Actively Recruiting
Proteomic Response to Exercise in Adults With Restless Legs Syndrome
Led by Stanford University · Updated on 2024-11-27
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how exercise affects molecules in the blood of adults with restless legs syndrome (RLS) to better understand what causes this condition. The study aims to find out how long-term exercise and a single exercise session change protein levels in the blood. Participants will be assigned to either an exercise group or a no-exercise group to compare these effects. Participants in the exercise group will follow a 12-week program specifically designed for people with RLS. This program includes strength training, cardiovascular exercise like walking or bicycling, and stretching sessions three times per week. Those in the no-exercise group will not receive any intervention or interaction during the same 12-week period. Both groups will complete exercise tests and provide blood samples before and after the program. Throughout the study, participants will undergo assessments including blood protein analysis and measures of RLS severity, cardiorespiratory fitness, and sleep patterns at the start and after 12 weeks. The researchers will monitor changes in protein expression profiles twice at baseline and twice at the 12-week follow-up. This will help determine the effects of exercise on RLS symptoms and related biological markers.
CONDITIONS
Brief Title
Blood Changes After Exercise in Restless Legs Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of restless legs syndrome (RLS)
- Moderate-to-severe RLS with IRLS score greater than 15
- Currently untreated for RLS
- Not regularly active (less than 30 minutes of activity on more than 2 days per week during past 6 months)
- Ability to walk without assistance (no cane, walker, or wheelchair use)
- Willingness to complete outcome measures and exercise program
You will not qualify if you...
- Conditions that mimic or cause secondary RLS such as iron deficiency anemia, radiculopathy, peripheral edema, peripheral neuropathy, or diabetes
- Moderate or high risk for strenuous or maximal exercise
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants complete baseline assessments including protein expression profiles, RLS severity, cardiorespiratory fitness, and sleep diary.
1 baseline visit (in-person)
Duration - 12 weeks
Participants assigned to the exercise group complete a 12-week Restless Legs Syndrome specific exercise program including cardiovascular exercise, strength training, and stretching. Participants in the non-exercise group have no intervention during this time.
Exercise group: 3 exercise sessions per week; Non-exercise group: no intervention visits
Duration - 1 day
Participants complete follow-up assessments including protein expression profiles, RLS severity, cardiorespiratory fitness, and sleep diary after the 12-week period.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94304
Actively Recruiting
Research Team
K
Katie Cederberg, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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