Restless Legs Syndrome Exercise Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Prevalence and Outcomes of Restless Legs Syndrome Among Veterans - Exercise Intervention

Conditions
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Insomnia, Restless Legs Syndrome

Intervention / Treatment
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* Behavioral: Aerobic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Aerobic exercise|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RLS symptom severity, measured bi-weekly |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency, measured bi-weekly |  |  | 
| Insomnia severity, measured bi-weekly |  |  | 
| Day time sleepiness, measured bi-weekly |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Restless legs syndrome, Insomnia, Daytime sleepiness, Exercise