Intrarater and Interrater Reliability Physical Function Measures in HD BCN

End Stage Renal Disease on Dialysis Clinical Trial

— ReliabilityBCN  

Official title:

Intrarater Reliability in Different Days and Interrater Reliability of Physical Function Assessment in HD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04049708
• Other study ID #: ReliabilityBCN
• Status: Completed
• Start date: August 7, 2019
• Est. completion date: August 29, 2019

Study information

• Verified date: August 2019
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Patients suffering from End Stage Renal Disease are commonly involved in haemodialysis treatment, which is the most common treatment at this stage. Haemodialysis substitutes the renal function but is associated with several alterations that lead to decrease in functional capacity. Many studies show that functional capacity is significantly worse than their healthy sedentary age - matched counterparts. The purpose of the present study is to calculate values of absolute and relative intrarater reliability (dialysis vs non dialysis day) and interrater reliability of different physical function measures (Short Physical Performance Battery, one-leg balance, Timed Up and go, sit to stand to sit tests, triceps and handgrip strength, six-minute walking test).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 3 months in hemodialysis treatment

• Clinically stable

Exclusion Criteria:

• Recent cardiac events (less than 3 months)

• Unable to exercise

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Failure, Chronic

Intervention

Other:
• Reliability of physical function
Test-retest reliability of physical function in hemodialysis patients

Locations

Country	Name	City	State
Spain	Hospital de Terrassa	Terrassa	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Cardenal Herrera University	Consorci Sanitari de Terrassa. Hospital de Terrassa

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Esteve Simo V, Junqué Jiménez A, Moreno Guzmán 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. — View Citation

Ortega-Pérez de Villar L, Martínez-Olmos FJ, Junqué-Jiménez A, Amer-Cuenca JJ, Martínez-Gramage J, Mercer T, Segura-Ortí 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. — View Citation

Segura-Ortí E, Martínez-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline Gait speed at one week at one week	Speed to cover 4 meters, in meters/second	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	Change from baseline One-leg standing test at one week	Time achieved while standing on one leg	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	Change from baseline Timed up and go at one week	Time to stand up, walk 3 meters, come back and sit down again	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	Change from baseline Sit to stand 10 test at one week	Time to perform 10 repetitions sit to stand	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	Change from baseline Sit to stand 60 test at one week	Sit to stand repetitions performed in 60 seconds	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	Change from baseline One-leg heel rise test at one week	Number of heel rise repetitions achieved	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	Change from baseline 6 minutes walk test at one week	Number of meters walked in 6 minutes	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	Change from baseline Handgrip at one week	Bilateral handgrip strength	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