Clinical trial NCT04538443: Impact of CKD on Children and Their Families
Official title: Impact of Chronic Kidney Disease on Children Functional Capacity and Their Families' Quality of Life: A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CKD (Chronic Kidney Disease) Stage 5D
Keywords: CKD
hemodialysis
functional capacity
QoL
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: functional capacity
timeFrame: 6 months
Secondary outcomes:
measure: muscle strength
timeFrame: 6 months
measure: quality of life of children
timeFrame: 6 months
measure: quality of life of families of children with CKD
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Professor of pediatrics Faculty of Physical Therapy, Cairo University
name: Amira M El Tohamy, Doctoral
role: STUDY_CHAIR
affiliation: Assistant Professor of pediatrics Faculty of Physical Therapy, Cairo University
name: Amira M Abd-Elmonem, Doctoral
role: STUDY_DIRECTOR
affiliation: Professor of pediatrics, Faculty of Medicine, Cairo University
name: Rasha EE Galal, Doctoral
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Maher 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.
citation: Pathare 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.
citation: Baek 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.