Effectiveness of Intradialytic Stretching Exercises on Prevention and Reduction of Leg Muscle Cramps Among Patients Undergoing Hemodialysis: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Muscle cramp questionnaire chart
研究概览
简要总结
Renal replacement therapy is a treatment option for people who have acute or chronic renal failure. A patient with increasing symptoms of renal failure is referred to a dialysis and transplantation center early in the course of progressive kidney disease. Hemodialysis is one of the most widely used dialysis procedures. Muscle cramps are the most common complication experienced by hemodialysis patients that usually develop during and in between hemodialysis therapy. These cramps appear to be the most common reason for the early termination of the hemodialysis session.
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Research Question: Is there a difference in leg muscle cramps levels between patients undergoing hemodialysis who received intradialytic stretching exercises compared to those patients who do not receive these exercises?
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Hypothesis: Leg muscle cramp levels are less among patients undergoing hemodialysis who receive intradialytic stretching exercises compared to those patients who do not receive such exercises.
详细描述
Study Sample:
Non-probability purposive sample of 60 patients undergoing hemodialysis. The sample is divided randomly into two groups; 30 patients as study group are exposed to intradialytic stretching exercises, and the other 30 patients are not exposed to the exercises considered as the control group.
The Study Instrument:
To determine the effectiveness of the intradialytic stretching exercises program on the prevention and reduction of leg muscle cramps among patients undergoing hemodialysis, the researcher has adopted an assessment tool in order to achieve each of the study objectives. This tool consists of three parts:
Part I: Socio-Demographic Data:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age group 20-60 years, because it is the most common age group affected by CKD and they appropriate to apply for the study program.
- •Both male and female patients who are undergoing hemodialysis and suffer from muscle cramps.
- •Patients who are receiving two or more HD sessions a week, to facilitate patients follow-up.
- •Patients who are willing to participate, because the patients' participation is voluntary.
- •Patients who are alert and able to communicate verbally, to make the program applicable and facilitate the data collection.
排除标准
- •Emergency hemodialysis patients, to avoid mal-efficient (harmlessly apply the program).
- •Patients with vascular access in a lower extremity, to avoid vascular access failure.
- •Patients with skin sores, wounds, dermatitis, or edema of the lower extremities, with a known history of deep vein thrombosis (DVT), peripheral vascular disease (PVD), or peripheral neuropathy, to prevent complications.
- •Patients who are unable to communicate, because the patients' communication is an essential part of data collection.
- •Patients who suffer from breathing difficulty, because the application of the program required patients compliance and may cause fatigue among involved patients
- •Not willing to participate, because the patients' participation is voluntary.
结局指标
主要结局
Muscle cramp questionnaire chart
时间窗: 4 week muscle cramp assessment
The muscle cramp questionnaire chart is adopted to assess the level of muscle cramps during hemodialysis, before and after the intervention.
次要结局
未报告次要终点
研究者
Amjed Abdulabbas Shraida
Principal Investigator
Kufa University