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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Participants will complete a 12-week, RLS specific exercise program including strength training, cardiovascular exercise, and stretching. |
|
| Non-Exercise | No Intervention | Participants will have no intervention or interaction for 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-Week RLS Exercise Program | Behavioral | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Protein Expression Profile | 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. | Twice at Baseline Appointment |
| Protein Expression Profile | 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. | Twice at the 12-week Follow-Up |
| Measure | Description | Time Frame |
|---|---|---|
| RLS Severity | 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 baseline testing session (before the 12-week intervention period). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katie Cederberg, PhD | Contact | (650) 725-6517 | kcederb@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Mignot, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94304 | United States |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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Participants will be randomized to one of two conditions that will be occurring simultaneously.
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|
| Baseline |
| RLS Severity | 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). | 12-weeks |
| Cardiorespiratory Fitness | 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 baseline testing session (before the 12-week intervention period). | Baseline |
| Cardiorespiratory Fitness | 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). | 12-weeks |
| Sleep Diary | 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 baseline testing session (before the 12-week intervention period). | Baseline |
| Sleep Diary | 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). | 12-weeks |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
| D001519 | Behavior |