NCT06481176 · Stanford University
Blood Changes After Exercise in Restless Legs Syndrome
(PEARLS)
What this study is 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.
View original scientific description
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.
Interventions
BEHAVIORAL
12-Week RLS Exercise Program
Participants will complete 12 weeks of an evidence-based exercise program that has been used for people with RLS, designed for people with RLS, and was informed by exercise guidelines outlined by the American College of Sports Medicine (ACSM) and the American Heart Association, and Center for Disease Control. The program includes three sessions per week for 12 weeks including: * cardiovascular exercise (e.g., walking/jogging, bicycling) for 30 minutes/day on at least 3 days/week at a moderate-to-vigorous intensity * strength training on 2 non-consecutive days/week targeting major muscle groups for approximately 30 minutes * Stretching all major muscle groups on three or more days per week
Primary outcome measures
Protein Expression Profile
Time frame: Twice at Baseline Appointment
Participants will provide blood samples that will be used to measure proteins in the blood with an aptamer-based multiplexed platform of 11,000+ proteins. Two samples will be collected at the baseline testing session (before the 12-week study period); one right before and one right after the cardiorespiratory fitness test.
Protein Expression Profile
Time frame: Twice at the 12-week Follow-Up
Participants will provide blood samples that will be used to measure proteins in the blood with an aptamer-based multiplexed platform of 11,000+ proteins. Two samples will be collected at the follow-up testing session (after the 12-week study period); one right before and one right after the cardiorespiratory fitness test.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Stanford, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 27, 2024 · Source of record for eligibility and locations