Chronic Kidney Disease(CKD)NCT06655181
Evaluating the Effectiveness of Respiratory Muscle Training in Pediatric Kidney Transplant Patient
A study testing Respiratory Muscle Training in people with Chronic Kidney Disease(CKD) and Pediatric ALL, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
Chronic kidney disease is defined as kidney damage lasting three months or longer and irreversible loss of renal function (glomerular, tubular and endocrine) or a glomerular filtration rate of less than 60 ml/min /1.73 m2 . Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Chronic Kidney Disease(CKD), Pediatric ALL, Pediatric Kidney Transplantation
- What is being tested?
- Respiratory Muscle Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 May 2024to 5 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being between 8-18 years old
- At least 6 months have passed since kidney transplantation
- Being able to walk, cooperate and clinically stable
- Volunteering to participate in the study
Who cannot join
- A history of hospitalization in the last four weeks before study participation History of hospitalization during the exercise training program
- Having secondary diseases such as kyphoscoliosis that may affect respiratory function
- Currently participating or have participated in regular exercise training in the last 1 year
- Having neurological, psychiatric, orthopedic, cardiovascular and pulmonary system comorbid conditions that prevent the performance of tests and participation in the treatment program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Respiratory Muscle Training in Children With Kidney Transplantation
Chronic kidney disease is defined as kidney damage lasting three months or longer and irreversible loss of renal function (glomerular, tubular and endocrine) or a glomerular filtration rate of less than 60 ml/min /1.73 m2 . Among the five stages of chronic kidney disease, the last and most severe stage is end-stage chronic kidney disease, which requires kidney transplantation. Many organs and systems are affected after kidney transplantation. Anemia, cardiovascular complications, secondary hyperparathyroidism, accumulation of uremic toxins, electrolyte disturbances, uremic myopathy, vitamin D deficiency, malnutrition, inflammation, atherosclerosis syndrome, and respiratory dysfunction and respiratory muscle weakness caused by oxidative stress leading to loss of muscle tissue are the most common changes seen in the pulmonary system. Children undergoing transplantation are at higher risk for cardiovascular diseases, usually associated with hypertension and dyslipidemia, which are already present in the chronic kidney disease stage and persist after transplantation. Significantly reduced muscle strength and physical activity in pediatric kidney transplant recipients is also frequently reported in the literature. Decreased exercise capacity, muscle strength and physical activity increase the risk of pulmonary and cardiovascular diseases. As chronic kidney disease progresses, pulmonary complications such as restrictive pulmonary dysfunction, respiratory muscle myopathy and decreased respiratory muscle strength are associated with disease severity. To improve respiratory muscle strength, respiratory muscle training is recommended for people with chronic kidney disease. The literature has so far demonstrated positive effects of inspiratory muscle training on respiratory muscle strength, diaphragm thickness and mobility, lung volumes, functional capacity and quality of life in many other patient populations, including lung and heart disease, cardiac surgery, thoracic surgery, multiple sclerosis and stroke. Although recent studies have found evidence of systemic changes after transplantation in both adults and children, there is little evidence of the efficacy of respiratory muscle training, especially in pediatric patients. In the light of all this information, the aim of our study was to investigate the efficacy of respiratory muscle training in children undergoing kidney transplantation.
Read the detailed description
Kidney transplantation is the main treatment for patients with end-stage renal failure. Although kidney transplantation offers a good quality of life to patients, some of the complications caused by the underlying kidney disease and during end-stage renal failure persist in the follow-up of these patients, as well as many complications related to the drugs used after transplantation. As chronic kidney disease progresses, especially restrictive type respiratory dysfunction, respiratory muscle myopathy and decreased respiratory muscle strength are the most common changes seen in the pulmonary system. To improve respiratory muscle strength, respiratory muscle training is recommended for people with chronic kidney disease. There is limited scientific evidence on respiratory muscle training methods and outcomes in patients with chronic kidney disease, especially focusing only on inspiratory muscle training. Considering the heterogeneity of the studies and the variability of the results, the effectiveness of respiratory muscle training in patients with chronic kidney disease and especially after transplantation remains unclear. In the light of all this information, the aim of our study was to investigate the effectiveness of respiratory muscle training in children undergoing kidney transplantation. Patients will be randomly divided into two groups as experimental and control groups. According to the sample size calculation, it was determined that at least 15 people should be included in each group. Children in the experimental and control groups will be taught a home-based chest physiotherapy program (breathing exercises, teaching relaxation positions, cough training, respiratory control, respiratory control, physical activity recommendation) to be applied for 30 minutes a day, 5 days a week for 8 weeks. In addition to this program, patients in the experimental group will be given inspiratory and expiratory combined respiratory muscle training at 30% of MEP and MIP values for 8 weeks, 2 times a day for 20 minutes each, at least 5 days a week. The resistance setting of the patients in the experimental group will be adjusted to be calculated by measuring MIP-MEP again. Patients in the control group will receive sham combined respiratory muscle training for a total of 8 weeks at the lowest constant load, 2 times a day for 20 minutes each, at least 5 days a week.
- Conditions
- Chronic Kidney Disease(CKD), Pediatric ALL, Pediatric Kidney Transplantation, Respiratory Muscle Training
- Being tested
- Respiratory Muscle Training
- Keywords
- Pediatric kidney transplantation, respiratory muscle training
- Medical subject headings
- Renal Insufficiency, Chronic, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Muscle TrainingDevice
Expiratory muscle training will be performed with POWERbreathe EX1 Medic (POWERbreathe®) device and inspiratory muscle training will be performed with POWERbreathe Medic Classic device.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in the experimental group will be taught a home-based chest physiotherapy program (breathing exercises, teaching relaxation positions, cough training, respiratory control, respiratory control, physical activity recommendation) to be applied for 30 minutes a day, 5 days a week for 8 weeks. In addition to this program, the participants in the experimental group will be given inspiratory and expiratory combined respiratory muscle training at 30% of MEP and MIP values for 8 weeks, 2 times a day for 20 minutes each, at least 5 days a week. The resistance setting of the participants in the experimental group will be adjusted to be calculated by measuring MIP-MEP again. Receives: Device: Respiratory Muscle Training |
| Control Group | Sham comparator | Participants in the control group will be taught a home-based chest physiotherapy program (breathing exercises, teaching relaxation positions, cough training, respiratory control, respiratory control, physical activity recommendation) to be applied for 30 minutes a day, 5 days a week for 8 weeks. Patients in the control group will receive sham combined respiratory muscle training at the lowest constant load, twice a day for 20 minutes each, at least 5 days a week for a total of 8 weeks. Receives: Device: Respiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Function Test
Change from baseline forced vital capacity (FVC) at 8 weeks.
Measured: Eight weeks
Respiratory Function Test
Change from baseline forced forced expiratory volume in 1 (FEV1) second at 8 weeks.
Measured: Eight weeks
Respiratory Function Test
Change from baseline peak expiratory flow (PEF) at 8 weeks.
Measured: Eight weeks
Respiratory Function Test
Change from baseline FEV1/FVC at 8 weeks.
Measured: Eight weeks
Respiratory Muscle Strength
Change from baseline maximum inspiratory pressure (MIP) at 8 weeks.
Measured: Eight weeks
Respiratory Muscle Strength
Change from baseline maximum expiratory pressure (MEP) at 8 weeks.
Measured: Eight weeks
Peripheral Muscle Strength
Change from baseline m. quadriceps strength at 8 weeks.
Measured: Eight weeks
Peripheral Muscle Strength
Change from baseline m. biceps strength at 8 weeks.
Measured: Eight weeks
Functional Capacity
Change from baseline distance covered in six minute walk test at 8 weeks.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start27 May 2024
- Primary completion31 Dec 2024
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease(CKD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Kaya, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655181
- Sponsor's protocol ID
- AtlasUmkaya03
- Status last verified
- Sep 2025
- First submitted
- 22 Oct 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Respiratory Muscle Training in Children With Kidney Transplantation
- ClinicalTrials.gov ID
- NCT06655181
- Acronym / sponsor ID
- AtlasUmkaya03
- Conditions
- Chronic Kidney Disease(CKD), Pediatric ALL, Pediatric Kidney Transplantation, Respiratory Muscle Training
- Keywords
- Pediatric kidney transplantation, respiratory muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 27 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 23 Oct 2024 (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.
Chronic kidney disease is defined as kidney damage lasting three months or longer and irreversible loss of renal function (glomerular, tubular and endocrine) or a glomerular filtration rate of less than 60 ml/min /1.73 m2 . Among the five stages of chronic kidney disease, the last and most severe stage is end-stage chronic kidney disease, which requires kidney transplantation. Many organs and systems are affected after kidney transplantation. Anemia, cardiovascular complications, secondary hyperparathyroidism, accumulation of uremic toxins, electrolyte disturbances, uremic myopathy, vitamin D deficiency, malnutrition, inflammation, atherosclerosis syndrome, and respiratory dysfunction and respiratory muscle weakness caused by oxidative stress leading to loss of muscle tissue are the most common changes seen in the pulmonary system. Children undergoing transplantation are at higher risk for cardiovascular diseases, usually associated with hypertension and dyslipidemia, which are already present in the chronic kidney disease stage and persist after transplantation. Significantly reduced muscle strength and physical activity in pediatric kidney transplant recipients is also frequently reported in the literature. Decreased exercise capacity, muscle strength and physical activity increase the risk of pulmonary and cardiovascular diseases. As chronic kidney disease progresses, pulmonary complications such as restrictive pulmonary dysfunction, respiratory muscle myopathy and decreased respiratory muscle strength are associated with disease severity. To improve respiratory muscle strength, respiratory muscle training is recommended for people with chronic kidney disease. The literature has so far demonstrated positive effects of inspiratory muscle training on respiratory muscle strength, diaphragm thickness and mobility, lung volumes, functional capacity and quality of life in many other patient populations, including lung and heart disease, cardiac surgery, thoracic surgery, multiple sclerosis and stroke. Although recent studies have found evidence of systemic changes after transplantation in both adults and children, there is little evidence of the efficacy of respiratory muscle training, especially in pediatric patients. In the light of all this information, the aim of our study was to investigate the efficacy of respiratory muscle training in children undergoing kidney transplantation.
