Effect of Intra-Dialytic Muscle Energy Technique on Restless Leg Syndrome in Hemodialysis Patients (NCT07748065) | Clinical Trial Compass
CompletedNot Applicable
Effect of Intra-Dialytic Muscle Energy Technique on Restless Leg Syndrome in Hemodialysis Patients
Egypt60 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range
55 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a hands-on physical therapy technique called Muscle Energy Technique performed during hemodialysis sessions to help with restless leg syndrome — do you know what the results showed, and whether this approach actually reduced RLS severity in the patients who received it?
2Since this trial has already been completed, has the evidence from it been published anywhere, and would it change how you might manage my restless leg syndrome during my dialysis sessions?
3The technique was performed during dialysis itself, which means it wouldn't require extra appointments — does that kind of in-session physical therapy seem realistic or practical at the dialysis center where I'm being treated?
4Right now, what are my standard treatment options for restless leg syndrome related to my end-stage renal disease, and how does a non-drug approach like this compare to medications you might normally prescribe?
5Are there any risks or downsides to trying a muscle energy technique during hemodialysis that I should be aware of before asking my dialysis team about incorporating something like this into my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.