Proteomic Response to Exercise in Adults With Restless Legs Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Protein Expression Profile
研究概览
简要总结
The goal of this clinical trial is to learn how exercise changes molecules in the blood in people with restless legs syndrome (RLS) to better understand the cause(s) of RLS. The main questions the investigators aim to answer are:
How does long-term exercise change proteins in the blood?
How does a single exercise session change proteins in the blood?
The investigators will compare long-term exercise to no exercise to see if the changes in proteins are specific to exercise.
Participants will complete an exercise test and provide blood samples before and after the exercise test. Participants will be randomized (like the flip of a coin) in to either the exercise or no-exercise group for 12 weeks and then complete the exercise test and blood samples again at the end.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 years or older;
- •diagnosis of RLS;
- •presence of moderate-to-severe RLS (IRLS score>15);
- •currently untreated RLS;
- •being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous six months;
- •ability to walk without assistance (does not use a cane/walker/wheelchair for mobility;
- •willing to complete outcome measures and complete the exercise program
排除标准
- •present with a condition that can mimic RLS or cause secondary RLS (e.g., iron deficiency anemia, radiculopathy, peripheral edema, peripheral neuropathy, diabetes);
- •are at moderate or high risk for undertaking strenuous or maximal exercise
结局指标
主要结局
Protein Expression Profile
时间窗: Twice at the 12-week Follow-Up
Participants will provide blood samples that will be used to measure proteins in the blood with an aptamer-based multiplexed platform of 11,000+ proteins. Two samples will be collected at the follow-up testing session (after the 12-week study period); one right before and one right after the cardiorespiratory fitness test.
次要结局
- Sleep Diary(12-weeks)
- RLS Severity(12-weeks)
- Cardiorespiratory Fitness(12-weeks)
研究者
Emmanuel Mignot
Craig Reynolds Professor of Sleep Medicine
Stanford University