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The Osteoarthritis Prevention Study (TOPS)

骨关节炎预防研究 (TOPS)

基本信息

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
项目类别：
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

项目摘要

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