Effect Of Autogenic Training On Restless Leg Syndrome And Sleep Disturbance In Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Dialysis adequacy
研究概览
简要总结
goal of this interventional study to investigate the effect of autogenic training on sleep disturbance , restless leg syndrome and fatigue on hemodialysis patient Is there any significant effect of autogenic training on restless leg syndrome, sleep disturbance and fatigue in patients with hemodialysis?
The intervention will include structured autogenic training sessions, and outcomes such as sleep quality and RLS severity and fatigue will be evaluated after 8 weeks of autogenic training on hemodialysis patients .
详细描述
Hemodialysis patients always face various problems such as fatigue and sleep disturbance due to the chronic nature and side effects of hemodialysis, which negatively affect their quality of life A variety of treatment regimens can be chosen to initially relieve symptoms of patients currently with RLS and fatigue, among available regimes, pharmacological treatments are mainly selected for cases with severe RLS, which, at times, lead to serious complications It is hypothesized that these patients, according to the above implications, require a treatment suitable to their somatopsychic necessity, that autogenic training should perform being a method of choice for these types of issues Few clinical trials have examined the efficacy of autogenic training in patients undergoing hemodialysis that suffering from fatigue, restless syndrome and sleep disturbance, this approach could be incorporated into routine care protocols, enhancing patient comfort, promoting self-management, and reducing reliance on medications and their complications.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 45 and 55 years.
- •Body Mass Index (BMI) between 25.0 and 29.9 kg/m².
- •Clinically and medically stable.
- •On hemodialysis for at least 6 months prior to enrollment.
- •Diagnosed with chronic kidney disease (CKD), defined by one or more of the following:
- •Evidence of kidney damage (e.g., albuminuria), or
- •Decreased kidney function with glomerular filtration rate (GFR) < 60 mL/min/1.73 m² for ≥ 3 months, irrespective of clinical diagnosis.
- •*Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg, and heart rate < 80 bpm.
排除标准
- •Uncontrolled pulmonary disease.
- •Severe vascular complications (e.g., critical limb ischemia).
- •Unstable angina.
- •Uncontrolled cardiac arrhythmia.
- •Decompensated heart failure.
- •Cognitive impairment.
- •Participants who miss more than two weeks of the program or request termination.
结局指标
主要结局
Dialysis adequacy
时间窗: 8 weeks
Dialysis adequacy will be assessed using URR (Urea Reduction Ratio) measured pre- and post-intervention to determine the effectiveness of the treatment in improving hemodialysis efficiency."
次要结局
- sleep disturbance(8 weeks)
- restless leg syndrome(8 weeks)
- fatigue(8 weeks)
- sleep disturbance(8 weeks)
- restless leg syndrome(8 weeks)
- fatigue(8 weeks)
研究者
Zainab Gamal Mohamed
Principal Investigator
Cairo University