Chronic Kidney DiseasesNCT05339997
Evaluation of Respiratory Function and Functional Capacity in Pediatric Patients With Chronic Kidney Disease (CKD)
An observational study of Chronic Kidney Diseases and Chronic Renal Disease, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Chronic kidney disease (CKD) is defined as a permanent abnormality in kidney structure or function that persists for more than 3 months (for example, glomerular filtration rate [GFR] <60 mL/min/1.73 m2 or albuminuria ≥30 mg/24 hours) and, it effects the 8% to 16% of the population worldwide.In pediatric patients with… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Chronic Kidney Diseases, Chronic Renal Disease, Chronic Renal Failure
- What is being tested?
- 6 minute walk test,
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 10 Jul 2022
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients aged 5-18 years with stage 1-5 chronic kidney disease
Who may be able to join
- Being between the ages of 5-18, having stage I-V chronic kidney disease,
- Having chronic kidney disease for at least 6 months,
- Not having visual and hearing impairment
Who cannot join
- Presence of mental retardation,
- Insufficient Turkish communication, Inability to communicate,
- Having metabolic-neurological problems,
- Presence of cardiomyopathy, angina pectoris,
- Presence of orthopedic problem that will prevent standing and walking
- Cerebrovascular disease
- Patients will not be included in the study in the presence of metastatic carcinoma.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem Mehmet Ali Aydınlar University
Istanbul, 34752
About this study
Chronic kidney disease (CKD) is defined as a permanent abnormality in kidney structure or function that persists for more than 3 months (for example, glomerular filtration rate [GFR] <60 mL/min/1.73 m2 or albuminuria ≥30 mg/24 hours) and, it effects the 8% to 16% of the population worldwide.In pediatric patients with CKD, exercise capacity begins to decline in stage 3 of the disease and progressively decreases in stage 5, in dialysis and transplant patients (4, 5). Reduction in respiratory muscle strength and six minute walk test (6MWT) is observed in patients with CKD treated with hemodialysis (HD).The aim in present study is to evaluate the relationship between functional capacity and respiratory functions in stage 1-5 pediatric chronic kidney disease patients.
Read the detailed description
The aim of this study is to evaluate functional capacity with six minutes walk test (6MWT), respiratory functions with spirometer and the correlation between functional capacity and respiratory functions in pediatric CKD patients.
- Being tested
- 6 minute walk test,
- Keywords
- pediatric chronic kidney disease, pulmonary function, functional capacity
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 minute walk test,Other
Also called pulmonary function tests
submaximal exercise test used to evaluate the functional capacity of patients
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
its a submaximal exercise test. The 6MWT is carried out in a marked 30 meter corridor. Patients are asked to walk as quickly as possible. They can stop whenever they want. The distance walked is recorded in meters. And it is interpreted according to the reference values of healthy children.quicly as possible and the distance will be record in meter.
Measured: during the procedure
Secondary outcomes (1)
pulmonary function test
FVC, FEV1, FEV1/FVC, PEF parameters will be eveluated.Patients sit with a clip on their noses. After 3 technically appropriate tests, the best measured values are recorded and compared against reference values.The measurements obtained are recorded as a percentage relative to their ratio to the expected reference values.FEV1, FVC,PEF measurements are recorded as a volume in ml.
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start15 Feb 2022
- Primary completion30 Jun 2022
- Study completion10 Jul 2022
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.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irmak ÇAVUŞOĞLU, Acibadem University
- Investigators
- Irmak Çavuşoğlu, MSc, Study director, Acibadem UniversityElif Esma Safran, MSc, Study chair, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339997
- Sponsor's protocol ID
- ırmak çavuşoğlu
- Status last verified
- Jul 2023
- First submitted
- 14 Apr 2022
- Last updated
- 25 Jul 2023
- 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Respiratory Function and Functional Capacity in Pediatric Patients With Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT05339997
- Acronym / sponsor ID
- ırmak çavuşoğlu
- Keywords
- pediatric chronic kidney disease, pulmonary function, functional capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 21 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.
Chronic kidney disease (CKD) is defined as a permanent abnormality in kidney structure or function that persists for more than 3 months (for example, glomerular filtration rate [GFR] <60 mL/min/1.73 m2 or albuminuria ≥30 mg/24 hours) and, it effects the 8% to 16% of the population worldwide.In pediatric patients with CKD, exercise capacity begins to decline in stage 3 of the disease and progressively decreases in stage 5, in dialysis and transplant patients (4, 5). Reduction in respiratory muscle strength and six minute walk test (6MWT) is observed in patients with CKD treated with hemodialysis (HD).The aim in present study is to evaluate the relationship between functional capacity and respiratory functions in stage 1-5 pediatric chronic kidney disease patients.
Detailed description
The aim of this study is to evaluate functional capacity with six minutes walk test (6MWT), respiratory functions with spirometer and the correlation between functional capacity and respiratory functions in pediatric CKD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients aged 5-18 years with stage 1-5 chronic kidney disease
Key inclusion criteria (3 listed)
- Being between the ages of 5-18, having stage I-V chronic kidney disease,
- Having chronic kidney disease for at least 6 months,
- Not having visual and hearing impairment
Key exclusion criteria (7 listed)
- Presence of mental retardation,
- Insufficient Turkish communication, Inability to communicate,
- Having metabolic-neurological problems,
- Presence of cardiomyopathy, angina pectoris,
- Presence of orthopedic problem that will prevent standing and walking
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 |
|---|---|---|
| 6 minute walk test,Also: pulmonary function testssubmaximal exercise test used to evaluate the functional capacity of patients | Other | – |
Primary outcome
6 minute walk test
Time frame: during the procedure
its a submaximal exercise test. The 6MWT is carried out in a marked 30 meter corridor. Patients are asked to walk as quickly as possible. They can stop whenever they want. The distance walked is recorded in meters. And it is interpreted according to the reference values of healthy children.quicly as possible and the distance will be record in meter.
1 secondary outcome
pulmonary function test
Time frame: during the procedure
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 25 Jul 2023.
- 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.
Irmak Çavuşoğlu, MSc study director
Acibadem University
Elif Esma Safran, MSc study chair
Acibadem University
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 and Chronic Renal Disease, run by Acibadem 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 3 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 25 Jul 2023. 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?
6 minute walk test (time frame: during the procedure). 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 25 Jul 2023.