This trial is active, not recruiting.

Conditions restless legs syndrome, insomnia
Treatment aerobic exercise
Phase phase 1/phase 2
Sponsor Northeastern Ohio Universities College of Medicine
Collaborator Louis Stokes VA Medical Center
Start date December 2005
End date January 2007
Trial size 30 participants
Trial identifier NCT00258492, DAMD17-03-1-0082


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment

Primary Outcomes

RLS symptom severity, measured bi-weekly
time frame:

Secondary Outcomes

Sleep efficiency, measured bi-weekly
time frame:
Insomnia severity, measured bi-weekly
time frame:
Day time sleepiness, measured bi-weekly
time frame:

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title The Prevalence and Outcomes of Restless Legs Syndrome Among Veterans - Exercise Intervention
Principal investigator Claire C. Bourguet, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2007.
Information provided to ClinicalTrials.gov by Northeastern Ohio Universities College of Medicine.