Electrical Muscle Stimulation Versus Resistive Training On Physical Measures, And Fatigue In Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessing the change in maximal strength of quadriceps and calf muscles
研究概览
简要总结
The aim of this study is to compare effect of intradialytic NMES versus resistive training on physical measures and fatigue in HDP.
详细描述
In this study we will compare between the effect of intradialytic neuromuscular electrical stimulation and resistive training on physical measures, dialysis efficiency and fatigue in HDP. This is first study that will compare between NMES and resistive training in HDP, investigating their effect on physical performance; dialysis efficiency and level of fatigue as previous studies show effect of each intervention alone.
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
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes, with CKF on HD for more than 3 years.
- •Age between 40 to 55 years old.
- •BMI is between 25 and 29.9 kg/m2.
排除标准
- •Patients who have one of the following contraindications to the interventions or affect the results
- •Cognitive impairment that prevented them from performing the evaluations and who were unable to understand and sign the written informed consent.
- •Anemic patients
- •Osteoarticular or disabling musculoskeletal disorders
- •Uncontrolled hypertension (systolic blood pressure>230 mm Hg and diastolic blood pressure>120 mm Hg)
- •Patients with coronary artery disease or heart failure.
- •Diabetic patients
- •Infectious diseases and chest diseases
- •Active smokers' patients with peripheral vascular disease in the lower limbs such as deep vein thrombosis or thromboangiitis
结局指标
主要结局
Assessing the change in maximal strength of quadriceps and calf muscles
时间窗: at baseline and after 16 weeks of intervention
By using a Hand held dynamometer: A Kern-type standardized traction dynamometer (Kern CH50 50KG dynamometer) will used to assess the maximal strength of quadriceps and calf muscles will estimate. The patient will remain seated in a fixed chair so the back will supported on the back rest with the hip and knee at 90°, the subject will be asked to exert the greatest possible force without holding the chair with his/her arms,the values of muscular strength variables will be the mean of 3 consecutive measurements obtained by the same investigator to minimize errors
Assessing the change in predicted peak vo2 max
时间窗: at baseline and after 16 weeks of intervention
By using a 6-minute walk test (6MWT): It consisted of measuring the maximum distance covered during a 6 min period at an active pace, along a 20 m corridor near the HD unit. At the end of the test period, the total distance travelled was recorded by means of a standardized odometer,that will be used to calculate predicted peak vo2 by using the following equation Mean Peak VO2( ml /kg/min)= 4. 948+ 0. 023\*Mean 6 MWD (meters) (SEE 1.1 ml/ kg/ min), standard error of estimate (SEE).
次要结局
- Assessing the change in Dialysis efficiency(at baseline and after 16 weeks of intervention)
- Assessing the change in physical and psychological fatigue(at baseline and after 16 weeks of intervention)
研究者
Asmaa Ibrahim Yacoub
Principal Investigator
Cairo University