Effect of Intra-Dialytic Muscle Energy Technique on Restless Leg Syndrome in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Restless Leg Syndrome Severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Muscle Energy Technique (Procedure)
Routine Hemodialysis and Medical Treatment Group
Participants received routine medical treatment and maintenance hemodialysis without additional physical therapy intervention.
干预措施: Routine Medical Treatment and Hemodialysis (Other)
结局指标
主要结局
Restless Leg Syndrome Severity
时间窗: Baseline and after 8 weeks
Assessed using the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale. Higher scores indicate greater symptom severity.
次要结局
- 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)
研究者
Sara Ali Ibrahim Marei
Principal Investigator
Cairo University