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Impact of CKD on Children and Their Families

Conditions
CKD (Chronic Kidney Disease) Stage 5D
Interventions
Other: functional capacity
Other: muscle strength
Other: Quality of life of children
Other: Quality of life of families
Registration Number
NCT04538443
Lead Sponsor
Cairo University
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
hemodialysis groupfunctional capacityOne 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
hemodialysis groupQuality of life of familiesOne 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
hemodialysis groupmuscle strengthOne 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
hemodialysis groupQuality of life of childrenOne 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
Primary Outcome Measures
NameTimeMethod
functional capacity6 months

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

Secondary Outcome Measures
NameTimeMethod
quality of life of families of children with CKD6 months

The PedsQL FIM appears to be a useful tool for the assessment of family impact on children with ESRD

muscle strength6 months

Hand grip strength HGS is a noninvasive and reliable method for assessment of muscle power and nutritional status in CKD children

quality of life of children6 months

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.

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