Restless Legs Syndrome Exercise Intervention

Phase 1

• Conditions: Restless Legs Syndrome; Insomnia

• Registration Number: NCT00258492
• Lead Sponsor: Northeastern Ohio Universities College of Medicine

Brief Summary

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:

1. reduced RLS symptoms;

2. improved sleep quality;

3. reduced daytime sleepiness.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2005-11-22
• Study First Submitted QC: 2005-11-23
• Study First Posted: 2005-11-24
• Study Start: 2005-12
• Status Verified: 2006-07
• Study Completion: 2007-01
• Last Update Submitted: 2007-01-25
• Last Update Posted: 2007-01-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
RLS symptom severity, measured bi-weekly

Secondary Outcome Measures

Name	Time	Method
Sleep efficiency, measured bi-weekly
Insomnia severity, measured bi-weekly
Day time sleepiness, measured bi-weekly