Randomized controlled trial evaluating an innovative community-based intervention combining group-based exercise and behavioral health skills-training for older adults with painful knee osteoarthritis

随机对照试验评估基于社区的创新干预措施，结合团体锻炼和行为健康技能培训，治疗患有疼痛性膝骨关节炎的老年人

• 批准号: 9759629
• 负责人: Kushang Patel
• 金额: $ 68.4万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9759629
• 关键词: Accelerometer; Activities of Daily Living; Address; Adult; Aftercare; Age; Arthritis; Attention; Behavior; Behavioral; Belief; Clinical Practice Guideline; Communities; Complement; Control Groups; Coping Skills; Depressed mood; Elderly; Enrollment; Equilibrium; Exercise; Failure; Fatigue; Generations; Goals; Health education; Hour; Intervention; Intervention Studies; Knee Osteoarthritis; Measures; Monitor; Outcome; Pain; Pain management; Participant; Physical Exercise; Physical Function; Physical activity; Pilot Projects; Population; Problem Solving; Public Health; Publishing; Randomized Controlled Trials; Recommendation; Reporting; Rest; Role; Self Efficacy; Self Management; Severities; Single-Blind Study; Site; Sleep; Structure; Study Subject; Symptoms; Thinking; Time; Training; Walking; active control; active lifestyle; associated symptom; base; behavior change; behavioral health; behavioral health intervention; chronic musculoskeletal pain; chronic pain; community setting; coping; cost effective; design; disability; exercise intervention; exercise program; experience; fall risk; fear of falling; fitbit; fitness; follow-up; healthy aging; high risk; human old age (65+); improved; innovation; knee pain; moderate-to-vigorous physical activity; multidisciplinary; osteoarthritis pain; pain reduction; patient population; prevent; primary endpoint; primary outcome; programs; secondary outcome; sedentary lifestyle; self-management program; skills; skills training; symptom management; systematic review

PROJECT SUMMARY Knee osteoarthritis (OA) is a highly prevalent, leading cause of pain that limits physical functioning in older adults. Although clinical practice guidelines recommend physical exercise for managing symptoms of knee OA, several systematic reviews indicate that exercise intervention studies provide only short-term benefits (lasting <6 months) for knee OA. Many older adults with painful knee OA return to sedentary lifestyles when structured exercise programs end. Indeed, studies show that physical activity levels are low in this large, rapidly growing population. Activity restriction (e.g., “resting”) is a key challenge to address as it is a common strategy older adults use to reduce or prevent pain. Further, pain in older adults is strongly associated with fear of falling and other comorbid symptoms, such as depressed mood, fatigue, and difficulty sleeping, all of which further limit activity. Thus, efforts to increase and sustain physical activity in the geriatric knee OA population will require restructuring maladaptive beliefs about exercise and pain, as well as promoting self-regulatory skills to develop confidence to maintain an active lifestyle and manage symptoms that often limit activity. Therefore, we developed a group-based behavioral health (BH) program for older adults with painful knee OA that complements Enhance Fitness (EF) – a multicomponent, community-based exercise program for older adults, involving balance, strength, and endurance training. The BH program (1) teaches coping skills to address pain and related symptoms, emphasizing self-management and self-efficacy; (2) addresses fear of falling by restructuring misconceptions to promote a view that falls risk is controllable; and (3) promotes walking behavior by (a) using Fitbits for objective self-monitoring and goal-setting, (b) helping discouraged participants reframe attributions of failure from uncontrollable to controllable causes, and (c) using group-based problem-solving of barriers to physical activity. Combining exercise with BH skills training can have reinforcing effects by improving functional capacity, reducing pain, and increasing self-efficacy for managing arthritis symptoms and achieving personal activity goals. Accordingly, our objective is to conduct a single-blind, randomized controlled trial in 280 community-dwelling adults age ≥65 years with painful knee OA to determine the efficacy of a 4- month intervention of EF+BH versus an active control group of EF and health education (EF+HE). We hypothesize the EF+BH intervention will produce greater improvements in accelerometer-measured minutes of moderate-to-vigorous physical activity (primary outcome) than compared with the EF+HE control group at 6- month follow-up. Secondary outcomes include knee pain severity, knee pain-related functional limitations, mobility function, and fatigue. We will also examine the mediational role of short-term changes (over 4 months) in measures of self-efficacy and pain coping with physical activity outcomes at 6-month follow-up. If successful, the EF+BH intervention has high potential for dissemination as a community-based, non-pharmacologic pain management program for older adults with knee OA.

项目概要 膝骨关节炎 (OA) 是一种非常普遍的疼痛原因，会限制老年人的身体功能 尽管临床实践指南建议进行体育锻炼来控制膝关节骨关节炎的症状， 一些系统评价表明，运动干预研究仅提供短期益处（持久的益处）。 <6 个月），许多患有膝骨关节炎的老年人在调整后会恢复久坐的生活方式。 事实上，研究表明，在这个快速增长的大型地区，体力活动水平较低。 活动限制（例如“休息”）是一个需要解决的关键挑战，因为它是较早的常见策略。 此外，老年人的疼痛与跌倒和恐惧密切相关。 其他共病症状，例如情绪低落、疲劳和睡眠困难，所有这些都进一步限制了 因此，需要努力增加和维持老年膝骨关节炎人群的体力活动。 重建关于运动和疼痛的适应不良信念，并促进自我调节技能的发展 有信心保持积极的生活方式并控制经常限制活动的症状。 为患有膝骨关节炎的老年人制定了一项基于团体的行为健康 (BH) 计划 补充增强健身 (EF) – 一项针对老年人的多组成部分、基于社区的锻炼计划， BH 计划 (1) 涉及平衡、力量和耐力训练，教授应对疼痛的技能。 和相关症状，强调自我管理和自我效能（2）解决对跌倒的恐惧； 纠正错误观念，提倡跌倒风险是可控的观点；(3) 提倡步行行为； 通过 (a) 使用 Fitbit 进行客观的自我监控和目标设定，(b) 帮助灰心丧气的参与者重新构建 将失败归因于不可控原因到可控原因，以及 (c) 采用基于小组的问题解决方法 将运动与 BH 技能训练相结合可以通过以下方式产生强化效果。 提高功能能力、减轻疼痛并提高治疗关节炎症状的自我效能 因此，我们的目标是进行单盲、随机对照。 对 280 名年龄≥65 岁患有膝关节疼痛的社区居民进行的试验，以确定 4- EF+BH 一个月的干预与 EF 和健康教育 (EF+HE) ​​的积极对照组进行比较。 维持 EF+BH 干预将在加速计测量的分钟数方面产生更大的改善 与 EF+HE 对照组相比，6- 中度至剧烈的体力活动（主要结果） 次要结果包括膝关节疼痛的严重程度、膝关节疼痛相关的功能限制、 我们还将研究短期变化（超过 4 个月）的中介作用。 如果成功，在 6 个月的随访中衡量自我效能和应对身体活动结果的疼痛。 EF+BH 干预作为一种基于社区的非药物止痛方法具有很高的传播潜力 患有膝骨关节炎的老年人的管理计划。