Effects of Whole-body Electrostimulation on Patients With Chronic Kidney Disease

NCT06502522 | Not Yet Recruiting DMC

• 1 other identifier: WB-EMS-KIDNEY
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (2)

• Change in kidney function

  Change in kidney function will be assessed by alpha klotho protein dosage

  Baseline, after 4 and 8 weeks

• Change in kidney function

  Change in kidney function will be assessed by serum creatinine measurement

  Baseline, after 4 and 8 weeks

Secondary Outcomes (11)

• Change in inflammatory profile

  Baseline, after 4 and 8 weeks

• Change in inflammatory profile

  Baseline, after 4 and 8 weeks

• Change in inflammatory profile

  Baseline, after 4 and 8 weeks

• Change in well-being levels

  Baseline, after 4 and 8 weeks

• Change in muscle damage levels

  Baseline, after 4 and 8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Whole-body neuromuscular electrical stimulation will be administered for three times week for eight weeks, totaling 24 sessions.

Other: Whole-body electrical stimulation

Control group

NO INTERVENTION

No intervention will be carried out.

Interventions

Whole-body electrical stimulation OTHER

Symmetrical biphasic current, pulse width of 400 μs, frequency of 75 Hz, contraction time of five seconds and rest time of 10 seconds. The intensity will be individually adjusted to the patient's maximum tolerance limit to reach the motor threshold and the volunteer will be instructed to achieve a score of 7 on the modified BORG scale to ensure a moderate-intense effort. The session time will be 16 minutes, resulting in a total of 64 contractions per session. The progression of overload will only occur with an increase in the intensity of all muscle groups during the sessions. Concomitantly with the electrical stimuli, the volunteer will perform exercises for the upper, lower limbs and trunk. After performing neuromuscular electrical stimulation, the patient will remain in the supine position to receive sensory stimulation throughout the body. The parameters used will be: frequency of 20 Hz and pulse width of 400 μs for 44 minutes.

Also known as: Whole-body electrical muscle stimulation, Whole-body neuromuscular electrical stimulation, Whole-body electromyostimulation

Intervention group

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 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead
• Leonhardt Ventures LLC: collaborator

MeSH Terms

Conditions

Renal Insufficiency, Chronic

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

Study Officials

• Jociane Schardong, PhD

  Federal University of Health Sciences of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jociane Schardong, PhD

CONTACT

55981348114; joci_fisioufsm@yahoo.com.br

Jociane Schardong, PhD

CONTACT

55981348114; jocianeschardong@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07