Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT06481176

Conditions

Restless Legs Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

12-Week RLS Exercise Program

Study Details

Brief 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 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

Study ID

NCT06481176

Start date

Oct 21, 2024

Status verified date

Nov, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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-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

Primary outcome measure

  • Protein Expression Profile [ Time Frame: Twice at Baseline Appointment ]
  • Protein Expression Profile [ Time Frame: Twice at the 12-week Follow-Up ]

Central Contacts and Locations

Central contacts

Katie Cederberg, PhD

(650) 725-6517kcederb@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94304

Contacts

Katie Cederberg, PhD

650-725-6517RLSresearch@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Nov 27, 2024

Last verified

Nov, 2024

Keywords

  • Exercise
  • Proteomics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2024-11-27.