Pelletier-Visa Mathilde, Dobija Lech, Bonhomme Alexis, Lanhers Charlotte, Pereira Bruno, Coudeyre Emmanuel
Médecine Physique et de Réadaptation, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
Unité de Nutrition Humaine, INRAE, Université Clermont Auvergne, France, Clermont-Ferrand, France.
BMJ Open. 2025 Jan 20;15(1):e088860. doi: 10.1136/bmjopen-2024-088860.
Osteoarthritis, the most prevalent joint disease, poses a significant challenge due to its progressive nature and impact on the whole joint and periarticular structures. Although exercise is crucial for symptom improvement and progression slowdown, adherence to exercise programmes remains a concern. In response, we have developed a novel smartphone-based m-health application, ARTH-e, specifically designed to enhance adherence to adapted physical activity in individuals with knee osteoarthritis. We aim to perform a prospective,multicenter, randomized (1:1) controlled trial to compare the effectiveness of m-health application ARTH-e (intervention group) with standard care (control group) on exercise adherence in people with knee osteoarthritis. We hypothesise that adherence will be stronger among users of the ARTH-e application.
We will recruit 120 participants from 5 hospitals in France. The participants will undergo a comprehensive assessment, including the Exercise Adherence Rating Scale (EARS) at 2, 4 and 6 months, Knee Injury and Osteoarthritis Outcome Score, Evaluation of the Perception of Physical Activity, Tampa Scale of Kinesiophobia, European Quality of Life 5 Dimensions and 3 Lines and a Visual Analogue Scale rating of pain at baseline and 6 months. Adherence will be monitored using a connected bracelet. The intervention group will use the ARTH-e application for 6 months, while the control group will follow stay-active advice from their physician. The primary outcome will be the difference between groups in the evolution of the EARS score at 6 months.
The study has been approved by the medical ethics committee (Comité de Protection des Personnes) XI of Saint Germain en Laye (27 March 2024) (ID for ethics approval: 24.00330.000201). Eligible individuals will sign the informed consent form before enrolment. Study results will be reported in peer-reviewed publications and at scientific meetings.
NCT06359171.
骨关节炎是最常见的关节疾病，因其渐进性以及对整个关节和关节周围结构的影响而构成重大挑战。尽管运动对于改善症状和减缓病情发展至关重要，但坚持运动计划仍是一个问题。作为回应，我们开发了一款基于智能手机的新型移动健康应用程序ARTH-e，专门用于提高膝关节骨关节炎患者对适应性体育活动的依从性。我们旨在进行一项前瞻性、多中心、随机（1:1）对照试验，比较移动健康应用程序ARTH-e（干预组）与标准护理（对照组）对膝关节骨关节炎患者运动依从性的有效性。我们假设ARTH-e应用程序的用户依从性会更强。
我们将从法国的5家医院招募120名参与者。参与者将接受全面评估，包括在2个月、4个月和6个月时使用运动依从性评定量表（EARS）、膝关节损伤和骨关节炎结局评分、身体活动感知评估、坦帕运动恐惧量表、欧洲生活质量5维度和3水平量表，以及在基线和6个月时进行疼痛视觉模拟量表评分。将使用智能手环监测依从性。干预组将使用ARTH-e应用程序6个月，而对照组将遵循医生提供的保持活跃的建议。主要结局将是两组在6个月时EARS评分变化的差异。
该研究已获得圣日耳曼昂莱第十一医学伦理委员会（保护人类委员会）的批准（2024年3月27日）（伦理批准编号：24.00330.000201）。符合条件的个体将在入组前签署知情同意书。研究结果将在同行评审的出版物和科学会议上报告。
NCT06359171。
