<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03779126</url>
  </required_header>
  <id_info>
    <org_study_id>HSL 2017-95</org_study_id>
    <nct_id>NCT03779126</nct_id>
  </id_info>
  <brief_title>Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis</brief_title>
  <official_title>Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Sirio-Libanes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Sirio-Libanes</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic kidney disease is a systemic disease that affects not only renal function, but also,&#xD;
      several organs, bringing social, psychological and physical impact to the patients under this&#xD;
      condition. Due to long periods of inactivity during hemodialysis, electrical stimulation&#xD;
      becomes a feasible alternative for development physical activity in these patients.&#xD;
      Objective: Assess the efficacy of combined low and high frequency electrical stimulation in&#xD;
      peripheral muscle function during hemodialysis. Methods: A randomised double-blind clinical&#xD;
      trial with chronic kidney disease patient's under hemodialysis, whose will be allocated in&#xD;
      four groups: low frequency electrical stimulation (LF) ; high frequency (HF); low and high&#xD;
      frequency (LHF); and sham electrical stimulation. The groups will receive quadriceps&#xD;
      application bilaterally, for sixty minutes, three times a week, for two months. In the&#xD;
      intervention groups will be used highest intensity tolerated by the individual, and in the&#xD;
      sham will be maintained the minimum intensity after beginning of the perception of the&#xD;
      electric current. The individuals will be evaluated for anthropometry, functional capacity,&#xD;
      quality of life and biochemical parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients in the present study will be submitted to an evaluation protocol that must be&#xD;
      started after the consent of the responsible medical team, and the patient through the&#xD;
      Informed Consent Term. On the first day, patients will be evaluated for their personal&#xD;
      antecedents, life habits, inflammatory and nutritional status, quality of life, Medical&#xD;
      Research Council (MRC) and biochemical markers. On the second day, anthropometry, body&#xD;
      composition and functional capacity will be performed. On the third day, the muscular&#xD;
      function will be assessed by isokinetic evaluation. After completing the evaluations,&#xD;
      patients will be allocated into four groups: low frequency (LF), high frequency (HF), low and&#xD;
      high frequency (LHF), and sham.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">October 3, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 3, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the improvement of muscle mass</measure>
    <time_frame>Eight weeks</time_frame>
    <description>The muscle mass will be assessed by electric bioimpedance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the improvement of muscle strength</measure>
    <time_frame>Eight weeks</time_frame>
    <description>The muscle strength will be assessed using isokinetic by peak torque</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the improvement of muscle resistance</measure>
    <time_frame>Eight weeks</time_frame>
    <description>The muscle resistance will be assessed using isokinetic by fatigue index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess the improvement of intervention in quality of life</measure>
    <time_frame>Eight weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlate peripheral muscle function using medical research council score with nutritional status</measure>
    <time_frame>Eight weeks</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlate peripheral muscle function using hand grip with nutritional status</measure>
    <time_frame>Eight weeks</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlate peripheral muscle function with body composition</measure>
    <time_frame>Eight weeks</time_frame>
