Blood Changes After Exercise in Restless Legs Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 12-Week RLS Exercise Program.
- Who it may be relevant to
- Registry conditions: Restless Legs Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Proteomic Response to Exercise in Adults With Restless Legs Syndrome
Overview
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.
Interventions
- Behavioral 12-Week RLS Exercise Program
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-
Primary outcome measures
- Protein Expression Profile [Time frame: Twice at Baseline Appointment]
- Protein Expression Profile [Time frame: Twice at the 12-week Follow-Up]
Secondary outcome measures (6)
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University — Stanford
Identifiers
NCT: NCT06481176 · 75422