Six Minutes Walk Test in Children on Regular Hemodialysis

April 2, 2025 updated by: Caroline Fayez Abdelmalak, Assiut University

Six Minutes Walk Test in Children on Regular Hemodialysis at Assiut University Children Hospital

To evaluate exercise tolerance and the reproducibility of the six minute walk test in children and adolescents with ESRD on regular hemodialysis and to compare their functional exercise capacities with reference values for healthy children. To investigate predictors of poor 6MWT performance in children on regular HD

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The six-minute walk test (6MWT) is a submaximal test that assesses the functional exercise capacities of healthy subjects or those with a chronic disease, as well as the effects of interventions, such as pulmonary rehabilitation or drug therapies. It can predict prognosis, mortality and morbidity in adults and children with lung and/or heart diseases . A study with of children with stage V chronic kidney disease (CKD) has used the 6MWT to demonstrate decreased exercise tolerance , which appears to be caused by several factors, such as anemia, metabolic acidosis, electrolyte imbalance, osteopenia, growth deficiency, malnutrition, inactivity, uremic muscle dysfunction and associated comorbidities . The findings of this study suggest that the 6MWT could be used as a clinical tool to monitor functional exercise capacity in children with kidney disease. The 6MWT is a sub-maximum effort test that is more representative of daily life activities than other effort tests and has low cost and easy applicability . The distance walked in the 6MWT shows an association with VO2 peak, making it a viable and safe alternative for patients who cannot tolerate the ergometric test .

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Salah Eldin Amry Ahmad, Professor of pediatrics
  • Phone Number: ‪011 46082024‬
  • Email: S_amry@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The patient observed the researcher performing the test and then was instructed to walk as far as possible for 6- min and maintain a normal walking pace. Patients are able to interrupt the test if necessary. At each minute of walking the researcher communicated clearly and calmly how many minutes remained until the end of the test. In the end, the walked distance will be measured. HR, %HRmax, SpO2, SBP, and DBP delta values are to be measured before and after participating test.

During the test the researcher will monitor the patient for untoward signs and symptoms while using a stop watch to calculate time of the walked distance.If the patient stops before the 6 minutes are up and refuse to continue or the researcher decide that they should not continue, the researcher must wheel the chair over for the patient to sit on, discontinue the walk and note on the worksheet the distance , the time stopped and the reason for stopping prematurely.

Description

Inclusion Criteria:

  • Children with ESRD who on regular hemodialysis at Assiut University Children Hospital .

Exclusion Criteria:

  • Any subject with underlying primary cardio-pulmonary disease or condition that interfere with the walk test as hemiplegia and cerebral palsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the reproducibility of the six-minute walk test in children and adolescents with end stage renal disease on regular dialysis
Time Frame: One year from may 2025 to may 2026
One year from may 2025 to may 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Ahlam Badawy Ali, Assistant professor of pediat

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 6 minutes walk test

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemodialysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe