30 Participants Needed

Exercise Program for Restless Legs Syndrome

(PEARLS Trial)

KC
Overseen ByKatie Cederberg, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise affects molecules in the blood of people with restless legs syndrome (RLS) to better understand the condition. Researchers compare the impact of a 12-week RLS exercise program with no exercise on blood proteins. Participants will be randomly assigned to either exercise regularly or not exercise at all for 12 weeks, with blood samples taken before and after the trial. People with moderate-to-severe RLS who aren't currently active or receiving treatment might be a good fit.

As an unphased trial, this study offers a unique opportunity to contribute to foundational research that could lead to new insights and treatments for RLS.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but it requires that participants have untreated restless legs syndrome (RLS). This suggests that you should not be on any current treatment for RLS to participate.

What prior data suggests that this exercise program is safe for people with restless legs syndrome?

Research has shown that exercise is generally safe for people with Restless Legs Syndrome (RLS). In past studies, various types of exercise, such as yoga and strength training, have been tested with individuals who have RLS. These studies found that exercise can safely help reduce RLS symptoms. Specifically, one study found that a 12-week exercise program was safe when combined with RLS medication.

Participants in these studies did not report any serious side effects from the exercise programs. This suggests that the 12-week exercise plan being tested is likely manageable for most people. Therefore, if you decide to join this trial, the exercise program should be safe based on past research.12345

Why are researchers excited about this trial?

Researchers are excited about this exercise program for Restless Legs Syndrome (RLS) because it offers a non-pharmaceutical approach to managing symptoms. Unlike standard treatments like medications that often target neurotransmitters, this program focuses on physical activity, which can enhance overall well-being and potentially reduce symptoms through improved circulation and muscle conditioning. The program combines strength training, cardiovascular exercise, and stretching specifically tailored for RLS, offering a holistic way to address the condition. This approach might appeal to those seeking alternatives to medication-related side effects or those who prefer lifestyle modifications.

What evidence suggests that this exercise program is effective for restless legs syndrome?

Research has shown that exercise can help people with restless legs syndrome (RLS). In this trial, participants in the exercise arm will complete a 12-week RLS-specific exercise program. Studies have found that such a program can greatly reduce RLS symptoms. For example, one study reported a clear decrease in symptom severity after participants finished the 12-week exercise routine. Another study observed better mood and lower stress levels, which are often connected to RLS symptoms. Overall, exercise seems to help manage RLS by lessening symptoms and boosting overall well-being.12567

Who Is on the Research Team?

Emmanuel Mignot, MD, PhD | Stanford ...

Emmanuel Mignot, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate-to-severe untreated Restless Legs Syndrome (RLS) who can walk without assistance. Participants should not be regularly active, defined as engaging in activity for more than two days a week in the past six months.

Inclusion Criteria

I have not been regularly active for the last six months.
I am willing to follow the exercise program and track my progress.
I have restless legs syndrome that hasn't been treated yet.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete an exercise test and provide blood samples before and after the exercise test

1 week
1 visit (in-person)

Intervention

Participants are randomized into either the exercise or no-exercise group for 12 weeks

12 weeks
Regular exercise sessions for the exercise group

Follow-up

Participants complete the exercise test and provide blood samples again at the end of the 12-week period

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • 12-Week RLS Exercise Program
Trial Overview The study tests how a 12-week exercise program affects blood proteins in RLS patients compared to no exercise. It involves an initial exercise test and blood samples, followed by random assignment to either continue exercising or not, then another test and samples after 12 weeks.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: ExerciseExperimental Treatment1 Intervention
Group II: Non-ExerciseActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Published Research Related to This Trial

A 6-week speed-based exercise program for older adults showed significant improvements in mobility, with a 2-second enhancement in the timed up and go test and a 34% increase in rapid knee extension strength, indicating its efficacy in improving neuromuscular function.
The program not only benefited the lower body but also led to improvements in upper body strength and dexterity, suggesting that speed-based exercises can have widespread neural adaptations even in untrained muscle groups.
High-Speed Cycling Intervention Improves Rate-Dependent Mobility in Older Adults.Bellumori, M., Uygur, M., Knight, CA.[2018]
A randomized controlled trial is set to evaluate a 12-week home-based exercise program for patients aged 70 and older, aiming to improve functional lower body strength and overall physical functioning.
The program, delivered through general practitioners and exercise therapists, is based on behavior change strategies and will assess various outcomes, including physical activity levels and health-related quality of life, to determine its effectiveness compared to a control group.
Effects of an exercise programme for chronically ill and mobility-restricted elderly with structured support by the general practitioner's practice (HOMEfit) - study protocol of a randomised controlled trial.Hinrichs, T., Moschny, A., Brach, M., et al.[2023]
The PAR-Q and PARmed-X are important tools for screening individuals before they engage in physical activity, but they need updates to better accommodate people with chronic health conditions and to include individuals of all ages.
Research shows that the risks of being inactive are much greater than the temporary risks associated with exercise, highlighting the need for effective risk stratification and the involvement of qualified exercise professionals in the clearance process.
Evidence-based risk assessment and recommendations for physical activity clearance: Consensus Document 2011.Warburton, DE., Gledhill, N., Jamnik, VK., et al.[2022]

Citations

Effects of a 12-week yoga versus a 12-week educational film ...Findings of this exploratory RCT suggest that yoga may be effective in reducing RLS symptoms and symptom severity, decreasing perceived stress, and improving ...
an exploratory randomized controlled trialPost-intervention, both groups showed significant improvement in RLS symptoms and severity, perceived stress, mood, and QOL-mental health (P ≤ .
Effectiveness of Additional Strengthening Exercises...At 12 weeks, the intervention group showed a mean IRLSSG severity score reduction of -12.1 (95% CI: -15.05 to -9.23) compared to -5.4 (95% CI: -7.76 to -3.00) ...
An Exploratory Randomized Controlled Trial of a 12-Week ...Of note, two exploratory studies conducted by our group suggest that Iyengar yoga may decrease RLS symptoms, improve sleep, reduce stress, and ...
Exercise and Restless Legs Syndrome: A Randomized ...The study was a randomized controlled trial of an exercise program for adults with RLS. The exercise program consisted of 12 weeks of aerobic and re- sistance ...
An Exploratory Randomized Controlled Trial of a 12-Week ...The findings of this study suggest that a larger RCT comparing yoga with an educational film group for the management of RLS is feasible.
Restless Legs Syndrome Exercise InterventionA pilot study of an aerobic exercise intervention to moderate symptoms and improve sleep quality among patients with Restless Legs Syndrome (RLS) ...
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