An interventional study of Myofascial Self-Stretching Exercise Program and Buerger-Allen Exercise Program in Willis-Ekbom Disease and Restless Legs Syndrome (RLS), sponsored by Universidad Pontificia Comillas. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Universidad Pontificia Comillas · Not applicable, Interventional, and Treatment
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Among 11 studies in Restless Legs Syndrome with a site in Spain — none open to participants now, none under way, none of them phase 3. Restless Legs Syndrome · Spain.
Among the 11 studies in Restless Legs Syndrome with a site in Spain, this one is the 10th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2026, is the only one with no phase, and was the 11th registered.
259 studies on the registry are indexed under Restless Legs Syndrome; 38 are open to participants now.
Browse Restless Legs Syndrome studies →None of the 11 studies in Restless Legs Syndrome with a site in Spain is open now. The open studies under Restless Legs Syndrome, anywhere →
Of the 25 Restless Legs Syndrome studies recruiting now, 10 (40%) set no upper age limit and 12 (48%) stop at 75 or younger; none take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 27 is below the median of 53 across 200 interventional studies indexed under Restless Legs Syndrome.
Median enrollment 350 across the 10 interventional studies, 20 across the 1 observational. Of the 10 that completed or were terminated, 5 (50%) have results posted.
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9 of 11 have an industry lead sponsor. The 7 most frequent:
Universidad Pontificia Comillas is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
Universidad Pontificia Comillas has 1 study filed under Restless Legs Syndrome — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Restless Legs Syndrome with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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:
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:
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.
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Exclusion Criteria:
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 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 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.
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.
Change in Restless Legs Syndrome Symptom Severity Assessed by the International Restless Legs Scale (IRLS)
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.
Time frame: Baseline and end of the 2-week intervention
Change in Daytime Sleepiness Assessed by the Epworth Sleepiness Scale (ESS)
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.
Time frame: Baseline and end of the 2-week intervention
Change in Restless Legs Syndrome-Specific Quality of Life Assessed by the RLSQoL Questionnaire
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.
Time frame: Baseline and end of the 2-week intervention
Change in Health-Related Quality of Life Assessed by the EQ-5D
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.
Time frame: Baseline and end of the 2-week intervention
Adherence to the Home-Based Exercise Program
Adherence is assessed as the proportion of participants that completed the intervention period.
Time frame: After the 2-week intervention
Plan to share: No — 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.
Ran from Mar 2026 to primary completion in Jul 2026, 4 months.
Of 46 non-industry interventional studies with no phase under Restless Legs Syndrome, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 42. This study's 4 months is below that.
Counting every sponsor, half of 53 studies reached it within 12 months; a quarter within 5 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Universidad Pontificia Comillas