Impact of CKD on Children and Their Families

NCT04538443 | Unknown

• 1 other identifier: CKD comorbidity
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

CKD (Chronic Kidney Disease) Stage 5D

Keywords

CKD; hemodialysis; functional capacity; QoL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• muscle strength

  6 months

• quality of life of children

  6 months

• quality of life of families of children with CKD

  6 months

Study Arms (1)

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; Other: muscle strength; Other: Quality of life of children; Other: Quality of life of families

Interventions

functional capacity OTHER

impact of hemodialysis on functional capacity in children with CKD

hemodialysis group

muscle strength OTHER

impact of hemodialysis on muscle strength in children with CKD

hemodialysis group

Quality of life of children OTHER

impact of hemodialysis on Quality of life in children with CKD

hemodialysis group

Quality of life of families OTHER

impact of hemodialysis on Quality of life of families of children with CKD

hemodialysis group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related 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.

  PMID: 29731235 BACKGROUND

• 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.

  PMID: 18467936 BACKGROUND

• 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.

  PMID: 23304095 BACKGROUND

• 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.

  PMID: 28612957 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Functional Residual Capacity; Muscle Strength

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Physical Examination; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Amira M El Tohamy, Doctoral

  Professor of pediatrics Faculty of Physical Therapy, Cairo University

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Central Study Contacts

Shaymaa R Mahmoud, Master

CONTACT

01145050053 - 01002452555; shaymaarushdy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 30, 2020
• First Posted: September 4, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 30, 2021
• Last Updated: September 9, 2020

Record last verified: 2020-09