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Restless Legs Syndrome Exercise Intervention

NCT ID: NCT00258492

Last Updated: 2007-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-01-31

Brief Summary

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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

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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.

Conditions

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Restless Legs Syndrome Insomnia

Keywords

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Restless legs syndrome Insomnia Daytime sleepiness Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Aerobic exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Louis Stokes VA Medical Center

FED

Sponsor Role collaborator

The University of Akron

OTHER

Sponsor Role collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Northeastern Ohio Universities College of Medicine

OTHER

Sponsor Role lead

Principal Investigators

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Claire C. Bourguet, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Northeastern Ohio Universities College of Medicine

Countries

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United States

Other Identifiers

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DAMD17-03-1-0082

Identifier Type: -

Identifier Source: secondary_id

DAMD17-03-1-0082

Identifier Type: -

Identifier Source: org_study_id