NCT05339997

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2022

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

April 14, 2022

Last Update Submit

July 24, 2023

Conditions

Keywords

pediatric chronic kidney diseasepulmonary functionfunctional capacity

Outcome Measures

Primary Outcomes (1)

  • 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.

    during the procedure

Secondary Outcomes (1)

  • pulmonary function test

    during the procedure

Interventions

submaximal exercise test used to evaluate the functional capacity of patients

Also known as: pulmonary function tests

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Pediatric patients aged 5-18 years with stage 1-5 chronic kidney disease

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem Mehmet Ali Aydınlar University

Istanbul, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, Chronic

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

  • Irmak Çavuşoğlu, MSc

    Acıbadem Mehmet Ali Aydınlar University

    STUDY DIRECTOR
  • Elif Esma Safran, MSc

    Acıbadem Mehmet Ali Aydınlar University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist physiotherapist-Lecturer

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 21, 2022

Study Start

February 15, 2022

Primary Completion

June 30, 2022

Study Completion

July 10, 2022

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations