Exercise Program for Restless Legs Syndrome
(PEARLS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how exercise affects molecules in the blood of people with restless legs syndrome (RLS) to better understand the condition. Researchers compare the impact of a 12-week RLS exercise program with no exercise on blood proteins. Participants will be randomly assigned to either exercise regularly or not exercise at all for 12 weeks, with blood samples taken before and after the trial. People with moderate-to-severe RLS who aren't currently active or receiving treatment might be a good fit.
As an unphased trial, this study offers a unique opportunity to contribute to foundational research that could lead to new insights and treatments for RLS.
Will I have to stop taking my current medications?
The trial does not specify whether you need to stop taking your current medications, but it requires that participants have untreated restless legs syndrome (RLS). This suggests that you should not be on any current treatment for RLS to participate.
What prior data suggests that this exercise program is safe for people with restless legs syndrome?
Research has shown that exercise is generally safe for people with Restless Legs Syndrome (RLS). In past studies, various types of exercise, such as yoga and strength training, have been tested with individuals who have RLS. These studies found that exercise can safely help reduce RLS symptoms. Specifically, one study found that a 12-week exercise program was safe when combined with RLS medication.
Participants in these studies did not report any serious side effects from the exercise programs. This suggests that the 12-week exercise plan being tested is likely manageable for most people. Therefore, if you decide to join this trial, the exercise program should be safe based on past research.12345Why are researchers excited about this trial?
Researchers are excited about this exercise program for Restless Legs Syndrome (RLS) because it offers a non-pharmaceutical approach to managing symptoms. Unlike standard treatments like medications that often target neurotransmitters, this program focuses on physical activity, which can enhance overall well-being and potentially reduce symptoms through improved circulation and muscle conditioning. The program combines strength training, cardiovascular exercise, and stretching specifically tailored for RLS, offering a holistic way to address the condition. This approach might appeal to those seeking alternatives to medication-related side effects or those who prefer lifestyle modifications.
What evidence suggests that this exercise program is effective for restless legs syndrome?
Research has shown that exercise can help people with restless legs syndrome (RLS). In this trial, participants in the exercise arm will complete a 12-week RLS-specific exercise program. Studies have found that such a program can greatly reduce RLS symptoms. For example, one study reported a clear decrease in symptom severity after participants finished the 12-week exercise routine. Another study observed better mood and lower stress levels, which are often connected to RLS symptoms. Overall, exercise seems to help manage RLS by lessening symptoms and boosting overall well-being.12567
Who Is on the Research Team?
Emmanuel Mignot, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for adults over 18 with moderate-to-severe untreated Restless Legs Syndrome (RLS) who can walk without assistance. Participants should not be regularly active, defined as engaging in activity for more than two days a week in the past six months.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete an exercise test and provide blood samples before and after the exercise test
Intervention
Participants are randomized into either the exercise or no-exercise group for 12 weeks
Follow-up
Participants complete the exercise test and provide blood samples again at the end of the 12-week period
What Are the Treatments Tested in This Trial?
Interventions
- 12-Week RLS Exercise Program
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor