Impact of CKD on Children and Their Families

Study Overview
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Brief Summary
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Based on the available literatures, previous studies have investigated the impact of CKD and dialysis on patient's health among adult and elderly population. As far as we know, this is the first empirical study that investigates the impact of CKD on children functional capacity and their families QOL.

Detailed Description
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The current study will be done to investigate the long term effect of the CKD itself on different dimensions of the child health to understand the unique characteristics of pediatric CKD. Also, it will be beneficial for designing a comprehensive physical therapy protocol for prevention of different complications and to improve their wellbeing healthcare. Additionally, it will be beneficial to determine the family and parental stresses and to build the rehabilitation plan for the child considering the possible family issues regarding the child condition.

Official Title
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Impact of Chronic Kidney Disease on Children Functional Capacity and Their Families' Quality of Life: A Cross Sectional Study

Conditions
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CKD (Chronic Kidney Disease) Stage 5D

Intervention / Treatment
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* Other: functional capacity
* Other: muscle strength
* Other: Quality of life of children
* Other: Quality of life of families


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from eight to twelve years. Both genders. Diagnosed with ESRD (stage 5) based on the glomerular filtration rate (GFR < 15 mL/minute/1.73 m2). Able to understand and follow instructions during assessment procedures. Willing to participate in the study and attend the assessment procedures. Exclusion Criteria: Children of the following criteria will be excluded from the study: Cardiopulmonary disorders Uncontrolled hypertension Unstable angina Severe uncontrolled diabetes Neurological or cognitive disorders with functional deficits Significant cerebral or peripheral vascular disease.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hemodialysis group<br>One hundred children with ESRD who are treated with hemodialysis and their caregivers will participate in this study. They will be recruited from Nephrology Unit at Abo-Elreesh Hospital, Cairo University | Other: functional capacity<br>* impact of hemodialysis on functional capacity in children with CKD<br>Other: muscle strength<br>* impact of hemodialysis on muscle strength in children with CKD<br>Other: Quality of life of children<br>* impact of hemodialysis on Quality of life in children with CKD<br>Other: Quality of life of families<br>* impact of hemodialysis on Quality of life of families of children with CKD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional capacity | 6 minute walking test is commonly used to evaluate functional capacity in children with CKD. It is a simple, practical, reliable, and valid measure of submaximal exercise capacity in healthy children and children with chronic disease or neuromuscular disorders or cardiopulmonary disease | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength | Hand grip strength HGS is a noninvasive and reliable method for assessment of muscle power and nutritional status in CKD children | 6 months | 
| quality of life of children | The Arabic version of the PedsQLTM 4.0 Generic Core Scales version proved to be understandable and feasible to use. It showed good reliability for healthy children and children with chronic medical conditions and their parents. | 6 months | 
| quality of life of families of children with CKD | The PedsQL FIM appears to be a useful tool for the assessment of family impact on children with ESRD | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD, hemodialysis, functional capacity, QoL