Blood Changes After Exercise in Restless Legs Syndrome (PEARLS)

Stanford University

Status

Enrolling

Conditions

Restless Legs Syndrome

Treatments

Behavioral: 12-Week RLS Exercise Program

Study type

Interventional

Funder types

Other

Identifiers

NCT06481176

75422

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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