NCT04049708

Brief Summary

The investigators will calculate values of absolute and relative reliability for intrarater reliability when the measures are taken during a hemodialysis treatment day and during a non-dialysis day. Interrater reliability between two different observers will be also calculated

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 5, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

August 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2019

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

22 days

First QC Date

August 5, 2019

Last Update Submit

August 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Short Physical Performance Battery at one week

    Assess lower extremity, which includes objective performance-based measure of balance (side-by-side, semitandem and tandem), endurance (4m gait speed) and strength (five chair stands). Each component was scored from 0 to 4 and when summed yielded SPPB scores between 0 (poor) and 12 (best).

    It will perform the test three times with one week interval between the testing sessions, one before hemodialysis, and the other one next week during a non-dialysis day

Secondary Outcomes (8)

  • Change from baseline Gait speed at one week at one week

    It will perform the test three times with one week interval between the testing sessions, one before hemodialysis, and the other one next week during a non-dialysis day

  • Change from baseline One-leg standing test at one week

    It will perform the test three times with one week interval between the testing sessions, one before hemodialysis, and the other one next week during a non-dialysis day

  • Change from baseline Timed up and go at one week

    It will perform the test three times with one week interval between the testing sessions, one before hemodialysis, and the other one next week during a non-dialysis day

  • Change from baseline Sit to stand 10 test at one week

    It will perform the test three times with one week interval between the testing sessions, one before hemodialysis, and the other one next week during a non-dialysis day

  • Change from baseline Sit to stand 60 test at one week

    It will perform the test three times with one week interval between the testing sessions, one before hemodialysis, and the other one next week during a non-dialysis day

  • +3 more secondary outcomes

Interventions

Test-retest reliability of physical function in hemodialysis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with Chronic Kidney Diseases undergoing hemodialysis treatment

You may qualify if:

  • At least 3 months in hemodialysis treatment
  • Clinically stable

You may not qualify if:

  • Recent cardiac events (less than 3 months)
  • Unable to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Related Publications (3)

  • Esteve Simo V, Junque Jimenez A, Moreno Guzman F, Carneiro Oliveira J, Fulquet Nicolas M, Pou Potau M, Saurina Sole A, Duarte Gallego V, Tapia Gonzalez I, Ramirez de Arellano M. Benefits of a low intensity exercise programme during haemodialysis sessions in elderly patients. Nefrologia. 2015;35(4):385-94. doi: 10.1016/j.nefro.2015.03.006. Epub 2015 Jul 21. English, Spanish.

    PMID: 26306966BACKGROUND
  • Segura-Orti E, Martinez-Olmos FJ. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis. Phys Ther. 2011 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30.

    PMID: 21719637BACKGROUND
  • Ortega-Perez de Villar L, Martinez-Olmos FJ, Junque-Jimenez A, Amer-Cuenca JJ, Martinez-Gramage J, Mercer T, Segura-Orti E. Test-retest reliability and minimal detectable change scores for the short physical performance battery, one-legged standing test and timed up and go test in patients undergoing hemodialysis. PLoS One. 2018 Aug 22;13(8):e0201035. doi: 10.1371/journal.pone.0201035. eCollection 2018.

    PMID: 30133445BACKGROUND

Study Officials

  • Vicent Esteve-Simó, PhD

    Hospital de Terrassa

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 8, 2019

Study Start

August 7, 2019

Primary Completion

August 29, 2019

Study Completion

August 29, 2019

Last Updated

September 3, 2019

Record last verified: 2019-08

Locations