CKD (Chronic Kidney Disease) Stage 5DNCT04538443
Impact of CKD on Children and Their Families
An observational study of CKD (Chronic Kidney Disease) Stage 5D, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- CKD (Chronic Kidney Disease) Stage 5D
- What is being tested?
- functional capacity, muscle strength and Quality of life of children
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 30 Oct 2021
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- CKD (Chronic Kidney Disease) Stage 5D
- Being tested
- functional capacity, muscle strength, Quality of life of children, Quality of life of families
- Keywords
- CKD, hemodialysis, functional capacity, QoL
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional capacityOther
impact of hemodialysis on functional capacity in children with CKD
muscle strengthOther
impact of hemodialysis on muscle strength in children with CKD
Quality of life of childrenOther
impact of hemodialysis on Quality of life in children with CKD
Quality of life of familiesOther
impact of hemodialysis on Quality of life of families of children with CKD
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: functional capacity; Other: muscle strength; Other: Quality of life of children; Other: Quality of life of families |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
muscle strength
Hand grip strength HGS is a noninvasive and reliable method for assessment of muscle power and nutritional status in CKD children
Measured: 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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CKD (Chronic Kidney Disease) Stage 5DStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaymaa Rushdy Mahmoud, Cairo University
- Investigators
- Amira M El Tohamy, Doctoral, Study chair, Professor of pediatrics Faculty of Physical Therapy, Cairo UniversityAmira M Abd-Elmonem, Doctoral, Study director, Assistant Professor of pediatrics Faculty of Physical Therapy, Cairo UniversityRasha EE Galal, Doctoral, Study director, Professor of pediatrics, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538443
- Sponsor's protocol ID
- CKD comorbidity
- Status last verified
- Sep 2020
- First submitted
- 30 Aug 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abd El Basset Bakr AM, Hasaneen BM, AbdelRasoul Helal Bassiouni D. Assessment of Nutritional Status in Children With Chronic Kidney Disease Using Hand Grip Strength Tool. J Ren Nutr. 2018 Jul;28(4):265-269. doi: 10.1053/j.jrn.2017.12.007. Epub 2018 May 3.
PubMed 29731235Maher CA, Williams MT, Olds TS. The six-minute walk test for children with cerebral palsy. Int J Rehabil Res. 2008 Jun;31(2):185-8. doi: 10.1097/MRR.0b013e32830150f9.
PubMed 18467936Pathare N, Haskvitz EM, Selleck M. 6-Minute Walk Test Performance in Young Children who are Normal Weight and Overweight. Cardiopulm Phys Ther J. 2012 Dec;23(4):12-8.
PubMed 23304095Baek HS, Park KS, Ha IS, Kang HG, Cheong HI, Park YS, Lee JH, Cho HY, Cho MH. Impact of end-stage renal disease in children on their parents. Nephrology (Carlton). 2018 Aug;23(8):764-770. doi: 10.1111/nep.13083.
PubMed 28612957