Chronic Kidney DiseasesNCT05354726
Skeletal and Respiratory Muscle Strength, Pulmonary Function, Exercise Capacity and Physical Activity in Pediatric Chronic Kidney Disease
An observational study of Chronic Kidney Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Studies examining musculoskeletal strength, respiratory function and muscle strength, physical activity level and exercise capacity in children with CKD and evaluating the relationships between these parameters have not been found both in the world and in our country. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Assessments parameters
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Mar 2022to 4 Dec 2023
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children who applied to Gazi University, Faculty of Medicine, Department of Pediatrics, Department of Pediatric Nephrology and met the specified inclusion criteria will be included in our study. Patients will be referred to Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit after the routine evaluations including demographic and clinical characteristics, laboratory tests and anthropometric measurements are completed. Here, patients will be evaluated with physical therapy and rehabilitation measurement and evaluation methods such as muscle strength, exercise capacity and physical activity. The healthy control group will be formed by inviting the healthy relatives of the patients who applied to our faculty to participate in the study. After obtaining informed consent, healthy children will be evaluated.
Who may be able to join
- 6-18 age range,
- According to the Chronic Kidney Disease Assessment and Classification Guide prepared by the National Kidney Foundation- Kidney Disease Outcomes Quality Initiative (NKF-KDOQI); Stage 2, glomerular filtration rate 60-89 ml/min/1.73 m2, Stage 3, glomerular filtration rate 30-59 ml/min/1.73 m2, Stage 4, glomerular filtration rate 15-29 ml/min/1.73 m2,
- Presence of kidney transplantation was determined as inclusion criteria.
- Not have cardiovascular, neurological and/or genetic musculoskeletal disease
- Not having orthopedic and cognitive problems that prevent testing
- The patient's and/or family's willingness to participate in the study
Who cannot join
- acute infection,
- Ongoing dialysis,
- Congenital heart disease,
- Hypertension that cannot be controlled with dual antihypertensive medication,
- Neurological and/or genetic musculoskeletal disease,
- The presence of orthopedic and cognitive problems that prevented the tests from being performed were determined as exclusion criteria.
- Group: Control Group
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University and Hacettepe University
Ankara
About this study
Official title: Investigation of Skeletal and Respiratory Muscle Strength, Pulmonary Function, Exercise Capacity and Physical Activity in Children With Chronic Kidney Disease
Studies examining musculoskeletal strength, respiratory function and muscle strength, physical activity level and exercise capacity in children with CKD and evaluating the relationships between these parameters have not been found both in the world and in our country. In this study, it is aimed to evaluate skeletal and respiratory muscle strength, respiratory parameters and exercise capacity in children with CKD primarily and compare them with healthy children. Secondly, it is to examine the relationship between endothelial function, arterial stiffness, sarcopenia and physical activity in children with CKD. It is thought that the results to be obtained with the study will support the literature with the prediction that rehabilitation programs for patients in all stages of CKD will be structured and in this way will contribute positively to the management and prognosis of the disease.
Hypotheses H0: There is no difference between children with chronic kidney disease and healthy children in terms of skeletal and respiratory muscle strength, respiratory parameters and exercise capacity.
Read more
H1: There is a difference between children with chronic kidney disease and healthy children in terms of skeletal and respiratory muscle strength, parameters and exercise capacity.
H0: There is no relationship between endothelial function, arterial stiffness, sarcopenia and physical activity in children with chronic kidney disease.
H1: There is a relationship between endothelial function, arterial stiffness, sarcopenia and physical activity in children with chronic kidney disease.
Read the detailed description
Children who applied to Gazi University, Faculty of Medicine, Department of Pediatrics, Department of Pediatric Nephrology and met the specified inclusion criteria will be included in our study. Patients will be referred to Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit after the routine evaluations including demographic and clinical characteristics, laboratory tests and anthropometric measurements are completed. Here, patients will be evaluated with physical therapy and rehabilitation measurement and evaluation methods such as muscle strength, exercise capacity and physical activity. The healthy control group will be formed by inviting the healthy relatives of the patients who applied to our faculty to participate in the study. After obtaining informed consent, healthy children will be evaluated.
