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

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ClinicalTrials.gov Identifier: NCT03779126
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Wellington Yamaguti, Hospital Sirio-Libanes

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Device: Electrical stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Investigator)
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.
Primary Purpose: Treatment
Official Title: Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 3, 2019
Estimated Study Completion Date : October 3, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Assess the improvement of muscle mass [ Time Frame: Eight weeks ]
    The muscle mass will be assessed by electric bioimpedance

  2. Assess the improvement of muscle strength [ Time Frame: Eight weeks ]
    The muscle strength will be assessed using isokinetic by peak torque

  3. Assess the improvement of muscle resistance [ Time Frame: Eight weeks ]
    The muscle resistance will be assessed using isokinetic by fatigue index


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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)

  5. 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.

  6. Assess the improvement of intervention in hemodialysis effusion [ Time Frame: Eight weeks ]
    The hemodialysis efficacy will be assessed by Kt/v

  7. Assess the improvement of intervention in functional capacity [ Time Frame: Eight weeks ]
    Functional capacity will be assessed using six minute step test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779126


Contacts
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Contact: Wellington PS Yamaguti, Phd 1133940200 ext 4395 wellington.psyamaguti@hsl.org.br
Contact: Igor G Moraes, Ms 1133940200 ext 5326 igor.gmoraes@hsl.org.br

Locations
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Brazil
Hospitalsiriolibanes Recruiting
São Paulo, Brazil, 01308-050
Contact: Wellington Yamaguti    551131550393    wellington.psyamaguti@hsl.org.br   
Contact: Igor Moraes    551131550200    Igorgutierrezmoraes@yahoo.com.br   
Sponsors and Collaborators
Hospital Sirio-Libanes
Investigators
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Principal Investigator: Wellington PS Yamaguti, Phd Hospital Sírio-Libanês
Publications of Results:
Other Publications:

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Responsible Party: Wellington Yamaguti, Wellington Pereira dos Santos Yamaguti, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier: NCT03779126    
Other Study ID Numbers: HSL 2017-95
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wellington Yamaguti, Hospital Sirio-Libanes:
Chronic Kidney Disease
Electrical stimulation
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency