Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- DYNAPENIA
研究概览
简要总结
Chronic Kidney Disease (CKD) induces many metabolic troubles especially for the advanced CKD (stage 3b-5) patients and their prevalence and importance grow with the deterioration of the glomerular filtration rate (GFR). Among them, muscle wasting is common and multifactorial, partially explained by an imbalance between protein catabolism and synthesis. Muscular strength is also affected beyond the reduction of the lean body mass, resulting in profound fatigue.
The present study seeks to quantify the prevalence of low muscular strength production (dynapenia) in a cohort of elderly patients with advanced CKD, through a maximal voluntary contraction (MVC) handgrip test compared to control data available in the literature, matched in term of age and sex. It also aims to investigate the link between the reported fatigue (subjective) and the evolution of the MVC, called critical force (fcrit) during a fatiguing task (objective fatigability).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults, aged 60 and over
- •Social security coverage
- •Signed informed consent
- •For patient with Chronic Kidney Disease, estimated glomerular filtration rate (eGFR) less than 45ml/min/1.73m2 (Stage 3b) for at least 3 months
- •For patient with Chronic Kidney Disease, stable clinical condition (i.e., Creatinine increased by a maximum of 25% in the previous 3 months)
- •For control group, 1:1 recruitment with case matching with CDK patients on gender (i.e., male and female) and the presence of diabètes (i.e., presence and absence)
- •For control group, blood test with control of renal function available and dated less than 6 months: with eGFR > 60ml/min/1.73m2 (and control of glucose or glycated hemoglobin for diabetic controls)
排除标准
- •Pregnant women
- •Under guardianship or minor
- •Neuromuscular disease
- •Upper limbs history of surgery or pathologies preventing from fitting EMG electrodes or measuring handgrip force
- •Life expectancy of less than 3 months estimated by medical judgment
- •Programed hospitalization in the previous 3 months
- •Participation to another interventional clinical trial
- •Acute kidney disease
- •On dialysis or expected start of dialysis within next 3 months
研究组 & 干预措施
Patient with chronic kidney disease
Patients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue.
干预措施: Handgrip fatigability test (Other)
Patient with chronic kidney disease
Patients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue.
干预措施: Questionnaires (Other)
CONTROL GROUP
Patients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue.
干预措施: Handgrip fatigability test (Other)
CONTROL GROUP
Patients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue.
干预措施: Questionnaires (Other)
结局指标
主要结局
DYNAPENIA
时间窗: 1 day
The main outcome of the study is to defined the prevalence of dynapenia for advanced CKD elderly patients. Dynapenia will be established when the mean of the first three MVC of the protocol is lower compared to the reference values appaired for age and sex. For reference values of elderly, please see Ramírez-Vélez et al., (2019).
次要结局
- Objective fatigue(1 day)
- EMG signal(1 day)
- Subjective fatigue(1 day)