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

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.