Chronic Kidney FailureNCT06981585
Physical Impairments in Children With Chronic Renal Failure
An observational study of Chronic Kidney Failure and Chronic Kidney Diseases, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
When the literature is examined, it is seen that the extent to which cough strength, grip strength, physical activity level and quality of life levels are affected in children with chronic kidney failure compared to healthy children is not sufficiently clarified. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Failure, Chronic Kidney Diseases
- What is being tested?
- Physical Evaluations of Patients with Chronic Kidney Failure and Physical Evaluations of Healthy Children
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Mar 2027
- Phase
- Observational
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: At least 25 patients with Chronic Kidney Failure will be included in the research group and at least 25 healthy individuals will be included in the control group.
Who may be able to join
- Being between the ages of 8-18,
- Having the necessary cooperation for the measurements,
- Being willing to participate in the research
- Exclusion Criteria: for Children and Adolescents with Chronic Kidney Failure
- Having any orthopedic, neurological, cardiovascular or psychological problems that may prevent measurements from being taken in the last 6 months
- Being a smoker or having quit
- Having had a kidney transplant.
Who cannot join
- Having a history of any orthopedic, neurological, cardiovascular or psychological problems that may prevent measurements from being taken in the last 6 months
- Having any chronic disease
- Being a smoker or having quit smoking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İzmir Demokrasi Üniversitesi
Izmir, 35140
GÜLŞAH BARĞI, +90 531 793 8766, gulsahbargi35@gmail.com
HÜSEYİN KIRAN
About this study
Official title: Comparison of Muscle Strength, Physical Activity, Sleep Quality and Quality of Life Between Children With Chronic Kidney Failure and Healthy Children
When the literature is examined, it is seen that the extent to which cough strength, grip strength, physical activity level and quality of life levels are affected in children with chronic kidney failure compared to healthy children is not sufficiently clarified. For this reason, this study aimed to reveal impairments in grip strength, cough strength, physical activity, sleep quality or quality of life in children with chronic renal failure compared to healthy children.
Read the detailed description
The aim of this study is to compare children and adolescents with chronic kidney disease with healthy children and adolescents in terms of grip strength, cough strength, physical activity, sleep quality and quality of life. Participants will be evaluated for these parameters through clinical assessments, questionnaires and measurements. The aim of the study is to understand the health effects of chronic kidney disease and to provide the basis for improvements in the health management of these individuals.
- Conditions
- Chronic Kidney Failure, Chronic Kidney Diseases
- Being tested
- Physical Evaluations of Patients with Chronic Kidney Failure, Physical Evaluations of Healthy Children
- Keywords
- Chronic Kidney Failure, Muscle Strength, Physical Activity, Sleep Quality, Quality of Life
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Motor Activity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Evaluations of Patients with Chronic Kidney FailureOther
In this study, data from children and adolescents with chronic kidney disease will be collected through face-to-face assessments. Grip strength, cough strength, physical activity, sleep quality and quality of life will be assessed in children and adolescents who meet the inclusion criteria. All data obtained through these assessments will be collected from participants face-to-face at one time and for a maximum of approximately 1 hour.
Physical Evaluations of Healthy ChildrenOther
In this study, data from healthy children and adolescents will be collected through face-to-face assessments. Grip strength, cough strength, physical activity, sleep quality and quality of life will be assessed in children and adolescents who meet the inclusion criteria. Data obtained through all these assessments will be collected from participants face-to-face at once and for a maximum of approximately 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney Failure Group | This group will consist of children and adolescents with chronic kidney failure. Receives: Other: Physical Evaluations of Patients with Chronic Kidney Failure | |
| Control Group | This group will consist of healthy children and adolescents. Receives: Other: Physical Evaluations of Healthy Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life score
The scale we will use to assess health-related quality of life, the Pediatric Quality of Life Inventory (PedsQL 4.0). The scale was developed to assess the health-related quality of life of children and adolescents between the ages of 2 and 18 and consists of physical, emotional, social and school functioning items, totaling 23 items.Scores from this questionnaire are converted to a scale of 0 to 100. Higher scores indicate better health-related quality of life.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Cough Strength
The peak cough expiratory flow (PEF) of the individual will be assessed in the upright sitting position using a peak cough flow meter (PEF meter) (Expirite Peak Flow Meter, China). The individual coughs into the PEF meter as forcefully as possible following deep inspiration. The best of at least three repetitions is recorded.
