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（由适用提供）：不安的腿综合征（RLS）是一种朴实的睡眠障碍，影响总数的12％，而初级保健患者的19.5％。特点是要移动腿部的令人痛苦的冲动，通常伴随着不愉快的，通常是痛苦的感觉，在静止或晚上更糟，并且因运动而缓解，RLS与睡眠，情绪和生活质量的严重损害有关，并且与健康，社会和经济狂热有关。尽管RLS的病因仍然不确定，但最近的研究将RLS与增加心血管疾病风险的增加联系起来，并在RLS发病机理中实施了自主神经和代谢失调。迄今为止，无法治愈RLS。现有的药物治疗旨在减轻症状，通常会随着时间的流逝而降低，并且可能会带来严重的副作用，而这在老年人中尤其有问题，这是受RLS影响不成比例的人群。显然，有必要调查安全，可持续性且适合长期使用的RLS治疗方法，并且不仅可以减轻症状，而且可以解决明显的潜在危险因素。尽管通常建议使用包括瑜伽在内的放松疗法，但仍缺乏指南，但缺乏非特异性和严格的支持性研究。我们最近的小型试点研究表明，瑜伽可能为RLS患者提供可接受，可行和有效的治疗，参与者在RLS症状，睡眠和情绪中表现出与药品试验中报道的相当或更大的RLS症状，睡眠和情绪的改善。但是，在进行更大的严格试验以探索瑜伽对RLS管理的效率之前，需要进行其他工作。这项可行性研究将解决关键的剩余问题，包括随机的可行性和可接受性 对照试验（RCT）比较了12周的瑜伽与12周比较器计划（即随机化和招聘，保留率和依从性率的可接受性）；治疗保真度；这些干预措施对核心结果的影响；和可接受的瑜伽剂量进行试验。我们的主要目标是评估有症状性RLS的成年人，将瑜伽与注意力控制进行了12周的RCT的可接受性和可行性。四十四名卧床，整体健康的成年人= 21岁，确认的中度至重度RLS将被招募，并随机分为12周的开始瑜伽计划（n = 22）或标准化的12周教育电影计划（n = 22），以我们先前试验中使用的干预措施进行建模。我们还将确定瑜伽和教育电影计划的核心结果中的效果大小；这些数据对于为未来的研究供电至关重要。还将收集有关参与愿意参加不同持续时间和强度的瑜伽计划的其他数据。拟议的研究将 为学生接触并参与临床干预研究的各个阶段提供机会。研究发现还将使我们能够评估和优化方案设计和性能，并确定计划中较大的RCT的最佳样本量，以调查瑜伽在减轻RLS症状的有效性，并在患有这种挑战和昂贵的疾病的成年人中燃烧。