Restless Legs SyndromePEARLSNCT06481176
Blood Changes After Exercise in Restless Legs Syndrome
A study testing 12-Week RLS Exercise Program in people with Restless Legs Syndrome, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- 12-Week RLS Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94304
Katie Cederberg, PhD, 650-725-6517, RLSresearch@stanford.edu
About this study
Official title: Proteomic Response to Exercise in Adults With Restless Legs Syndrome
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?
Read more
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.
- Conditions
- Restless Legs Syndrome
- Being tested
- 12-Week RLS Exercise Program
- Keywords
- Exercise, Proteomics
- Medical subject headings
- Restless Legs Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-Week RLS Exercise ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Participants will complete a 12-week, RLS specific exercise program including strength training, cardiovascular exercise, and stretching. Receives: Behavioral: 12-Week RLS Exercise Program |
| Non-Exercise | No intervention | Participants will have no intervention or interaction for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Twice at the 12-week Follow-Up
Secondary outcomes (6)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start21 Oct 2024
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two conditions that will be occurring simultaneously.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanuel Mignot, Stanford University
- Investigators
- Emmanuel Mignot, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481176
- Sponsor's protocol ID
- 75422
- Acronym
- PEARLS
- Status last verified
- Nov 2024
- First submitted
- 14 Jun 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Response to Exercise in Adults With Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT06481176
- Acronym / sponsor ID
- PEARLS / 75422
- Conditions
- Restless Legs Syndrome
- Keywords
- Exercise, Proteomics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two conditions that will be occurring simultaneously.
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: 12-Week RLS Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-Week RLS Exercise ProgramParticipants 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 | Behavioural | Exercise |
Primary outcome
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.
6 secondary outcomes
RLS Severity
Time frame: Baseline
RLS Severity
Time frame: 12-weeks
Cardiorespiratory Fitness
Time frame: Baseline
Cardiorespiratory Fitness
Time frame: 12-weeks
Sleep Diary
Time frame: Baseline
Sleep Diary
Time frame: 12-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emmanuel Mignot, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-Week RLS Exercise Program in people with Restless Legs Syndrome, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie Cederberg, PhD ((650) 725-6517, kcederb@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein Expression Profile (time frame: Twice at Baseline Appointment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.