Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis
NCT ID: NCT03779126
Last Updated: 2023-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
56 participants
INTERVENTIONAL
2018-02-01
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active comparator
Low frequency electrical stimulation for 60 minutes, three times a week during 60 days.
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
High frequency electrical stimulation for 60 minutes, three times a week during 60 days.
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.
Experimental group
Low and High frequency electrical stimulation for 60 minutes, three times a week during 60 days.
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.
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
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Inability to perform the tests
18 Years
ALL
No
Sponsors
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Hospital Sirio-Libanes
OTHER
Responsible Party
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Wellington Yamaguti
Wellington Pereira dos Santos Yamaguti
Principal Investigators
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Wellington PS Yamaguti, Phd
Role: PRINCIPAL_INVESTIGATOR
Hospital Sírio-Libanês
Locations
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Hospitalsiriolibanes
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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. English, Portuguese.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
de Souza Francisco D, Moraes IG, Brito CP, Righetti RF, Yamaguti WP. The phase angle cut-off point capable of discriminating hemodialysis patients with reduced exercise tolerance: a cross-sectional study. BMC Sports Sci Med Rehabil. 2024 Feb 2;16(1):34. doi: 10.1186/s13102-024-00825-5.
Moraes IG, Brito CP, Francisco DS, Faria LM, Luders C, de Brito CMM, Yamaguti WP. Efficacy of neuromuscular electrical stimulation with combined low and high frequencies on body composition, peripheral muscle function and exercise tolerance in patients with chronic kidney disease undergoing haemodialysis: a protocol for a randomised, double-blind clinical trial. BMJ Open. 2022 Nov 9;12(11):e062062. doi: 10.1136/bmjopen-2022-062062.
Other Identifiers
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HSL 2017-95
Identifier Type: -
Identifier Source: org_study_id
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