Details of Working Method For each child with chronic kidney disease, age, gender, body weight, height, systolic and diastolic blood pressure, and results of routine blood tests (complete blood count test parameters: hemoglobin, hematocrit, erythrocyte, leukocyte and platelet count) biochemistry test parameters (blood sugar, blood urea nitrogen, creatinine, uric acid, sodium, potassium, chlorine, calcium, phosphorus, alkaline phosphatase, total protein, albumin, alanine aminotransferase, aspartate aminotransferase, triglyceride, total cholesterol, high-density lipoprotein, low-density lipoprotein levels , venous blood pH and bicarbonate etc. values), ferritin, parathormone, 25 hydroxy vitamin D level) will be recorded. The age at diagnosis, duration and etiology of the disease, current treatment information and drugs used will be recorded. Body composition data will also be recorded for children with CKD. Bone mineral density parameters in the last six months, left ventricular mass index values in the last three months, 24-hour blood pressure monitoring (ABPM) in the last month, and heart rate measured on the same device are used in the follow-up of the patients. wave velocity (pulse wave velocity-PWV) evaluation results will be used, if there is none, ABPM and PWV will be performed again. After these evaluations, parameters such as skeletal muscle strength, respiratory muscle strength, and exercise capacity will be evaluated in both the patient group and healthy children, and the obtained data will be compared. In addition, the relationship between parameters such as complete blood count parameters, biochemistry test parameters, routine bone markers, BMD, heart and vascular function evaluations and parameters such as skeletal and respiratory muscle strength, exercise capacity, and physical activity level will be examined in children with CKD. In case of adequate data, children with CKD will be subgrouped according to disease stage and assessment data will be analyzed by subgroups.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Assessments parameters
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessments parametersOther
Demographic and Clinical Characteristics, Bone Mineral Density, Sarcopenia, Body Composition, Arterial Stiffness, Endothelial Function, Echocardiography,Pulmonary Function, Respiratory Muscle Strength, Submaximal exercise capacity, Maximal Exercise Capacity, Physical Activity Level, Hand Grip Strength, Lower Extremity Muscle Strength
| Study group | Role | What they receive |
|---|---|---|
| CKD group | Inclusion Criteria for Volunteers (Inclusion Criteria):
* 6-18 age range,
* According to the Chronic Kidney Disease Assessment and Classification Guide prepared by the National Kidney Foundation- Kidney Disease Outcomes Quality Initiative (NKF-KDOQI); Stage 2, glomerular filtration rate 60-89 ml/min/1.73 m2, Stage 3, glomerular filtration rate 30-59 ml/min/1.73 m2, Stage 4, glomerular filtration rate 15-29 ml/min/1.73 m2,
* Presence of kidney transplantation was determined as inclusion criteria.
Exclusion Criteria for Volunteers:
* acute infection,
* Ongoing dialysis,
* Congenital heart disease,
* Hypertension that cannot be controlled with dual antihypertensive medication,
* Neurological and/or genetic musculoskeletal disease,
* The presence of orthopedic and cognitive problems that prevented the tests from being performed were determined as exclusion criteria. Receives: Other: Assessments parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density (BMD) z-score
Bone mineral density (BMD) measurement will be measured with a double X-ray absorptiometry device (DEXA (Horizon Wi (S/N 300796M))). Lumbar vertebral total BMD value and BMD z score will be calculated for each child. BMD z score -1 standard between -2 and -2 standard deviations, it will be considered as osteopenia, if it is less than -2 standard deviations, it will be considered as osteoporosis.This evaluation parameter will be recorded from the most recent test results for diagnosis and clinical course.
Measured: 15-25 minutes
Skeletal muscle mass (SMM) z-score
Total/regional (obsolute/t-score and z-score) fat mass, lean mass (lean mass) and lean-boneless mass (lean mass) will be measured by dual energy X-ray absorptiometry device (DEXA (device tag). Skeletal muscle mass ( SMM), SMM z score and appendicular lean-boneless mass (appendicular lean mass) will be calculated according to the SMM values of healthy children based on age and gender.If the SMM z score is below -2 standard deviations, it will be considered as sarcopenia.
Measured: 15-25 minutes
Arterial stiffness
Arterial stiffness will be assessed using the pulse wave velocity (PWV) technique with the blood pressure holter-ABPM (spacelabs) device. Pulse waves will be recorded by placing the proximal sensor of the device in the places where the carotid artery and the distal sensor of the femoral artery are best palpated. The distance between these two points and the pulse propagation velocity will be calculated with the help of a computer in m/sec. High velocity data indicates high arterial stiffness, low velocity indicates less arterial stiffness.
