The Prevalence and Outcomes of Restless Legs Syndrome Among Veterans - Exercise Intervention
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 主要终点
- RLS symptom severity, measured bi-weekly
研究概览
简要总结
A pilot study of an aerobic exercise intervention to moderate symptoms and improve sleep quality among patients with Restless Legs Syndrome (RLS). We, the researchers at Northeastern Ohio Universities College of Medicine, hypothesize that, relative to a control group, RLS sufferers who participate in an aerobic exercise intervention will demonstrate:
- reduced RLS symptoms;
- improved sleep quality;
- reduced daytime sleepiness.
详细描述
We will implement an exercise intervention among persons who suffer from RLS.
Study members will be Veterans, over the age of 40, who have been identified as RLS cases as part of our larger study of "The Prevalence and Outcomes of Restless Legs Syndrome among Veterans." We will use a cross-over design in which Veterans will be randomly assigned to the exercise intervention or control. Each arm of the study will be 3 months duration.
The protocol for the intervention will consist of twice weekly supervised exercise sessions. The goal for exercise participants will be to engage in continuous aerobic exercise for 45 minutes at an intensity of approximately 60% of VO2max. The control will be weekly support group meetings.
Outcomes will be measured using standardized sleep scales, actigraphy, and daily sleep and exercise logs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets case definition for RLS with symptoms at least one day a week
- •Age 40 and older
- •Moderate or severe insomnia
- •Able to engage in moderate exercise
- •Permission of primary care physician to participate in exercise.
排除标准
- •Serum ferritin below 50 ng/ml
- •Body mass index (BMI) greater than 40
- •History of recent myocardial infarction or stroke
- •Alcohol use, more than 3 drinks a day
- •Current use of medications for sleep
结局指标
主要结局
RLS symptom severity, measured bi-weekly
次要结局
- Day time sleepiness, measured bi-weekly
- Sleep efficiency, measured bi-weekly
- Insomnia severity, measured bi-weekly