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

瑜伽可治疗不宁腿综合症，这是一种常见且令人烦恼的睡眠障碍。

• 批准号: 8957416
• 负责人: KAREN-KIM E INNES
• 金额: $ 44.85万
• 依托单位: WEST VIRGINIA UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8957416
• 关键词: 21 year old; Address; Adherence; Adult; Adverse effects; Affect; Attention; Benchmarking; Chronic; Clinical; Clinical Treatment; Data; Disease; Distress; Dose; Economic Burden; Elderly; Enrollment; Esthesia; Etiology; Exposure to; Feasibility Studies; Film; Future; General Population; Goals; Guidelines; Health; Health Care Costs; Home environment; Impairment; Intervention; Intervention Studies; Leg; Link; Metabolic; Modeling; Monitor; Moods; Motor; Movement; Outcome; Pain; Participant; Pathogenesis; Patient Self-Report; Patients; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Pilot Projects; Population; Primary Health Care; Protocols documentation; Quality of life; Randomized; Randomized Controlled Trials; Recruitment Activity; Relaxation Therapy; Reporting; Research; Research Design; Rest; Restless Legs Syndrome; Risk; Risk Factors; Sample Size; Sleep; Sleep Disorders; Stress; Structure; Students; Symptoms; Time; Work; Yoga; actigraphy; base; cardiovascular disorder risk; design; economic cost; health related quality of life; instrument; novel; preference; programs; public health relevance; trial comparing; willingness

 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.

 描述（由申请人提供）：不宁腿综合症 (RLS) 是一种令人难以忍受的睡眠障碍，影响着大约 12% 的普通人群和 19.5% 的初级保健患者，其特征是令人痛苦的移动双腿的冲动，通常伴随着不愉快的感觉。不宁腿综合症通常是痛苦的感觉，在休息或夜间更严重，通过运动可以缓解，不宁腿综合症与睡眠、情绪和生活质量的严重损害有关，并带来重大的健康、社会和经济负担。不宁腿综合症的病因仍不清楚，最近的研究表明不宁腿综合症与心血管疾病风险增加有关，并且与不宁腿综合症的发病机制有关。迄今为止，现有的旨在减轻不宁腿综合症的药物治疗方法往往会减弱。随着时间的推移，疗效可能会降低，并且可能会带来严重的副作用，这对老年人来说尤其成问题，而老年人是受不宁腿综合症影响最严重的人群，显然需要研究安全、可持续且适合长期使用的不宁腿综合症治疗方法。不是虽然放松疗法（包括瑜伽）通常被推荐用于不宁腿综合征患者，但指南仍然不具体，并且缺乏严格的支持性研究表明瑜伽可能提供可接受的治疗。对于不宁腿综合症患者来说，这是一种可行且有效的治疗方法，参与者在不宁腿综合症症状、睡眠和情绪方面表现出与药物试验中报告的相当或更好的结果，但在进行更大规模的改进严格试验来探索其疗效之前，还需要做更多的工作。这项可行性研究将解决不宁腿综合症 (RLS) 管理的瑜伽问题。剩下的关键问题，包括随机研究的可行性和可接受性 对照试验 (RCT) 将 12 周瑜伽与 12 周对照计划进行比较（即随机化和招募的可接受性、保留率和坚持率）；这些干预措施对核心结果的影响大小以及可接受的瑜伽剂量；我们的主要目标是评估有 RLS 症状的成年人对 44 名 21 岁左右的整体健康成年人进行为期 12 周的随机对照试验的可接受性和可行性。我们将根据之前试验中使用的干预措施，招募患有中度至重度不宁腿综合症的年数，并将其随机分配到为期 12 周的初学者瑜伽课程（n = 22）或标准化的 12 周教育电影课程（N = 22）。还确定瑜伽和教育电影项目的核心成果的影响大小；这些数据对于推动未来的研究至关重要。拟议的研究将收集参与者参加不同持续时间和强度的瑜伽项目的意愿。 为学生提供接触和参与临床干预研究各个阶段的机会 研究结果还将使我们能够评估和优化方案设计和性能，并确定计划的更大随机对照试验的最佳样本量，该随机对照试验调查瑜伽对减少体重的功效。患有这种具有挑战性且代价高昂的疾病的成年人的 RLS 症状和相关负担。