Inspiratory Muscle Training for Chronic Kidney Disease Patients on Hemodialysis

Chronic Kidney Disease Stage 5 on Dialysis Clinical Trial

Official title:

Strong Point of Inspiratory Muscle Training for Kidney and Immune Functions, and Quality of Life of Chronic Kidney Disease Patients on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05241652
• Other study ID #: IKFR-202201.01
• Status: Completed
• Phase: N/A
• Start date: February 20, 2022
• Est. completion date: May 5, 2022

Study information

• Verified date: March 2023
• Source: Universitas Padjadjaran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Exercise causes a variety of immunological responses, including the production of interleukins. There is some evidence that exercise is correlated with a reduction in systemic inflammation. Prolonged exercise and regular exercise decrease baseline IL-6 levels as a pro-inflammatory cytokine. Inspiratory Muscle Training (IMT) exercise program can improve endothelial function and oxidative stress, both of which affect the progression of kidney disease. The IMT exercise program can induce a decrease in sympathoadrenal activation, as well as a decrease in adrenaline and noradrenaline circulation, thereby preventing endothelial and glycocalyx injury. So, the IMT can improve kidney function. Previous study showed IMT reducing urea and creatinine levels in CKD patients receiving HD thrice a week. The IMT also can improve quality of life of CKD patients receiving HD thrice a week. Hemodialysis remains the primary RRT modality in Indonesia, and practice is strongly influenced by the socioeconomics of the region due to lack of third-party payers. Stretching resources to maximize outcome benefit is critical, and twice-weekly HD sessions are an improved and cost-effective clinical practice. Observational studies of twice-weekly HD in Taiwan and China have shown a possible benefit of the slower decline of renal function and acceptable nutritional status in recent years. However, there are limited data from performing IMT can improve kidney and immune function, and quality of life of CKD patients receiving HD twice a week. As result of limited data, the investigators is looked forward to answer about the effect of the IMT exercise program on improving inflammatory cytokine IL-6, kidney function, and quality of life in end-stage CKD patients receiving HD twice a week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 5, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 54 Years

Eligibility

Inclusion Criteria:

• can perform inspiratory muscle training (IMT) procedures,
• have a MIP (Maximal Inspiratory Pressure) value of less than 70% of the predicted measurement results using the micro respiratory pressure meter (RPM) tool,
• hemoglobin level greater than 8 g/dL,
• ability to understand oral and written instructions,
• cooperative and willing to participate in the research,
• able to do exercises after signing an informed consent form.

Exclusion Criteria:

• patients with obstructive lung disease, pleural effusion, cardiomegaly, heart failure, coronary heart disease, history of pneumothorax, history of thoracic or abdominal surgery in the last six months, disturbances related to eardrum damage
• have received inspiratory and expiratory muscle training in the past six months
• blood pressure >180/110 mmHg or <80/60 mmHg

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 5 on Dialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Inspiratory Muscle Training with an intensity of 50% MIP
Patients received IMT exercise program at a 50% MIP intensity for 12 weeks
• Inspiratory Muscle Training with an intensity of 10% MIP
Patients received IMT exercise program at a 10% MIP intensity for 12 weeks

Locations

Country	Name	City	State
Indonesia	Al Ihsan Province Hospital	Bandung	Jawa Barat

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Padjadjaran

Country where clinical trial is conducted

Indonesia, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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