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

NCT07810127 | Completed

• 2 other identifiers: 26/020-EC_XEJER-EWE-2025
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Willis-Ekbom Disease; Restless Legs Syndrome (RLS)

Keywords

Restless Legs Syndrome; Willis-Ekbom Disease; Myofascial Stretching; Mézières Method; Non-Pharmacological Intervention; Therapeutic Exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and end of the 2-week intervention

Secondary Outcomes (4)

• Change in Daytime Sleepiness Assessed by the Epworth Sleepiness Scale (ESS)

  Baseline and end of the 2-week intervention

• Change in Restless Legs Syndrome-Specific Quality of Life Assessed by the RLSQoL Questionnaire

  Baseline and end of the 2-week intervention

• Change in Health-Related Quality of Life Assessed by the EQ-5D

  Baseline and end of the 2-week intervention

• Adherence to the Home-Based Exercise Program

  After the 2-week intervention

Study Arms (2)

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.

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.

Behavioral: Buerger-Allen Exercise Program

Interventions

Buerger-Allen Exercise Program BEHAVIORAL

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.

Buerger-Allen Exercise Program

Myofascial Self-Stretching Exercise Program BEHAVIORAL

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.

Myofascial Self-Stretching Exercise Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Pontificia Comillas: lead
• Asociación Española de Síndrome de Piernas Inquietas (AESPI): collaborator
• Hospital Ruber Internacional: collaborator

Study Sites (1)

Asociación Española de Piernas Inquietas (AESPI)

Madrid, Spain

Location

Related Publications (5)

• 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.

  PMID: 39173210 BACKGROUND

• Thakur 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.

  PMID: 35085917 BACKGROUND

• Rodrigues 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.

  PMID: 39234297 BACKGROUND

• Ratnani 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.

  PMID: 37954781 BACKGROUND

• Allen 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.

  PMID: 25023924 BACKGROUND

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Laura Lillo Triguero, MD

  Hospital Ruber Internacional

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were assigned to one of two parallel groups receiving either a myofascial self-stretching exercise program or a Buerger-Allen exercise program.

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: March 3, 2026
• Primary Completion: July 22, 2026
• Study Completion: July 22, 2026
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)