End Stage Renal DiseaseNCT02830490
Reliability of Functional Measures in Hemodialysis Patient.
An observational study of End Stage Renal Disease, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
The investigators pretend to calculate values absolute and relative reliability that have not been yet reported (Short Physical Performance Battery, one-leg balance and Timed Up and go). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- functional tests
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Dec 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with Chronic Kidney Diseases undergoing hemodialysis treatment
Who may be able to join
- people under hemodialysis treatment at least 3 months
- be medicable stable
- complete all the physical tests
Who cannot join
- heart stroke in the previous 6 weeks of the study
- inferior limb amputation without artificial aids
- cerebral vascular disease (ictus, ischemic)
- disability to complete functional tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Test-retest Reliability and Minimal Detectable Change Scores for the Short Physical Performance Battery (SPPB), One Leg Balance and Timed up and go.
The investigators pretend to calculate values absolute and relative reliability that have not been yet reported (Short Physical Performance Battery, one-leg balance and Timed Up and go).
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 and health related quality of life (HRQoL). Many studies show that functional capacity, physical activity level and HRQoL is significantly worse than their healthy sedentary age - matched counterparts. It is unknown if low physical activity, uraemia or anaemia are responsible for the decreased functional capacity of this cohort. Physical performance tests are frequently used to assess haemodialysis patients since is a feasible and low-cost evaluation. The purpose of the present study is quantified how the functional capacity changes over a -6 months period in a group of haemodialysis patients. Additionally the investigators pretend to calculate values absolute and relative reliability that have not been yet reported (Short Physical Performance Battery, one-leg balance and Timed Up and go).
- Conditions
- End Stage Renal Disease
- Being tested
- functional tests
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional testsOther
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.
Short Physical Performance Battery
Assess lower extremity, which includes objective performance-based measure of balance (side-by-side, semitanden 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 twice with one to two weeks interval between the testing session
Secondary outcomes (2)
One Leg Standing Test
Consist in maintain one leg stance for as long as possible. The test was considered normal if the one leg standing time reached 45 seconds.
Measured: It will perform the test twice with one to two weeks interval between the testing session
Timed Up and Go
To stand up from a standard arms chair, walk 3 meters, turn back the cone walk back and sit down to the chair. The time in seconds is record.
Measured: It will perform the test twice with one to two weeks interval between the testing session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startSep 2014
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Segura Ortí, Cardenal Herrera University
- Investigators
- Eva Segura-Ortí, PhD, Principal investigator, Professor at Universidad CEU Cardenal Herrera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830490
- Sponsor's protocol ID
- CardenalHU
- Status last verified
- Apr 2017
- First submitted
- 1 Dec 2015
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Segura-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 21719637
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-retest Reliability and Minimal Detectable Change Scores for the Short Physical Performance Battery (SPPB), One Leg Balance and Timed up and go.
- ClinicalTrials.gov ID
- NCT02830490
- Acronym / sponsor ID
- CardenalHU
- Conditions
- End Stage Renal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Jul 2016 (estimated)
- 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 pretend to calculate values absolute and relative reliability that have not been yet reported (Short Physical Performance Battery, one-leg balance and Timed Up and go).
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 and health related quality of life (HRQoL). Many studies show that functional capacity, physical activity level and HRQoL is significantly worse than their healthy sedentary age - matched counterparts. It is unknown if low physical activity, uraemia or anaemia are responsible for the decreased functional capacity of this cohort. Physical performance tests are frequently used to assess haemodialysis patients since is a feasible and low-cost evaluation. The purpose of the present study is quantified how the functional capacity changes over a -6 months period in a group of haemodialysis patients. Additionally the investigators pretend to calculate values absolute and relative reliability that have not been yet reported (Short Physical Performance Battery, one-leg balance and Timed Up and go).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with Chronic Kidney Diseases undergoing hemodialysis treatment
Key inclusion criteria (3 listed)
- people under hemodialysis treatment at least 3 months
- be medicable stable
- complete all the physical tests
Key exclusion criteria (4 listed)
- heart stroke in the previous 6 weeks of the study
- inferior limb amputation without artificial aids
- cerebral vascular disease (ictus, ischemic)
- disability to complete functional tests
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 |
|---|---|---|
| functional testsTest-retest reliability of physical function in hemodialysis patients | Other | – |
Primary outcome
Short Physical Performance Battery
Time frame: It will perform the test twice with one to two weeks interval between the testing session
Assess lower extremity, which includes objective performance-based measure of balance (side-by-side, semitanden 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).
2 secondary outcomes
One Leg Standing Test
Time frame: It will perform the test twice with one to two weeks interval between the testing session
Timed Up and Go
Time frame: It will perform the test twice with one to two weeks interval between the testing session
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 4 Apr 2017.
- 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.
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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.
Eva Segura-Ortí, PhD principal investigator
Professor at Universidad CEU Cardenal Herrera
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, 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 3 inclusion and 4 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 4 Apr 2017. 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?
Short Physical Performance Battery (time frame: It will perform the test twice with one to two weeks interval between the testing session). 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 NCT02830490, which also lists 1 linked publication.
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 4 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.