Move and Snooze: Adding insomnia treatment to an exercise program to improve pain outcomes in older adults with knee osteoarthritis

活动和小睡：在锻炼计划中添加失眠治疗，以改善患有膝骨关节炎的老年人的疼痛结果

• 批准号: 10797056
• 负责人: Daniel Whibley
• 金额: $ 77.95万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10797056
• 关键词: Accelerometer; Address; Adherence; Adoption; Adult; Affect; Age; Algorithms; Awareness; Behavior Therapy; Behavioral; Characteristics; Clinical; Clinical Practice Guideline; Clinical Trials; Cognitive; Cognitive Therapy; Data; Degenerative polyarthritis; Disease; Ecological momentary assessment; Education; Effectiveness; Effectiveness of Interventions; Elderly; Exercise; Fatigue; Focus Groups; Future; Goals; Guidelines; Health; Hybrids; Individual; Intervention; Knee Osteoarthritis; Link; Literature; Measures; Mediation; Mediator; Medicine; Meta-Analysis; Methods; Observational Study; Pain; Pain intensity; Pain management; Participant; Pathway interactions; Patient Outcomes Assessments; Patients; Personal Satisfaction; Persons; Phenotype; Physical Exercise; Physical activity; Physical therapy; Population; Program Acceptability; Psychological Factors; Publishing; Quality of life; Randomized; Recommendation; Reporting; Research; Role; Severities; Sleep; Sleep disturbances; Sleeplessness; Specific qualifier value; Strategic vision; Subgroup; Symptoms; Testing; United States National Institutes of Health; acceptability and feasibility; anxiety symptoms; arm; behavior change; biopsychosocial; central pain; chronic pain; compare effectiveness; depressive symptoms; digital; digital delivery; economic impact; effectiveness evaluation; evidence base; exercise program; experience; feasibility testing; follow-up; human old age (65+); improved; improvement on sleep; intervention effect; member; multidisciplinary; negative affect; osteoarthritis pain; pain outcome; pain reduction; pain relief; peripheral pain; precision medicine; programs; psychosocial; randomized trial; reduced muscle strength; remote delivery; sleep health; vigilance

Osteoarthritis (OA) affects an estimated 32.5 million US adults and up to 50% of those aged over 65; over 80% of this burden is attributable to knee OA. Pain is consistently identified as the most troublesome symptom for people living with knee OA, with higher pain intensity associated with reduced muscle strength, activity limitations, and reduced quality of life. Exercise is central in clinical practice guidelines for knee OA pain management; however, evidence synthesis has demonstrated variable and, overall, modest effects. Observational studies have indicated that the pain-relieving effects of exercise may be modulated by sleep disturbances, including symptoms of insomnia, thus providing one possible explanation for the variable effect of exercise on OA pain reduction. This information is especially critical given that an estimated 70% of older adults with knee OA report having problems with sleep. This study is based on the premise that improving sleep may improve the pain-relieving benefits of exercise for knee OA. Informed by existing evidence and focus groups conducted with people living with OA and sleep disturbances, we developed and subsequently feasibility-tested a hybrid exercise and sleep improvement intervention for OA pain management (Move and Snooze). The intervention combines a personalized exercise program with an automated and digitally delivered evidence-based course of Cognitive Behavioral Therapy for Insomnia (CBT-I). The primary aim of this clinical trial is to determine the effectiveness of the eight-week hybrid program on knee OA pain reduction. Participants will be randomized to receive the hybrid intervention (personalized exercise program + CBT-I) or the personalized exercise program alone. In addition to determining effectiveness, we will investigate whether specific characteristics identify individuals who derive particular benefit from the hybrid intervention. Specifically, we will determine whether insomnia symptoms need to exceed a specific threshold for provision of the sleep-enhanced exercise program to be warranted and will examine whether the intervention is more effective for people presenting with indication of centralized pain (as opposed to predominantly peripheral pain). We will also determine whether pre-specified psychological factors (e.g., symptoms of depression and anxiety) alter the effectiveness of the intervention. Finally, as we will collect data on hypothesized possible mediators of the intervention throughout the course of the trial (e.g., pain vigilance and awareness; positive and negative affect; fatigue intensity), we will apply contemporary causal inference methods to determine pathways by which the hybrid intervention, and exercise alone, exert their effects on changes in pain. This research will generate evidence to advance osteoarthritis pain management towards greater efficacy and personalization, serving our long-term goal of improving pain outcomes for the vast and growing number of people living with OA by identifying the most appropriate behavior change interventions for specific patient phenotypes.

据估计，美国有3250万成年人患有骨性关节炎，65岁以上人群中高达50%；80%以上。 这一负担的主要原因是膝骨性关节炎。疼痛一直被认为是最麻烦的症状 患有膝骨性关节炎的人，疼痛强度更高，肌肉力量和活动减少 限制，降低了生活质量。运动是膝骨性关节炎疼痛临床实践指南的核心 然而，证据合成显示了多变的、总体上温和的影响。 观察性研究表明，运动的止痛效果可能受睡眠的调节 干扰，包括失眠症状，从而为可变效应提供了一种可能的解释 运动对减少骨性关节炎疼痛的作用。这些信息尤其重要，因为据估计，70%的老年人 据报道，患有膝骨性关节炎的成年人存在睡眠问题。这项研究的前提是提高 睡眠可能会改善锻炼对膝骨性关节炎的缓解疼痛的好处。根据现有证据提供信息，并 与患有骨关节炎和睡眠障碍的人一起进行的焦点小组，我们开发并随后 针对骨性关节炎疼痛管理(运动和睡眠改善)的可行性测试混合运动和睡眠改善干预 打盹)。该干预结合了个性化的锻炼计划与自动化和数字化的 提供失眠认知行为疗法循证课程(CBT-I)。的主要目的是 这项临床试验是为了确定为期八周的混合方案在膝关节骨性关节炎疼痛减轻方面的有效性。 参与者将随机接受混合干预(个性化锻炼计划+CBT-I)或 仅仅是个性化的锻炼计划。除了确定有效性外，我们还将调查是否 特定的特征确定了从混合干预中获得特殊好处的个人。 具体来说，我们将确定失眠症状是否需要超过特定的门槛才能提供 加强睡眠的锻炼计划是有根据的，并将检查干预是否更多 对有集中性疼痛迹象的人有效(与以外周为主的疼痛相反 疼痛)。我们还将确定预先指定的心理因素(例如，抑郁症状和 焦虑)改变干预的有效性。最后，由于我们将收集关于假设的可能性的数据 整个试验过程中干预措施的调解人(例如，疼痛警觉和意识；积极的 和消极情绪；疲劳强度)，我们将应用当代因果推理方法来确定 混合干预以及单独的运动对疼痛变化产生影响的途径。这 研究将产生证据，推动骨关节炎疼痛管理朝着更有效和 个性化，服务于我们的长期目标，即改善广大且越来越多的患者的疼痛结果 通过为特定患者确定最合适的行为改变干预措施，帮助生活在骨关节炎患者中的人 表型。