The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients
19. marts 2014 opdateret af: Dr Jennifer MacRae, University of Calgary
The purpose of this study is to explore the impact of an intradialytic exercise program on functional capacity, aerobic capacity, strength, quality of life, depression, hospitalizations and intradialytic episodes of hypotension.
The investigators would also like to look at the impact of exercise training over twelve weeks on hemoglobin levels as well as the clearance of potassium, phosphate and urea.
Our hypothesis is that the above mentioned outcomes will positively improve over the twelve week intervention.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Alberta
-
Calgary, Alberta, Canada, T2L 2J8
- Northwest Dialysis Centre
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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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Cardiac and hemodynamic stability
- Absence of severe musculoskeletal impairment
- Increased musculoskeletal weakness
- Vital signs within normal range for exercise
- Desire/motivated to exercise
- Clearance from nephrologist and Kinesiologist
Exclusion Criteria:
- Compromised cardiac profiles
- Hemodynamic instability
- Severe bone disease
- Medical conditions which contraindicate exercise
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: intradialytic exercise
baseline data prior to starting exercise program will be obtained and then compared to the data after 12 weeks of an intradialtyic biking program
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12 weeks of intradialytic biking at Borg intensity 3 - 4 for 15 to 60 minutes on each dialysis run
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional Capacity
Tidsramme: 12 weeks
|
Functional capacity is measured by the DASI score which gives an estimated V02 peak in ml/min/kg.
The difference between the mean score at baseline and 12 weeks will be determined.
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12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Aerobic capacity
Tidsramme: 12 weeks
|
Aerobic capacity is measured as a function of the DASI score
|
12 weeks
|
|
Strength
Tidsramme: 12 weeks
|
Strength is determined as bilateral hand grip strength (measured in kg) as well as by the 30 second sit to stand test(the number of repetitions achieved in 30 seconds).
These measures are obtained at baseline and again at 12 weeks.
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12 weeks
|
|
Quality of life
Tidsramme: 12 weeks
|
The KDQOL- SF36 will be used to measure the quality of life at baseline and again at 12 weeks.
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12 weeks
|
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Hospitalizations
Tidsramme: 12 weeks
|
The number and rate of hospitalizations will be determined prior to exercise start and during the 12 week exercise program.
Length of stay is also tracked.
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12 weeks
|
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Hypotension
Tidsramme: 12 weeks
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Intradialytic hypotension, defined as a drop in systolic blood pressure (SBP) of 20 mmHg for patients with pre-dialysis blood pressure > 100 mmHg or a drop in SBP of 10 mmHg for patients with pre-dialysis blood pressure < = 90 mmHg.
IDH with patient symptoms and nursing interventions will be obtained as well.
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12 weeks
|
|
Hemoglobin levels
Tidsramme: 12 weeks
|
The baseline hemoglobin and hemoglobin at 12 weeks will be tracked.
|
12 weeks
|
|
Potassium levels
Tidsramme: 12 weeks
|
The baseline potassium and potassium at 12 weeks as well as the K gradient (pre -dialysis - dialysate K level)will be monitored.
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12 weeks
|
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Urea removal
Tidsramme: 12 weeks
|
The baseline and 12 week pre and post dialysis urea levels will be monitored.
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12 weeks
|
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Phosphate levels
Tidsramme: 12 weeks
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The baseline and 12 week pre-dialysis phosphate levels will be tracked.
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12 weeks
|
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Bioimpedance derived volume and body mass determinations
Tidsramme: 12 weeks
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In a small subset of patients (n=10) the bioimpedance derived fluid compartments (ECF, ICF, E:I ratio) and fat free body mass will be determined at both baseline and 12 weeks.
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12 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jennifer MacRae, University of Calgary
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. maj 2013
Primær færdiggørelse (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
27. maj 2013
Først indsendt, der opfyldte QC-kriterier
13. juni 2013
Først opslået (Skøn)
14. juni 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. marts 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. marts 2014
Sidst verificeret
1. marts 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- E-25253
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