Willis-Ekbom DiseaseNCT07810127
EXPLORATORY STUDY OF THE POTENTIAL OF THERAPEUTIC EXERCISE IN THE TREATMENT OF WILLIS-EKBOM DISEASE
A study testing Myofascial Self-Stretching Exercise Program and Buerger-Allen Exercise Program in people with Willis-Ekbom Disease and Restless Legs Syndrome (RLS), run by Universidad Pontificia Comillas at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Willis-Ekbom Disease, Restless Legs Syndrome (RLS)
- What is being tested?
- Myofascial Self-Stretching Exercise Program and Buerger-Allen Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- 3 Mar 2026to 22 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Willis-Ekbom Disease, Restless Legs Syndrome (RLS)
- Being tested
- Myofascial Self-Stretching Exercise Program, Buerger-Allen Exercise Program
- Keywords
- Restless Legs Syndrome, Willis-Ekbom Disease, Myofascial Stretching, Mézières Method, Non-Pharmacological Intervention, Therapeutic Exercise
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial Self-Stretching Exercise ProgramBehavioural
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.
Buerger-Allen Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial Self-Stretching Exercise Program | Experimental | 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. Receives: Behavioral: Myofascial Self-Stretching Exercise Program |
| Buerger-Allen Exercise Program | Active comparator | 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. Receives: Behavioral: Buerger-Allen Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and end of the 2-week intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After the 2-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start3 Mar 2026
- Primary completion22 Jul 2026
- Study completion22 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Willis-Ekbom DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to one of two parallel groups receiving either a myofascial self-stretching exercise program or a Buerger-Allen exercise program.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Pontificia Comillas
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación Española de Síndrome de Piernas Inquietas (AESPI), Hospital Ruber Internacional
- Responsible party
- Sponsor
- Investigators
- Laura Lillo Triguero, MD, Principal investigator, Hospital Ruber Internacional
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810127
- Sponsor's protocol ID
- 26/020-EC_X
- Other IDs
- EJER-EWE-2025
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Singh H, Baker FC, Ojile J, Adlou B, Kolotovska V, Rigot SK, Charlesworth JD. Efficacy and safety of TOMAC for treatment of medication-naive and medication-refractory restless legs syndrome: A randomized clinical trial and meta-analysis. Sleep Med. 2024 Oct;122:141-148. doi: 10.1016/j.sleep.2024.08.017. Epub 2024 Aug 18.
PubMed 39173210Thakur A, Sharma R, Sharma SK, Thakur K, Jelly P. Effect of buerger allen exercise on foot perfusion among patient with diabetes mellitus: A systematic review & meta-analysis. Diabetes Metab Syndr. 2022 Feb;16(2):102393. doi: 10.1016/j.dsx.2022.102393. Epub 2022 Jan 13.
PubMed 35085917Rodrigues E, Pontes AR, Brochado G, Bessa I, Carvalho P, Crasto C. Immediate effects of Global Active Stretching on strength and flexibility: Randomised Controlled Trial. S Afr J Sports Med. 2024 Aug 15;36(1):v36i1a16618. doi: 10.17159/2078-516X/2024/v36i1a16618. eCollection 2024.
PubMed 39234297Ratnani G, Harjpal P. Advancements in Restless Leg Syndrome Management: A Review of Physiotherapeutic Modalities and Their Efficacy. Cureus. 2023 Oct 10;15(10):e46779. doi: 10.7759/cureus.46779. eCollection 2023 Oct.
PubMed 37954781Allen RP, Picchietti DL, Garcia-Borreguero D, Ondo WG, Walters AS, Winkelman JW, Zucconi M, Ferri R, Trenkwalder C, Lee HB; International Restless Legs Syndrome Study Group. Restless legs syndrome/Willis-Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria--history, rationale, description, and significance. Sleep Med. 2014 Aug;15(8):860-73. doi: 10.1016/j.sleep.2014.03.025. Epub 2014 May 17.
