Restless Legs Syndrome Exercise Intervention
Primary Purpose
Restless Legs Syndrome, Insomnia
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Aerobic exercise
Sponsored by
About this trial
This is an interventional treatment trial for Restless Legs Syndrome focused on measuring Restless legs syndrome, Insomnia, Daytime sleepiness, Exercise
Eligibility 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
Sites / Locations
Outcomes
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
Full Information
NCT ID
NCT00258492
First Posted
November 22, 2005
Last Updated
January 25, 2007
Sponsor
Northeastern Ohio Universities College of Medicine
Collaborators
Louis Stokes VA Medical Center, The University of Akron, U.S. Army Medical Research and Development Command, Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00258492
Brief Title
Restless Legs Syndrome Exercise Intervention
Official Title
The Prevalence and Outcomes of Restless Legs Syndrome Among Veterans - Exercise Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Unknown status
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Northeastern Ohio Universities College of Medicine
Collaborators
Louis Stokes VA Medical Center, The University of Akron, U.S. Army Medical Research and Development Command, Pfizer
4. Oversight
5. 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:
reduced RLS symptoms;
improved sleep quality;
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome, Insomnia
Keywords
Restless legs syndrome, Insomnia, Daytime sleepiness, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Primary Outcome Measure Information:
Title
RLS symptom severity, measured bi-weekly
Secondary Outcome Measure Information:
Title
Sleep efficiency, measured bi-weekly
Title
Insomnia severity, measured bi-weekly
Title
Day time sleepiness, measured bi-weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire C. Bourguet, Ph.D.
Organizational Affiliation
Northeastern Ohio Universities College of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Restless Legs Syndrome Exercise Intervention
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