NCT06481176NARecruiting

Blood Changes After Exercise in Restless Legs Syndrome

Stanford University

Start Date

10/21/2024

Completion Date

12/1/2026

Summary

The goal of this clinical trial is to learn how exercise changes molecules in the blood in people with restless legs syndrome (RLS) to better understand the cause(s) of RLS. The main questions the investigators aim to answer are: How does long-term exercise change proteins in the blood? How does a single exercise session change proteins in the blood? The investigators will compare long-term exercise to no exercise to see if the changes in proteins are specific to exercise. Participants will complete an exercise test and provide blood samples before and after the exercise test. Participants will be randomized (like the flip of a coin) in to either the exercise or no-exercise group for 12 weeks and then complete the exercise test and blood samples again at the end.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * age 18 years or older; * diagnosis of RLS; * presence of moderate-to-severe RLS (IRLS score\>15); * currently untreated RLS; * being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous six months; * ability to walk without assistance (does not use a cane/walker/wheelchair for mobility; * willing to complete outcome measures and complete the exercise program Exclusion Criteria: * present with a condition that can mimic RLS or cause secondary RLS (e.g., iron deficiency anemia, radiculopathy, peripheral edema, peripheral neuropathy, diabetes); * are at moderate or high risk for undertaking strenuous or maximal exercise

Interventions

BEHAVIORAL

12-Week RLS Exercise Program

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Conditions

Restless Legs Syndrome

Locations

Stanford University

Stanford, California 94304

United States