Comprehensive Lifestyle Intervention Program for Knee Osteoarthritis Patients (CLIP-OA)

 描述（由申请人提供）：总结膝关节骨关节炎（OA）是一种流行的慢性退行性疾病，是美国老年人活动能力障碍的主要原因。肥胖是症状性膝关节OA进展的主要可改变风险因素，与疼痛增加和功能限制风险增加相关。人们普遍认为，运动（EX）是一种安全、有效的生活方式干预，可持续改善相关膝关节OA结局，并具有临床意义。虽然EX是关节炎基金会（AF）基于社区的自我管理计划的基石，但在老年超重膝关节OA患者中，运动和饮食减肥（EX+DWL）相结合的生活方式干预措施在移动性能，疼痛和体重减轻方面产生了更有利的变化。不幸的是，超重膝关节OA患者获得全面体重管理计划的机会仍然有限。从转化的角度来看，需要建立有效的社区伙伴关系，提供广泛可及的生活方式干预措施，以预防这一人群的肥胖和行动不便。因此， 迫切需要确定在社区实施EX+DWL干预措施的效用，并确定这种方法与目前可用的传统OA自我管理计划的可比功效。我们的总体研究目标是在健康促进和疾病预防工作中制定有效和可持续的生活方式干预措施。我们在本申请中的目标是与中央俄亥俄州AF合作进行一项两组、24个月的随机对照试验，以确定基于社区的EX+DWL计划与AF的轻松行走EX计划的可比疗效，该计划目前是AF自我管理计划的重点，在老年超重或肥胖膝关节OA患者中，相关OA结局产生具有临床意义的改善。我们的中心假设是，EX+DWL干预将是一种安全、有效的方法，相对于AF的轻松行走EX计划，该方法在移动性残疾和体重减轻、疼痛和生活质量等次要结局方面具有上级改善。这一假设是基于我们强有力的初步数据制定的，这些数据表明，本研究中提出的EX+DWL干预措施在膝关节OA患者以及存在移动性残疾风险的肥胖老年人中产生了有意义的改善。在这个项目完成时，我们希望已经确定了这两个社区为基础的干预措施的相对有效性。简而言之，拟议试验的主要积极影响是，这项研究的结果可能会改变AF在全国社区老年人中管理膝关节OA功能后果和症状的方法。

 DESCRIPTION (provided by applicant): Summary Knee osteoarthritis (OA) is a prevalent chronic degenerative disease that is a primary cause of mobility disability among older adults in the U.S. Obesity is a primary modifiable risk factor for the progression of symptomatic knee OA that is associated with increased pain and an increased risk of functional limitations. It is widel accepted that Exercise (EX) is a safe, efficacious lifestyle intervention that consistently yields clinically meaningful improvements in relevant knee OA outcomes. Although EX is a cornerstone of the Arthritis Foundation's (AF) community-based self-management programs, lifestyle interventions combining Exercise and Dietary Weight Loss (EX+DWL) has yielded more favorable change in mobility performance, pain, and weight loss relative to either EX or DWL alone in older overweight knee OA patients. Unfortunately, access to comprehensive weight management programs for overweight knee OA patients remains limited. From a translational perspective, effective community partnerships are needed to deliver widely accessible lifestyle interventions to prevent obesity and mobility disability in this population. Consequently, there is a critical need to determine the utility of delivering EX+DWL interventions in the community and to determine the comparable efficacy of this approach with those of traditional OA self-management programs currently available. Our overarching research goal is to develop efficacious and sustainable lifestyle interventions in health promotion and disease prevention efforts. Our objective in this application is to conduct a two-arm, 24 month randomized controlled trial, in collaboration with the Central Ohio AF, to determine the comparable efficacy of a community- based EX+DWL program versus the AF's Walk With Ease EX program which is now the focus of AF's self- management programming, in producing clinically meaningful improvements in relevant OA outcomes among older overweight or obese knee OA patients. Our central hypothesis is that the EX+DWL intervention will be a safe, efficacious approach that produces superior improvements in mobility disability and the secondary outcomes of weight loss, pain, and quality of life relative to the AF's Walk with Ease EX program. This hypothesis is formulated on the basis of our strong preliminary data demonstrating that the EX+DWL intervention proposed in this investigation yields meaningful improvements in these outcomes in knee OA patients as well as obese older adults at risk for mobility disability. At the completion o this project, we expect to have determined the comparative effectiveness of these two community-based interventions. In short, the primary positive impact of the proposed trial is that the results of this study could alter the AF's approach to the management of the functional consequences and symptoms of knee OA among older adults in communities nationwide.