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NCT Number: NCT07748065

Effect of Intra-Dialytic Muscle Energy Technique on Restless Leg Syndrome in Hemodialysis Patients

The goal of this clinical trial is to learn if intra-dialytic Muscle Energy Technique (MET) can reduce symptoms of restless legs syndrome (RLS) in people with end-stage renal disease (ESRD) receiving maintenance hemodialysis. The study also aims to learn if this treatment can improve sleep quality, muscle strength, blood pressure, and oxygen saturation.

The main questions it aims to answer are:

* Does intra-dialytic Muscle Energy Technique reduce the severity of restless legs syndrome? * Does intra-dialytic Muscle Energy Technique improve sleep quality, muscle strength, blood pressure, and oxygen saturation?

Researchers compared people who received intra-dialytic Muscle Energy Technique together with routine medical treatment and hemodialysis with people who received routine medical treatment and hemodialysis alone to find out whether adding Muscle Energy Technique provides greater benefits.

Participants:

* Were randomly placed into one of two groups. * Received routine medical treatment and hemodialysis. * Received intra-dialytic Muscle Energy Technique during the second hour of hemodialysis if they were in the intervention group. * Had three treatment sessions each week for eight weeks. * Had assessments before and after the eight-week treatment.

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Key information

Conditions

Restless Legs Syndrome (RLS) Chronic Disease Disease Attributes Dyssomnias End-stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Mental Disorders Nervous System Diseases Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Restless Legs Syndrome Sleep Disorders, Intrinsic Sleep Wake Disorders Urogenital Diseases Urologic Diseases

Age range

55 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tala Central Hospital

Tala, Menoufia Governorate, Egypt

About this study

Restless legs syndrome (RLS) is a common neurological disorder among people with end-stage renal disease (ESRD) receiving maintenance hemodialysis. The condition is associated with sleep disturbances, reduced physical function, and impaired quality of life. Although medications are commonly used to manage RLS, symptoms may persist despite treatment, highlighting the need for effective non-pharmacological interventions.

This randomized controlled trial was conducted to evaluate the effectiveness of intra-dialytic Muscle Energy Technique (MET) as an adjunct to routine medical treatment and maintenance hemodialysis for reducing RLS symptoms. The study compared routine medical treatment and maintenance hemodialysis alone with the same treatment combined with intra-dialytic Muscle Energy Technique to determine whether the additional intervention improved clinical outcomes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 55 to 65 years.
  • Diagnosed with end-stage renal disease (ESRD).
  • Receiving maintenance hemodialysis three times per week for at least one year, with each session lasting approximately 4 hours.
  • Diagnosed with restless legs syndrome using the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale.
  • Under regular medical care.
  • Body mass index (BMI) between 25.8 and 28.8 kg/m².
  • Men and women were eligible.

Exclusion criteria

  • Resting systolic blood pressure >200 mmHg and/or diastolic blood pressure >120 mmHg.
  • Neurological disorders (e.g., stroke or head injury) associated with chronic pain.
  • Uncontrolled pulmonary disease.
  • Cognitive impairment or mental disorders that prevented participation in the intervention.
  • Missed more than two weeks of the intervention program or withdrew from the study.
  • Severe obesity.
  • Malignant disease.
  • Unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure, acute pericarditis, or myocarditis.
  • Hearing impairment.
  • Receiving muscle relaxant medications.

Treatment and study plan

muscle energy technique

Procedure

Intra-dialytic Muscle Energy Technique (MET) was performed for 20 minutes during the second hour of maintenance hemodialysis, three sessions per week for eight weeks.

Other names: MET

Routine Medical Treatment and Hemodialysis

Other

Routine medical treatment and maintenance hemodialysis without additional physical therapy intervention.

Primary outcomes

  1. Restless Leg Syndrome Severity

    Time frame: Baseline and after 8 weeks

    Assessed using the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale. Higher scores indicate greater symptom severity.

Secondary outcomes

  1. Sleep Quality

    Time frame: Baseline and after 8 weeks

    Assessed using the Pittsburgh Sleep Quality Index (PSQI) Total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

  2. Calf and Hamstring muscles strength

    Time frame: Baseline and after 8 weeks

    Handheld Dynamometer: Muscle strength was measured in kilograms (kg). Higher values indicate greater muscle strength.

  3. Systolic and diastolic Blood Pressure

    Time frame: Baseline and after 8 weeks

    Measured using a mercury sphygmomanometer, was measured in millimeters of mercury (mmHg) Lower values indicate better blood pressure control

  4. Oxygen Saturation

    Time frame: Baseline and after 8 weeks

    Measured using a pulse oximeter was measured as a percentage (%). Higher values indicate better oxygen saturation

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: MET-RLS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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