Detailed description
Kidney transplantation is the main treatment for patients with end-stage renal failure. Although kidney transplantation offers a good quality of life to patients, some of the complications caused by the underlying kidney disease and during end-stage renal failure persist in the follow-up of these patients, as well as many complications related to the drugs used after transplantation. As chronic kidney disease progresses, especially restrictive type respiratory dysfunction, respiratory muscle myopathy and decreased respiratory muscle strength are the most common changes seen in the pulmonary system. To improve respiratory muscle strength, respiratory muscle training is recommended for people with chronic kidney disease. There is limited scientific evidence on respiratory muscle training methods and outcomes in patients with chronic kidney disease, especially focusing only on inspiratory muscle training. Considering the heterogeneity of the studies and the variability of the results, the effectiveness of respiratory muscle training in patients with chronic kidney disease and especially after transplantation remains unclear. In the light of all this information, the aim of our study was to investigate the effectiveness of respiratory muscle training in children undergoing kidney transplantation. Patients will be randomly divided into two groups as experimental and control groups. According to the sample size calculation, it was determined that at least 15 people should be included in each group. Children in the experimental and control groups will be taught a home-based chest physiotherapy program (breathing exercises, teaching relaxation positions, cough training, respiratory control, respiratory control, physical activity recommendation) to be applied for 30 minutes a day, 5 days a week for 8 weeks. In addition to this program, patients in the experimental group will be given inspiratory and expiratory combined respiratory muscle training at 30% of MEP and MIP values for 8 weeks, 2 times a day for 20 minutes each, at least 5 days a week. The resistance setting of the patients in the experimental group will be adjusted to be calculated by measuring MIP-MEP again. Patients in the control group will receive sham combined respiratory muscle training for a total of 8 weeks at the lowest constant load, 2 times a day for 20 minutes each, at least 5 days a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Respiratory Muscle TrainingParticipants in the experimental group will be taught a home-based chest physiotherapy program (breathing exercises, teaching relaxation positions, cough training, respiratory control, respiratory control, physical activity recommendation) to be applied for 30 minutes a day, 5 days a week for 8 weeks. In addition to this program, the participants in the experimental group will be given inspiratory and expiratory combined respiratory muscle training at 30% of MEP and MIP values for 8 weeks, 2 times a day for 20 minutes each, at least 5 days a week. The resistance setting of the participants in the experimental group will be adjusted to be calculated by measuring MIP-MEP again. |
| Control Group | Sham comparator | Device: Respiratory Muscle TrainingParticipants in the control group will be taught a home-based chest physiotherapy program (breathing exercises, teaching relaxation positions, cough training, respiratory control, respiratory control, physical activity recommendation) to be applied for 30 minutes a day, 5 days a week for 8 weeks. Patients in the control group will receive sham combined respiratory muscle training at the lowest constant load, twice a day for 20 minutes each, at least 5 days a week for a total of 8 weeks. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Being between 8-18 years old
- At least 6 months have passed since kidney transplantation
- Being able to walk, cooperate and clinically stable
- Volunteering to participate in the study
Key exclusion criteria (4 listed)
- A history of hospitalization in the last four weeks before study participation History of hospitalization during the exercise training program
- Having secondary diseases such as kyphoscoliosis that may affect respiratory function
- Currently participating or have participated in regular exercise training in the last 1 year
- Having neurological, psychiatric, orthopedic, cardiovascular and pulmonary system comorbid conditions that prevent the performance of tests and participation in the treatment program
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 |
|---|---|---|
| Respiratory Muscle TrainingExpiratory muscle training will be performed with POWERbreathe EX1 Medic (POWERbreathe®) device and inspiratory muscle training will be performed with POWERbreathe Medic Classic device. | Device | Control Group, Experimental Group |
Primary outcome
Respiratory Function Test
Time frame: Eight weeks
Change from baseline forced vital capacity (FVC) at 8 weeks.
Respiratory Function Test
Time frame: Eight weeks
Change from baseline forced forced expiratory volume in 1 (FEV1) second at 8 weeks.
Respiratory Function Test
Time frame: Eight weeks
Change from baseline peak expiratory flow (PEF) at 8 weeks.
Respiratory Function Test
Time frame: Eight weeks
Change from baseline FEV1/FVC at 8 weeks.
Respiratory Muscle Strength
Time frame: Eight weeks
Change from baseline maximum inspiratory pressure (MIP) at 8 weeks.
Respiratory Muscle Strength
Time frame: Eight weeks
Change from baseline maximum expiratory pressure (MEP) at 8 weeks.
Peripheral Muscle Strength
Time frame: Eight weeks
Change from baseline m. quadriceps strength at 8 weeks.
Peripheral Muscle Strength
Time frame: Eight weeks
Change from baseline m. biceps strength at 8 weeks.
Functional Capacity
Time frame: Eight weeks
Change from baseline distance covered in six minute walk test at 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Muscle Training in people with Chronic Kidney Disease(CKD) and Pediatric ALL, run by Atlas University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Function Test (time frame: Eight weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.