Measured: 10 minutes
Carotid artery intima-media thickness (cIMT)
For endothelial function, standardized measurement of carotid artery intima-media thickness (cIMT) will be made by the same radiologist with a high-resolution US device (General Electric) with a multi-frequency liner probe (5-12 MHz). Measurements will be taken over the bilateral distal common carotid arteries (1 cm proximal to bufircation) while the patients are supine and their necks are in neutral extension. cIMT is defined as the distance between the lumen-intima interface and the media-adventitia interface. A total of 6 records, three from each side, will be taken and the average will be recorded as cIMT.
Measured: 10-15 minutes
Left ventricular mass index
Left ventricular mass index measurement and evaluation of left ventricular hypertrophy will be performed. Interventricular septum, posterior wall and left ventricular wall thickness measurements will be taken in diastole with M mode echocardiography. The presence of LVH will be evaluated by evaluating the left ventricular mass (LVMI) calculated and indexed by using the Devereux formula according to age, gender and height.
Measured: 10-15 minutes
Forced expiratory volume in 1 second (FEV1)
Pulmonary function testing will be performed with a portable spirometer (Spirodoc, Medical International Research, Rome, Italy) using standard procedures. Forced expiratory volume in 1 second (FEV1), will be saved.
Measured: 10-15 minutes
Forced vital capacity (FVC)
Pulmonary function testing will be performed with a portable spirometer (Spirodoc, Medical International Research, Rome, Italy) using standard procedures. Forced vital capacity (FVC) parameter will be saved.
Measured: 10-15 minutes
FEV1/FVC
Pulmonary function testing will be performed with a portable spirometer (Spirodoc, Medical International Research, Rome, Italy) using standard procedures. FEV1/FVC parameter will be saved.
Measured: 10-15 minutes
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) will be used as indicators of respiratory muscle strength (28). A portable intraoral pressure gauge (MicroRPM, Micromedical, Kent, UK) and nose clip will be used during MIP and MEP assessments. MIP and MEP measurements will be obtained using standard procedures. 3 measurements will be made where the difference between each measurement is not more than 10% and the maximum value of MIP and MEP will be recorded.
Measured: 10-15 minutes
6-Minute Walk Test (6 MWT) distance
Submaximal exercise capacity will be evaluated with the 6-Minute Walk Test (6 MWT). The standard protocol will be implemented in a continuous corridor of 30 meters. The patient wearing comfortable clothes and shoes will be given standard instructions and verbal guidance during the test. The distance the patient walked during the test will be recorded in meters.
Measured: 10-15 minutes
ISWT distance
Maximal exercise capacity will be evaluated with the incremental shuttle walk test (ISWT). For the ISWT, it will be adjusted to a total of 10 meters with 2 cones placed at a distance of 9.0 meters from each other and a rotational margin of 0.5 meters. In this system, the patient will be asked to walk in a round-trip way, adapting to the increasing speed and the sound coming from outside. In the shuttles that are getting faster and faster, the lap number of the patients, the number of laps of the last level they can reach, and the walking/running distances in meters will be recorded.
Measured: 10-15 minutes
Physical Activity Level
The scale to be used for this purpose is the Child Physical Activity Questionnaire (MFAA) developed by Kowalski et al. It is a seven-day self-reported recall scale designed to assess moderate-intensity physical activity in children aged 8-14 years. CFAA is designed to be implemented throughout the school year. The Turkish validity and reliability of the questionnaire was made and permission was obtained from the responsible author for its use.
Measured: 5-10 minutes
Hand Grip Strenght
Hand grip strength will be measured using a hand dynamometer (Jamar, Sammons Preston, Rolyon, Bolingbrook, IL). Measurements will be made using standard procedures, right and left sides, with the arms at the side of the trunk, the elbow in a 90-degree flexion position, and the forearm and wrist in a neutral position. The highest of the three measurements will be considered as hand grip strength.
Measured: 10-15 minutes
Maximum isometric muscle strength of the quadriceps femoris
Maximum isometric muscle strength of the quadriceps femoris muscle will be measured with a dynamometer (Lafayette Instrument Company, Lafayette, Indiana).
