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

Completed

• Conditions: Chronic Kidney Diseases; Chronic Renal Failure; Chronic Renal Disease

• Registration Number: NCT05339997
• Lead Sponsor: Acibadem University

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.

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 Timeline

• Study Start: 2022-02-15
• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-21
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6 minute walk test	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.

Secondary Outcome Measures

Name	Time	Method
pulmonary function test	during the procedure	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.

Trial Locations

Locations (1)

Acibadem Mehmet Ali Aydınlar University; 🇹🇷 Istanbul, Turkey