Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients: Effects on Muscle and Fatigue - A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Muscle mass
研究概览
简要总结
The goal of this randomized clinical trial is to observe the effect of Amino acids (AAs)supplementation and exercises in haemodialysis patients . The main question it aims to answer is :
Does AAs supplementation and regular exercises have an effect on the muscle mass and function in haemodialysis patients ? Participants will receive daily a total of six tablets of amino acids supplementation divided into three doses. And some Participants will also be asked to do intradialytic exercise.
Researchers will compare the effects of these interventions on the muscle mass and fatigue, among four groups:
- A group that will be only taking AAs supplementation
- A group taking AAs supplementation along with intradialytic exercise
- A group only performing intradialytic exercise
- A passive control group This will be monitored through BMI, anthropometric measures, Musculoskeletal ultrasound assessment of the quadriceps muscle , fatigue questionnaires and sit and stand test.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodialysis patients due to chronic kidney diseases
- •Age between 18 - 60
排除标准
- •Frail patients
- •The patients who refused to participate
- •Growth retarded patients
- •Disabilities
结局指标
主要结局
Muscle mass
时间窗: 3 months
skeletal muscle mass (SMM) will be assessed using the Inbody test before and after this trial .
The thickness of the quadriceps rectus femoris and quadriceps vastus intermedius
时间窗: 3 months
The thickness of the quadriceps rectus femoris (QRFT) and quadriceps vastus intermedius (QVIT) will be assessed before and after this trial using Ultrasonography. The measurements will be conducted in a standardized manner at two specific landmarks: the midpoint and the border between the lower third and upper two-thirds between the superior anterior iliac spine and the upper pole of the patella .
Muscle function test
时间窗: 3 months
The muscle function will be assessed by the Sit-to-Stand Test (STS) . The test is comprised of counting the maximum number of times that the subject is able to stand up unassisted or assisted from a chair in 30 seconds .
次要结局
- Fatigue score(3 months)
研究者
Emad Magdy
Associate Professor Of Nephrology
Mansoura University