Measured: 10-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start7 Mar 2022
- Primary completion7 Nov 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haluk TEKERLEK, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354726
- Sponsor's protocol ID
- pedichronickidneydisease
- Status last verified
- Aug 2026
- First submitted
- 20 Apr 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Skeletal and Respiratory Muscle Strength, Pulmonary Function, Exercise Capacity and Physical Activity in Children With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05354726
- Acronym / sponsor ID
- pedichronickidneydisease
- Conditions
- Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 29 Apr 2022 (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.
Studies examining musculoskeletal strength, respiratory function and muscle strength, physical activity level and exercise capacity in children with CKD and evaluating the relationships between these parameters have not been found both in the world and in our country. In this study, it is aimed to evaluate skeletal and respiratory muscle strength, respiratory parameters and exercise capacity in children with CKD primarily and compare them with healthy children. Secondly, it is to examine the relationship between endothelial function, arterial stiffness, sarcopenia and physical activity in children with CKD. It is thought that the results to be obtained with the study will support the literature with the prediction that rehabilitation programs for patients in all stages of CKD will be structured and in this way will contribute positively to the management and prognosis of the disease.
Hypotheses H0: There is no difference between children with chronic kidney disease and healthy children in terms of skeletal and respiratory muscle strength, respiratory parameters and exercise capacity.
H1: There is a difference between children with chronic kidney disease and healthy children in terms of skeletal and respiratory muscle strength, parameters and exercise capacity.
H0: There is no relationship between endothelial function, arterial stiffness, sarcopenia and physical activity in children with chronic kidney disease.
H1: There is a relationship between endothelial function, arterial stiffness, sarcopenia and physical activity in children with chronic kidney disease.
Detailed description
Children who applied to Gazi University, Faculty of Medicine, Department of Pediatrics, Department of Pediatric Nephrology and met the specified inclusion criteria will be included in our study. Patients will be referred to Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit after the routine evaluations including demographic and clinical characteristics, laboratory tests and anthropometric measurements are completed. Here, patients will be evaluated with physical therapy and rehabilitation measurement and evaluation methods such as muscle strength, exercise capacity and physical activity. The healthy control group will be formed by inviting the healthy relatives of the patients who applied to our faculty to participate in the study. After obtaining informed consent, healthy children will be evaluated.
Details of Working Method For each child with chronic kidney disease, age, gender, body weight, height, systolic and diastolic blood pressure, and results of routine blood tests (complete blood count test parameters: hemoglobin, hematocrit, erythrocyte, leukocyte and platelet count) biochemistry test parameters (blood sugar, blood urea nitrogen, creatinine, uric acid, sodium, potassium, chlorine, calcium, phosphorus, alkaline phosphatase, total protein, albumin, alanine aminotransferase, aspartate aminotransferase, triglyceride, total cholesterol, high-density lipoprotein, low-density lipoprotein levels , venous blood pH and bicarbonate etc. values), ferritin, parathormone, 25 hydroxy vitamin D level) will be recorded. The age at diagnosis, duration and etiology of the disease, current treatment information and drugs used will be recorded. Body composition data will also be recorded for children with CKD. Bone mineral density parameters in the last six months, left ventricular mass index values in the last three months, 24-hour blood pressure monitoring (ABPM) in the last month, and heart rate measured on the same device are used in the follow-up of the patients. wave velocity (pulse wave velocity-PWV) evaluation results will be used, if there is none, ABPM and PWV will be performed again. After these evaluations, parameters such as skeletal muscle strength, respiratory muscle strength, and exercise capacity will be evaluated in both the patient group and healthy children, and the obtained data will be compared. In addition, the relationship between parameters such as complete blood count parameters, biochemistry test parameters, routine bone markers, BMD, heart and vascular function evaluations and parameters such as skeletal and respiratory muscle strength, exercise capacity, and physical activity level will be examined in children with CKD. In case of adequate data, children with CKD will be subgrouped according to disease stage and assessment data will be analyzed by subgroups.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD group | – | Other: Assessments parametersInclusion Criteria for Volunteers (Inclusion Criteria): * 6-18 age range, * According to the Chronic Kidney Disease Assessment and Classification Guide prepared by the National Kidney Foundation- Kidney Disease Outcomes Quality Initiative (NKF-KDOQI); Stage 2, glomerular filtration rate 60-89 ml/min/1.73 m2, Stage 3, glomerular filtration rate 30-59 ml/min/1.73 m2, Stage 4, glomerular filtration rate 15-29 ml/min/1.73 m2, * Presence of kidney transplantation was determined as inclusion criteria. Exclusion Criteria for Volunteers: * acute infection, * Ongoing dialysis, * Congenital heart disease, * Hypertension that cannot be controlled with dual antihypertensive medication, * Neurological and/or genetic musculoskeletal disease, * The presence of orthopedic and cognitive problems that prevented the tests from being performed were determined as exclusion criteria. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children who applied to Gazi University, Faculty of Medicine, Department of Pediatrics, Department of Pediatric Nephrology and met the specified inclusion criteria will be included in our study. Patients will be referred to Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit after the routine evaluations including demographic and clinical characteristics, laboratory tests and anthropometric measurements are completed. Here, patients will be evaluated with physical therapy and rehabilitation measurement and evaluation methods such as muscle strength, exercise capacity and physical activity. The healthy control group will be formed by inviting the healthy relatives of the patients who applied to our faculty to participate in the study. After obtaining informed consent, healthy children will be evaluated.
