Effects of Bioelectric Stimulation on Kidney Function and Sarcopenia in Patients With Non-Dialysis Dependent Chronic Kidney Disease (CKD): Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Change from kidney function
研究概览
简要总结
Chronic kidney disease (CKD) consists of kidney damage, with a consequent progressive and irreversible loss of kidney function. In the early stages of the disease, there is already a reduction in circulating levels of α-klotho protein, which is related to worsening renal function. Therapeutic strategies that increase serum α-klotho levels can be of great value in the treatment of CKD. Electrical stimulation contributes to the reduction of reactive oxygen species, DNA damage and improves the efficiency rate of dialysis, suggesting a systemic effect in patients with end-stage CKD. The aim of this study is to evaluate the effects of bioelectric stimulation on renal function and physical capacity in patients with CKD. For this, patients will be randomized into bioelectric stimulation or a control group. Bioelectric stimulation will be performed three times a week for eight weeks. The control group will only be evaluated and re-evaluated. The following pre-and post-intervention assessments will be performed: analysis of the plasma content of α-Klotho and soluble creatinine to assess renal function, six-minute walk test to assess functional capacity; dosage of interleukins and tumor necrosis factor to analyze the inflammatory profile; sit and stand test with 10 repetitions and load cell dynamometry to assess lower limb muscle strength and application of the EuroQoL-5D questionnaire for quality of life. Biochemical analyzes for renal function and inflammatory profile will also be performed after four weeks of follow-up.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years of age;
- •CKD with glomerular filtration rate (GFR) between 15-59 ml/min (III and IV stage of CKD) for more than 3 months;
- •To be able to ambulate > 300 meters in 6 minutes walk test.
排除标准
- •Cognitive dysfunction that prevents the performance of evaluations, as well as an inability to understand and sign the informed consent form;
- •Intolerance to the electrostimulator and/or alteration of skin sensitivity;
- •Skin lesions/burns at the electrode placement site;
- •Patients with stroke in past 6 months with residual limitation to ambulation;
- •Disabling musculoskeletal disease;
- •Uncontrolled hypertension (systolic blood pressure > 230 mmHg and diastolic blood pressure > 120 mmHg);
- •Grade III or IV heart failure (NYHA);
- •Patient with a pacemaker;
- •Uncontrolled diabetes (fasting blood glucose > 250 mg/dL);
- •Unstable angina;
- •Coronary stent placement in past 3 months;
- •Recent acute myocardial infarction (two months);
- •Fever and/or infectious disease;
- •Peripheral vascular disease in the lower limbs that limits ambulation or deep vein thrombosis;
- •Chronic obstructive lung disease that limits ambulation or need for oxygen therapy;
- •Obesity (Body Mass Index≥35);
- •Patient with active cancer.
结局指标
主要结局
Change from kidney function
时间窗: Baseline, after 4 weeks and after 8 weeks
The kidney function will be assessed through the blood collection and dosage of serum creatinine
次要结局
- Change in quality of life evaluation(Baseline and after 8 weeks)
- Adverse effects(After 8 weeks)
- Change in functional capacity(Baseline and after 8 weeks)
- Change in muscle strength of the lower limbs(Baseline and after 8 weeks)
- Change in muscle strength(Baseline and after 8 weeks)
- Change in inflammatory profile(Baseline, after 4 weeks and after 8 weeks)
研究者
Rodrigo Della Méa Plentz
Principal Investigator
Federal University of Health Science of Porto Alegre