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Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis

4. april 2017 opdateret af: Eva Segura Ortí, Cardenal Herrera University

Comparison of Intradialytic Versus Home-based Programmes on Adherence and Strength of Stage 5 Chronic Kidney Disease Patients

Although exercise training of haemodialysis patients is associated with generally positive outcomes few haemodialysis units routinely offer intradialytic exercise therapy. This is often related to financial cost and/or staffing limitations. Home-based programs could be an alternative means of providing exercise benefits without associated implementation costs The aim of this study was to compare the effects of 4 weeks intradialytic versus home based exercise for haemodialysis patients regarding adherence and strength gains.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
    • Valencia
      • Moncada, Valencia, Spanien, 46113
        • Universidad CEU Cardenal Herrera

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

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

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Intradialytic exercise
Exercise during hemodialysis
Andet: Exercise programmes
Andet: Home-based exercise
Exercise at home
Andet: Exercise programmes

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline Short Physical Performance Battery at 4 months
Tidsramme: At the beginning and after 4 months
Assess lower extremity, which includes objective performance-based measure of balance (side-by-side, semi-tandem 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 and after 4 months
Change from Baseline One leg standing test at 4 months
Tidsramme: At the beginning and after 4 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 and after 4 months
Change from Baseline Timed Up and Go test at 4 months
Tidsramme: At the beginning and after 4 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 and after 4 months
Change from Baseline Sit to stand to sit 10 and 60 at 4 months
Tidsramme: At the beginning and after 4 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 and after 4 months
Change from Baseline One leg heel rise at 4 months
Tidsramme: At the beginning and after 4 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 and after 4 months
Change from Baseline Handgrip Strength at 4 months
Tidsramme: At the beginning and after 4 months
To measure the amount of strength developed by each hand in kg
At the beginning and after 4 months
Change from Baseline Six minutes walking test at 4 months
Tidsramme: At the beginning and after 4 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 and after 4 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cardenal Herrera University

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

  • CEU Card Herrera

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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