Key inclusion criteria (6 listed)
- 6-18 age range,
- According to the Chronic Kidney Disease Assessment and Classification Guide prepared by the National Kidney Foundation- Kidney Disease Outcomes Quality Initiative (NKF-KDOQI); Stage 2, glomerular filtration rate 60-89 ml/min/1.73 m2, Stage 3, glomerular filtration rate 30-59 ml/min/1.73 m2, Stage 4, glomerular filtration rate 15-29 ml/min/1.73 m2,
- Presence of kidney transplantation was determined as inclusion criteria.
- Not have cardiovascular, neurological and/or genetic musculoskeletal disease
- Not having orthopedic and cognitive problems that prevent testing
Key exclusion criteria (7 listed)
- acute infection,
- Ongoing dialysis,
- Congenital heart disease,
- Hypertension that cannot be controlled with dual antihypertensive medication,
- Neurological and/or genetic musculoskeletal disease,
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 |
|---|---|---|
| Assessments parametersDemographic and Clinical Characteristics, Bone Mineral Density, Sarcopenia, Body Composition, Arterial Stiffness, Endothelial Function, Echocardiography,Pulmonary Function, Respiratory Muscle Strength, Submaximal exercise capacity, Maximal Exercise Capacity, Physical Activity Level, Hand Grip Strength, Lower Extremity Muscle Strength | Other | CKD group |
Primary outcome
Bone mineral density (BMD) z-score
Time frame: 15-25 minutes
Bone mineral density (BMD) measurement will be measured with a double X-ray absorptiometry device (DEXA (Horizon Wi (S/N 300796M))). Lumbar vertebral total BMD value and BMD z score will be calculated for each child. BMD z score -1 standard between -2 and -2 standard deviations, it will be considered as osteopenia, if it is less than -2 standard deviations, it will be considered as osteoporosis.This evaluation parameter will be recorded from the most recent test results for diagnosis and clinical course.
Skeletal muscle mass (SMM) z-score
Time frame: 15-25 minutes
Total/regional (obsolute/t-score and z-score) fat mass, lean mass (lean mass) and lean-boneless mass (lean mass) will be measured by dual energy X-ray absorptiometry device (DEXA (device tag). Skeletal muscle mass ( SMM), SMM z score and appendicular lean-boneless mass (appendicular lean mass) will be calculated according to the SMM values of healthy children based on age and gender.If the SMM z score is below -2 standard deviations, it will be considered as sarcopenia.
Arterial stiffness
Time frame: 10 minutes
Arterial stiffness will be assessed using the pulse wave velocity (PWV) technique with the blood pressure holter-ABPM (spacelabs) device. Pulse waves will be recorded by placing the proximal sensor of the device in the places where the carotid artery and the distal sensor of the femoral artery are best palpated. The distance between these two points and the pulse propagation velocity will be calculated with the help of a computer in m/sec. High velocity data indicates high arterial stiffness, low velocity indicates less arterial stiffness.
