Proteomic Response to Exercise in Adults With Restless Legs Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Protein Expression Profile
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Exercise
Participants will complete a 12-week, RLS specific exercise program including strength training, cardiovascular exercise, and stretching.
Intervention: 12-Week RLS Exercise Program (Behavioral)
Non-Exercise
Participants will have no intervention or interaction for 12 weeks.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Sleep Diary(12-weeks)
- RLS Severity(12-weeks)
- Cardiorespiratory Fitness(12-weeks)
- RLS Severity(Baseline)
- Cardiorespiratory Fitness(Baseline)
- Sleep Diary(Baseline)
Investigators
Emmanuel Mignot
Craig Reynolds Professor of Sleep Medicine
Stanford University