Effects of Whole-body Electrostimulation on Patients With Chronic Kidney Disease
- Conditions
- Renal Insufficiency, Chronic
- Interventions
- Other: Whole-body electrical stimulation
- Registration Number
- NCT06502522
- Lead Sponsor
- Federal University of Health Science of Porto Alegre
- Brief Summary
Chronic kidney disease (CKD) consists of kidney damage, with consequent progressive and irreversible loss of kidney function. In the early stages of the disease, a reduction in circulating levels of the α-klotho protein is already observed, which is related to worsening renal function. Therapeutic strategies that increase serum levels of α-klotho may be of great value in the treatment of CKD. Electrical stimulation contributes to the reduction of reactive oxygen species, DNA damage and improves the effectiveness rate of dialysis, suggesting a systemic effect in patients with terminal CKD. The objective of this study is to evaluate the effects of whole body electrical stimulation on renal function and physical capacity in patients with CKD not dependent on dialysis.
- Detailed Description
Patients with stage III and IV chronic kidney disease will be randomized into two groups, one group will receive whole-body electrical stimulation and the other group will be a control group (it will only be evaluated and reevaluated at the same times as the intervention group). The intervention group will perform the protocol three times a week, for eight weeks. The following assessments will be conducted pre- and post-intervention: analysis of plasma content of soluble α-Klotho and creatinine to assess renal function; measurement of interleukins and tumor necrosis factor by ELISA to analyze the inflammatory profile; beta-endorphin measurement by ELISA to assess well-being; creatine kinase dosage to assess muscle damage; 10-repetition sit-to-stand test and quadriceps muscle dynamometry to assess lower limb muscle strength; handgrip test with a dynamometer to assess upper limb strength; six-minute walk test to assess functional capacity; application of the EuroQoL-5D questionnaire for quality of life and the Pittsburgh scale to assess sleep quality.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Patients diagnosed with CKD (≥ 3 months) in stages 3-4 (GFR between 59 and 15 ml/min/1.73m2);
- Age between 18 and 80 years old;
- Functional capacity ≥ 300 meters in the six-minute walk test.
- Cognitive dysfunction that prevents assessments from being carried out or inability to understand and sign the informed consent form;
- Intolerance to electrical stimulator and/or changes in skin sensitivity;
- Skin injuries or burns where the electrodes are positioned;
- Patients with stroke sequelae;
- Recent acute myocardial infarction (two months);
- Uncontrolled hypertension (SBP>230 mmHg and DBP>120 mmHg);
- New York Heart Association grade IV heart failure or decompensated;
- Unstable angina or arrhythmia;
- Artificial cardiac pacemaker or implantable cardioverter defibrillator;
- Peripheral vascular changes in the lower limbs such as deep vein thrombosis;
- Disabling osteoarticular or musculoskeletal disease;
- Uncontrolled diabetes (glycemia > 300mg/dL);
- Patients with cancer and/or undergoing oncological treatment;
- Epilepsy;
- Hemophilia;
- Chronic obstructive pulmonary disease;
- Grade II obesity (BMI≥35).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Whole-body electrical stimulation Whole-body neuromuscular electrical stimulation will be administered for three times week for eight weeks, totaling 24 sessions.
- Primary Outcome Measures
Name Time Method Change in kidney function Baseline, after 4 and 8 weeks Change in kidney function will be assessed by serum creatinine measurement
- Secondary Outcome Measures
Name Time Method Change in muscle damage levels Baseline, after 4 and 8 weeks Change in muscle damage levels will be assessed by serum creatine kinase (CK) measurement
Change in inflammatory profile Baseline, after 4 and 8 weeks Change in inflammatory profile will be assessed by measurement of tumor necrosis factor alpha (TNF-a)
Change in well-being levels Baseline, after 4 and 8 weeks Change in well-being levels will be assessed by serum beta-endorphin dosage
Change in handgrip muscle strength Baseline and 8 weeks Change in handgrip muscle strength will be assessed by dynamometry
Change in functional capacity Baseline and 8 weeks Change in functional capacity will be assessed through the distance covered in the six-minute walk test (6MWT)
Change in sleep quality Baseline and 8 weeks Change in sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI).The score ranges from 0 to 21. Lower scores reflect worse sleep quality.
Change in quality of life Baseline and 8 weeks Change in quality of life will be assessed using the EuroQoL-5D (EQ-5D) questionnaire
Change in isometric muscle strength of the quadriceps Baseline and 8 weeks Change in isometric muscle strength of the quadriceps will be assessed by dynamometry
Change in lower limb muscle strength Baseline and 8 weeks Change in lower limb muscle strength will be assessed using the 10-repetition sit-and-stand test (10SST)