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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active comparator | Experimental | Low frequency electrical stimulation for 60 minutes, three times a week during 60 days. |
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| Other | Experimental | High frequency electrical stimulation for 60 minutes, three times a week during 60 days. |
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| Experimental group | Experimental | Low and High frequency electrical stimulation for 60 minutes, three times a week during 60 days. |
|
| Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the improvement of muscle mass | The muscle mass will be assessed by electric bioimpedance | Eight weeks |
| Assess the improvement of muscle strength | The muscle strength will be assessed using isokinetic by peak torque | Eight weeks |
| Assess the improvement of muscle resistance | The muscle resistance will be assessed using isokinetic by fatigue index | Eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Eight weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wellington PS Yamaguti, Phd | Contact | 1133940200 | 4395 | wellington.psyamaguti@hsl.org.br |
| Igor G Moraes, Ms | Contact | 1133940200 | 5326 | igor.gmoraes@hsl.org.br |
| Name | Affiliation | Role |
|---|---|---|
| Wellington PS Yamaguti, Phd | Hospital Sirio-Libanes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospitalsiriolibanes | Recruiting | São Paulo | 01308-050 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21541465 | Background | 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. | |
| 27570755 | Background | 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. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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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.
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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.
|
| 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). | Eight weeks |
| 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). | Eight weeks |
| 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) | Eight weeks |
| 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. | Eight weeks |
| Assess the improvement of intervention in hemodialysis effusion | The hemodialysis efficacy will be assessed by Kt/v | Eight weeks |
| Assess the improvement of intervention in functional capacity | Functional capacity will be assessed using six minute step test | Eight weeks |
| 9031268 | Background | 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. |
| 17942969 | Background | 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. |
| 19932545 | Background | 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. |
| 23249530 | Background | 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. |
| 23249532 | Background | 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. |
| 28093194 | Background | 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. |
| 27049365 | Background | 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. |
| 7841967 | Background | 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. |
| 15785838 | Background | 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. |
| 15632660 | Background | 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. |
| 21276225 | Background | 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. |
| 7573334 | Background | 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. |
| 18511703 | Background | 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. |
| 22441178 | Background | 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. |
| 27827911 | Background | 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. |
| 25706661 | Background | 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. |
| 25003275 | Background | 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. |
| 25108833 | Background | 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. |
| 24768534 | Background | 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. |
| 21848929 | Result | 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. |
| 38308310 | Derived | 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. |
| 36351736 | Derived | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |