11周运动康复锻炼对髋膝骨关节炎有效性和充分性：2016年德国 卫生服务研究背景下的对照研究方案

11周运动康复锻炼对髋膝骨关节炎有效性和充分性：2016年德国

卫生服务研究背景下的对照研究方案

作者：Inga Krauss, Gerhard Mueller, Georg Haupt, Benjamin Steinhilber, Pia Janssen, Nicola Jentner, Peter Martus.

作者单位: Medical Clinic, Department of Sports Medicine, University Hospital, Hoppe-Seyler-Str. 6, 72076, Tuebingen, Germany. inga.krauss@med.uni-tuebingen.de.

译者：陶可（北京大学人民医院骨关节科）

摘要

背景：骨关节炎是老年人疼痛的最常见原因，造成的个人和经济负担巨大。骨关节炎的慢性特征需要长期治疗。在这方面，建议由患者自己进行的生活方式干预（例如体育锻炼）作为一线治疗。有证据表明运动疗法在减轻疼痛和身体机能方面具有短期益处。尽管如此，研究议程强调了将运动策略纳入患者护理的多方面干预措施的必要性。研究应以适当的样本量进行，并应允许对长期影响以及成本效用和安全性进行陈述。这些尚未解决的问题都是本研究内容。

方法/设计：这是一项在卫生服务研究背景下的对照研究。研究人群包括n = 1400名患有髋关节或膝关节骨关节炎的受试者。干预组将从全国范围内为髋关节或膝关节骨关节炎患者提供健康保险的参与者中招募。对照组的潜在参与者（比例10:1（控制与干预）将根据预定义的匹配标准从保险数据库中过滤出来，并通过信件询问他们的参与。来自响应者的最终统计双胞胎(1:1)将通过倾向得分匹配确定。渐进式训练干预包括8次有监督的小组课程，辅以家庭练习（每周2次，超过11周）。练习包括动员、加强和训练姿势控制。主要结果是疼痛和干预期后立即使用WOMAC指数测量功能。其中，健康相关的生活质量、自我效能、成本效用和安全性将作为次要结果进行评估。参与者将在基线后6、12和24个月进行随访。

讨论：本试验的结果将在大样本量的基础上记录常规医疗保健环境中临床和经济结果的影响。因此，该试验的结果可能对未来在髋关节或膝关节骨性关节炎中实施团体和家庭锻炼产生重大影响。

跟踪注册：德国临床试验注册DRKS00009251。2015年9月10日注册。

关键词：成本分析；集体培训；医疗保健研究；髋骨关节炎；家庭锻炼；膝关节骨关节炎；长期影响；倾向得分匹配；安全；WOMAC评分。

Fig.2 Example of an exercise for hip and knee motor learning and mobilization (MM)

图2 髋关节和膝关节运动学习和动员(MM)的锻炼示范

Fig. 3 Example of static and dynamic exercises for postural control (PC)

图3 姿势控制（PC）的静态和动态练习示范

Fig. 4 Examples for progressive strength training exercises (S)

图4 渐进式髋关节周围肌肉力量训练示范（S）

Fig. 1 Study flow chart

图1 研究流程图

Table 1 Inclusion and exclusion criteria for study participation (t0 = baseline)

Effectiveness and efficiency of an 11-week exercise intervention for patients with hip or knee osteoarthritis: a protocol for a controlled study in the context of health services research.

Abstract

Background: Osteoarthritis is the most common reason for pain in older adults, and the individual and economic burden of this disease is immense. The chronic character of osteoarthritis requires a long-term therapeutic treatment. In this regard life-style interventions such as physical exercises that can be carried out by the patient himself are recommended as first line treatment. There is evidence for the short-term benefit of exercise therapy in terms of pain reduction and physical functioning. Nonetheless research agendas highlight the need for multifaceted interventions that incorporate exercise strategies into patient care. Studies should be conducted with appropriate sample sizes and should allow statements on long-term effects as well as cost-utility and safety. These open questions are under the scope of this study.

Methods/design: This is a controlled study in the context of health services research. The study population consists of n = 1400 subjects with hip or knee osteoarthritis. The intervention group will be recruited from participants of a country-wide health insurance offer for people with hip or knee osteoarthritis. Potential participants for the control group (ratio 10:1 (control vs. intervention) will be filtered out from the insurance data base according to pre-defined matching criteria and asked by letter for their participation. The final statistical twins from the responders (1:1) will be determined via propensity score matching. The progressive training intervention comprises 8 supervised group sessions, supplemented by home exercises (2/week over 11 weeks). Exercises include mobilization, strengthening and training of postural control. Primary outcomes are pain and function measured with the WOMAC Index immediately after the intervention period. Among other things, health related quality of life, self-efficacy, cost utility and safety will be evaluated as secondary outcomes. Participants will be followed up 6, 12 and 24 month after baseline.

Discussion: Results of this trial will document the effects of clinical as well as economic outcomes in a regular health care setting on the basis of a large sample size. As such, results of this trial might have great impact on future implementations of group- and home-based exercises in hip or knee osteoarthritis.

Trail registration: German Clinical Trial Register DRKS00009251 . Registered 10 September 2015.

Keywords: Cost-analysis; Group training; Health care research; Hip osteoarthritis; Home exercise; Knee osteoarthritis; Long-term effects; Propensity score matching; Safety; WOMAC.

文献出处：Inga Krauss, Gerhard Mueller, Georg Haupt, Benjamin Steinhilber, Pia Janssen, Nicola Jentner, Peter Martus. Effectiveness and efficiency of an 11-week exercise intervention for patients with hip or knee osteoarthritis: a protocol for a controlled study in the context of health services research. Controlled Clinical Trial, BMC Public Health. 2016 Apr 30;16:367. doi: 10.1186/s12889-016-3030-0.