Measured: through study completion, an average of 1 year
Hand Grip Strength
Grip strength will be measured using a dynamometer. Each hand will be tested three times, and the highest value will be recorded for both sides.
Measured: through study completion, an average of 1 year
Evaluation of Physical Activities
The Godin-Shephard leisure-time physical activity questionnaire will be used to determine the number of times individuals engage in physical activity during a one-week period. The questionnaireasks how many times individuals engage in physical activity lasting at least 15 minutes or longer during their free time over a 7-day period. This is used to calculate individuals' total physical activity scores. The higher the total score, the higher the individual's physical activity level. According to the score obtained from this questionnaire using moderate and strenuous physical activities; those who score 24 units or more are classified as Active (Significant benefits), those who score between 14-23 units are classified as Moderately active (Some benefits), and those who score less than 14 units are classified as Insufficiently active (Less important or low benefits).
Measured: through study completion, an average of 1 year
Evaluation of sleep quality
Children's Sleep Habits Questionnaire-Short Form will be used to evaluate sleep disorder in individuals and it consists of a total of 33 items.The total score is calculated.The lowest possible score for the questionnaire is 0, and the highest is 99. The higher the total score, the more sleep problems the individual has.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Aug 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney FailureStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsah Bargi, Izmir Democracy University
- Investigators
- Gülşah Barğı, Study director, İzmir Demokrasi ÜniversitesiHüseyin Kıran, Principal investigator, İzmir Demokrasi ÜniversitesiNida Dinçel, Study director, SBÜ İTF DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981585
- Sponsor's protocol ID
- Healthy and Kidney Failure
- Status last verified
- Nov 2026
- First submitted
- 12 May 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clark SL, Denburg MR, Furth SL. Physical activity and screen time in adolescents in the chronic kidney disease in children (CKiD) cohort. Pediatr Nephrol. 2016 May;31(5):801-8. doi: 10.1007/s00467-015-3287-z. Epub 2015 Dec 18.
PubMed 26684326Taner S, Ekberli G, Gunes S. The Effect of Sleep Habits on Quality of Life in Pediatric Patients With Chronic Kidney Disease. Cureus. 2024 Jul 15;16(7):e64585. doi: 10.7759/cureus.64585. eCollection 2024 Jul.
PubMed 39144881Darwish AH, Abdel-Nabi H. Sleep disorders in children with chronic kidney disease. Int J Pediatr Adolesc Med. 2016 Sep;3(3):112-118. doi: 10.1016/j.ijpam.2016.06.001. Epub 2016 Jun 29.
PubMed 30805480
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Muscle Strength, Physical Activity, Sleep Quality and Quality of Life Between Children With Chronic Kidney Failure and Healthy Children
- ClinicalTrials.gov ID
- NCT06981585
- Acronym / sponsor ID
- Healthy and Kidney Failure
- Conditions
- Chronic Kidney Failure, Chronic Kidney Diseases
- Keywords
- Chronic Kidney Failure, Muscle Strength, Physical Activity, Sleep Quality, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 20 May 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.
When the literature is examined, it is seen that the extent to which cough strength, grip strength, physical activity level and quality of life levels are affected in children with chronic kidney failure compared to healthy children is not sufficiently clarified. For this reason, this study aimed to reveal impairments in grip strength, cough strength, physical activity, sleep quality or quality of life in children with chronic renal failure compared to healthy children.