    <description>Peripheral muscle function will be assessed by isokinetic dynamometer and body composition will be assessed by bioimpedance (Fresenius)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlate peripheral muscle function with functional capacity</measure>
    <time_frame>Eight weeks</time_frame>
    <description>Peripheral muscle function will be assessed by isokinetic dynamometer and functional capacity will be assessed by six minute step test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the improvement of intervention in hemodialysis effusion</measure>
    <time_frame>Eight weeks</time_frame>
    <description>The hemodialysis efficacy will be assessed by Kt/v</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the improvement of intervention in functional capacity</measure>
    <time_frame>Eight weeks</time_frame>
    <description>Functional capacity will be assessed using six minute step test</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>Active comparator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low frequency electrical stimulation for 60 minutes, three times a week during 60 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High frequency electrical stimulation for 60 minutes, three times a week during 60 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low and High frequency electrical stimulation for 60 minutes, three times a week during 60 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electrical stimulation</intervention_name>
    <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.</description>
    <arm_group_label>Active comparator</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_label>Other</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Low frequency electrical stimulation (LF)</other_name>
    <other_name>High frequency (HF)</other_name>
    <other_name>Low and High frequency (LHF)</other_name>
    <other_name>sham stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic kidney disease&#xD;
&#xD;
          -  Classical hemodialysis&#xD;
&#xD;
          -  Over 18 years old&#xD;
&#xD;
          -  No pace maker&#xD;
&#xD;
          -  Without cognitive or motor deficit&#xD;
&#xD;
          -  No regular physical activity in the last six months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abstention for more than two consecutive sessions or four in total&#xD;
&#xD;
          -  Inability to perform the tests&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wellington PS Yamaguti, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Sírio-Libanês</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wellington PS Yamaguti, Phd</last_name>
    <phone>1133940200</phone>
    <phone_ext>4395</phone_ext>
    <email>wellington.psyamaguti@hsl.org.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Igor G Moraes, Ms</last_name>
    <phone>1133940200</phone>
    <phone_ext>5326</phone_ext>
    <email>igor.gmoraes@hsl.org.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospitalsiriolibanes</name>
      <address>
        <city>São Paulo</city>
        <zip>01308-050</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wellington Yamaguti</last_name>
      <phone>551131550393</phone>
      <email>wellington.psyamaguti@hsl.org.br</email>
    </contact>
    <contact_backup>
      <last_name>Igor Moraes</last_name>
      <phone>551131550200</phone>
      <email>Igorgutierrezmoraes@yahoo.com.br</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Silva VG, Amaral C, Monteiro MB, Nascimento DM, Boschetti JR. Effects of inspiratory muscle training in hemodialysis patients. J Bras Nefrol. 2011 Mar;33(1):62-8. Erratum In: J Bras Nefrol. 2011 Apr-Jun;33(2):282. English, Portuguese.</citation>
    <PMID>21541465</PMID>
  </reference>
  <reference>
    <citation>Hirai K, Ookawara S, Morishita Y. Sarcopenia and Physical Inactivity in Patients With Chronic Kidney Disease. Nephrourol Mon. 2016 Apr 26;8(3):e37443. doi: 10.5812/numonthly.37443. eCollection 2016 May.</citation>
    <PMID>27570755</PMID>
  </reference>
  <reference>
    <citation>Eidemak I, Haaber AB, Feldt-Rasmussen B, Kanstrup IL, Strandgaard S. Exercise training and the progression of chronic renal failure. Nephron. 1997;75(1):36-40. doi: 10.1159/000189497.</citation>
    <PMID>9031268</PMID>
  </reference>
  <reference>
    <citation>Kopple JD, Wang H, Casaburi R, Fournier M, Lewis MI, Taylor W, Storer TW. Exercise in maintenance hemodialysis patients induces transcriptional changes in genes favoring anabolic muscle. J Am Soc Nephrol. 2007 Nov;18(11):2975-86. doi: 10.1681/ASN.2006070794. Epub 2007 Oct 17. No abstract available.</citation>
    <PMID>17942969</PMID>
  </reference>
  <reference>
    <citation>Koh KP, Fassett RG, Sharman JE, Coombes JS, Williams AD. Effect of intradialytic versus home-based aerobic exercise training on physical function and vascular parameters in hemodialysis patients: a randomized pilot study. Am J Kidney Dis. 2010 Jan;55(1):88-99. doi: 10.1053/j.ajkd.2009.09.025. Epub 2009 Nov 22.</citation>
    <PMID>19932545</PMID>
  </reference>
  <reference>
    <citation>Klassen A, Racasan S, Gherman-Caprioara M, Kurner B, Blaser C, Bahner U, Heidland A. High-tone external muscle stimulation in endstage renal disease: effects on quality of life in patients with peripheral neuropathy. Clin Nephrol. 2013 Jan;79 Suppl 1:S28-33.</citation>
    <PMID>23249530</PMID>
  </reference>
  <reference>
    <citation>Di Iorio B, Torraca S, Gustaferro P, Fazeli G, Heidland A. High-frequency external muscle stimulation in acute kidney injury (AKI): potential shortening of its clinical course. Clin Nephrol. 2013 Jan;79 Suppl 1:S37-45.</citation>
    <PMID>23249532</PMID>
  </reference>
  <reference>
    <citation>Bruggemann AK, Mello CL, Dal Pont T, Hizume Kunzler D, Martins DF, Bobinski F, Pereira Yamaguti W, Paulin E. Effects of Neuromuscular Electrical Stimulation During Hemodialysis on Peripheral Muscle Strength and Exercise Capacity: A Randomized Clinical Trial. Arch Phys Med Rehabil. 2017 May;98(5):822-831.e1. doi: 10.1016/j.apmr.2016.12.009. Epub 2017 Jan 16.</citation>
    <PMID>28093194</PMID>
  </reference>
  <reference>
    <citation>Sesso RC, Lopes AA, Thome FS, Lugon JR, Martins CT. Brazilian Chronic Dialysis Census 2014. J Bras Nefrol. 2016 Mar;38(1):54-61. doi: 10.5935/0101-2800.20160009. English, Portuguese.</citation>
    <PMID>27049365</PMID>
  </reference>
  <reference>
    <citation>Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res. 1994 Oct;3(5):329-38. doi: 10.1007/BF00451725.</citation>
    <PMID>7841967</PMID>
  </reference>
  <reference>
    <citation>Duarte PS, Ciconelli RM, Sesso R. Cultural adaptation and validation of the &quot;Kidney Disease and Quality of Life--Short Form (KDQOL-SF 1.3)&quot; in Brazil. Braz J Med Biol Res. 2005 Feb;38(2):261-70. doi: 10.1590/s0100-879x2005000200015. Epub 2005 Feb 15.</citation>
    <PMID>15785838</PMID>
  </reference>
  <reference>
    <citation>Franssen FM, Broekhuizen R, Janssen PP, Wouters EF, Schols AM. Limb muscle dysfunction in COPD: effects of muscle wasting and exercise training. Med Sci Sports Exerc. 2005 Jan;37(1):2-9. doi: 10.1249/01.mss.0000150082.59155.4f.</citation>
    <PMID>15632660</PMID>
  </reference>
  <reference>
    <citation>Hough CL, Lieu BK, Caldwell ES. Manual muscle strength testing of critically ill patients: feasibility and interobserver agreement. Crit Care. 2011;15(1):R43. doi: 10.1186/cc10005. Epub 2011 Jan 28.</citation>
    <PMID>21276225</PMID>
  </reference>
  <reference>
    <citation>Desrosiers J, Bravo G, Hebert R, Dutil E. Normative data for grip strength of elderly men and women. Am J Occup Ther. 1995 Jul-Aug;49(7):637-44. doi: 10.5014/ajot.49.7.637.</citation>
    <PMID>7573334</PMID>
  </reference>
  <reference>
    <citation>Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.</citation>
    <PMID>18511703</PMID>
  </reference>
  <reference>
    <citation>Breitsameter G, Figueiredo AE, Kochhann DS. Calculation of Kt/V in haemodialysis: a comparison between the formulas. J Bras Nefrol. 2012 Mar;34(1):22-6. English, Portuguese.</citation>
    <PMID>22441178</PMID>
  </reference>
  <reference>
    <citation>Keane D, Gardiner C, Lindley E, Lines S, Woodrow G, Wright M. Changes in Body Composition in the Two Years after Initiation of Haemodialysis: A Retrospective Cohort Study. Nutrients. 2016 Nov 4;8(11):702. doi: 10.3390/nu8110702.</citation>
