Impact of Acute Leg Cycling at Different Intensities on Restless Legs Syndrome Severity in Persons With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
研究概览
简要总结
The purpose of this study is to evaluate the impact of acute leg cycling conditions at three different intensities versus a control condition condition on symptoms of restless legs syndrome (RLS) in persons with multiple sclerosis (MS). This study includes a proposed sample of 24 participants diagnosed with both MS and RLS that will complete four sessions of supervised exercise or rest conditions in the lab, one session per week, over the course of four weeks.
详细描述
The aim of this study is to evaluate the impact of acute leg cycling conditions at three different intensities (i.e., light, moderate, and vigorous) versus a control condition (i.e., quiet rest) on symptoms of RLS in persons with MS. This study involves a within-subjects, repeated measures design that includes a proposed sample of 24 participants diagnosed with both MS and RLS. Participants will complete four sessions with supervised exercise or rest conditions in the lab, one session per week, over the course of four weeks. The order of the three conditions will be randomized and counterbalanced and include: (1) leg cycling with no resistance (i.e., light), (2) leg cycling at moderate intensity, (3) leg cycling at vigorous intensity, and (4) seated, quiet rest (i.e., control condition). The primary study outcome includes the objective measure of RLS severity using the Suggested Immobilization Test (SIT) that will be administered immediately before and immediately after each condition (i.e., light, moderate, vigorous, and quiet rest).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-54 years of age
- •Diagnosis of multiple sclerosis
- •Has not experienced a relapse in the last 30 days
- •Positive screening for restless legs syndrome
- •Restless legs syndrome severity of moderate or greater
- •Ambulatory with or without an aide
排除标准
- •Moderate or high risk for undertaking strenuous or maximal exercise
- •Diagnosis of: radiculopathy, peripheral edema, peripheral neuropathy, iron deficiency (i.e., anemia), renal disease, or diabetes
结局指标
主要结局
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
时间窗: 10 minutes post-rest (Control) condition
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the seated, quiet rest condition to capture post-rest RLS severity.
次要结局
- Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)(week 4 through week 5)
研究者
Robert W Motl
Primary Investigator
University of Alabama at Birmingham