End Stage Renal DiseaseNCT02832466
Quantifying the Deterioration of Physical Function in Renal Patients
An observational study of End Stage Renal Disease, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
Patients undergoing haemodialysis present a decrease in physical function, but little is known about the rate at which function decreases. The purpose of this study is quantifying the nature and degree of functional deterioration experienced by stage 5 chronic kidney disease patients during a six month period of… 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 Test
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Jan 2017
- 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: Quantifying the Deterioration of Physical Function Along 6 Months in Patients in End Stage Renal Disease
Patients undergoing haemodialysis present a decrease in physical function, but little is known about the rate at which function decreases.
The purpose of this study is quantifying the nature and degree of functional deterioration experienced by stage 5 chronic kidney disease patients during a six month period of maintenance haemodialysis therapy.
- Conditions
- End Stage Renal Disease
- Being tested
- Functional Test
- 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 TestOther
Observation of physical function in hemodialysis patients during a period of 6 months
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 6 months
Assess lower extremity, which includes objective performance-based measure of balance (side-by-side, semi-tanden and tandem), endurance (4m gait speed) and strength (five chair stands). Each component was scored from 0 to 4 and when summed yielded Short Physical Performance Battery scores between 0 (poor) and 12 (best).
Measured: At the beginning of the study and after 6 months
Change from Baseline One Leg Standing Test at 6 months
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: At the beginning of the study and after 6 months
Change from Baseline Timed Up and Go at 6 months
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: At the beginning of the study and after 6 months
Change from Baseline Sit to Stand to Sit 10 and 60 at 6 months
For the Sit To Stand 10 participant has to stand up and sit down 10 times and the time needed is record; while for the Sit to stand to sit 60 the participant consist in measures how many repetition the participant can to stand up and sit down during 60 seconds
Measured: At the beginning of the study and after 6 months
Change from Baseline On leg heel rise at 6 months
It measures the strength in the triceps surae in the one leg standing position and has to rise the heel. It measures how many repetitions the participants is can do
Measured: At the beginning of the study and after 6 months
Change from Baseline Handgrip strength at 6 months
To measure the amount of strength developed by each hand in kg
Measured: At the beginning of the study and after 6 months
Change from Baseline Six Minutes Walking Time at 6 months
To walk the longest distance possible in 6 minutes by walking continuously the 20 or 30 metres indicated on the floor. It measures the distance in meters
Measured: At the beginning of the study and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startSep 2014
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 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, Principal investigator, Lecturer in the Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832466
- Sponsor's protocol ID
- Cardenal Herrera Univeristy
- Status last verified
- Apr 2017
- First submitted
- 8 Jul 2016
- Last updated
- 5 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying the Deterioration of Physical Function Along 6 Months in Patients in End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT02832466
- Acronym / sponsor ID
- Cardenal Herrera Univeristy
- Conditions
- End Stage Renal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 14 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.
Patients undergoing haemodialysis present a decrease in physical function, but little is known about the rate at which function decreases.
The purpose of this study is quantifying the nature and degree of functional deterioration experienced by stage 5 chronic kidney disease patients during a six month period of maintenance haemodialysis therapy.
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 TestObservation of physical function in hemodialysis patients during a period of 6 months | Other | – |
Primary outcome
Change from Baseline Short Physical Performance Battery at 6 months
Time frame: At the beginning of the study and after 6 months
Assess lower extremity, which includes objective performance-based measure of balance (side-by-side, semi-tanden and tandem), endurance (4m gait speed) and strength (five chair stands). Each component was scored from 0 to 4 and when summed yielded Short Physical Performance Battery scores between 0 (poor) and 12 (best).
Change from Baseline One Leg Standing Test at 6 months
Time frame: At the beginning of the study and after 6 months
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.
Change from Baseline Timed Up and Go at 6 months
Time frame: At the beginning of the study and after 6 months
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.
Change from Baseline Sit to Stand to Sit 10 and 60 at 6 months
Time frame: At the beginning of the study and after 6 months
For the Sit To Stand 10 participant has to stand up and sit down 10 times and the time needed is record; while for the Sit to stand to sit 60 the participant consist in measures how many repetition the participant can to stand up and sit down during 60 seconds
Change from Baseline On leg heel rise at 6 months
Time frame: At the beginning of the study and after 6 months
It measures the strength in the triceps surae in the one leg standing position and has to rise the heel. It measures how many repetitions the participants is can do
Change from Baseline Handgrip strength at 6 months
Time frame: At the beginning of the study and after 6 months
To measure the amount of strength developed by each hand in kg
Change from Baseline Six Minutes Walking Time at 6 months
Time frame: At the beginning of the study and after 6 months
To walk the longest distance possible in 6 minutes by walking continuously the 20 or 30 metres indicated on the floor. It measures the distance in meters
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 5 Apr 2017.
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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 principal investigator
Lecturer in the Cardenal Herrera University
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 5 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?
Change from Baseline Short Physical Performance Battery at 6 months (time frame: At the beginning of the study and after 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2017.