Blood Changes After Exercise in Restless Legs Syndrome

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT06481176
Status
Recruiting
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Conditions

  • Restless Legs Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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: * 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 Details

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.

Key Dates

Start date
Oct 21, 2024
Status verified
Nov 2024
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Exercise
    Participants will complete a 12-week, RLS specific exercise program including strength training, cardiovascular exercise, and stretching.
  • No Intervention: Non-Exercise
    Participants will have no intervention or interaction for 12 weeks.

Primary Outcome Measure

Protein Expression Profile [ Time Frame: Twice at Baseline Appointment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94304
Katie Cederberg, PhD
[email protected]
650-725-6517

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