HemodialysisHemodialysisNCT07094347
Effects of Intradialytic Inspiratory Muscle Training on Functional Capacity in Hemodialysis Patients
A study testing inspiratory muscle training in people with Hemodialysis, run by Baskent University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Being tested
- inspiratory muscle training
- Keywords
- powerbreathe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training Group | Experimental | 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. Receives: Device: inspiratory muscle training |
| control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory muscle strength
The respiratory muscle strength measuring device Power Breathe (Power Breathe, K5, HaB International Ltd England) will be used to assess inspiratory muscle strength. During the assessment, the patient will be asked to sit in a chair with back support and no arm support, with shoulders relaxed, and a nose clip will be used. Patients will be asked to take a deep breath through the device placed in their mouth. The inspiratory force index (S-index) obtained as a result of the measurement will be recorded.
Measured: The individuals participating in the study will be evaluated twice: before the application (week 0) and after the application (after 12 weeks).
Secondary outcomes (1)
Exercise Capacity Assessment
The 6-minute walk test (6MWT), which is clinically easy to apply and reliable, will be used to assess the functional capacity of individuals.The 6-minute walk test (6MWT), which is clinically easy to apply and reliable, will be used to assess the functional capacity of individuals. At the end of 6 minutes, the distance walked in meters (m) will be recorded.
Measured: The individuals participating in the study will be evaluated twice: before the application (week 0) and after the application (after 12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start20 Aug 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094347
- Sponsor's protocol ID
- KA24/416
- Acronym
- Hemodialysis
- Status last verified
- Jul 2025
- First submitted
- 28 May 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38811888
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intradialytic Inspiratory Muscle Training on Functional Capacity in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07094347
- Acronym / sponsor ID
- Hemodialysis / KA24/416
- Conditions
- Hemodialysis
- Keywords
- powerbreathe
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It is a randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training Group | Experimental | Device: inspiratory muscle trainingThe 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. |
| control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inspiratory muscle trainingPowerbreathe® 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. | Device | Inspiratory Muscle Training Group |
Primary outcome
Inspiratory muscle strength
Time frame: The individuals participating in the study will be evaluated twice: before the application (week 0) and after the application (after 12 weeks).
The respiratory muscle strength measuring device Power Breathe (Power Breathe, K5, HaB International Ltd England) will be used to assess inspiratory muscle strength. During the assessment, the patient will be asked to sit in a chair with back support and no arm support, with shoulders relaxed, and a nose clip will be used. Patients will be asked to take a deep breath through the device placed in their mouth. The inspiratory force index (S-index) obtained as a result of the measurement will be recorded.
1 secondary outcome
Exercise Capacity Assessment
Time frame: The individuals participating in the study will be evaluated twice: before the application (week 0) and after the application (after 12 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Results publication: PubMed 38811888Katayifci 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.
- Individual participant dataSharing planned: No
Related trials for Hemodialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle training in people with Hemodialysis, run by Baskent University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yasemin kavuncubaşı genç, phd canditate (+905321764598, ykavuncubasigenc@baskent.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory muscle strength (time frame: The individuals participating in the study will be evaluated twice: before the application (week 0) and after the application (after 12 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07094347, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.