HemodialysisNCT06910319
Six Minutes Walk Test in Children on Regular Hemodialysis
An observational study of Hemodialysis, run by Assiut University.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Hemodialysis
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- Children with ESRD who on regular hemodialysis at Assiut University Children Hospital .
Who cannot join
- Any subject with underlying primary cardio-pulmonary disease or condition that interfere with the walk test as hemiplegia and cerebral palsy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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 .
- Conditions
- Hemodialysis
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the reproducibility of the six-minute walk test in children and adolescents with end stage renal disease on regular dialysis
Measured: One year from may 2025 to may 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Fayez Abdelmalak, Assiut University
- Investigators
- Ahlam Badawy Ali, Assistant professor of pediat, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910319
- Sponsor's protocol ID
- 6 minutes walk test
- Status last verified
- Apr 2025
- First submitted
- 21 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lipkin DP, Scriven AJ, Crake T, Poole-Wilson PA. Six minute walking test for assessing exercise capacity in chronic heart failure. Br Med J (Clin Res Ed). 1986 Mar 8;292(6521):653-5. doi: 10.1136/bmj.292.6521.653.
PubMed 3081210Gayda M, Temfemo A, Choquet D, Ahmaidi S. Cardiorespiratory requirements and reproducibility of the six-minute walk test in elderly patients with coronary artery disease. Arch Phys Med Rehabil. 2004 Sep;85(9):1538-43. doi: 10.1016/j.apmr.2003.11.037.
PubMed 15375831Painter P. Physical functioning in end-stage renal disease patients: update 2005. Hemodial Int. 2005 Jul;9(3):218-35. doi: 10.1111/j.1492-7535.2005.01136.x.
PubMed 16191072Bittner V, Weiner DH, Yusuf S, Rogers WJ, McIntyre KM, Bangdiwala SI, Kronenberg MW, Kostis JB, Kohn RM, Guillotte M, et al. Prediction of mortality and morbidity with a 6-minute walk test in patients with left ventricular dysfunction. SOLVD Investigators. JAMA. 1993 Oct 13;270(14):1702-7.
PubMed 8411500Savci S, Inal-Ince D, Arikan H, Guclu-Gunduz A, Cetisli-Korkmaz N, Armutlu K, Karabudak R. Six-minute walk distance as a measure of functional exercise capacity in multiple sclerosis. Disabil Rehabil. 2005 Nov 30;27(22):1365-71. doi: 10.1080/09638280500164479.
PubMed 16372431Du H, Newton PJ, Salamonson Y, Carrieri-Kohlman VL, Davidson PM. A review of the six-minute walk test: its implication as a self-administered assessment tool. Eur J Cardiovasc Nurs. 2009 Mar;8(1):2-8. doi: 10.1016/j.ejcnurse.2008.07.001. Epub 2008 Aug 9.
PubMed 18694656Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.
PubMed 12890299Solway S, Brooks D, Lacasse Y, Thomas S. A qualitative systematic overview of the measurement properties of functional walk tests used in the cardiorespiratory domain. Chest. 2001 Jan;119(1):256-70. doi: 10.1378/chest.119.1.256.
PubMed 11157613Watanabe FT, Koch VH, Juliani RC, Cunha MT. Six-minute walk test in children and adolescents with renal diseases: tolerance, reproducibility and comparison with healthy subjects. Clinics (Sao Paulo). 2016 Jan;71(1):22-7. doi: 10.6061/clinics/2016(01)05.
PubMed 26872080Painter P, Krasnoff J, Mathias R. Exercise capacity and physical fitness in pediatric dialysis and kidney transplant patients. Pediatr Nephrol. 2007 Jul;22(7):1030-9. doi: 10.1007/s00467-007-0458-6. Epub 2007 Mar 20.
PubMed 17372771Takken T, Engelbert R, van Bergen M, Groothoff J, Nauta J, van Hoeck K, Lilien M, Helders P. Six-minute walking test in children with ESRD: discrimination validity and construct validity. Pediatr Nephrol. 2009 Nov;24(11):2217-23. doi: 10.1007/s00467-009-1259-x. Epub 2009 Jul 25.
PubMed 19633871Pattaragarn A, Warady BA, Sabath RJ. Exercise capacity in pediatric patients with end-stage renal disease. Perit Dial Int. 2004 May-Jun;24(3):274-80.
PubMed 15185776Weaver DJ Jr, Kimball TR, Knilans T, Mays W, Knecht SK, Gerdes YM, Witt S, Glascock BJ, Kartal J, Khoury P, Mitsnefes MM. Decreased maximal aerobic capacity in pediatric chronic kidney disease. J Am Soc Nephrol. 2008 Mar;19(3):624-30. doi: 10.1681/ASN.2007070773. Epub 2008 Jan 9.
