Strong Point of Inspiratory Muscle Training for Kidney and Immune Functions, and Quality of Life of Chronic Kidney Disease Patients on Hemodialysis
Sponsor study identifier
interventional
32
1 country
1
Study Start
February 20, 2022
Actual (reported)Primary Completion
April 26, 2022
Actual (reported)Study Completion
May 5, 2022
Actual (reported)Chronic Kidney Disease (CKD) is a global public health problem with an increasing prevalence and incidence, poor prognosis, and high costs. It is characterized by changes in the kidney structure and functions for more than three months. It is grouped into several stages, including end-stage kidney disease requiring renal replacement therapy (RRT). Hemodialysis (HD) is one of the RRT options other than kidney transplantation. Regular moderate-intensity exercise may improve certain elements of the immune system and have anti-inflammatory benefits. Aerobic exercise, extremity muscle strength exercises, and inspiratory muscle training have been reported to improve kidney function and quality of life in CKD patients receiving hemodialysis three times a week. However, the effect of inspiratory muscle training on kidney and immune function, and quality of life in CKD patients receiving HD twice a week remains unclear.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 5, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 31, 2022
Actual (reported)February 16, 2022
Actual (reported)February 20, 2022
Actual (reported)April 26, 2022
Actual (reported)May 5, 2022
Actual (reported)Urea levels
Kidney function will measure with urea and creatinine levels. The level of urea will examine before and 12 weeks after IMT program exercise. The examination is conducted by laboratory staff, followed by the enzymatic method. The urea level in miligrams per deciliter (mg/dL).
84 days
Creatinine levels
Kidney function will measure with urea and creatinine levels. The level of creatinine will examine before and 12 weeks after IMT program exercise. The examination is conducted by laboratory staff, followed by the enzymatic method. The creatinine level in miligrams per deciliter (mg/dL).
84 days
IL-6 level
Immune function will measure with IL-6 level. The level of IL-6 will examine before and 12 weeks after IMT program exercise. The examination is conducted by laboratory staff, followed by the enzymatic method. The IL-6 levels in picograms per mililiter (pg/ml).
84 days
Physical component summary (PCS)
Quality of life will assess using the KDQOL-SFTM v1.3 questionnaire.This questionnaire consists of a physical component summary (PCS), mental component summary (MCS), and kidney disease component summary (KDCS). We will perform interview using the KDQOL-SFTM v1.3 questionnaire before and 12 weeks after IMT program exercise. PCS measure in Unit on Scale with range 0 to 100, higher value mean better outcome.
84 days
Sixteen patients are assigned an IMT exercise program that included inspiratory muscle strengthening exercises thrice a week at a 50% MIP intensity, five sets per time, ten breathing repetitions per set, for an estimated duration of 20 minutes each using Threshold IMT for 12 weeks.
Sixteen patients are assigned an IMT exercise program that included inspiratory muscle strengthening exercises thrice a week at a 10% MIP intensity, five sets per time, ten breathing repetitions per set, for an estimated duration of 20 minutes each using Threshold IMT for 12 weeks.
Patients received IMT exercise program at a 50% MIP intensity for 12 weeks
Patients received IMT exercise program at a 10% MIP intensity for 12 weeks
Al Ihsan Province Hospital
Bandung, West Java, 40375, Indonesia
GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13.
National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
Irma Ruslina Defi, M.D., Ph.D.
Universitas Padjadjaran
32 participants (actual enrollment reported by the registry).
First Submitted
January 31, 2022
First Posted
February 16, 2022
Study Start
February 20, 2022
Actual (reported)Mental component summary (MCS)
Quality of life will assess using the KDQOL-SFTM v1.3 questionnaire.This questionnaire consists of a physical component summary (PCS), mental component summary (MCS), and kidney disease component summary (KDCS). We will perform interview using the KDQOL-SFTM v1.3 questionnaire before and 12 weeks after IMT program exercise. MCS measure in Unit on Scale with range 0 to 100, higher value mean better outcome.
84 days
Kidney disease component summary (KDCS)
Quality of life will assess using the KDQOL-SFTM v1.3 questionnaire.This questionnaire consists of a physical component summary (PCS), mental component summary (MCS), and kidney disease component summary (KDCS). We will perform interview using the KDQOL-SFTM v1.3 questionnaire before and 12 weeks after IMT program exercise. KDCS measure in Unit on Scale with range 0 to 100, higher value mean better outcome.
84 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Andrassy KM. Comments on 'KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease'. Kidney Int. 2013 Sep;84(3):622-3. doi: 10.1038/ki.2013.243. No abstract available.
Pellizzaro CO, Thome FS, Veronese FV. Effect of peripheral and respiratory muscle training on the functional capacity of hemodialysis patients. Ren Fail. 2013;35(2):189-97. doi: 10.3109/0886022X.2012.745727. Epub 2012 Nov 30.
Fassbinder TR, Winkelmann ER, Schneider J, Wendland J, Oliveira OB. Functional Capacity and Quality of Life in Patients with Chronic Kidney Disease In Pre-Dialytic Treatment and on Hemodialysis--A Cross sectional study. J Bras Nefrol. 2015 Jan-Mar;37(1):47-54. doi: 10.5935/0101-2800.20150008. English, Portuguese.
Figueiredo RR, Castro AA, Napoleone FM, Faray L, de Paula Junior AR, Osorio RA. Respiratory biofeedback accuracy in chronic renal failure patients: a method comparison. Clin Rehabil. 2012 Aug;26(8):724-32. doi: 10.1177/0269215511431088. Epub 2012 Jan 18.
Peres A, Perotto DL, Dorneles GP, Fuhro MI, Monteiro MB. Effects of intradialytic exercise on systemic cytokine in patients with chronic kidney disease. Ren Fail. 2015;37(9):1430-4. doi: 10.3109/0886022X.2015.1074473. Epub 2015 Aug 14.
Viana JL, Kosmadakis GC, Watson EL, Bevington A, Feehally J, Bishop NC, Smith AC. Evidence for anti-inflammatory effects of exercise in CKD. J Am Soc Nephrol. 2014 Sep;25(9):2121-30. doi: 10.1681/ASN.2013070702. Epub 2014 Apr 3.
Figueiredo PHS, Lima MMO, Costa HS, Martins JB, Flecha OD, Goncalves PF, Alves FL, Rodrigues VGB, Maciel EHB, Mendonca VA, Lacerda ACR, Vieira ELM, Teixeira AL, de Paula F, Balthazar CH. Effects of the inspiratory muscle training and aerobic training on respiratory and functional parameters, inflammatory biomarkers, redox status and quality of life in hemodialysis patients: A randomized clinical trial. PLoS One. 2018 Jul 26;13(7):e0200727. doi: 10.1371/journal.pone.0200727. eCollection 2018.
Bieber B, Qian J, Anand S, Yan Y, Chen N, Wang M, Wang M, Zuo L, Hou FF, Pisoni RL, Robinson BM, Ramirez SP. Two-times weekly hemodialysis in China: frequency, associated patient and treatment characteristics and Quality of Life in the China Dialysis Outcomes and Practice Patterns study. Nephrol Dial Transplant. 2014 Sep;29(9):1770-7. doi: 10.1093/ndt/gft472. Epub 2013 Dec 8.
Defi IR, Otafirda MV, Novitri N, Rachmi A. Feasibility of inspiratory muscle training as a rehabilitation program for chronic kidney disease patients in a developing country. Eur Rev Med Pharmacol Sci. 2023 Sep;27(18):8330-8339. doi: 10.26355/eurrev_202309_33755.
Primary Completion
April 26, 2022
Actual (reported)Study Completion
May 5, 2022
Actual (reported)Last Updated
March 22, 2023
Record last verified: 2023-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: