Restless Legs Syndrome Exercise Intervention

Insomnia Clinical Trial

Official title:

The Prevalence and Outcomes of Restless Legs Syndrome Among Veterans - Exercise Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00258492
• Other study ID #: DAMD17-03-1-0082
• Secondary ID: DAMD17-03-1-0082
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: November 22, 2005
• Last updated: January 25, 2007
• Start date: December 2005
• Est. completion date: January 2007

Study information

• Verified date: July 2006
• Source: Northeastern Ohio Universities College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia
• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Behavioral:
• Aerobic exercise

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Northeastern Ohio Universities College of Medicine	Louis Stokes VA Medical Center, Pfizer, The University of Akron, U.S. Army Medical Research and Materiel Command

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RLS symptom severity, measured bi-weekly
Secondary	Sleep efficiency, measured bi-weekly
Secondary	Insomnia severity, measured bi-weekly
Secondary	Day time sleepiness, measured bi-weekly