The Osteoarthritis Prevention Study (TOPS)

骨关节炎预防研究 (TOPS)

• 批准号: 10585634
• 负责人: Stephen P Messier
• 金额: $ 330.03万
• 依托单位: WAKE FOREST UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-10 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10585634
• 关键词: Address; Adult; Affect; Analgesics; Australia; Body Weight decreased; Body mass index; Boston; Cartilage; Clinical; Communities; Computer Simulation; Control Groups; County; Data; Degenerative polyarthritis; Development; Diagnosis; Dietary Intervention; Disease; Disease Pathway; Effectiveness of Interventions; Eligibility Determination; Exercise; Female; Health Benefit; Hospitals; Individual; Inflammatory; Inpatients; Interleukin-6; Intervention; Joints; Knee; Knee Injuries; Knee Osteoarthritis; Knee joint; Magnetic Resonance Imaging; Maintenance; Measures; Mental Health; Obesity; Outcome; Overweight; Pain; Participant; Phase; Plasma; Play; Populations at Risk; Prevention; Prevention strategy; Preventive therapy; Primary Prevention; Risk; Role; SF-36; Safety; Self Efficacy; Site; Testing; Treatment Efficacy; Walking; Weight-Bearing state; aged; attentional control; cohort; comorbidity; cost; cost effective; cost effectiveness; design; dietary; disability; disorder prevention; effective therapy; health related quality of life; high risk; improved; innovation; intervention effect; joint inflammation; joint loading; knee pain; male; models and simulation; multimodality; physical conditioning; prevent; preventive intervention; programs; radiological imaging; randomized, clinical trials; secondary outcome; therapy design

PROJECT SUMMARY / ABSTRACT Osteoarthritis (OA), the leading cause of disability among adults, is without a cure and is associated with significant comorbidities. OA ranks as the third most common diagnosis for hospital inpatient stays with 1.25 M per year, with the knee the most commonly affected weight-bearing joint. We address knee OA disease prevention in adult females because prevention of OA is preferable to treatment, females are affected at nearly twice the rate as males, and to date interventions designed to slow or stop knee OA progression have failed. Dietary weight loss, with and without exercise, has level 1 evidence of effective treatment for adults with knee OA and overweight and obesity. Reduced degenerative cartilage changes are also associated with weight loss, making it a possible preventive therapy for people at risk for knee OA. The objective of this Phase III, multi-site (Boston, MA, Chapel Hill, NC, Broward County, FL, Sydney, Australia, and Winston-Salem, NC) randomized clinical trial is to establish the efficacy of an intervention of dietary weight loss, exercise, and weight-loss maintenance for knee OA prevention. We will establish efficacy in structural, symptomatic, and mechanistic outcomes compared to attention control, and determine the cost-effectiveness of this non- pharmacologic, non-surgical intervention in preventing incident knee OA in adult females aged ≥ 50 years with obesity and no or infrequent knee pain, a cohort at high risk for knee OA. Participants will be 1,230 ambulatory, community dwelling females with obesity (BMI ≥ 30 kg/m2), and aged ≥ 50 years. Structural and symptomatic eligibility will be determined at the individual knee level. The eligible knee will have no radiographic (Kellgren Lawrence (KL) score ≤ 1) and no MRI knee OA with no or infrequent knee pain (< 15 days/month) in the same knee. The primary aim is to compare the effects of a 48-month intervention of dietary weight loss, exercise, and weight-loss maintenance to an attention control group in preventing the development of structural (MRI) knee OA using the MRI OA Knee Score (MOAKS). Secondary aims will determine the intervention effects on the Knee Injury and Osteoarthritis Outcome Score (KOOS total), KOOS pain, mobility (6 minute walk distance), and health-related quality of life (SF-36). Mechanistic secondary outcomes include knee joint compressive forces as a measure of joint loading, IL-6 as an inflammatory measure, and weight loss and exercise self-efficacy. We will also establish the cost-effectiveness of this intervention. This study is significant in that it will test a critically needed primary prevention intervention of dietary weight loss, exercise, and weight-loss maintenance for females at risk for knee OA.

项目摘要 /摘要 骨关节炎（OA）是成年人残疾的主要原因，是无法治愈的，并且是相关的 具有重大合并症。 OA是医院住院住院的第三大常见诊断 每年1.25 m，膝盖是最常见的承重关节。我们解决 成年女性的膝盖OA预防疾病，因为预防OA比治疗更可取 女性的影响几乎是男性的两倍，迄今为止，旨在减慢或 停止膝盖的进展失败了。饮食体重减轻，无论有没有运动，都有1级 有效治疗膝盖OA，超重和肥胖的证据。减少 退化性软骨变化也与体重减轻有关，使其成为可能的预防 对有膝盖OA风险的人进行治疗。该阶段III，多站点的目的（波士顿，马萨诸塞州，教堂 北卡罗来纳州希尔，佛罗里达州布劳沃德县，澳大利亚悉尼和北卡罗来纳州温斯顿·塞勒姆）随机临床试验 确定饮食减肥，运动和减肥减肥的干预效率 预防膝盖。我们将在结构，症状和机械方面建立效率 与注意力控制相比，结果确定了这种非 - 药理学，非手术干预以防止≥50岁的成年女性膝关节OA事件 多年的肥胖症，没有或不经常膝盖疼痛，这是一个膝盖OA高风险的队列。 参与者将是1,230个卧床，肥胖的社区住宅（BMI≥30） kg/m2），年龄≥50岁。结构和有症状的资格将在个人上确定 膝盖水平。符合条件的膝盖将没有放射线图（Kellgren Lawrence（KL）得分≤1），没有MRI 同一膝盖的膝盖OA没有或不频繁的膝盖疼痛（<15天/月）。主要目的是 比较饮食减肥，运动和减肥48个月干预的影响 维护注意力控制组，以防止结构（MRI）膝关节OA的发展 使用MRI OA膝盖评分（Moaks）。次要目的将确定干预对 膝关节损伤和骨关节炎结局评分（koos总数），koos疼痛，移动性（步行6分钟 距离）和与健康相关的生活质量（SF-36）。机械次要结果包括膝关节 压缩力作为关节载荷的测量，IL-6作为炎症测量和体重减轻 并锻炼自我效能。我们还将确定这种干预的成本效益。 这项研究很重要，因为它将测试急需的一级预防干预措施 饮食减肥，运动和减肥女性的膝盖OA风险。