Progressive Muscle Relaxation Versus Manual Lymphatic Drainage on Restless Leg Syndrome and Sleep Quality in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
Progressive muscle relaxation versus manual lymphatic drainage on restless leg syndrome and sleep quality in hemodialysis patients
详细描述
Restless legs syndrome (RLS) is a sensory motor disturbance with features of both neurologic and sleeps disorders. The patients complain of strong, irresistible urge to move the legs, often accompanied by uncomfortable sensations deeply in the legs. Poor sleep quality affects many hemodialysis patients and can potentially predict their morbidity, mortality, quality of life and pattern of medication use. Progressive muscle relaxation (PMR) is one way to improve physical work capacity and reduce functional limitations. Manual lymphatic drainage (MLD) is a traditional therapy in which the hands work on the tissues of the body, including tuina, acupressure, and the likes. It is beneficial to the well-being of patients both physically and mentally
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults ranging from 35- 65 years old.
- •Able to communicate verbally and agree to participate in the study.
- •On maintenance arteriovenous fistula (AVF) hemodialysis 3 times weekly.
- •None of the research participants had a lower extremity dialysis graft, and they were all taking medication to maintain their health.
- •Prior to the study procedure, all patients underwent a nephrologist assessment
- •All patients had good compliance with their dialysis treatment (not missing more than 2 dialysis sessions in the prior 3 months
排除标准
- •Peripheral neuropathy or vascular diseases of the lower limbs.
- •Skin diseases including acute psoriasis or eczema.
- •Recent fractures or lower limbs surgeries.
- •Feet injuries including severe muscle weakness, bruises, ulcers, Open wounds or recent burns
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: base line and 12 weeks
It is a self-report questionnaire that assesses sleep quality. The patient asked to rate his/ her sleep quality
International restless legs syndrome rating scale (IRLS)
时间窗: base line and 12 weeks.
It consists of 10 questions considering different aspects of the impact of RLS on a patient's life. Each question can be answered with a Likert-type scale ranging from "none" (0) to "very severe" (4).
次要结局
- Patient Health Questionnaire (PHQ-9)(base line and 12 weeks)
- Leg cramps severity scale(base line and 12 weeks)
研究者
Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d
lectrurer of physical therapy for general surgery and dermatology
MTI University