We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Restless Legs Syndrome Exercise Intervention

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2006 by Northeastern Ohio Universities College of Medicine.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00258492
First Posted: November 24, 2005
Last Update Posted: January 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Louis Stokes VA Medical Center
The University of Akron
U.S. Army Medical Research and Materiel Command
Pfizer
Information provided by:
Northeastern Ohio Universities College of Medicine
  Purpose

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 Intervention Phase
Restless Legs Syndrome Insomnia Behavioral: Aerobic exercise Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Sleep efficiency, measured bi-weekly
  • Insomnia severity, measured bi-weekly
  • Day time sleepiness, measured bi-weekly

Estimated Enrollment: 30
Study Start Date: December 2005
Estimated Study Completion Date: January 2007
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Pfizer
Investigators
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 Submitted: November 22, 2005
First Posted: November 24, 2005
Last Update Posted: January 26, 2007
Last Verified: July 2006

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

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