    <PMID>27827911</PMID>
  </reference>
  <reference>
    <citation>Arcuri JF, Borghi-Silva A, Labadessa IG, Sentanin AC, Candolo C, Pires Di Lorenzo VA. Validity and Reliability of the 6-Minute Step Test in Healthy Individuals: A Cross-sectional Study. Clin J Sport Med. 2016 Jan;26(1):69-75. doi: 10.1097/JSM.0000000000000190.</citation>
    <PMID>25706661</PMID>
  </reference>
  <reference>
    <citation>Pessoa BV, Arcuri JF, Labadessa IG, Costa JN, Sentanin AC, Di Lorenzo VA. Validity of the six-minute step test of free cadence in patients with chronic obstructive pulmonary disease. Braz J Phys Ther. 2014 May-Jun;18(3):228-36. doi: 10.1590/bjpt-rbf.2014.0041.</citation>
    <PMID>25003275</PMID>
  </reference>
  <reference>
    <citation>Segers J, Hermans G, Bruyninckx F, Meyfroidt G, Langer D, Gosselink R. Feasibility of neuromuscular electrical stimulation in critically ill patients. J Crit Care. 2014 Dec;29(6):1082-8. doi: 10.1016/j.jcrc.2014.06.024. Epub 2014 Jun 30.</citation>
    <PMID>25108833</PMID>
  </reference>
  <reference>
    <citation>Parry SM, Berney S, Warrillow S, El-Ansary D, Bryant AL, Hart N, Puthucheary Z, Koopman R, Denehy L. Functional electrical stimulation with cycling in the critically ill: a pilot case-matched control study. J Crit Care. 2014 Aug;29(4):695.e1-7. doi: 10.1016/j.jcrc.2014.03.017. Epub 2014 Mar 26.</citation>
    <PMID>24768534</PMID>
  </reference>
  <results_reference>
    <citation>Dobsak P, Homolka P, Svojanovsky J, Reichertova A, Soucek M, Novakova M, Dusek L, Vasku J, Eicher JC, Siegelova J. Intra-dialytic electrostimulation of leg extensors may improve exercise tolerance and quality of life in hemodialyzed patients. Artif Organs. 2012 Jan;36(1):71-8. doi: 10.1111/j.1525-1594.2011.01302.x. Epub 2011 Aug 16.</citation>
    <PMID>21848929</PMID>
  </results_reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>November 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>January 14, 2022</last_update_submitted>
  <last_update_submitted_qc>January 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Sirio-Libanes</investigator_affiliation>
    <investigator_full_name>Wellington Yamaguti</investigator_full_name>
    <investigator_title>Wellington Pereira dos Santos Yamaguti</investigator_title>
  </responsible_party>
  <keyword>Chronic Kidney Disease</keyword>
  <keyword>Electrical stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03779126
org study id: HSL 2017-95
nct id: NCT03779126
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
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.
primary purpose: Treatment
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.
measure: Assess the improvement of muscle mass
time frame: Eight weeks
description: The muscle mass will be assessed by electric bioimpedance
measure: Assess the improvement of muscle strength
time frame: Eight weeks
description: The muscle strength will be assessed using isokinetic by peak torque
measure: Assess the improvement of muscle resistance
time frame: Eight weeks
description: The muscle resistance will be assessed using isokinetic by fatigue index
measure: Assess the improvement of intervention in quality of life
time frame: Eight weeks
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.
measure: Correlate peripheral muscle function using medical research council score with nutritional status
time frame: Eight weeks
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).
measure: Correlate peripheral muscle function using hand grip with nutritional status
time frame: Eight weeks
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).
measure: Correlate peripheral muscle function with body composition
time frame: Eight weeks
description: Peripheral muscle function will be assessed by isokinetic dynamometer and body composition will be assessed by bioimpedance (Fresenius)
measure: Correlate peripheral muscle function with functional capacity
time frame: Eight weeks
description: Peripheral muscle function will be assessed by isokinetic dynamometer and functional capacity will be assessed by six minute step test.