Detailed description
The aim of this study is to compare children and adolescents with chronic kidney disease with healthy children and adolescents in terms of grip strength, cough strength, physical activity, sleep quality and quality of life. Participants will be evaluated for these parameters through clinical assessments, questionnaires and measurements. The aim of the study is to understand the health effects of chronic kidney disease and to provide the basis for improvements in the health management of these individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Failure Group | – | Other: Physical Evaluations of Patients with Chronic Kidney FailureThis group will consist of children and adolescents with chronic kidney failure. |
| Control Group | – | Other: Physical Evaluations of Healthy ChildrenThis group will consist of healthy children and adolescents. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- At least 25 patients with Chronic Kidney Failure will be included in the research group and at least 25 healthy individuals will be included in the control group.
Key inclusion criteria (7 listed)
- Being between the ages of 8-18,
- Having the necessary cooperation for the measurements,
- Being willing to participate in the research
- Exclusion Criteria: for Children and Adolescents with Chronic Kidney Failure
- Having any orthopedic, neurological, cardiovascular or psychological problems that may prevent measurements from being taken in the last 6 months
Key exclusion criteria (3 listed)
- Having a history of any orthopedic, neurological, cardiovascular or psychological problems that may prevent measurements from being taken in the last 6 months
- Having any chronic disease
- Being a smoker or having quit smoking
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 |
|---|---|---|
| Physical Evaluations of Patients with Chronic Kidney FailureIn this study, data from children and adolescents with chronic kidney disease will be collected through face-to-face assessments. Grip strength, cough strength, physical activity, sleep quality and quality of life will be assessed in children and adolescents who meet the inclusion criteria. All data obtained through these assessments will be collected from participants face-to-face at one time and for a maximum of approximately 1 hour. | Other | Chronic Kidney Failure Group |
| Physical Evaluations of Healthy ChildrenIn this study, data from healthy children and adolescents will be collected through face-to-face assessments. Grip strength, cough strength, physical activity, sleep quality and quality of life will be assessed in children and adolescents who meet the inclusion criteria. Data obtained through all these assessments will be collected from participants face-to-face at once and for a maximum of approximately 1 hour. | Other | Control Group |
Primary outcome
Quality of life score
Time frame: through study completion, an average of 1 year
The scale we will use to assess health-related quality of life, the Pediatric Quality of Life Inventory (PedsQL 4.0). The scale was developed to assess the health-related quality of life of children and adolescents between the ages of 2 and 18 and consists of physical, emotional, social and school functioning items, totaling 23 items.Scores from this questionnaire are converted to a scale of 0 to 100. Higher scores indicate better health-related quality of life.
4 secondary outcomes
Cough Strength
Time frame: through study completion, an average of 1 year
Hand Grip Strength
Time frame: through study completion, an average of 1 year
Evaluation of Physical Activities
Time frame: through study completion, an average of 1 year
Evaluation of sleep quality
Time frame: through study completion, an average of 1 year
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 5 Nov 2026.
- Background: PubMed 26684326Clark SL, Denburg MR, Furth SL. Physical activity and screen time in adolescents in the chronic kidney disease in children (CKiD) cohort. Pediatr Nephrol. 2016 May;31(5):801-8. doi: 10.1007/s00467-015-3287-z. Epub 2015 Dec 18.
- Background: PubMed 39144881Taner S, Ekberli G, Gunes S. The Effect of Sleep Habits on Quality of Life in Pediatric Patients With Chronic Kidney Disease. Cureus. 2024 Jul 15;16(7):e64585. doi: 10.7759/cureus.64585. eCollection 2024 Jul.
- Background: PubMed 30805480Darwish AH, Abdel-Nabi H. Sleep disorders in children with chronic kidney disease. Int J Pediatr Adolesc Med. 2016 Sep;3(3):112-118. doi: 10.1016/j.ijpam.2016.06.001. Epub 2016 Jun 29.
- 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.
Gülşah Barğı study director
İzmir Demokrasi Üniversitesi
Hüseyin Kıran principal investigator
İzmir Demokrasi Üniversitesi
Nida Dinçel study director
SBÜ İTF DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ
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 Failure and Chronic Kidney Diseases, run by Izmir Democracy 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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Nov 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?
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 Gülşah Barğı (+90 232 299 0739, gulsahbargi35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life score (time frame: through study completion, an average of 1 year). 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 NCT06981585, which also lists 3 linked publications.
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 5 Nov 2026.