Intrarater and Interrater Reliability Physical Function Measures in HD BCN (ReliabilityBCN)

August 30, 2019 updated by: Eva Segura Ortí, Cardenal Herrera University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08227
        • Hospital de Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People with Chronic Kidney Diseases undergoing hemodialysis treatment

Description

Inclusion Criteria:

  • At least 3 months in hemodialysis treatment
  • Clinically stable

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
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 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
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 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
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 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cardenal Herrera University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Consorci Sanitari de Terrassa. Hospital de Terrassa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ReliabilityBCN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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