measure: Assess the improvement of intervention in hemodialysis effusion
time frame: Eight weeks
description: The hemodialysis efficacy will be assessed by Kt/v
measure: Assess the improvement of intervention in functional capacity
time frame: Eight weeks
description: Functional capacity will be assessed using six minute step test
arm group label: Active comparator
arm group type: Experimental
description: Low frequency electrical stimulation for 60 minutes, three times a week during 60 days.
arm group label: Other
arm group type: Experimental
description: High frequency electrical stimulation for 60 minutes, three times a week during 60 days.
arm group label: Experimental group
arm group type: Experimental
description: Low and High frequency electrical stimulation for 60 minutes, three times a week during 60 days.
arm group label: Placebo
arm group type: Placebo Comparator
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: Electrical stimulation
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.
arm group label: Active comparator
arm group label: Experimental group
arm group label: Other
arm group label: Placebo
other name: Low frequency electrical stimulation (LF)
other name: High frequency (HF)
other name: Low and High frequency (LHF)
other name: sham stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wellington PS Yamaguti, Phd
role: Principal Investigator
affiliation: Hospital Sírio-Libanês
last name: Wellington PS Yamaguti, Phd
phone: 1133940200
phone ext: 4395
email: wellington.psyamaguti@hsl.org.br
last name: Igor G Moraes, Ms
phone: 1133940200
phone ext: 5326
email: igor.gmoraes@hsl.org.br
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
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PMID: 21541465
citation: Hirai K, Ookawara S, Morishita Y. Sarcopenia and Physical Inactivity in Patients With Chronic Kidney Disease. Nephrourol Mon. 2016 Apr 26;8(3):e37443. doi: 10.5812/numonthly.37443. eCollection 2016 May.
PMID: 27570755
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PMID: 9031268
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PMID: 17942969
citation: Koh KP, Fassett RG, Sharman JE, Coombes JS, Williams AD. Effect of intradialytic versus home-based aerobic exercise training on physical function and vascular parameters in hemodialysis patients: a randomized pilot study. Am J Kidney Dis. 2010 Jan;55(1):88-99. doi: 10.1053/j.ajkd.2009.09.025. Epub 2009 Nov 22.
PMID: 19932545
citation: Klassen A, Racasan S, Gherman-Caprioara M, Kurner B, Blaser C, Bahner U, Heidland A. High-tone external muscle stimulation in endstage renal disease: effects on quality of life in patients with peripheral neuropathy. Clin Nephrol. 2013 Jan;79 Suppl 1:S28-33.
PMID: 23249530
citation: Di Iorio B, Torraca S, Gustaferro P, Fazeli G, Heidland A. High-frequency external muscle stimulation in acute kidney injury (AKI): potential shortening of its clinical course. Clin Nephrol. 2013 Jan;79 Suppl 1:S37-45.
PMID: 23249532
citation: Bruggemann AK, Mello CL, Dal Pont T, Hizume Kunzler D, Martins DF, Bobinski F, Pereira Yamaguti W, Paulin E. Effects of Neuromuscular Electrical Stimulation During Hemodialysis on Peripheral Muscle Strength and Exercise Capacity: A Randomized Clinical Trial. Arch Phys Med Rehabil. 2017 May;98(5):822-831.e1. doi: 10.1016/j.apmr.2016.12.009. Epub 2017 Jan 16.
PMID: 28093194
citation: Sesso RC, Lopes AA, Thome FS, Lugon JR, Martins CT. Brazilian Chronic Dialysis Census 2014. J Bras Nefrol. 2016 Mar;38(1):54-61. doi: 10.5935/0101-2800.20160009. English, Portuguese.
PMID: 27049365
citation: Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res. 1994 Oct;3(5):329-38. doi: 10.1007/BF00451725.
