Inspiratory Muscle Training for Chronic Kidney Disease Patients on Hemodialysis

NCT ID: NCT05241652

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-20
• Study Completion Date: 2022-05-05

Brief 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.

Detailed 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.

Conditions

Chronic Kidney Disease Stage 5 on Dialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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.

Group Type: ACTIVE_COMPARATOR

Inspiratory Muscle Training with an intensity of 50% MIP

Intervention Type: OTHER

Patients received IMT exercise program at a 50% MIP intensity for 12 weeks

Control group

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.

Group Type: PLACEBO_COMPARATOR

Inspiratory Muscle Training with an intensity of 10% MIP

Intervention Type: OTHER

Patients received IMT exercise program at a 10% MIP intensity for 12 weeks

Interventions

Inspiratory Muscle Training with an intensity of 50% MIP

Patients received IMT exercise program at a 50% MIP intensity for 12 weeks

Intervention Type: OTHER

Inspiratory Muscle Training with an intensity of 10% MIP

Patients received IMT exercise program at a 10% MIP intensity for 12 weeks

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Padjadjaran

OTHER

Sponsor Role: lead

Responsible Party

Irma Ruslina Defi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irma Ruslina Defi, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universitas Padjadjaran

Locations

Al Ihsan Province Hospital

Bandung, West Java, Indonesia

Countries

Indonesia

References

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 11904577 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23989362 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 23199095 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 24700875 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30048473 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: DERIVED

PMID: 37782150 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IKFR-202201.01

Identifier Type: -

Identifier Source: org_study_id