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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
Northeastern Ohio Universities College of Medicine
About
Eligibility
Locations
Outcomes
Full info

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

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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