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Restless Legs Syndrome Exercise Intervention

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ClinicalTrials.gov Identifier: NCT00258492
Recruitment Status : Unknown
Verified July 2006 by Northeastern Ohio Universities College of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : November 24, 2005
Last Update Posted : January 26, 2007
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Insomnia Behavioral: Aerobic exercise Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Prevalence and Outcomes of Restless Legs Syndrome Among Veterans - Exercise Intervention
Study Start Date : December 2005
Estimated Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. RLS symptom severity, measured bi-weekly

Secondary Outcome Measures :
  1. Sleep efficiency, measured bi-weekly
  2. Insomnia severity, measured bi-weekly
  3. Day time sleepiness, measured bi-weekly

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258492

Sponsors and Collaborators
Northeastern Ohio Universities College of Medicine
Louis Stokes VA Medical Center
The University of Akron
U.S. Army Medical Research and Materiel Command
Principal Investigator: Claire C. Bourguet, Ph.D. Northeastern Ohio Universities College of Medicine
More Information

ClinicalTrials.gov Identifier: NCT00258492     History of Changes
Other Study ID Numbers: DAMD17-03-1-0082
First Posted: November 24, 2005    Key Record Dates
Last Update Posted: January 26, 2007
Last Verified: July 2006

Keywords provided by Northeastern Ohio Universities College of Medicine:
Restless legs syndrome
Daytime sleepiness

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms