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Completed

NCT Number: NCT05241652

Inspiratory Muscle Training for Chronic Kidney Disease Patients on Hemodialysis

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.

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Key information

Conditions

Chronic Kidney Disease Stage 5 on Dialysis

Age range

45 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Ihsan Province Hospital

Bandung, West Java, 40375, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training with an intensity of 50% MIP

Other

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

Inspiratory Muscle Training with an intensity of 10% MIP

Other

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

Primary outcomes

  1. Urea levels

    Time frame: 84 days

    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).

  2. Creatinine levels

    Time frame: 84 days

    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).

  3. IL-6 level

    Time frame: 84 days

    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).

  4. Physical component summary (PCS)

    Time frame: 84 days

    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.

  5. Mental component summary (MCS)

    Time frame: 84 days

    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.

  6. Kidney disease component summary (KDCS)

    Time frame: 84 days

    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.

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 16, 2022
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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