NCT06981585

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
10mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Aug 2025Mar 2027

First Submitted

Initial submission to the registry

May 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

May 12, 2025

Last Update Submit

August 26, 2025

Conditions

Keywords

Chronic Kidney FailureMuscle StrengthPhysical ActivitySleep QualityQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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.

    through study completion, an average of 1 year

Secondary Outcomes (4)

  • Cough Strength

    through study completion, an average of 1 year

  • Hand Grip Strength

    through study completion, an average of 1 year

  • Evaluation of Physical Activities

    through study completion, an average of 1 year

  • Evaluation of sleep quality

    through study completion, an average of 1 year

Study Arms (2)

Chronic Kidney Failure Group

This group will consist of children and adolescents with chronic kidney failure.

Other: Physical Evaluations of Patients with Chronic Kidney Failure

Control Group

This group will consist of healthy children and adolescents.

Other: Physical Evaluations of Healthy Children

Interventions

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.

Chronic Kidney Failure Group

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.

Control Group

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Being between the ages of 8-18
  • Being clinically stable for at least the last 3 weeks
  • Having the necessary cooperation for the measurements
  • Being willing to participate in the study
  • Being between the ages of 8-18,
  • Having the necessary cooperation for the measurements,
  • Being willing to participate in the research

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir Demokrasi Üniversitesi

Izmir, 35140, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 26684326BACKGROUND
  • Taner 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.

    PMID: 39144881BACKGROUND
  • Darwish 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.

    PMID: 30805480BACKGROUND

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency, ChronicMotor ActivitySleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Gülşah Barğı

    İzmir Demokrasi Üniversitesi

    STUDY DIRECTOR
  • Hüseyin Kıran

    İzmir Demokrasi Üniversitesi

    PRINCIPAL INVESTIGATOR
  • Nida Dinçel

    SBÜ İTF DR. BEHÇET UZ ÇOCUK HASTALIKLARI VE CERRAHİSİ EĞİTİM VE ARAŞTIRMA HASTANESİ

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2025

First Posted

May 20, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations