Blood Changes After Exercise in Restless Legs Syndrome

NCT06481176 | Recruiting

• 1 other identifier: 75422
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise; Proteomics

Outcome Measures

Primary Outcomes (2)

• Protein Expression Profile

  Participants will provide blood samples that will be used to measure proteins in the blood with an aptamer-based multiplexed platform of 11,000+ proteins. Two samples will be collected at the baseline testing session (before the 12-week study period); one right before and one right after the cardiorespiratory fitness test.

  Twice at Baseline Appointment

• Protein Expression Profile

  Participants will provide blood samples that will be used to measure proteins in the blood with an aptamer-based multiplexed platform of 11,000+ proteins. Two samples will be collected at the follow-up testing session (after the 12-week study period); one right before and one right after the cardiorespiratory fitness test.

  Twice at the 12-week Follow-Up

Secondary Outcomes (6)

• RLS Severity

  Baseline

• RLS Severity

  12-weeks

• Cardiorespiratory Fitness

  Baseline

• Cardiorespiratory Fitness

  12-weeks

• Sleep Diary

  Baseline

Study Arms (2)

Exercise

EXPERIMENTAL

Participants will complete a 12-week, RLS specific exercise program including strength training, cardiovascular exercise, and stretching.

Behavioral: 12-Week RLS Exercise Program

Non-Exercise

NO INTERVENTION

Participants will have no intervention or interaction for 12 weeks.

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

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Restless Legs Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Behavior

Study Officials

• Emmanuel Mignot, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Cederberg, PhD

CONTACT

(650) 725-6517; kcederb@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Craig Reynolds Professor of Sleep Medicine

Model Details: Participants will be randomized to one of two conditions that will be occurring simultaneously.

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: July 1, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)