Impact of CKD on Children and Their Families

September 6, 2020 updated by: Shaymaa Rushdy Mahmoud, Cairo University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hemodialysis group
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
impact of hemodialysis on functional capacity in children with CKD
Other: muscle strength
impact of hemodialysis on muscle strength in children with CKD
Other: Quality of life of children
impact of hemodialysis on Quality of life in children with CKD
Other: Quality of life of families
impact of hemodialysis on Quality of life of families of children with CKD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle strength
Time Frame: 6 months
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
Time Frame: 6 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.
6 months
quality of life of families of children with CKD
Time Frame: 6 months
The PedsQL FIM appears to be a useful tool for the assessment of family impact on children with ESRD
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Amira M El Tohamy, Doctoral, Professor of pediatrics Faculty of Physical Therapy, Cairo University
  • Study Director: Amira M Abd-Elmonem, Doctoral, Assistant Professor of pediatrics Faculty of Physical Therapy, Cairo University
  • Study Director: Rasha EE Galal, Doctoral, Professor of pediatrics, Faculty of Medicine, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 30, 2021

Study Registration Dates

First Submitted

August 30, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 4, 2020

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 6, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CKD comorbidity

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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