PubMed 25023924
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio Exploratorio Del Potencial Del Ejercicio Terapeútico en el Tratamiento de la Enfermedad de Willis-Ekbom
- ClinicalTrials.gov ID
- NCT07810127
- Acronym / sponsor ID
- 26/020-EC_X
- Conditions
- Willis-Ekbom Disease, Restless Legs Syndrome (RLS)
- Keywords
- Restless Legs Syndrome, Willis-Ekbom Disease, Myofascial Stretching, Mézières Method, Non-Pharmacological Intervention, Therapeutic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Universidad Pontificia ComillasUniversity, hospital or other
- Collaborators
- Asociación Española de Síndrome de Piernas Inquietas (AESPI), Hospital Ruber Internacional
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 22 Jul 2026 (actual)
- Study completion
- 22 Jul 2026 (actual)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants were assigned to one of two parallel groups receiving either a myofascial self-stretching exercise program or a Buerger-Allen exercise program.
| Arm | Type | Receives |
|---|---|---|
| Myofascial Self-Stretching Exercise Program | Experimental | Behavioral: Myofascial Self-Stretching Exercise ProgramParticipants 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. |
| Buerger-Allen Exercise Program | Active comparator | Behavioral: Buerger-Allen Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofascial Self-Stretching Exercise ProgramParticipants 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. | Behavioural | Myofascial Self-Stretching Exercise Program |
| Buerger-Allen Exercise ProgramParticipants 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. | Behavioural | Buerger-Allen Exercise Program |
Primary outcome
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.
4 secondary outcomes
Change in Daytime Sleepiness Assessed by the Epworth Sleepiness Scale (ESS)
Time frame: 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
Change in Health-Related Quality of Life Assessed by the EQ-5D
Time frame: Baseline and end of the 2-week intervention
Adherence to the Home-Based Exercise Program
Time frame: After the 2-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 39173210Singh H, Baker FC, Ojile J, Adlou B, Kolotovska V, Rigot SK, Charlesworth JD. Efficacy and safety of TOMAC for treatment of medication-naive and medication-refractory restless legs syndrome: A randomized clinical trial and meta-analysis. Sleep Med. 2024 Oct;122:141-148. doi: 10.1016/j.sleep.2024.08.017. Epub 2024 Aug 18.
- Background: PubMed 35085917Thakur A, Sharma R, Sharma SK, Thakur K, Jelly P. Effect of buerger allen exercise on foot perfusion among patient with diabetes mellitus: A systematic review & meta-analysis. Diabetes Metab Syndr. 2022 Feb;16(2):102393. doi: 10.1016/j.dsx.2022.102393. Epub 2022 Jan 13.
- Background: PubMed 39234297Rodrigues E, Pontes AR, Brochado G, Bessa I, Carvalho P, Crasto C. Immediate effects of Global Active Stretching on strength and flexibility: Randomised Controlled Trial. S Afr J Sports Med. 2024 Aug 15;36(1):v36i1a16618. doi: 10.17159/2078-516X/2024/v36i1a16618. eCollection 2024.
- Background: PubMed 37954781Ratnani G, Harjpal P. Advancements in Restless Leg Syndrome Management: A Review of Physiotherapeutic Modalities and Their Efficacy. Cureus. 2023 Oct 10;15(10):e46779. doi: 10.7759/cureus.46779. eCollection 2023 Oct.
- Background: PubMed 25023924Allen RP, Picchietti DL, Garcia-Borreguero D, Ondo WG, Walters AS, Winkelman JW, Zucconi M, Ferri R, Trenkwalder C, Lee HB; International Restless Legs Syndrome Study Group. Restless legs syndrome/Willis-Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria--history, rationale, description, and significance. Sleep Med. 2014 Aug;15(8):860-73. doi: 10.1016/j.sleep.2014.03.025. Epub 2014 May 17.
- Individual participant dataSharing planned: 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.
Related trials for Willis-Ekbom Disease
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Lillo Triguero, MD principal investigator
Hospital Ruber Internacional
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Self-Stretching Exercise Program and Buerger-Allen Exercise Program in people with Willis-Ekbom Disease and Restless Legs Syndrome (RLS), run by Universidad Pontificia Comillas at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07810127, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.