Understanding blood changes after exercise in people with restless legs syndrome
Proteomic Response to Exercise in Adults With Restless Legs Syndrome
This study tests how regular exercise affects blood proteins in people with restless legs syndrome compared to those who don’t exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT06481176 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate how exercise affects blood molecules in individuals diagnosed with restless legs syndrome (RLS). Participants will be randomly assigned to either an exercise group or a no-exercise group for 12 weeks. Blood samples will be collected before and after an exercise test to analyze changes in protein levels. The study seeks to determine the specific effects of long-term exercise compared to no exercise on blood proteins associated with RLS.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of moderate-to-severe restless legs syndrome who are currently untreated and non-active.
Not a fit: Patients with conditions that mimic restless legs syndrome or those at risk for strenuous exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the biological mechanisms of restless legs syndrome and inform new treatment strategies.
How similar studies have performed: While there is limited research specifically on exercise and blood changes in RLS, studies on exercise's effects on other conditions have shown promising results, making this approach potentially novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Emmanuel Mignot, MD, PhD — Stanford University
- Study coordinator: Katie Cederberg, PhD
- Email: kcederb@stanford.edu
- Phone: (650) 725-6517
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.