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.

骨关节炎（OA）估计有3250万美国成年人，最多50％的年龄在65岁以上；超过80％ 这个负担归因于膝盖OA。疼痛始终被确定为最麻烦的症状 患有膝盖OA的人，疼痛强度较高，肌肉力量降低，活动 局限性和生活质量降低。运动在膝盖疼痛的临床实践指南中是核心 管理;但是，证据综合证明了变量，总体上是适度的效果。 观察性研究表明，运动可以通过睡眠调节运动的疼痛效果 干扰，包括失眠症状，因此为可变效应提供了一种可能的解释 减轻OA的运动。鉴于估计有70％的年长 膝盖OA的成年人报告睡眠问题。这项研究基于改善的前提 睡眠可以改善膝盖OA运动的疼痛益处。以现有证据和 我们与患有OA和睡眠障碍的人进行的焦点小组，我们发展了 可行性测试了OA疼痛管理的混合运动和睡眠改善干预措施（移动和 贪睡）。干预措施将个性化练习计划与自动化和数字化结合 提供了基于证据的失眠症的认知行为疗法（CBT-I）。主要目的 该临床试验是确定八周混合计划在减轻膝关节疼痛方面的有效性。 参与者将被随机接受混合干预（个性化锻炼计划 + CBT-I）或 单独的个性化锻炼计划。除了确定有效性外，我们还将调查是否 特定特征确定了从混合干预中获得特殊利益的个体。 具体而言，我们将确定失眠症状是否需要超过特定阈值以提供 有必要的睡眠增强运动计划，并将检查干预是否更多 对于表现出集中疼痛的人有效的有效（主要是外围 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，因为我们将收集有关假设的数据 整个试验过程中干预的调解人（例如，疼痛的警惕和意识；积极 和负面影响；疲劳强度），我们将采用当代因果推理方法来确定 混合干预和单独运动的途径对疼痛的变化产生了影响。这 研究将产生证据，以使骨关节炎疼痛管理朝着更大的疗效和 个性化，为我们的长期目标服务，即改善大量越来越多的疼痛结果 通过确定特定患者最适当的行为改变干预措施，与OA一起生活 表型。