Health TrialsbyHealthPanel

Blood Changes After Exercise in Restless Legs Syndrome

ConditionRestless Legs Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 18 years or older;

diagnosis of RLS;

presence of moderate-to-severe RLS (IRLS score>15);

currently untreated RLS;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: ExerciseExperimental treatment 1 intervention
Group B: Non-ExerciseNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Twice at Baseline Appointment
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 follow-up testing session (after the 12-week study period); one right before and one right after the cardiorespiratory fitness test.

Time frame
Twice at the 12-week Follow-Up

Secondary outcomes

1

RLS Severity

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).

Time frame
Baseline
2

RLS Severity

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).

Time frame
12-weeks
3

Cardiorespiratory Fitness

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).

Time frame
Baseline
4

Cardiorespiratory Fitness

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).

Time frame
12-weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov
Apply now