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Trial record 1 of 1 for:    NCT00258492
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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
Sponsor:
Collaborators:
Louis Stokes VA Medical Center
The University of Akron
U.S. Army Medical Research and Development Command
Pfizer
Information provided by:
Northeastern Ohio Universities College of Medicine

Tracking Information
First Submitted Date  ICMJE November 22, 2005
First Posted Date  ICMJE November 24, 2005
Last Update Posted Date January 26, 2007
Study Start Date  ICMJE December 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2005)
RLS symptom severity, measured bi-weekly
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2005)
  • Sleep efficiency, measured bi-weekly
  • Insomnia severity, measured bi-weekly
  • Day time sleepiness, measured bi-weekly
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Restless Legs Syndrome Exercise Intervention
Official Title  ICMJE The Prevalence and Outcomes of Restless Legs Syndrome Among Veterans - Exercise Intervention
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Restless Legs Syndrome
  • Insomnia
Intervention  ICMJE Behavioral: Aerobic exercise
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: November 23, 2005)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00258492
Other Study ID Numbers  ICMJE DAMD17-03-1-0082
DAMD17-03-1-0082
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Northeastern Ohio Universities College of Medicine
Collaborators  ICMJE
  • Louis Stokes VA Medical Center
  • The University of Akron
  • U.S. Army Medical Research and Development Command
  • Pfizer
Investigators  ICMJE
Principal Investigator: Claire C. Bourguet, Ph.D. Northeastern Ohio Universities College of Medicine
PRS Account Northeastern Ohio Universities College of Medicine
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP