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: 10403500
• 负责人: Kushang Patel
• 金额: $ 56.81万
• 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/10403500
• 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; Persons; 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; 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 risk; 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; pain-related disability; patient population; prevent; primary endpoint; primary outcome; programs; secondary outcome; sedentary lifestyle; self-management program; skills; skills training; sleep difficulty; 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.

项目摘要 膝关节骨关节炎（OA）是一种高度流行的，主要的疼痛原因，限制了老年人的身体功能。 成年人了尽管临床实践指南建议通过体育锻炼来控制膝关节OA的症状， 一些系统的回顾表明，运动干预研究只提供短期的好处（持久的， <6个月）。许多患有疼痛的膝关节OA的老年人在结构化时恢复久坐的生活方式 锻炼计划结束。事实上，研究表明，在这个庞大的、快速增长的国家， 人口活动限制（例如，“休息”）是一个关键的挑战，因为它是一个共同的战略， 成人用来减轻或预防疼痛的药物。此外，老年人的疼痛与害怕摔倒密切相关， 其他共病症状，如情绪低落、疲劳和睡眠困难，所有这些都进一步限制了 活动因此，增加和维持老年膝关节OA人群的体力活动需要 重建对运动和疼痛的适应不良信念，以及促进自我调节技能， 保持积极的生活方式和管理往往限制活动的症状的信心。所以我们 为患有疼痛性膝关节OA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）-一个多成分的，以社区为基础的老年人锻炼计划， 包括平衡力量和耐力训练BH计划（1）教授应对疼痛的技巧 和相关症状，强调自我管理和自我效能;（2）解决跌倒的恐惧， 重建误解，以促进福尔斯风险可控的观点;（3）促进步行行为 通过（a）使用Fitbit进行客观的自我监控和目标设定，（B）帮助沮丧的参与者重新构建 失败的归因从不可控到可控的原因，以及（c）使用基于小组的问题解决方法， 身体活动的障碍。将锻炼与BH技能训练相结合， 改善功能能力，减轻疼痛，提高管理关节炎症状的自我效能， 实现个人活动目标。因此，我们的目的是进行一项单盲、随机对照研究， 在280名年龄≥65岁的社区居住成人疼痛性膝关节OA患者中进行的一项试验，旨在确定4- 采用EF+BH干预1个月，并与EF+HE对照组进行比较。我们 假设EF+BH干预将在加速计测量的分钟数方面产生更大的改善， 在6- 10岁时，与EF+HE对照组相比， 月随访。次要结局包括膝关节疼痛严重程度、膝关节疼痛相关功能限制， 运动功能和疲劳。我们还将研究短期变化（超过4个月）的中介作用 在6个月随访时，自我效能和疼痛应对体力活动结果的措施。如果成功， EF+BH干预作为一种以社区为基础的非药物性疼痛具有很高的传播潜力 膝关节OA老年患者的管理计划。