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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic Kidney Disease on Children Functional Capacity and Their Families' Quality of Life: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04538443
- Acronym / sponsor ID
- CKD comorbidity
- Conditions
- CKD (Chronic Kidney Disease) Stage 5D
- Keywords
- CKD, hemodialysis, functional capacity, QoL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hemodialysis group | – | Other: functional capacity, Other: muscle strength, Other: Quality of life of children, Other: Quality of life of familiesOne 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 qualify
- Ages
- 8 to 12 years
- Sex
- All
- Age groups
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Cardiopulmonary disorders
- Uncontrolled hypertension
- Unstable angina
- Severe uncontrolled diabetes
- Neurological or cognitive disorders with functional deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional capacityimpact of hemodialysis on functional capacity in children with CKD | Other | hemodialysis group |
| muscle strengthimpact of hemodialysis on muscle strength in children with CKD | Other | hemodialysis group |
| Quality of life of childrenimpact of hemodialysis on Quality of life in children with CKD | Other | hemodialysis group |
| Quality of life of familiesimpact of hemodialysis on Quality of life of families of children with CKD | Other | hemodialysis group |
Primary outcome
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
3 secondary outcomes
muscle strength
Time frame: 6 months
quality of life of children
Time frame: 6 months
quality of life of families of children with CKD
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 29731235Abd 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.
- Background: PubMed 18467936Maher 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.
- Background: PubMed 23304095Pathare 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.
- Background: PubMed 28612957Baek 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.
Related trials for CKD (Chronic Kidney Disease) Stage 5D
Recruiting
Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD
CKD (Chronic Kidney Disease) Stage 5D
Active, not recruitingPhase 4
ASPIrin in Reducing Events in Dialysis ( ASPIRED )
CKD (Chronic Kidney Disease) Stage 5D
RecruitingPhase 2
Effect of Canagliflozin on Ultrafiltration & Fibrosis in Patients on Peritoneal Dialysis
ESRD, CKD (Chronic Kidney Disease) Stage 5D
Not yet recruiting
Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation
Kidney Transplantation, CKD (Chronic Kidney Disease) Stage 5D
Recruiting
Studies on Adsorption International Learning Initiative Global
CKD (Chronic Kidney Disease) Stage 5D, Uremia; Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira M El Tohamy, Doctoral study chair
Professor of pediatrics Faculty of Physical Therapy, Cairo University
Amira M Abd-Elmonem, Doctoral study director
Assistant Professor of pediatrics Faculty of Physical Therapy, Cairo University
Rasha EE Galal, Doctoral study director
Professor of pediatrics, Faculty of Medicine, Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of CKD (Chronic Kidney Disease) Stage 5D, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaymaa R Mahmoud, Master (01145050053 - 01002452555, shaymaarushdy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional capacity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04538443, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.