Restless Legs Syndrome Exercise Intervention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Northeastern Ohio Universities College of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00258492
First received: November 22, 2005
Last updated: January 25, 2007
Last verified: July 2006
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00258492     History of Changes
Other Study ID Numbers: DAMD17-03-1-0082, DAMD17-03-1-0082
Study First Received: November 22, 2005
Last Updated: January 25, 2007
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 22, 2014