EXPLORATORY STUDY OF THE POTENTIAL OF THERAPEUTIC EXERCISE IN THE TREATMENT OF WILLIS-EKBOM DISEASE

September 3, 2026 updated by: Universidad Pontificia Comillas

Estudio Exploratorio Del Potencial Del Ejercicio Terapeútico en el Tratamiento de la Enfermedad de Willis-Ekbom

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Restless legs syndrome (RLS), also known as Willis-Ekbom disease, is a neurological disorder characterized by an urge to move the legs, usually accompanied by unpleasant sensations that begin or worsen during rest and are more prominent in the evening or at night. Pharmacological treatments are available, but some people have an insufficient response, experience adverse effects, or develop worsening of symptoms over time. This exploratory study evaluates a non-pharmacological and non-invasive home-based exercise approach intended to provide preliminary evidence for future studies.

The investigational exercise program consists of self-administered myofascial stretching derived from the Mézières therapeutic approach and Global Active Stretching. The exercises combine sustained low-load muscle activity, low-intensity stretching, controlled breathing with emphasis on expiration, and focused attention to posture and movement. The comparator is a Buerger-Allen exercise routine based mainly on lower-limb positioning and ankle movements. No investigational drug or medical device is used.

The study uses a randomized, two-sequence design. Participants complete 2 weeks of home-based exercise. One group of participants performs the myofascial self-stretching routine and the other group completes the Buerger-Allen exercise routine. Allocation is intended to maintain comparable groups with respect to relevant participant characteristics. Participants are not told which routine is hypothesized to have a greater effect on RLS symptoms, and the evaluating research team is blinded to group assignment. Participants are also asked not to discuss their assigned exercise routines with other participants.

Participants are recruited from volunteers linked to the Spanish Restless Legs Syndrome Association (Asociación Española de Piernas Inquietas, AESPI). Clinical eligibility and the diagnosis of RLS are confirmed by a neurologist. Exercise instructions are provided before the intervention, with the possibility of in-person or remote participation for people living outside the Madrid region. Participants receive detailed instructional material, including videos and written guidance, and perform the exercises independently at home, preferably shortly before bedtime. Usual RLS medication is kept stable during the study unless a treating physician determines that a change is clinically necessary.

Clinical assessments are performed at the beginning and end of the study using validated measures of RLS symptom severity, daytime sleepiness, and health-related quality of life. Participants also record symptom intensity daily and may report comments about sleep, discomfort, symptoms, or difficulties with the exercises. Baseline information includes relevant clinical and lifestyle variables and recent laboratory measures related to iron metabolism. AESPI collects participant-reported information and provides pseudonymized data to the research team.

The analysis is exploratory. Quantitative variables will be summarized using means and standard deviations or medians and interquartile ranges, as appropriate, and categorical variables using frequencies and percentages. Changes over time will be evaluated using paired statistical tests, with non-parametric methods used when appropriate for the sample size and data distribution. Associations between variables will be explored using correlation analyses. Statistical significance will be assessed using a two-sided threshold of p < 0.05.

The study is intended to explore the therapeutic potential, tolerability, and feasibility of a simple home-based exercise program. It is not designed to replace established RLS treatments or to provide definitive evidence of clinical efficacy.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Asociación Española de Piernas Inquietas (AESPI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Myofascial Self-Stretching Exercise Program
Participants perform a home-based myofascial self-stretching exercise program derived from the Mézières therapeutic approach and Global Active Stretching. The exercises combine sustained low-load muscle activity, low-intensity stretching, controlled breathing, and postural control. The routine is performed in the evening, preferably shortly before bedtime, for approximately 15-20 minutes per session.
Behavioral: Myofascial Self-Stretching Exercise Program
Participants perform a home-based myofascial self-stretching exercise program derived from the Mézières therapeutic approach and Global Active Stretching. The program combines sustained low-load activation of agonist muscles, sustained low-intensity stretching of antagonist muscles, controlled breathing with emphasis on expiration, and postural and attentional control. The exercises are performed progressively according to each participant's capabilities. Each session lasts approximately 15 to 20 minutes and is performed in the evening, preferably shortly before bedtime.
Active Comparator: Buerger-Allen Exercise Program
Participants perform a home-based Buerger-Allen exercise program involving lower-limb positioning and ankle movements. The routine is performed in the evening, preferably shortly before bedtime, for approximately 10-15 minutes per session. This exercise program is used as the comparator intervention and is not expected to have a specific therapeutic effect on restless legs syndrome symptoms.
Behavioral: Buerger-Allen Exercise Program
Participants perform a home-based Buerger-Allen exercise program consisting of a sequence of three exercises involving changes in lower-limb position and repeated ankle movements. The routine includes ankle flexion-extension movements with the legs elevated, circular ankle movements while seated with the legs hanging, and repeated ankle flexion-extension movements while lying down. Each exercise is performed for approximately 3 to 5 minutes, resulting in a total session duration of approximately 10 to 15 minutes. The sessions are performed in the evening, preferably shortly before bedtime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Restless Legs Syndrome Symptom Severity Assessed by the International Restless Legs Scale (IRLS)
Time Frame: Baseline and end of the 2-week intervention
The International Restless Legs Scale (IRLS) is a 10-item questionnaire used to assess the severity of restless legs syndrome symptoms. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 40, with higher scores indicating greater symptom severity. The outcome is the change in total IRLS score from baseline to the end of the intervention.
Baseline and end of the 2-week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Daytime Sleepiness Assessed by the Epworth Sleepiness Scale (ESS)
Time Frame: Baseline and end of the 2-week intervention
Daytime sleepiness is assessed using the Epworth Sleepiness Scale (ESS), an 8-item questionnaire in which each item is scored from 0 to 3. Total scores range from 0 to 24, with higher scores indicating greater daytime sleepiness. The outcome is the change in total ESS score from baseline to the end of the intervention.
Baseline and end of the 2-week intervention
Change in Restless Legs Syndrome-Specific Quality of Life Assessed by the RLSQoL Questionnaire
Time Frame: Baseline and end of the 2-week intervention
Restless legs syndrome-specific quality of life is assessed using the Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL). Higher scores indicate better quality of life and a lower impact of restless legs syndrome. The outcome is the change in the RLSQoL score from baseline to the end of the intervention.
Baseline and end of the 2-week intervention
Change in Health-Related Quality of Life Assessed by the EQ-5D
Time Frame: Baseline and end of the 2-week intervention
Health-related quality of life is assessed using the EQ-5D questionnaire. The outcome is the change in EQ-5D score from baseline to the end of the intervention.
Baseline and end of the 2-week intervention
Adherence to the Home-Based Exercise Program
Time Frame: After the 2-week intervention
Adherence is assessed as the proportion of participants that completed the intervention period.
After the 2-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Pontificia Comillas

Collaborators

Hospital Ruber Internacional
Asociación Española de Síndrome de Piernas Inquietas (AESPI)

Investigators

  • Principal Investigator: Laura Lillo Triguero, MD, Hospital Ruber Internacional

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2026

Primary Completion (Actual)

July 22, 2026

Study Completion (Actual)

July 22, 2026

Study Registration Dates

First Submitted

September 3, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 9, 2026

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26/020-EC_X
  • EJER-EWE-2025 (Other Identifier: Universidad Pontificia Comillas)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to external researchers. The study protocol and participant information and consent documents did not prospectively establish a mechanism for sharing participant-level data outside the study research team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe