A pilot study of an aerobic exercise intervention to moderate symptoms and improve sleep quality among patients with Restless Legs Syndrome. We 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.

Condition	Intervention	Phase
Restless Legs Syndrome Insomnia Daytime Sleepiness	Behavior: Aerobic exercise	Phase I Phase II

Further study details as provided by Northeastern Ohio Universities College of Medicine:

Primary Outcomes: RLS symptom severity, measured bi-weekly
Secondary Outcomes: Sleep efficiency, measured bi-weekly; Insomnia severity, measured bi-weekly; Day time sleepiness, measured bi-weekly
Expected Total Enrollment:  30

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.

Ages Eligible for Study:  40 Years and above,  Genders Eligible for Study:  Both

Criteria

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
• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00258492

Claire C. Bourguet, Ph.D.      330-325-6163    Bourguet@neoucom.edu
Scott K. Ober, MD, MBA      216-791-3800  Ext. 4414    Scott.Ober@med.va.gov

Ohio
      Northeastern Ohio Universities College of Medicine, Rootstown,  Ohio,  44272,  United States

Study chairs or principal investigators

Claire C. Bourguet, Ph.D.,  Principal Investigator,  Northeastern Ohio Universities College of Medicine   

Study ID Numbers:  DAMD17-03-1-0082; DAMD17-03-1-0082
Last Updated:  December 8, 2005
Record first received:  November 22, 2005
ClinicalTrials.gov Identifier:  NCT00258492
Health Authority: United States: Office of Human Research Protections
ClinicalTrials.gov processed this record on 2006-01-10