Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis

October 25, 2023 updated by: Wellington Yamaguti, Hospital Sirio-Libanes
Chronic kidney disease is a systemic disease that affects not only renal function, but also, several organs, bringing social, psychological and physical impact to the patients under this condition. Due to long periods of inactivity during hemodialysis, electrical stimulation becomes a feasible alternative for development physical activity in these patients. Objective: Assess the efficacy of combined low and high frequency electrical stimulation in peripheral muscle function during hemodialysis. Methods: A randomised double-blind clinical trial with chronic kidney disease patient's under hemodialysis, whose will be allocated in four groups: low frequency electrical stimulation (LF) ; high frequency (HF); low and high frequency (LHF); and sham electrical stimulation. The groups will receive quadriceps application bilaterally, for sixty minutes, three times a week, for two months. In the intervention groups will be used highest intensity tolerated by the individual, and in the sham will be maintained the minimum intensity after beginning of the perception of the electric current. The individuals will be evaluated for anthropometry, functional capacity, quality of life and biochemical parameters.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients in the present study will be submitted to an evaluation protocol that must be started after the consent of the responsible medical team, and the patient through the Informed Consent Term. On the first day, patients will be evaluated for their personal antecedents, life habits, inflammatory and nutritional status, quality of life, Medical Research Council (MRC) and biochemical markers. On the second day, anthropometry, body composition and functional capacity will be performed. On the third day, the muscular function will be assessed by isokinetic evaluation. After completing the evaluations, patients will be allocated into four groups: low frequency (LF), high frequency (HF), low and high frequency (LHF), and sham.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chronic kidney disease
  • Classical hemodialysis
  • Over 18 years old
  • No pace maker
  • Without cognitive or motor deficit
  • No regular physical activity in the last six months

Exclusion Criteria:

  • Abstention for more than two consecutive sessions or four in total
  • Inability to perform the tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active comparator
Low frequency electrical stimulation for 60 minutes, three times a week during 60 days.
Device: Electrical stimulation
1) Low frequency electrical stimulation (LF) ; High frequency (HF); Low and High frequency (LHF) ; and sham stimulation. Groups will receive bilaterally electrical stimulation, for 60 minutes, three times a week, during two months.
Other Names:
  • Low frequency electrical stimulation (LF)
  • High frequency (HF)
  • Low and High frequency (LHF)
  • sham stimulation
Experimental: Other
High frequency electrical stimulation for 60 minutes, three times a week during 60 days.
Device: Electrical stimulation
1) Low frequency electrical stimulation (LF) ; High frequency (HF); Low and High frequency (LHF) ; and sham stimulation. Groups will receive bilaterally electrical stimulation, for 60 minutes, three times a week, during two months.
Other Names:
  • Low frequency electrical stimulation (LF)
  • High frequency (HF)
  • Low and High frequency (LHF)
  • sham stimulation
Experimental: Experimental group
Low and High frequency electrical stimulation for 60 minutes, three times a week during 60 days.
Device: Electrical stimulation
1) Low frequency electrical stimulation (LF) ; High frequency (HF); Low and High frequency (LHF) ; and sham stimulation. Groups will receive bilaterally electrical stimulation, for 60 minutes, three times a week, during two months.
Other Names:
  • Low frequency electrical stimulation (LF)
  • High frequency (HF)
  • Low and High frequency (LHF)
  • sham stimulation
Placebo Comparator: Placebo
Placebo electrical stimulation for 60 minutes, three times a week during 60 days. In the intervention groups will be used highest intensity tolerated by the individual, and in the sham will be maintained the minimum intensity after beginning of the perception of the electric current
Device: Electrical stimulation
1) Low frequency electrical stimulation (LF) ; High frequency (HF); Low and High frequency (LHF) ; and sham stimulation. Groups will receive bilaterally electrical stimulation, for 60 minutes, three times a week, during two months.
Other Names:
  • Low frequency electrical stimulation (LF)
  • High frequency (HF)
  • Low and High frequency (LHF)
  • sham stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the improvement of muscle mass
Time Frame: Eight weeks
The muscle mass will be assessed by electric bioimpedance
Eight weeks
Assess the improvement of muscle strength
Time Frame: Eight weeks
The muscle strength will be assessed using isokinetic by peak torque
Eight weeks
Assess the improvement of muscle resistance
Time Frame: Eight weeks
The muscle resistance will be assessed using isokinetic by fatigue index
Eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the improvement of intervention in quality of life
Time Frame: Eight weeks
The quality of life will be assessed by kidney disease quality of life-short form questionnaire (KDQOL-SF).It is eighty questions about physical aspects, economical and psychological with 80 items. The range could be from 0 to 100. A less score reflect better quality of life.
Eight weeks
Correlate peripheral muscle function using medical research council score with nutritional status
Time Frame: Eight weeks
Peripheral muscle strength will be assessed by medical research council score. It is a score which measure the muscle strength in six plans of movement with range 0 to 60. Higher values represent a better outcome. The findings will be correlated with biomarkers (urea, creatinine, ferritin, lactate and insulin growth factor 1).
Eight weeks
Correlate peripheral muscle function using hand grip with nutritional status
Time Frame: Eight weeks
Peripheral muscle strength will be assessed by hand grip strength. It is a measure the hand grip strength with range 0 to 120 pounds. Higher values represent a better outcome.The findings will be correlated with biomarkers (urea, creatinine, ferritin, lactate and insulin growth factor 1).
Eight weeks
Correlate peripheral muscle function with body composition
Time Frame: Eight weeks
Peripheral muscle function will be assessed by isokinetic dynamometer and body composition will be assessed by bioimpedance (Fresenius)
Eight weeks
Correlate peripheral muscle function with functional capacity
Time Frame: Eight weeks
Peripheral muscle function will be assessed by isokinetic dynamometer and functional capacity will be assessed by six minute step test.
Eight weeks
Assess the improvement of intervention in hemodialysis effusion
Time Frame: Eight weeks
The hemodialysis efficacy will be assessed by Kt/v
Eight weeks
Assess the improvement of intervention in functional capacity
Time Frame: Eight weeks
Functional capacity will be assessed using six minute step test
Eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sirio-Libanes

Investigators

  • Principal Investigator: Wellington PS Yamaguti, Phd, Hospital Sírio-Libanês

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

December 14, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSL 2017-95

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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