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Restless Legs Syndrome Exercise Intervention

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00258492
Enrollment
30
Registered
2005-11-24
Start date
2005-12-31
Completion date
2007-01-31
Last updated
2007-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Restless Legs Syndrome

Keywords

Restless legs syndrome, Insomnia, Daytime sleepiness, Exercise

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.

Interventions

BEHAVIORALAerobic exercise

Sponsors

Louis Stokes VA Medical Center
CollaboratorFED
The University of Akron
CollaboratorOTHER
U.S. Army Medical Research and Development Command
CollaboratorFED
Pfizer
CollaboratorINDUSTRY
Northeastern Ohio Universities College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
RLS symptom severity, measured bi-weekly

Secondary

MeasureTime frame
Sleep efficiency, measured bi-weekly
Insomnia severity, measured bi-weekly
Day time sleepiness, measured bi-weekly

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026