Blood Changes After Exercise in Restless Legs Syndrome
- Conditions
- Restless Legs Syndrome
- Interventions
- Behavioral: 12-Week RLS Exercise Program
- Registration Number
- NCT06481176
- Lead Sponsor
- Stanford University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise 12-Week RLS Exercise Program Participants will complete a 12-week, RLS specific exercise program including strength training, cardiovascular exercise, and stretching.
- Primary Outcome Measures
Name Time Method Protein Expression Profile 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.
- Secondary Outcome Measures
Name Time Method Sleep Diary 12-weeks Participants will be asked to keep a sleep diary and answer questions related to their sleep and RLS every night for 7-days. The diary will be completed every day for 7 days around the 12 week follow up testing session (after the 12-week intervention period).
RLS Severity 12-weeks Participants will complete the International Restless Legs Syndrome Study Group Scale (IRLS), a 10-item questionnaire that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life over the previous week. Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with total scores ranging from 0-40 and higher scores indicating a greater severity of symptoms. This survey will be completed at the follow-up testing session (after the 12-week intervention period).
Cardiorespiratory Fitness 12-weeks Changes in physiological fitness levels will be measured with a submaximal exercise test that uses heart rate response to submaximal power output to estimate VO2 max. The Modified Bruce Treadmill Test protocol will be used, whereby participants begin walking at 1.7 mph at 0% grade with increases in grade and/or speed every 3 minutes until volitional fatigue. This test will be completed at the follow-up testing session (after the 12-week intervention period).
Trial Locations
- Locations (1)
Stanford University
🇺🇸Stanford, California, United States