NCT06910319

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

March 21, 2025

Last Update Submit

April 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • To evaluate the reproducibility of the six-minute walk test in children and adolescents with end stage renal disease on regular dialysis

    One year from may 2025 to may 2026

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • Watanabe 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.

    PMID: 26872080BACKGROUND
  • 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.

    PMID: 3081210BACKGROUND
  • Gayda 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.

    PMID: 15375831BACKGROUND
  • Painter 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.

    PMID: 16191072BACKGROUND
  • Bittner 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.

    PMID: 8411500BACKGROUND
  • Savci 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.

    PMID: 16372431BACKGROUND
  • Du 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.

    PMID: 18694656BACKGROUND
  • Painter 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.

    PMID: 17372771BACKGROUND
  • Takken 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.

    PMID: 19633871BACKGROUND
  • Pattaragarn 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.

    PMID: 15185776BACKGROUND
  • Weaver 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.

    PMID: 18184856BACKGROUND
  • Sethna 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.

    PMID: 19667944BACKGROUND
  • Lammers 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.

    PMID: 17675356BACKGROUND
  • Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.

    PMID: 12890299BACKGROUND
  • Solway 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.

    PMID: 11157613BACKGROUND

Study Officials

  • Ahlam Badawy Ali, Assistant professor of pediat

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Fayez Abdelmalak, Pediatric residant doctor

CONTACT

Salah Eldin Amry Ahmad, Professor of pediatrics

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 21, 2025

First Posted

April 4, 2025

Study Start

May 1, 2025

Primary Completion

May 1, 2026

Study Completion

June 1, 2026

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share