Carotid artery intima-media thickness (cIMT)
Time frame: 10-15 minutes
For endothelial function, standardized measurement of carotid artery intima-media thickness (cIMT) will be made by the same radiologist with a high-resolution US device (General Electric) with a multi-frequency liner probe (5-12 MHz). Measurements will be taken over the bilateral distal common carotid arteries (1 cm proximal to bufircation) while the patients are supine and their necks are in neutral extension. cIMT is defined as the distance between the lumen-intima interface and the media-adventitia interface. A total of 6 records, three from each side, will be taken and the average will be recorded as cIMT.
Left ventricular mass index
Time frame: 10-15 minutes
Left ventricular mass index measurement and evaluation of left ventricular hypertrophy will be performed. Interventricular septum, posterior wall and left ventricular wall thickness measurements will be taken in diastole with M mode echocardiography. The presence of LVH will be evaluated by evaluating the left ventricular mass (LVMI) calculated and indexed by using the Devereux formula according to age, gender and height.
Forced expiratory volume in 1 second (FEV1)
Time frame: 10-15 minutes
Pulmonary function testing will be performed with a portable spirometer (Spirodoc, Medical International Research, Rome, Italy) using standard procedures. Forced expiratory volume in 1 second (FEV1), will be saved.
Forced vital capacity (FVC)
Time frame: 10-15 minutes
Pulmonary function testing will be performed with a portable spirometer (Spirodoc, Medical International Research, Rome, Italy) using standard procedures. Forced vital capacity (FVC) parameter will be saved.
FEV1/FVC
Time frame: 10-15 minutes
Pulmonary function testing will be performed with a portable spirometer (Spirodoc, Medical International Research, Rome, Italy) using standard procedures. FEV1/FVC parameter will be saved.
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Time frame: 10-15 minutes
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) will be used as indicators of respiratory muscle strength (28). A portable intraoral pressure gauge (MicroRPM, Micromedical, Kent, UK) and nose clip will be used during MIP and MEP assessments. MIP and MEP measurements will be obtained using standard procedures. 3 measurements will be made where the difference between each measurement is not more than 10% and the maximum value of MIP and MEP will be recorded.
6-Minute Walk Test (6 MWT) distance
Time frame: 10-15 minutes
Submaximal exercise capacity will be evaluated with the 6-Minute Walk Test (6 MWT). The standard protocol will be implemented in a continuous corridor of 30 meters. The patient wearing comfortable clothes and shoes will be given standard instructions and verbal guidance during the test. The distance the patient walked during the test will be recorded in meters.
ISWT distance
Time frame: 10-15 minutes
Maximal exercise capacity will be evaluated with the incremental shuttle walk test (ISWT). For the ISWT, it will be adjusted to a total of 10 meters with 2 cones placed at a distance of 9.0 meters from each other and a rotational margin of 0.5 meters. In this system, the patient will be asked to walk in a round-trip way, adapting to the increasing speed and the sound coming from outside. In the shuttles that are getting faster and faster, the lap number of the patients, the number of laps of the last level they can reach, and the walking/running distances in meters will be recorded.
Physical Activity Level
Time frame: 5-10 minutes
The scale to be used for this purpose is the Child Physical Activity Questionnaire (MFAA) developed by Kowalski et al. It is a seven-day self-reported recall scale designed to assess moderate-intensity physical activity in children aged 8-14 years. CFAA is designed to be implemented throughout the school year. The Turkish validity and reliability of the questionnaire was made and permission was obtained from the responsible author for its use.
Hand Grip Strenght
Time frame: 10-15 minutes
Hand grip strength will be measured using a hand dynamometer (Jamar, Sammons Preston, Rolyon, Bolingbrook, IL). Measurements will be made using standard procedures, right and left sides, with the arms at the side of the trunk, the elbow in a 90-degree flexion position, and the forearm and wrist in a neutral position. The highest of the three measurements will be considered as hand grip strength.
Maximum isometric muscle strength of the quadriceps femoris
Time frame: 10-15 minutes
Maximum isometric muscle strength of the quadriceps femoris muscle will be measured with a dynamometer (Lafayette Instrument Company, Lafayette, Indiana).
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 20 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Chronic Kidney Diseases, run by Hacettepe 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 6 inclusion and 7 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 20 Aug 2026. 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. 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?
Bone mineral density (BMD) z-score (time frame: 15-25 minutes). The study lists 14 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 20 Aug 2026.