Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06481176

Blood Changes After Exercise in Restless Legs Syndrome

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Restless Legs Syndrome Behavior Dyssomnias Mental Disorders Motor Activity Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94304, United States

Location status: Recruiting

Location contact

Katie Cederberg, PhD

CONTACT

[email protected]

650-725-6517

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Protein Expression Profile

    Time frame: Twice at Baseline Appointment

    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.

  2. Protein Expression Profile

    Time frame: Twice at the 12-week Follow-Up

    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.

Secondary outcomes

  1. RLS Severity

    Time frame: Baseline

    Participants will complete the International Restless Legs Syndrome Study Group Scale (IRLS), a 10-item questionnaire that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life over the previous week. Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with total scores ranging from 0-40 and higher scores indicating a greater severity of symptoms. This survey will be completed at the baseline testing session (before the 12-week intervention period).

  2. RLS Severity

    Time frame: 12-weeks

    Participants will complete the International Restless Legs Syndrome Study Group Scale (IRLS), a 10-item questionnaire that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life over the previous week. Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with total scores ranging from 0-40 and higher scores indicating a greater severity of symptoms. This survey will be completed at the follow-up testing session (after the 12-week intervention period).

  3. Cardiorespiratory Fitness

    Time frame: Baseline

    Changes in physiological fitness levels will be measured with a submaximal exercise test that uses heart rate response to submaximal power output to estimate VO2 max. The Modified Bruce Treadmill Test protocol will be used, whereby participants begin walking at 1.7 mph at 0% grade with increases in grade and/or speed every 3 minutes until volitional fatigue. This test will be completed at the baseline testing session (before the 12-week intervention period).

  4. Cardiorespiratory Fitness

    Time frame: 12-weeks

    Changes in physiological fitness levels will be measured with a submaximal exercise test that uses heart rate response to submaximal power output to estimate VO2 max. The Modified Bruce Treadmill Test protocol will be used, whereby participants begin walking at 1.7 mph at 0% grade with increases in grade and/or speed every 3 minutes until volitional fatigue. This test will be completed at the follow-up testing session (after the 12-week intervention period).

  5. Sleep Diary

    Time frame: Baseline

    Participants will be asked to keep a sleep diary and answer questions related to their sleep and RLS every night for 7-days. The diary will be completed every day for 7 days around the baseline testing session (before the 12-week intervention period).

  6. Sleep Diary

    Time frame: 12-weeks

    Participants will be asked to keep a sleep diary and answer questions related to their sleep and RLS every night for 7-days. The diary will be completed every day for 7 days around the 12 week follow up testing session (after the 12-week intervention period).

Study contacts

Contact information is provided by the study sponsor or research team.

Katie Cederberg, PhD

CONTACT

[email protected]

(650) 725-6517

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Proteomic Response to Exercise in Adults With Restless Legs Syndrome

Acronym: PEARLS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.