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Clinical Trials/NCT04538443
NCT04538443UnknownNot Applicable

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

Cairo University0 sites100 target enrollmentStarted: October 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Primary Endpoint
functional capacity

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
8 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

functional capacity

Time Frame: 6 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 Outcomes

  • quality of life of families of children with CKD(6 months)
  • muscle strength(6 months)
  • quality of life of children(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shaymaa Rushdy Mahmoud

principal investigator

Cairo University

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