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Completed

NCT Number: NCT04049708

Intrarater and Interrater Reliability Physical Function Measures in HD BCN

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

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Key information

Conditions

End Stage Renal Disease on Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Terrassa

Terrassa, Barcelona, 08227, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 3 months in hemodialysis treatment
  • Clinically stable

Exclusion criteria

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

Treatment and study plan

Reliability of physical function

Other

Test-retest reliability of physical function in hemodialysis patients

Primary outcomes

  1. Change from baseline Short Physical Performance Battery at one week

    Time frame: 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 outcomes

  1. Change from baseline Gait speed at one week at one week

    Time frame: 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

  2. Change from baseline One-leg standing test at one week

    Time frame: 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

  3. Change from baseline Timed up and go at one week

    Time frame: 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

  4. Change from baseline Sit to stand 10 test at one week

    Time frame: 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

  5. Change from baseline Sit to stand 60 test at one week

    Time frame: 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

  6. Change from baseline One-leg heel rise test at one week

    Time frame: 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

  7. Change from baseline 6 minutes walk test at one week

    Time frame: 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

  8. Change from baseline Handgrip at one week

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Collaborators

  • Consorci Sanitari de Terrassa

Registry information

Official study title

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

Acronym: ReliabilityBCN

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2019
Registry last updated
Sep 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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