Yoga for restless legs syndrome, a common and burdensome sleep disorder. A feasibility trial

 描述(申请人提供)：不宁腿综合症(RLS)是一种负担沉重的睡眠障碍，估计有12%的普通人口和19.5%的初级保健患者受到影响。RLS的特征是双腿移动的痛苦冲动，通常伴随着不愉快的、通常是疼痛的感觉，在休息或晚上更糟，并通过运动缓解，RLS与睡眠、情绪和生活质量的严重损害有关，并与重大的健康、社会和经济负担有关。虽然RLS的病因仍不确定，但最近的研究已将RLS与心血管疾病风险增加联系起来，并在RLS的发病机制中牵涉到自主神经和代谢失调。到目前为止，RLS还没有治愈的方法。现有的药物治疗旨在减少症状，效果往往随着时间的推移而减弱，并可能带来严重的副作用，这些副作用在老年人中尤其严重，老年人受到RLS的影响不成比例。显然有必要研究安全、可持续和适合长期使用的RLS治疗方法，这些方法不仅可以缓解症状，还可以解决明显的潜在风险因素。虽然放松疗法，包括瑜伽，经常被推荐给RLS患者，但指南仍然没有针对性，缺乏严格的支持性研究。我们最近的小规模试点研究表明，瑜伽可能为RLS患者提供一种可接受、可行和有效的治疗方法，参与者在RLS症状、睡眠和情绪方面的改善与药物试验中报道的相当或更大。然而，在进行更大规模的严格试验以探索瑜伽对RLS管理的有效性之前，还需要进行额外的工作。这项可行性研究将解决关键的剩余问题，包括随机化的可行性和可接受性 对照试验(RCT)，比较12周瑜伽和12周对照项目(即随机和招募的可接受性、保留率和依从率)；治疗保真度；这些干预措施对核心结果的效果大小；以及试验可接受的瑜伽剂量。我们的主要目标是评估患有症状性RLS的成年人接受12周RCT的可接受性和可行性，将瑜伽与注意力控制进行比较。将招募44名年龄=21岁的确诊为中到重度RLS的流动总体健康成年人，并随机参加12周的初学者瑜伽计划(n=22)或标准化的12周教育电影计划(N=22)，模拟我们之前试验中使用的干预措施。我们还将确定瑜伽和教育电影项目核心结果的影响大小；这些数据将对未来的研究起到关键作用。将收集关于参与者是否愿意参加不同持续时间和强度的瑜伽项目的更多数据。拟议的研究将 为学生提供接触和参与临床干预研究的所有阶段的机会。研究结果还将使我们能够评估和优化方案设计和性能，并为计划中的更大规模的随机对照试验确定最佳样本量，该试验旨在调查瑜伽对减轻这种具有挑战性和代价高昂的疾病的成年人的RLS症状和相关负担的效果。

 DESCRIPTION (provided by applicant): Restless legs syndrome (RLS) is a burdensome sleep disorder affecting an estimated 12% of the general population and 19.5% of primary care patients. Characterized by a distressing urge to move one's legs that is typically accompanied by unpleasant, often painful sensations, is worse at rest or at night, and is relieved by movement, RLS is associated with profound impairment of sleep, mood, and quality of life, and with significant health, societal and economic burden. While the etiology of RLS remains uncertain, recent research has linked RLS to increased cardiovascular disease risk, and implicated autonomic and metabolic dysregulation in RLS pathogenesis. To date, there is no cure for RLS. Existing drug treatments, aimed at symptom reduction, often diminish in efficacy with time and can carry serious side effects that are particularly problematic in older adults, a population disproportionately affected by RLS. There is clearly a need to investigate approaches to RLS treatment that are safe, sustainable, and suitable for long term use, and that not only alleviate symptoms but address apparent underlying risk factors. While relaxation therapies, including yoga, are often recommended for RLS patients, guidelines remain non-specific, and rigorous, supportive research is lacking. Our recent small pilot studies suggest that yoga may offer an acceptable, feasible and efficacious therapy for those with RLS, with participants showing improvements in RLS symptoms, sleep, and mood comparable to or greater than those reported in pharmaceutical trials. However, additional work is required before undertaking a larger rigorous trial to explore the efficacy of yoga for RLS management. This feasibility study will address the critical remaining issues, including feasibility and acceptability of a randomized controlled trial (RCT) comparing a 12 week yoga to a 12 week comparator program (i.e., acceptability of randomization and recruitment, retention, and adherence rates); treatment fidelity; effect sizes of these interventions for core outcomes; and acceptable doses of yoga for a trial. Our primary goal is to assess, in adults with symptomatic RLS, the acceptability and feasibility of a 12 week RCT comparing yoga to an attention control. Forty-four ambulatory, overall healthy adults aged = 21 years with confirmed moderate to severe RLS will be recruited and randomized to a 12 week beginner yoga program (n=22) or a standardized 12-week educational film program (N=22), modeled on interventions used in our previous trials. We will also determine effect sizes in core outcomes of the yoga and educational film programs; these data will be critical in powering future studies. Additional data will be collected on participant willingness to enroll in yoga programs of differing duration and intensity. The proposed study will provide opportunities for student exposure to and participation in all phases of clinical intervention research. Study findings will also allow us to evaluate and optimize the protocol design and performance, and to determine optimal sample sizes for a planned larger RCT investigating the efficacy of yoga for reducing RLS symptoms and associated burden in adults with this challenging and costly disorder.