End Stage Renal Disease on DialysisReliabilityBCNNCT04049708
Intrarater and Interrater Reliability Physical Function Measures in HD BCN
An observational study of End Stage Renal Disease on Dialysis, run by Cardenal Herrera University at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- Reliability of physical function
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 7 Aug 2019to 29 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with Chronic Kidney Diseases undergoing hemodialysis treatment
Who may be able to join
- At least 3 months in hemodialysis treatment
- Clinically stable
Who cannot join
- Recent cardiac events (less than 3 months)
- Unable to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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).
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- Reliability of physical function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reliability of physical functionOther
Test-retest reliability of physical function in hemodialysis patients
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 outcomes (8)
Change from baseline Gait speed at one week at one week
Speed to cover 4 meters, in meters/second
Measured: 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 achieved while standing on one leg
Measured: 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 to stand up, walk 3 meters, come back and sit down again
Measured: 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 to perform 10 repetitions sit to stand
Measured: 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
Sit to stand repetitions performed in 60 seconds
Measured: 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
Number of heel rise repetitions achieved
Measured: 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
Number of meters walked in 6 minutes
Measured: 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
Bilateral handgrip strength
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start7 Aug 2019
- Primary completion29 Aug 2019
- Study completion29 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa
- Responsible party
- Principal investigator, Eva Segura Ortí, Cardenal Herrera University
- Investigators
- Vicent Esteve-Simó, PhD, Study chair, Hospital de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049708
- Sponsor's protocol ID
- ReliabilityBCN
- Acronym
- ReliabilityBCN
- Status last verified
- Aug 2019
- First submitted
- 5 Aug 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Esteve Simo V, Junque Jimenez A, Moreno Guzman 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.
PubMed 26306966Segura-Orti E, Martinez-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.
PubMed 21719637Ortega-Perez de Villar L, Martinez-Olmos FJ, Junque-Jimenez A, Amer-Cuenca JJ, Martinez-Gramage J, Mercer T, Segura-Orti 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.
PubMed 30133445
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrarater Reliability in Different Days and Interrater Reliability of Physical Function Assessment in HD Patients
- ClinicalTrials.gov ID
- NCT04049708
- Acronym / sponsor ID
- ReliabilityBCN / ReliabilityBCN
- Conditions
- End Stage Renal Disease on Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with Chronic Kidney Diseases undergoing hemodialysis treatment
Key inclusion criteria (2 listed)
- At least 3 months in hemodialysis treatment
- Clinically stable
Key exclusion criteria (2 listed)
- Recent cardiac events (less than 3 months)
- Unable to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reliability of physical functionTest-retest reliability of physical function in hemodialysis patients | Other | – |
Primary outcome
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).
8 secondary outcomes
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Background: PubMed 26306966Esteve Simo V, Junque Jimenez A, Moreno Guzman 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.
- Background: PubMed 21719637Segura-Orti E, Martinez-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.
- Background: PubMed 30133445Ortega-Perez de Villar L, Martinez-Olmos FJ, Junque-Jimenez A, Amer-Cuenca JJ, Martinez-Gramage J, Mercer T, Segura-Orti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicent Esteve-Simó, PhD study chair
Hospital de Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease on Dialysis, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04049708, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.