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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05339997
• Other study ID #: irmak çavusoglu
• Status: Completed
• Start date: February 15, 2022
• Est. completion date: July 10, 2022

Study information

• Verified date: July 2023
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 10, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Chronic Renal Disease
• Chronic Renal Failure
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Other:
• 6 minute walk test,
submaximal exercise test used to evaluate the functional capacity of patients

Locations

Country	Name	City	State
Turkey	Acibadem Mehmet Ali Aydinlar University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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