Mutidimensional Intervention in Early Osteoarthritis

描述(申请人提供)：骨关节炎(OA)是美国最常见的风湿性疾病和最流行的关节炎形式。其管理的主要目标是减轻疼痛，提高功能能力和生活质量。建议将患者教育和锻炼作为治疗的两大支柱。到目前为止，只有少数精心设计的研究利用教育、锻炼或两者兼而有之的方式进行干预。大多数研究没有显示出足够的内部有效性，没有衡量所有相关的结果，只包括晚期疾病患者，没有检查干预措施的长期好处。我们假设，在早期膝骨性关节炎患者样本中实施长期多维干预，包括锻炼和自我管理计划，与单独实施这两个计划相比，将导致身体功能的显著改善。我们的目标是基于一个模型来检验这一假设，该模型假设运动干预将对身体功能产生直接和间接影响(通过应对效能和情感)。增加一项自我管理计划将对身体功能产生相加的影响，通过其对应对效能的影响；或者，另一种选择，是一种乘法效应，减缓锻炼对应对效能和情感的影响。综上所述，鉴于这一动态模型涉及多个因素，多维方案的使用，结合运动训练和自我管理，应该会对长期维持身体功能和预防残疾产生更强的效果。为此，我们将300名早期骨性关节炎患者随机分为：1)结合多方面运动训练和自我管理计划的24个月干预；2)运动计划；或3)自我管理计划。

DESCRIPTION (provided by applicant): Osteoarthritis (OA) is the most common rheumatic disease and most prevalent form of arthritis in the United States. Primary goals of its management are to reduce pain, and improve functional ability and quality of life. Patient education and exercise are recommended as two mainstays of treatment. Thus far, there are only a few well-designed studies that utilize education, exercise, or both as an intervention. Most studies have not shown adequate internal validity, have not measured all relevant outcomes, have included only advanced-disease patients and have not examined the long-term benefits of the interventions. We hypothesize that the implementation of a long-term multidimensional intervention incorporating both an exercise and a self-management program in a sample of subjects with early knee OA will result in a significant improvement in physical function, as compared with each of the two programs alone. We aim to test this hypothesis based on a model that assumes the exercise intervention would have both direct and indirect effects (mediated by coping efficacy and affectivity) on physical function. The addition of a self-management program would have an additive effect on physical function, through its effect on coping efficacy; or, alternatively a multiplicative effect moderating the effect of exercise on coping efficacy and affectivity. In conclusion, given that multiple factors are involved in this dynamic model, the use of a multidimensional program, combining exercise training and self-management, should result in a stronger effect on long-term maintenance of physical function and prevention of disability. For this purpose we will randomize 300 early OA patients to: 1) a 24-month intervention combining a multifaceted exercise training plus a self-management program; 2) an exercise program; or 3) a self-management program.