PMID: 7841967
citation: Duarte PS, Ciconelli RM, Sesso R. Cultural adaptation and validation of the "Kidney Disease and Quality of Life--Short Form (KDQOL-SF 1.3)" in Brazil. Braz J Med Biol Res. 2005 Feb;38(2):261-70. doi: 10.1590/s0100-879x2005000200015. Epub 2005 Feb 15.
PMID: 15785838
citation: Franssen FM, Broekhuizen R, Janssen PP, Wouters EF, Schols AM. Limb muscle dysfunction in COPD: effects of muscle wasting and exercise training. Med Sci Sports Exerc. 2005 Jan;37(1):2-9. doi: 10.1249/01.mss.0000150082.59155.4f.
PMID: 15632660
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PMID: 21276225
citation: Desrosiers J, Bravo G, Hebert R, Dutil E. Normative data for grip strength of elderly men and women. Am J Occup Ther. 1995 Jul-Aug;49(7):637-44. doi: 10.5014/ajot.49.7.637.
PMID: 7573334
citation: Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
PMID: 18511703
citation: Breitsameter G, Figueiredo AE, Kochhann DS. Calculation of Kt/V in haemodialysis: a comparison between the formulas. J Bras Nefrol. 2012 Mar;34(1):22-6. English, Portuguese.
PMID: 22441178
citation: Keane D, Gardiner C, Lindley E, Lines S, Woodrow G, Wright M. Changes in Body Composition in the Two Years after Initiation of Haemodialysis: A Retrospective Cohort Study. Nutrients. 2016 Nov 4;8(11):702. doi: 10.3390/nu8110702.
PMID: 27827911
citation: Arcuri JF, Borghi-Silva A, Labadessa IG, Sentanin AC, Candolo C, Pires Di Lorenzo VA. Validity and Reliability of the 6-Minute Step Test in Healthy Individuals: A Cross-sectional Study. Clin J Sport Med. 2016 Jan;26(1):69-75. doi: 10.1097/JSM.0000000000000190.
PMID: 25706661
citation: Pessoa BV, Arcuri JF, Labadessa IG, Costa JN, Sentanin AC, Di Lorenzo VA. Validity of the six-minute step test of free cadence in patients with chronic obstructive pulmonary disease. Braz J Phys Ther. 2014 May-Jun;18(3):228-36. doi: 10.1590/bjpt-rbf.2014.0041.
PMID: 25003275
citation: Segers J, Hermans G, Bruyninckx F, Meyfroidt G, Langer D, Gosselink R. Feasibility of neuromuscular electrical stimulation in critically ill patients. J Crit Care. 2014 Dec;29(6):1082-8. doi: 10.1016/j.jcrc.2014.06.024. Epub 2014 Jun 30.
PMID: 25108833
citation: Parry SM, Berney S, Warrillow S, El-Ansary D, Bryant AL, Hart N, Puthucheary Z, Koopman R, Denehy L. Functional electrical stimulation with cycling in the critically ill: a pilot case-matched control study. J Crit Care. 2014 Aug;29(4):695.e1-7. doi: 10.1016/j.jcrc.2014.03.017. Epub 2014 Mar 26.
PMID: 24768534
citation: Dobsak P, Homolka P, Svojanovsky J, Reichertova A, Soucek M, Novakova M, Dusek L, Vasku J, Eicher JC, Siegelova J. Intra-dialytic electrostimulation of leg extensors may improve exercise tolerance and quality of life in hemodialyzed patients. Artif Organs. 2012 Jan;36(1):71-8. doi: 10.1111/j.1525-1594.2011.01302.x. Epub 2011 Aug 16.
PMID: 21848929
responsible party type: Principal Investigator
investigator affiliation: Hospital Sirio-Libanes
investigator full name: Wellington Yamaguti
investigator title: Wellington Pereira dos Santos Yamaguti
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: No