ReliabilityBCN: Intrarater and Interrater Reliability Physical Function Measures in HD BCN

Sponsor
Cardenal Herrera University (Other)
Overall Status
Completed
CT.gov ID
NCT04049708
Collaborator
Consorci Sanitari de Terrassa. Hospital de Terrassa (Other)
30
1
22
41.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Reliability of physical function

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 Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Intrarater Reliability in Different Days and Interrater Reliability of Physical Function Assessment in HD Patients
Actual Study Start Date :
Aug 7, 2019
Actual Primary Completion Date :
Aug 29, 2019
Actual Study Completion Date :
Aug 29, 2019

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • At least 3 months in hemodialysis treatment

  • Clinically stable

Exclusion Criteria:
  • Recent cardiac events (less than 3 months)

  • Unable to exercise

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de Terrassa Terrassa Barcelona Spain 08227

Sponsors and Collaborators

  • Cardenal Herrera University
  • Consorci Sanitari de Terrassa. Hospital de Terrassa

Investigators

  • Study Chair: Vicent Esteve-Simó, PhD, Hospital de Terrassa

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Eva Segura Ortí, Professor, Cardenal Herrera University
ClinicalTrials.gov Identifier:
NCT04049708
Other Study ID Numbers:
  • ReliabilityBCN
First Posted:
Aug 8, 2019
Last Update Posted:
Sep 3, 2019
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 3, 2019