Impact of CKD on Children and Their Families

CKD (Chronic Kidney Disease) Stage 5D Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04538443
• Other study ID #: CKD comorbidity
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: September 2020
• Source: Cairo University
• Contact: Shaymaa R Mahmoud, Master
• Phone: 01145050053 - 01002452555
• Email: shaymaarushdy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 30, 2021
• Est. primary completion date: October 1, 2021
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• CKD (Chronic Kidney Disease) Stage 5D
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• functional capacity
impact of hemodialysis on functional capacity in children with CKD
• muscle strength
impact of hemodialysis on muscle strength in children with CKD
• Quality of life of children
impact of hemodialysis on Quality of life in children with CKD
• Quality of life of families
impact of hemodialysis on Quality of life of families of children with CKD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	muscle strength	Hand grip strength HGS is a noninvasive and reliable method for assessment of muscle power and nutritional status in CKD children	6 months
Secondary	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.	6 months
Secondary	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	6 months