患者接受了12周的标准治疗（一期），随后接受了12周的Axia治疗（二期）。主要终点是第24周（W24）与第12周（W12）和基线时的巴斯强直性脊柱炎计量指数（BASMI）。次要终点包括肌肉力量、巴斯强直性脊柱炎疾病活动指数（BASDAI）、骶髂关节的安全性和磁共振成像（MRI）。结果：32名参与者中有27人（84%）完成了研究（平均年龄49.1岁，48.1%为女性和x线摄影，66.7%为生物或靶向合成疾病改善抗风湿药物治疗）。在标准治疗期间，BASMI（基线3.1;W12 3.0; p > 0.05）和BASDAI（基线4.7;W12 4.9; p > 0.05）保持不变，而中位脊柱伸肌强度下降了14%。在使用Axia期间，BASMI提高到2.4 （p p p）。结论：使用Axia与脊柱活动度、伸肌力量和疾病活动度的改善有关，没有相关的安全问题。试验注册：该研究已在德国临床试验注册中心（DRKS00038067）注册。
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Therapeutic Advances in Musculoskeletal Disease delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of musculoskeletal disease.
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