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.

项目总结 膝关节骨关节炎(OA)是一种非常普遍的、主要的疼痛原因，限制了老年人的身体功能 成年人。尽管临床实践指南建议通过体育锻炼来控制膝骨性关节炎的症状， 一些系统的评论表明，运动干预研究只提供短期的益处(持久的 &lt；6个月)治疗膝骨性关节炎。许多患有膝骨性关节炎的老年人在结构调整时恢复了久坐不动的生活方式 锻炼计划结束。事实上，研究表明，在这个庞大、快速增长的国家里，体力活动水平很低 人口。限制活动(例如，“休息”)是一个需要解决的关键挑战，因为这是一种古老的常见策略 成人用来减轻或防止疼痛。此外，老年人的疼痛与害怕摔倒和 其他共病症状，如情绪低落、疲倦和难以入睡，所有这些都进一步限制了 活动。因此，在老年膝骨性关节炎人群中增加和维持体力活动的努力将需要 重建对运动和疼痛的不良适应观念，以及促进自我调节技能的发展 有信心保持积极的生活方式，并管理经常限制活动的症状。因此，我们 为患有膝盖骨关节炎的老年人开发了基于群体的行为健康(BH)计划， 补充剂增强健身(EF)--一项面向老年人的多成分社区锻炼计划， 包括平衡、力量和耐力训练。BH计划(1)教授应对疼痛的技巧 以及相关症状，强调自我管理和自我效能；(2)解决跌倒的恐惧 重组错误观念，以宣传跌倒风险是可控的观点；以及(3)促进步行行为 通过(A)使用Fitbit进行客观的自我监控和设定目标，(B)帮助气馁的参与者重新制定框架 从无法控制的原因到可控制的原因的失败归因，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技能训练相结合可以通过以下方式产生增强效果 改善功能能力，减轻疼痛，提高自我效能，管理关节炎症状和 实现个人活动目标。因此，我们的目标是进行单盲、随机对照。 对280名患有膝骨性关节炎的65岁≥社区成年人进行试验，以确定4- 每月干预EF+BH与积极对照组的EF和健康教育(EF+HE)。我们 假设EF+BH干预将在加速度计测量的分钟数方面产生更大的改善 与EF+HE对照组相比，在6-6个月时进行中等到剧烈的身体活动(主要结果) 一个月的随访。次要结果包括膝关节疼痛严重程度、膝关节疼痛相关的功能限制、 活动功能和疲劳感。我们还将研究短期变化的中介作用(超过4个月) 在自我效能感和疼痛应对体力活动方面的测量结果在6个月的随访中。如果成功， EF+BH干预作为一种基于社区的非药理性疼痛具有很高的传播潜力 为患有膝骨性关节炎的老年人制定管理计划。