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

Primary Purpose

Chronic Kidney Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Electrical stimulation
Sponsored by
Hospital Sirio-Libanes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Chronic Kidney Disease, Electrical stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HospitalsiriolibanesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Active comparator

Other

Experimental group

Placebo

Arm Description

Low frequency electrical stimulation for 60 minutes, three times a week during 60 days.

High frequency electrical stimulation for 60 minutes, three times a week during 60 days.

Low and High frequency electrical stimulation for 60 minutes, three times a week during 60 days.

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

Outcomes

Primary Outcome Measures

Assess the improvement of muscle mass
The muscle mass will be assessed by electric bioimpedance
Assess the improvement of muscle strength
The muscle strength will be assessed using isokinetic by peak torque
Assess the improvement of muscle resistance
The muscle resistance will be assessed using isokinetic by fatigue index

Secondary Outcome Measures

Assess the improvement of intervention in quality of life
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.
Correlate peripheral muscle function using medical research council score with nutritional status
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).
Correlate peripheral muscle function using hand grip with nutritional status
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).
Correlate peripheral muscle function with body composition
Peripheral muscle function will be assessed by isokinetic dynamometer and body composition will be assessed by bioimpedance (Fresenius)
Correlate peripheral muscle function with functional capacity
Peripheral muscle function will be assessed by isokinetic dynamometer and functional capacity will be assessed by six minute step test.
Assess the improvement of intervention in hemodialysis effusion
The hemodialysis efficacy will be assessed by Kt/v
Assess the improvement of intervention in functional capacity
Functional capacity will be assessed using six minute step test

Full Information

First Posted
November 6, 2018
Last Updated
January 14, 2022
Sponsor
Hospital Sirio-Libanes
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1. Study Identification

Unique Protocol Identification Number
NCT03779126
Brief Title
Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis
Official Title
Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
January 3, 2023 (Anticipated)
Study Completion Date
October 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sirio-Libanes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Chronic Kidney Disease, Electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The subjects will be randomised in four groups: 1) low frequency electrical stimulation (LF), 2) high frequency (HF), low and High frequency (LHF), and sham. The subjects will receive electrical stimulation in quadriceps bilaterally for 60 minutes , three times per week, during two months.
Masking
ParticipantInvestigator
Masking Description
The assessments will be conducted for a second investigator to ensure the blinding of first investigator. The subjects will be randomised in four groups (low frequency, high frequency, low and high frequency and sham stimulation) to ensure the blinding of participants.
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active comparator
Arm Type
Experimental
Arm Description
Low frequency electrical stimulation for 60 minutes, three times a week during 60 days.
Arm Title
Other
Arm Type
Experimental
Arm Description
High frequency electrical stimulation for 60 minutes, three times a week during 60 days.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Low and High frequency electrical stimulation for 60 minutes, three times a week during 60 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Electrical stimulation
Other Intervention Name(s)
Low frequency electrical stimulation (LF), High frequency (HF), Low and High frequency (LHF), sham stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess the improvement of muscle mass
Description
The muscle mass will be assessed by electric bioimpedance
Time Frame
Eight weeks
Title
Assess the improvement of muscle strength
Description
The muscle strength will be assessed using isokinetic by peak torque
Time Frame
Eight weeks
Title
Assess the improvement of muscle resistance
Description
The muscle resistance will be assessed using isokinetic by fatigue index
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Assess the improvement of intervention in quality of life
Description
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.
Time Frame
Eight weeks
Title
Correlate peripheral muscle function using medical research council score with nutritional status
Description
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).
Time Frame
Eight weeks
Title
Correlate peripheral muscle function using hand grip with nutritional status
Description
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).
Time Frame
Eight weeks
Title
Correlate peripheral muscle function with body composition
Description
Peripheral muscle function will be assessed by isokinetic dynamometer and body composition will be assessed by bioimpedance (Fresenius)
Time Frame
Eight weeks
Title
Correlate peripheral muscle function with functional capacity
Description
Peripheral muscle function will be assessed by isokinetic dynamometer and functional capacity will be assessed by six minute step test.
Time Frame
Eight weeks
Title
Assess the improvement of intervention in hemodialysis effusion
Description
The hemodialysis efficacy will be assessed by Kt/v
Time Frame
Eight weeks
Title
Assess the improvement of intervention in functional capacity
Description
Functional capacity will be assessed using six minute step test
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wellington PS Yamaguti, Phd
Phone
1133940200
Ext
4395
Email
wellington.psyamaguti@hsl.org.br
First Name & Middle Initial & Last Name or Official Title & Degree
Igor G Moraes, Ms
Phone
1133940200
Ext
5326
Email
igor.gmoraes@hsl.org.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wellington PS Yamaguti, Phd
Organizational Affiliation
Hospital Sírio-Libanês
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospitalsiriolibanes
City
São Paulo
ZIP/Postal Code
01308-050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wellington Yamaguti
Phone
551131550393
Email
wellington.psyamaguti@hsl.org.br
First Name & Middle Initial & Last Name & Degree
Igor Moraes
Phone
551131550200
Email
Igorgutierrezmoraes@yahoo.com.br

12. IPD Sharing Statement

Plan to Share IPD
No
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Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis

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