Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06502522

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Other names: Whole-body electrical muscle stimulation, Whole-body neuromuscular electrical stimulation, Whole-body electromyostimulation

Primary outcomes

  1. Change in kidney function

    Time frame: Baseline, after 4 and 8 weeks

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

  2. Change in kidney function

    Time frame: Baseline, after 4 and 8 weeks

    Change in kidney function will be assessed by serum creatinine measurement

Secondary outcomes

  1. Change in inflammatory profile

    Time frame: Baseline, after 4 and 8 weeks

    Change in inflammatory profile will be assessed by measurement of interleukin 6 (IL6)

  2. Change in inflammatory profile

    Time frame: Baseline, after 4 and 8 weeks

    Change in inflammatory profile will be assessed by measurement of interleukin 10 (IL10)

  3. Change in inflammatory profile

    Time frame: Baseline, after 4 and 8 weeks

    Change in inflammatory profile will be assessed by measurement of tumor necrosis factor alpha (TNF-a)

  4. Change in well-being levels

    Time frame: Baseline, after 4 and 8 weeks

    Change in well-being levels will be assessed by serum beta-endorphin dosage

  5. Change in muscle damage levels

    Time frame: Baseline, after 4 and 8 weeks

    Change in muscle damage levels will be assessed by serum creatine kinase (CK) measurement

  6. Change in isometric muscle strength of the quadriceps

    Time frame: Baseline and 8 weeks

    Change in isometric muscle strength of the quadriceps will be assessed by dynamometry

  7. Change in handgrip muscle strength

    Time frame: Baseline and 8 weeks

    Change in handgrip muscle strength will be assessed by dynamometry

  8. Change in lower limb muscle strength

    Time frame: Baseline and 8 weeks

    Change in lower limb muscle strength will be assessed using the 10-repetition sit-and-stand test (10SST)

  9. Change in functional capacity

    Time frame: Baseline and 8 weeks

    Change in functional capacity will be assessed through the distance covered in the six-minute walk test (6MWT)

  10. Change in sleep quality

    Time frame: 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.

  11. Change in quality of life

    Time frame: Baseline and 8 weeks

    Change in quality of life will be assessed using the EuroQoL-5D (EQ-5D) questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Jociane Schardong, PhD

CONTACT

[email protected]

55981348114

Jociane Schardong, PhD

CONTACT

[email protected]

55981348114

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Collaborators

  • Leonhardt Ventures LLC

Registry information

Official study title

Effects of Whole-body Electrostimulation on Kidney Function and Physical Capacity of Patients With Chronic Kidney Disease: Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 16, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.