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

NCT07748065 | Completed

• 1 other identifier: P.T.REC/012/004937
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Restless leg syndrome Hemodialysis Muscle energy technique

Outcome Measures

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.

  Baseline and after 8 weeks

Secondary Outcomes (4)

• Sleep Quality

  Baseline and after 8 weeks

• Calf and Hamstring muscles strength

  Baseline and after 8 weeks

• Systolic and diastolic Blood Pressure

  Baseline and after 8 weeks

• Oxygen Saturation

  Baseline and after 8 weeks

Study Arms (2)

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.

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.

Other: Routine Medical Treatment and Hemodialysis

Interventions

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.

Also known as: MET

muscle energy technique (MET) Group

Routine Medical Treatment and Hemodialysis OTHER

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

Routine Hemodialysis and Medical Treatment Group

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Tala Central Hospital

Tala, Menoufia Governorate, Egypt

Location

MeSH Terms

Conditions

Restless Legs Syndrome; Kidney Failure, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 5, 2026
• Study Start: August 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)