Quantifying the Deterioration of Physical Function in Renal Patients
4. april 2017 opdateret af: Eva Segura Ortí, Cardenal Herrera University
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.
Studieoversigt
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
60
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Valencia
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Moncada, Valencia, Spanien, 46113
- Universidad CEU Cardenal Herrera
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
People with Chronic Kidney Diseases undergoing hemodialysis treatment
Beskrivelse
Inclusion Criteria:
- people under hemodialysis treatment at least 3 months
- be medicable stable
- complete all the physical tests
Exclusion Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline Short Physical Performance Battery at 6 months
Tidsramme: 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).
|
At the beginning of the study and after 6 months
|
|
Change from Baseline One Leg Standing Test at 6 months
Tidsramme: 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.
|
At the beginning of the study and after 6 months
|
|
Change from Baseline Timed Up and Go at 6 months
Tidsramme: 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.
|
At the beginning of the study and after 6 months
|
|
Change from Baseline Sit to Stand to Sit 10 and 60 at 6 months
Tidsramme: 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
|
At the beginning of the study and after 6 months
|
|
Change from Baseline On leg heel rise at 6 months
Tidsramme: 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
|
At the beginning of the study and after 6 months
|
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Change from Baseline Handgrip strength at 6 months
Tidsramme: At the beginning of the study and after 6 months
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To measure the amount of strength developed by each hand in kg
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At the beginning of the study and after 6 months
|
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Change from Baseline Six Minutes Walking Time at 6 months
Tidsramme: 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
|
At the beginning of the study and after 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Eva Segura Ortí, Lecturer in the Cardenal Herrera University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2014
Primær færdiggørelse (Faktiske)
1. december 2016
Studieafslutning (Faktiske)
1. januar 2017
Datoer for studieregistrering
Først indsendt
8. juli 2016
Først indsendt, der opfyldte QC-kriterier
11. juli 2016
Først opslået (Skøn)
14. juli 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. april 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. april 2017
Sidst verificeret
1. april 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Cardenal Herrera Univeristy
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