Mutidimensional Intervention in Early Osteoarthritis

描述（由申请人提供）：骨关节炎（OA）是美国最常见的风湿性疾病和最普遍的关节炎形式。其治疗的主要目标是减轻疼痛，改善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，只有少数设计良好的研究利用教育、锻炼或两者作为干预手段。大多数研究没有显示出足够的内部效度，没有测量所有相关结果，只包括晚期疾病患者，也没有检查干预措施的长期益处。我们假设，与单独的两种方案相比，在早期膝关节OA患者样本中实施长期多维干预，包括锻炼和自我管理方案，将导致身体功能的显着改善。我们的目标是基于一个假设运动干预对身体功能有直接和间接影响（由应对效能和情感介导）的模型来检验这一假设。自我管理项目的增加会通过其对应对效能的影响对身体机能产生附加效应；或者，一个乘数效应调节运动对应对效能和情感的影响。综上所述，考虑到这一动态模型涉及多个因素，采用多维方案，结合运动训练和自我管理，应该会对身体功能的长期维持和残疾的预防产生更强的效果。为此，我们将随机选择300名早期OA患者：1)24个月的干预，包括多方面的运动训练和自我管理计划；2)锻炼计划；或者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.