Yoga vs. Education for Restless Legs Syndrome - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Retention rates
研究概览
简要总结
The purpose of this study is to see whether adults with Restless Legs Syndrome (RLS) are willing to be in a 12-week study where they have a 50-50 chance of being placed in either a gentle yoga program or a film-based education program designed for people with RLS. If so, do they complete the program, and does their RLS, sleep, mood, or quality of life improve?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ambulatory adults
- •at least 21 years of age
- •moderate-severe RLS, defined as:
- •symptoms that meet all five of the International RLS Study Group essential diagnostic criteria for RLS (i.e., 1) an urge to move the legs, often associated with discomfort or disagreeable sensations in the legs, that 2) begins or worsen during periods of rest or inactivity; 3) is partially or totally relieved by movement; 4) is worse or only occurs in the evening or night; and 5) is not solely accounted for by another condition (e.g. leg cramps, positional discomfort, habitual foot tapping));
- •RLS symptoms at least 1x/wk for the previous 3 months;
- •a score of at least 2 points (moderate) IRLS question 6: "How severe was your RLS as a whole?"; and
- •RLS diagnostic criteria applied as per training by the study physician, a sleep medicine expert; these criteria will help ensure exclusion of mimics (e.g. leg cramps, positional discomfort).
- •willingness and ability to complete the 12-week yoga or educational film program and all study assessments;
- •willingness to avoid use of any new drugs or treatments other than the assigned intervention.
排除标准
- •practiced yoga within the past year;
- •currently on dopaminergic agents (eg, ropinirole, pramipexole) or anti-psychotic medication;
- •changed dosage if any other central nervous system agents (e.g., sedative hypnotics, gamma-aminobutyric acid (GABA) analogs, narcotic analgesics, antiadrenergic agents, or anticonvulsants) within the past 3 months;
- •any orthopedic, neurologic or other condition that might prevent safe completion of a 12-week yoga program or confound assessments (e.g., neuropathy; Parkinson's disease; stroke; rheumatoid arthritis; renal failure; uncontrolled sleep apnea; recent (within the last 6 months) myocardial infarction; heart failure; cancer (other than non-melanoma skin cancer);
- •pregnant or within 6 months post-partum).
结局指标
主要结局
Retention rates
时间窗: 12 weeks
To determine feasibility and acceptability of the programs, we will collect comprehensive information, both overall and by treatment group, on: rates of retention (completion of assessment visits)
Adherence rates
时间窗: 12 weeks
To determine feasibility and acceptability of the programs, we will collect comprehensive information, both overall and by treatment group, on rates of adherence (completion of home logs and class attendance rates (yoga and film groups); completion of home practice (yoga group));
Recruitment rate
时间窗: 12 weeks
To determine feasibility and acceptability of the programs, we will collect comprehensive information, both overall and by treatment group, on: rates of recruitment and success of different recruitment strategies, and reasons for refusal to participate.
Participant satisfaction
时间窗: 12 weeks
To determine feasibility and acceptability of the programs, we will collect comprehensive information, both overall and by treatment group, on participant satisfaction, assessed via a structured program evaluation questionnaire regarding participant perceptions of and experiences with the study, and satisfaction regarding their respective programs
次要结局
- Profile of Mood States (POMS)(12 weeks)
- Medical Outcomes Study Short Form-36 (SF-36).(12 weeks)
- Yoga dosing preference(12 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(12 weeks)
- International RLS Rating Scale (IRLS)(12 weeks)
- Perceived Stress Scale (PSS)(12 weeks)