Bioeletric Stimulation in Patients With Chronic Kidney Failure

NCT04608422 | Unknown DMC

• 1 other identifier: CKF_BES
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the effects of electrical stimulation on renal function and physical capacity in patients with chronic kidney disease (CKD). This is a randomized controlled trial with patients from the HD outpatient of Santa Clara hospital at Irmandade Santa Casa de Misericórdia de Porto Alegre (ISCMPA), who will be allocated to a control group (it will be evaluated and reassessed) or intervention group (it will receive electrical stimulation). Interventions will occur during the HD session, twice a week, for eight weeks, totaling 16 sessions. The groups will be evaluated prior to physiotherapy intervention and at the end. The following outcomes will be measured: renal function, functional capacity, muscle strength of lower limbs and quality of life.

Conditions

Chronic Kidney Disease Stage 5; Electric Stimulation

Outcome Measures

Primary Outcomes (2)

• Change in soluble α-Klotho protein expression.

  It will be assessed by the analysis of the plasma content by immunoassay assay (ELISA).

  Baseline, after 4 weeks and after 8 weeks.

• Change in serum creatinine.

  It will be assessed by the analysis of the plasma content by spectrophotometry.

  Baseline, after 4 weeks and after 8 weeks.

Secondary Outcomes (4)

• Functional capacity.

  Baseline and after 8 weeks.

• Muscle strength of lower limbs.

  Baseline and after 8 weeks.

• Muscle strength of quadriceps.

  Evaluated: baseline and after 8 weeks.

• Quality of life evaluation.

  Baseline and after 8 weeks.

Study Arms (2)

Electrical stimulation

EXPERIMENTAL

The patients will receive neuromuscular electrical stimulation on quadriceps muscle and sensory stimulation in the anatomical region of the kidneys.

Other: Electrical stimulation

Control

NO INTERVENTION

The patients only will be evaluated and reassessed.

Interventions

Electrical stimulation OTHER

A protocol of neuromuscular electrical stimulation will be applied on the quadriceps muscle (symmetric biphasic pulsed current, 80 Hz, 400 µs, 10 s contraction time, 50s/30s/20s rest time, the reciprocal mode, 20 min. After, a protocol of sensory stimulation will be applied on the anatomical region of the kidneys (First: 50 pps, 300 µs, continuous mode for 5 min; Second: 30 pps, 100 µs, continuous mode for 10 min; Third: 20 pps, 1000 µs for 30 min).

Electrical stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with CKF on HD for a period ≥ 3 months;
• Kt/V ≥ 1.2 or URR ≥ 65%
• Age between 18 and 80 years old;
• Functional capacity ≥ 300 meters in the 6MWT.

You may not qualify if:

• 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;
• Patients with sequelae of stroke;
• Recent acute myocardial infarction (two months);
• Uncontrolled hypertension (SBP\> 230 mmHg and DBP\> 120 mmHg);
• Grade IV heart failure according to the New York Heart Association or decompensated;
• Unstable angina;
• Peripheral vascular changes in the lower limbs such as deep vein thrombosis;
• Disabling osteoarticular or musculoskeletal disease;
• Uncontrolled diabetes (blood glucose\> 300mg/dL);
• Feverish state and/or active infectious disease.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead
• Irmandade Santa Casa de Misericórdia de Porto Alegre: collaborator
• Leonhardt Ventures LLC: collaborator

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Rodrigo DM Plentz, PhD

  Federal University of Health Sciences of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo DM Plentz, PhD

CONTACT

+55 5191131651; roplentz@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 29, 2020
• Study Start: November 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: April 30, 2021
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share