Restless Legs Syndrome (RLS)MET-RLSNCT07748065
Effect of Intra-Dialytic Muscle Energy Technique on Restless Leg Syndrome in Hemodialysis Patients
A study testing Muscle Energy Technique and Routine Medical Treatment and Hemodialysis in people with Restless Legs Syndrome (RLS) and End-Stage Renal Disease, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Restless Legs Syndrome (RLS), End-Stage Renal Disease
- What is being tested?
- Muscle Energy Technique and Routine Medical Treatment and Hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 30 Apr 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 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Malignant disease.
- Unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure, acute pericarditis, or myocarditis.
- Hearing impairment.
- Receiving muscle relaxant medications.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
- Being tested
- Muscle Energy Technique, Routine Medical Treatment and Hemodialysis
- Keywords
- Restless leg syndrome Hemodialysis Muscle energy technique
- Medical subject headings
- Restless Legs Syndrome, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Energy TechniqueProcedure or surgery
Also called MET
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.
Routine Medical Treatment and HemodialysisOther
Routine medical treatment and maintenance hemodialysis without additional physical therapy intervention.
| Study group | Role | What they receive |
|---|---|---|
| muscle energy technique (MET) Group | Experimental | 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. Receives: Procedure: Muscle Energy Technique |
| Routine Hemodialysis and Medical Treatment Group | Active comparator | Participants received routine medical treatment and maintenance hemodialysis without additional physical therapy intervention. Receives: Other: Routine Medical Treatment and Hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restless Leg Syndrome Severity
Assessed using the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale. Higher scores indicate greater symptom severity.
Measured: Baseline and after 8 weeks
Secondary outcomes (4)
Sleep Quality
Assessed using the Pittsburgh Sleep Quality Index (PSQI) Total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline and after 8 weeks
Calf and Hamstring muscles strength
Handheld Dynamometer: Muscle strength was measured in kilograms (kg). Higher values indicate greater muscle strength.
Measured: Baseline and after 8 weeks
Systolic and diastolic Blood Pressure
Measured using a mercury sphygmomanometer, was measured in millimeters of mercury (mmHg) Lower values indicate better blood pressure control
Measured: Baseline and after 8 weeks
Oxygen Saturation
Measured using a pulse oximeter was measured as a percentage (%). Higher values indicate better oxygen saturation
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Aug 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs Syndrome (RLS)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel groups. The experimental group received intra-dialytic Muscle Energy Technique in addition to routine medical treatment and maintenance hemodialysis, while the control group received routine medical treatment and maintenance hemodialysis only.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ali Ibrahim Marei, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748065
- Sponsor's protocol ID
- P.T.REC/012/004937
- Acronym
- MET-RLS
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intra-Dialytic Muscle Energy Technique on Restless Leg Syndrome in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07748065
- Acronym / sponsor ID
- MET-RLS / P.T.REC/012/004937
- Keywords
- Restless leg syndrome Hemodialysis Muscle energy technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 5 Aug 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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups. The experimental group received intra-dialytic Muscle Energy Technique in addition to routine medical treatment and maintenance hemodialysis, while the control group received routine medical treatment and maintenance hemodialysis only.
| Arm | Type | Receives |
|---|---|---|
| muscle energy technique (MET) Group | Experimental | Procedure: Muscle Energy TechniqueParticipants 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. |
| Routine Hemodialysis and Medical Treatment Group | Active comparator | Other: Routine Medical Treatment and HemodialysisParticipants received routine medical treatment and maintenance hemodialysis without additional physical therapy intervention. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Muscle Energy TechniqueAlso: METIntra-dialytic Muscle Energy Technique (MET) was performed for 20 minutes during the second hour of maintenance hemodialysis, three sessions per week for eight weeks. | Procedure or surgery | muscle energy technique (MET) Group |
| Routine Medical Treatment and HemodialysisRoutine medical treatment and maintenance hemodialysis without additional physical therapy intervention. | Other | Routine Hemodialysis and Medical Treatment Group |
Primary outcome
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.
4 secondary outcomes
Sleep Quality
Time frame: Baseline and after 8 weeks
Calf and Hamstring muscles strength
Time frame: Baseline and after 8 weeks
Systolic and diastolic Blood Pressure
Time frame: Baseline and after 8 weeks
Oxygen Saturation
Time frame: Baseline and after 8 weeks
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 5 Aug 2026.
- Individual participant dataSharing planned: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Energy Technique and Routine Medical Treatment and Hemodialysis in people with Restless Legs Syndrome (RLS) and End-Stage Renal Disease, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 10 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 5 Aug 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 Egypt. 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?
Restless Leg Syndrome Severity (time frame: Baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.