Health Condition 1: N189- Chronic kidney disease, unspecified Health Condition 2: N186- End stage renal disease
Conditions
Interventions
Intervention1: The BES shall be provided using the device Sys Stim 240 (Mettler Electronics Corp, CA), which has been certified for external application and neuromuscular usage: 20 patients with CKD n
Sponsors
Dr Soumya Mishra
Dr Manoja Kumar Das
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 to 65 years Any gender CKD with Glomerular Filtration Rate (GFR) between 30-50 ml per min for more than 3 months Able to read and understand the study protocol Able to attend all 16 treatment sessions No evidence of current infection on clinical assessment Able to ambulate above 300 meters in 6 minutes
Exclusion criteria
Exclusion criteria: Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form Intolerance to low level bioelectric stimulation and, or skin sensitivity change History or clinical evidence of stroke in past 6 months with residual limitation to ambulation Disabling musculoskeletal disease Uncontrolled hypertension with Systolic blood pressure greater than 180 mmHg and diastolic blood pressure greater than 100 mmHg on two measurements Grade III or IV heart failure according to NYHA or hospitalization for heart failure in past 3 months Uncontrolled diabetes fasting blood glucose more than 250 mg per dL and HgbA1C greater than 10 Unstable angina Coronary stent placement in past 3 months Acute myocardial infarction within past three months Presence of fever and, or any acute illness Active smoker Peripheral vascular disease in the lower limbs that limits ambulation less 300 meters or has rest pain Chronic obstructive lung disease that limits ambulation or need for oxygen therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the serum Klotho protein levelTimepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| o Change in the renal function (BUN, serum creatinine) and GFR o Change in the systolic and diastolic blood pressures o Change in the 6 minute walk test performance o Change in Quality of Life status, as assessed by the questionnaire Kidney Disease and Quality-of-Life Short-F3rm (KDQOL-SFTM). o Tolerance and safety of BES therapy o Compliance to the BES therapy sessionsTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Soumya Mishra
Kalinga Institute of Medical Sciences
Outcome results
None listed