Intrarater and Interrater Reliability Physical Function Measures in HD BCN

Completed

• Conditions: End Stage Renal Disease on Dialysis

• Registration Number: NCT04049708
• Lead Sponsor: Cardenal Herrera University

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

Detailed 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).

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-08-06
• Study Start: 2019-08-07
• Study First Posted: 2019-08-08
• Primary Completion: 2019-08-29
• Study Completion: 2019-08-29
• Last Update Submitted: 2019-08-30
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• At least 3 months in hemodialysis treatment
• Clinically stable

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline Short Physical Performance Battery 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	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).

Secondary Outcome Measures

Name	Time	Method
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	Speed to cover 4 meters, in meters/second
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	Time achieved while standing on one leg
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	Time to perform 10 repetitions sit to stand
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	Sit to stand repetitions performed in 60 seconds
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	Time to stand up, walk 3 meters, come back and sit down again
Change from baseline One-leg heel rise 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	Number of heel rise repetitions achieved
Change from baseline 6 minutes walk 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	Number of meters walked in 6 minutes
Change from baseline Handgrip 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	Bilateral handgrip strength

Trial Locations

Locations (1)

Hospital de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain