Effects of Intradialytic Inspiratory Muscle Training on Functional Capacity in Hemodialysis Patients

NCT ID: NCT07094347

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2026-06-30

Brief Summary

There is a need for long-term sustainable studies that will increase the potential health benefits in hemodialysis patients. Inspiratory muscle training, one of the recommended treatments to increase exercise capacity and quality of life during dialysis treatment in people with chronic renal failure, is a method that can be applied intradialytically, in addition to being easy to apply, cheap and sustainable. It improves functional capacity by increasing respiratory muscle strength. In this context, our study aims to investigate the effects of inspiratory muscle training on functional parameters and on hemodialysis patients with a personalized portable device and to add it to the literature.

Detailed Description

Chronic kidney disease is defined as abnormalities in kidney structure or function that have been present for more than three months and will adversely affect health. Two markers used to define chronic kidney disease, which is characterized by progressive loss of kidney mass and function, are glomerular filtration rate (GFR) and albumin-creatinine ratio. Chronic kidney disease can be divided into five stages according to GFR, and the most severe end-stage chronic kidney disease is also defined as chronic renal failure and requires renal replacement therapy to maintain homeostasis. The most commonly applied method of renal replacement in our country is hemodialysis.

It is known that muscle atrophy, where muscle regeneration and repair capacity decrease, is frequently seen in chronic kidney disease patients. Although it is partly due to aging, muscle atrophy is frequently seen due to the accumulation of uremic toxins, inflammation, insulin resistance, malnutrition and lack of physical activity; increased muscle loss also increases the risk of morbidity, mortality and end-stage renal disease in patients.

Studies have shown that there is a decrease in respiratory muscle strength as well as skeletal muscle strength in chronic kidney disease patients. Decreased respiratory muscle strength causes individuals to have low cardiorespiratory fitness, and chronic kidney disease patients face limitations in daily life activities and increased mortality.

Pulmonary system involvement and decreased exercise tolerance are among the important causes of functional capacity and disease-related complications in chronic kidney disease patients. Inspiratory muscle strength is related to functional capacity in hemodialysis patients. In the literature, it is shown that inspiratory muscle training improves functional parameters and modulates inflammatory biomarkers, as in aerobic and combined exercise training. Inspiratory muscle training is a useful method to increase peripheral and inspiratory muscle strength, respiratory function, quality of life and balance, and to reduce dyspnea and fatigue in patients with chronic kidney disease.

Exercises performed during dialysis are called intradialytic exercises. It does not require extra time to exercise; The advantages of this exercise protocol include the fact that patients can be monitored by healthcare professionals during exercise and that any complications can be detected and treated immediately, and that intradialytic exercise increases blood flow to the muscles and increases solute removal. Inspiratory muscle training, one of the recommended treatments to increase exercise capacity and quality of life during dialysis treatment in people with chronic renal failure, is a method that can be applied intradialytically, in addition to being easy to apply, cheap and sustainable. It improves functional capacity by increasing respiratory muscle strength. It is stated that inspiratory muscle training protocols applied in the range of 30-60% of the individual's maximum inspiratory pressure improve respiratory muscle strength, functional capacity and quality of life in patients with chronic renal failure. However, the number of studies showing the effects of this type of training applied at different intensities in dialysis patients is quite low. In addition, the effects of intradialytic inspiratory muscle training applications have not yet been shown. There is a need for long-term sustainable studies in the literature that will increase the potential health benefits in hemodialysis patients. In this context, our study aims to investigate the effects of inspiratory muscle training on functional parameters and its contribution to the literature with a personalized portable device in hemodialysis patients.

Conditions

Hemodialysis

Study Design

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

Study Groups

Inspiratory Muscle Training Group

The individuals in the study group will be given a 12-week respiratory muscle training after the first assessment and training session. The Powerbreathe® threshold resistance loading device (POWERbreathe, HaB International) will be used for this training program that strengthens the inspiratory muscles. The PowerBreathe® device is a threshold device that creates resistance to inspiration. This resistance is created by the spring tension in the device's mechanism. The device has a mechanism that is adjusted according to 9 different levels in its mechanism specific to the individuals using it.

Group Type: EXPERIMENTAL

inspiratory muscle training

Intervention Type: DEVICE

Powerbreathe® threshold resistance loading device (POWERbreathe, HaB International) will be used for this training program that strengthens the inspiratory muscles. The PowerBreathe® device is a threshold device that creates resistance to inspiration. This resistance is created by the spring tension in the device mechanism. The device has a mechanism that is adjusted according to 9 different levels in its mechanism specific to the individuals using it.

control

At the beginning of the study after the first assessment, the control group will be given a training session lasting approximately 30 minutes. During the training session, participants will be given training on bronchial hygiene techniques and respiratory control, pursed lip breathing, diaphragmatic breathing exercises and thoracic expansion exercises that will improve lung health. Individuals in the control group will only receive the training session after the assessment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

inspiratory muscle training

Powerbreathe® threshold resistance loading device (POWERbreathe, HaB International) will be used for this training program that strengthens the inspiratory muscles. The PowerBreathe® device is a threshold device that creates resistance to inspiration. This resistance is created by the spring tension in the device mechanism. The device has a mechanism that is adjusted according to 9 different levels in its mechanism specific to the individuals using it.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Being on hemodialysis for at least 6 months
• Being on hemodialysis for 4 hours, 3 days a week
• Not having had a transplant
• Being able to continue sitting and standing
• Being able to walk without assistance
• Being willing to participate in the study

Exclusion Criteria

• Individuals with communication and/or cognitive problems that are unable to fulfill the assessment and treatment requirements
• Patients with uncontrolled cardiac, pulmonary or other systemic diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baskent University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

yasemin kavuncubaşı genç, phd canditate

Role: CONTACT

ykavuncubasigenc@baskent.edu.tr

+905321764598

References

Katayifci N, Huzmeli I, Iri S D, Turgut FH. Effects of different inspiratory muscle training protocols on functional exercise capacity and respiratory and peripheral muscle strength in patients with chronic kidney disease: a randomized study. BMC Nephrol. 2024 May 29;25(1):184. doi: 10.1186/s12882-024-03610-1.

Reference Type: RESULT

PMID: 38811888 (View on PubMed)

Other Identifiers

KA24/416

Identifier Type: -

Identifier Source: org_study_id