Estudio exploratorio del potencial del ejercicio terapeútico en el tratamiento de la enfermedad de Willis-Ekbom

NCT ID NCT07810127

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

The goal of this clinical trial is to learn whether a home-based therapeutic exercise program can improve symptoms of restless legs syndrome (RLS), also known as Willis-Ekbom disease, in adults with chronic RLS. It will also assess whether the program affects daytime sleepiness and quality of life, and whether participants can follow and tolerate the exercises. The main questions it aims to answer are: * Does a myofascial self-stretching routine improve RLS symptoms? * Does the exercise program affect daytime sleepiness and quality of life? Researchers will compare two low-risk home exercise routines: a myofascial self-stretching program based on Mézières and Global Active Stretching principles and Buerger-Allen exercises. Participants will be assigned to one of two exercise sequences and will complete their routine over 2 weeks. Participants will: * complete a clinical assessment at the start and end of the study; * perform a 10- to 20-minute exercise session at home each night, preferably before bedtime; * record their RLS symptoms each day; and * keep their usual RLS medication stable during the study.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

27 people

The number who actually took part.

Started

Mar 2026

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years. * Resident in Spain, preferably in or near the Community of Madrid. * Clinical diagnosis of restless legs syndrome (RLS) according to the 2014 International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria, confirmed through clinical assessment by a neurologist. * Symptoms predominantly affecting the legs. * Under medical follow-up for at least 3 months before enrollment, regardless of current treatment or response to medication. * If receiving pharmacological treatment for RLS, treatment must have remained stable for at least 1 month before enrollment and must remain stable throughout the study. Exclusion Criteria: * Acute or chronic musculoskeletal conditions, such as symptomatic disc herniation, radiculopathy, severe tendinopathy, recent muscle injury, or advanced osteoarthritis, that limit or contraindicate prolonged stretching exercises. * Severe uncontrolled pain in the lumbar region, pelvis, or lower extremities that prevents completion of the stretching positions required by the protocol. * Initiation, concurrently with this study, of another non-pharmacological therapy for RLS, such as vibration or compression devices, yoga, or dietary supplements. * Epilepsy or any other concomitant neurological or neuromuscular disease affecting muscle tone, strength, or postural control that could interfere with the study. * Pharmacological treatment requiring frequent adjustments that would prevent treatment stability during the study. * Significant functional limitations, including balance problems, reduced mobility, inability to perform exercises on the floor, or inability to maintain prolonged positions, that prevent correct performance of the exercise protocol. * Insomnia unrelated to RLS. * Pregnancy or breastfeeding.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Asociación Española de Piernas Inquietas (AESPI)

    Madrid, Spain

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