Intradialytic Aerobic Versus Resistive Exercises on Immunity Response in Patients With Chronic Kidney Disease
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
- Total leukocyte count
研究概览
简要总结
the purpose of this study is to compare between intradialytic aerobic versus resistive exercises on immunity response in patients with chronic kidney disease.
详细描述
The patients of this study will randomly assigned into three equal groups (n=20)
- Study Group A (20 patients) will receive intradialytic aerobic exercise and medical treatment.
- Study Group B (20 patients) will receive intradialytic resistive exercise and medical treatment.
- Control Group C (20 patients) will receive medical treatment only (HD session and drugs) Each patient will receive the treatment program three times per week for three months.
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
- None
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Sixty men chronic kidney disease (grade III RF). They received regular hemodialysis sessions at least one year ago, each one for four hours, three times per week.
- •They had a history of type II Diabetes more than five years.
- •Their age will be ranged from 50-60 years old.
- •They are Fit for exercise by functional assessment using six minute walk test.
- •Their Hemoglobin level more than 10 g\dl.
- •Their Body Mass Index (BMI) will be ranged from "18.5" to "24.9".
排除标准
- •Severe cardiac disorders.
- •Severe orthopedic problems (for example fractures).
- •Hepatic encephalopathy.
- •Preexisting neuromuscular diseases (e.g. myasthenia gravis). •Severe chest diseases.
- •Spinal cord injuries involved the phrenic nerve.
- •Uncontrolled diabetes or hypertension
- •Patients receiving inefficient hemodialysis session.
- •Patients with other cause for inflammation e.g. malignancy and autoimmune disease.
- •Active bleeding as alveolar hemorrhage, hemoptysis.
- •Physical limitation that would limit cycling.
研究组 & 干预措施
control group C
receive hemodialysis sessions
干预措施: hemodialysis sessions (Device)
study group A aerobic exercise
receive hemodialysis sessions and intradialytic aerobic exercise
干预措施: leg pedaling cycling device (Device)
study group A aerobic exercise
receive hemodialysis sessions and intradialytic aerobic exercise
干预措施: hemodialysis sessions (Device)
study group B resistive exercise
receive hemodialysis sessions and intradialytic resistive exercise
干预措施: sand bags (Device)
study group B resistive exercise
receive hemodialysis sessions and intradialytic resistive exercise
干预措施: hemodialysis sessions (Device)
结局指标
主要结局
Total leukocyte count
时间窗: baseline , 12 weeks for each patient
measured by (cell/mcl)\*\*\*\*1000
Concentration of immunoglobulin g
时间窗: baseline , 12 weeks for each patient
measured by mg/dl
Concentration of HbA1c
时间窗: baseline , 12 weeks for each patient
measured by percentage of blood sugar last 3 months
lymphocyte count
时间窗: baseline , 12 weeks for each patient
measured by (cell/mcl)\*\*\*\*1000
neutrophil count
时间窗: baseline , 12 weeks for each patient
measured by (cell/mcl)\*\*\*\*1000
次要结局
- hemoglobin concentration(baseline , 12 weeks for each patient)
- six minute walk test(baseline , 12 weeks for each patient)
- (KDQOL-SFTM) questionnaire(baseline , 12 weeks for each patient)
- thrombocytes count(baseline , 12 weeks for each patient)
- diastolic blood pressure(baseline , 12 weeks for each patient)
- Systolic blood pressure(baseline , 12 weeks for each patient)
研究者
Hazem Mohamed Yasin Abbas
physiotherapist
Cairo University