End-Stage Renal Disease, Restless Legs Syndrome (RLS)
Conditions
Keywords
Restless leg syndrome Hemodialysis Muscle energy technique
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.
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.
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.
OTHERRoutine Medical Treatment and Hemodialysis
Routine medical treatment and maintenance hemodialysis without additional physical therapy intervention.
Sponsors
Cairo University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
55 Years to 65 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Restless Leg Syndrome Severity | Baseline and after 8 weeks | Assessed using the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale. Higher scores indicate greater symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | 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. |
| Calf and Hamstring muscles strength | Baseline and after 8 weeks | Handheld Dynamometer: Muscle strength was measured in kilograms (kg). Higher values indicate greater muscle strength. |
| Systolic and diastolic Blood Pressure | Baseline and after 8 weeks | Measured using a mercury sphygmomanometer, was measured in millimeters of mercury (mmHg) Lower values indicate better blood pressure control |
| Oxygen Saturation | Baseline and after 8 weeks | Measured using a pulse oximeter was measured as a percentage (%). Higher values indicate better oxygen saturation |
Countries
Egypt
Outcome results
None listed