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CompletedNCT07748065MET-RLSUpdated Aug 5, 2026

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

An interventional study of Muscle Energy Technique and Routine Medical Treatment and Hemodialysis in Restless Legs Syndrome (RLS) and End-Stage Renal Disease, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 55 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Aug 2025, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
55 Years to 65 Years
Sex
All
01

Study summary

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.
Read the detailed description

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.

02

Conditions studied

  • Restless Legs Syndrome (RLS)
  • End-Stage Renal Disease

Keywords

  • Restless leg syndrome Hemodialysis Muscle energy technique
03

In context

Restless Legs Syndrome

248 studies on the registry are indexed under Restless Legs Syndrome; 39 are open to participants now.

This study's enrollment of 60 is above the median of 53 across 196 interventional studies indexed under Restless Legs Syndrome.

Browse Restless Legs Syndrome studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    muscle energy technique (MET) Group

    Participants received intra-dialytic Muscle Energy Technique (MET) for 20 minutes during the second hour of maintenance hemodialysis, three sessions per week for eight weeks, in addition to routine medical treatment and hemodialysis.

    Procedure: Muscle Energy Technique

  • Active comparator
    Routine Hemodialysis and Medical Treatment Group

    Participants received routine medical treatment and maintenance hemodialysis without additional physical therapy intervention.

    Other: Routine Medical Treatment and Hemodialysis

Interventions

  • ProcedureMuscle Energy Technique

    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.

    Also known as: MET

  • OtherRoutine Medical Treatment and Hemodialysis

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

06

What researchers measure

Primary outcomes

  1. Restless Leg Syndrome Severity

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

    Time frame: Baseline and after 8 weeks

Secondary outcomes

  1. Sleep Quality

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

    Time frame: Baseline and after 8 weeks

  2. Calf and Hamstring muscles strength

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

    Time frame: Baseline and after 8 weeks

  3. Systolic and diastolic Blood Pressure

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

    Time frame: Baseline and after 8 weeks

  4. Oxygen Saturation

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

    Time frame: Baseline and after 8 weeks

07

Study locations

1 site
  • Tala Central Hospital
    Tala, Menoufia Governorate, Egypt
08

References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared because this study was conducted as part of a master's degree research project, and no plan for public data sharing has been established.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07748065
Lead sponsor
Cairo University
Responsible party
Sara Ali Ibrahim Marei (Principal Investigator, Cairo University) — Principal investigator
First posted
Aug 5, 2026
Start date
Aug 1, 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026
Last update
Aug 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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