Evaluation of Respiratory Function and Functional Capacity in Pediatric Patients With Chronic Kidney Disease (CKD)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Chronic Renal Failure; Chronic Renal Disease
• Intervention / Treatment: Other: 6 minute walk test,

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34752
    • Acibadem Mehmet Ali Aydınlar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	during the procedure

Collaborators and Investigators

• Sponsor: Acibadem University
• Investigators: Study Director: Irmak Çavuşoğlu, MSc, Acıbadem Mehmet Ali Aydınlar University; Study Chair: Elif Esma Safran, MSc, Acıbadem Mehmet Ali Aydınlar University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 10, 2022

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: pulmonary function; functional capacity; pediatric chronic kidney disease
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: ırmak çavuşoğlu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No