PubMed 18184856Sethna CB, Salerno AE, McBride MG, Shults J, Paridon SM, Sharma N, Meyers KE, Leonard MB. Cardiorespiratory fitness in pediatric renal transplant recipients. Transplantation. 2009 Aug 15;88(3):395-401. doi: 10.1097/TP.0b013e3181aed7d1.
PubMed 19667944Lammers AE, Hislop AA, Flynn Y, Haworth SG. The 6-minute walk test: normal values for children of 4-11 years of age. Arch Dis Child. 2008 Jun;93(6):464-8. doi: 10.1136/adc.2007.123653. Epub 2007 Aug 3.
PubMed 17675356
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six Minutes Walk Test in Children on Regular Hemodialysis at Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT06910319
- Acronym / sponsor ID
- 6 minutes walk test
- Conditions
- Hemodialysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 4 Apr 2025 (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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Children with ESRD who on regular hemodialysis at Assiut University Children Hospital .
Key exclusion criteria (1 listed)
- Any subject with underlying primary cardio-pulmonary disease or condition that interfere with the walk test as hemiplegia and cerebral palsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 3081210Lipkin DP, Scriven AJ, Crake T, Poole-Wilson PA. Six minute walking test for assessing exercise capacity in chronic heart failure. Br Med J (Clin Res Ed). 1986 Mar 8;292(6521):653-5. doi: 10.1136/bmj.292.6521.653.
- Background: PubMed 15375831Gayda M, Temfemo A, Choquet D, Ahmaidi S. Cardiorespiratory requirements and reproducibility of the six-minute walk test in elderly patients with coronary artery disease. Arch Phys Med Rehabil. 2004 Sep;85(9):1538-43. doi: 10.1016/j.apmr.2003.11.037.
- Background: PubMed 16191072Painter P. Physical functioning in end-stage renal disease patients: update 2005. Hemodial Int. 2005 Jul;9(3):218-35. doi: 10.1111/j.1492-7535.2005.01136.x.
- Background: PubMed 8411500Bittner V, Weiner DH, Yusuf S, Rogers WJ, McIntyre KM, Bangdiwala SI, Kronenberg MW, Kostis JB, Kohn RM, Guillotte M, et al. Prediction of mortality and morbidity with a 6-minute walk test in patients with left ventricular dysfunction. SOLVD Investigators. JAMA. 1993 Oct 13;270(14):1702-7.
- Background: PubMed 16372431Savci S, Inal-Ince D, Arikan H, Guclu-Gunduz A, Cetisli-Korkmaz N, Armutlu K, Karabudak R. Six-minute walk distance as a measure of functional exercise capacity in multiple sclerosis. Disabil Rehabil. 2005 Nov 30;27(22):1365-71. doi: 10.1080/09638280500164479.
- Background: PubMed 18694656Du H, Newton PJ, Salamonson Y, Carrieri-Kohlman VL, Davidson PM. A review of the six-minute walk test: its implication as a self-administered assessment tool. Eur J Cardiovasc Nurs. 2009 Mar;8(1):2-8. doi: 10.1016/j.ejcnurse.2008.07.001. Epub 2008 Aug 9.
- Background: PubMed 12890299Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.
- Background: PubMed 11157613Solway S, Brooks D, Lacasse Y, Thomas S. A qualitative systematic overview of the measurement properties of functional walk tests used in the cardiorespiratory domain. Chest. 2001 Jan;119(1):256-70. doi: 10.1378/chest.119.1.256.
- Results publication: PubMed 26872080Watanabe FT, Koch VH, Juliani RC, Cunha MT. Six-minute walk test in children and adolescents with renal diseases: tolerance, reproducibility and comparison with healthy subjects. Clinics (Sao Paulo). 2016 Jan;71(1):22-7. doi: 10.6061/clinics/2016(01)05.
- Results publication: PubMed 17372771Painter P, Krasnoff J, Mathias R. Exercise capacity and physical fitness in pediatric dialysis and kidney transplant patients. Pediatr Nephrol. 2007 Jul;22(7):1030-9. doi: 10.1007/s00467-007-0458-6. Epub 2007 Mar 20.
- Results publication: PubMed 19633871Takken T, Engelbert R, van Bergen M, Groothoff J, Nauta J, van Hoeck K, Lilien M, Helders P. Six-minute walking test in children with ESRD: discrimination validity and construct validity. Pediatr Nephrol. 2009 Nov;24(11):2217-23. doi: 10.1007/s00467-009-1259-x. Epub 2009 Jul 25.
- Results publication: PubMed 15185776Pattaragarn A, Warady BA, Sabath RJ. Exercise capacity in pediatric patients with end-stage renal disease. Perit Dial Int. 2004 May-Jun;24(3):274-80.
- Individual participant dataSharing planned: No
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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.
Ahlam Badawy Ali, Assistant professor of pediat principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis, run by Assiut 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 4 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Fayez Abdelmalak, Pediatric residant doctor (01221010974, carolinefayez52@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT06910319, which also lists 15 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 4 Apr 2025.