Trial of Hemodialysis Based Exercise for Strength Improvement Study (THESIS)
18. april 2016 opdateret af: Scott Brimble, St. Joseph's Healthcare Hamilton
Comparison of Aerobic Exercise, Strength Training, or Its Combination in Hemodialysis Patients: a Randomized Controlled Trial
Study Hypothesis: The combination of aerobic and resistance exercise training will improve walking speed compared to either individual intervention.
Brief Summary:
Sixty hemodialysis participants who meet inclusion and exclusion criteria will be randomized to 20 weeks of supervised exercise, using either: (i) on-dialysis aerobic exercise using a bike ergometer; (ii) pre-dialysis leg strength training using weights; or (iii) both. The primary outcome is walking speed over 4-metres. Secondary outcomes will include:
(i) short physical performance battery; (ii) health-related quality of life [EuroQOL-5D-5L]; (iii) Dialysis recovery time; (iv) Nottingham extended activities of daily living (EADL) index; (v) Leg strength; (vi) body composition and anthropometry.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- St. Josephs Healthcare Hamilton
-
-
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- At least 18 years of age
- On hemodialysis minimum of 3 times per week
- On hemodialysis > 3 consecutive months
Exclusion Criteria:
- Inability to provide consent
- Inability to walk 4-metres
- Chest pain with exertion or myocardial infarction in past 6-months
- Pre-dialysis systolic blood pressure > 200 mm Hg or diastolic BP > 100 mm Hg in past 2-weeks
- Functional or cardiorespiratory limitations preventing use of cycle ergometer for at least five-minutes or the ability to perform single maximum rep with each of resistance exercises described
- Joint replacement or lower extremity fracture in previous 6-months
- Severe cognitive impairment
- Currently using corticosteroids >5 mg/day
- Pre-dialysis serum potassium in previous month less than 3.5 or greater than 6.0 mmol/L.
- Attending nephrologist feels exercise is medically contraindicated
- Scheduled living related kidney transplant in next 6 months
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 |
|---|---|
|
Aktiv komparator: aerobic exercise
patients will undergo supervised exercise on a bike ergometer for 30 minutes three times per week during hemodialysis
|
|
|
Aktiv komparator: resistance training
patients will undergo supervised lower extremity strength training three times per week pre-hemodialysis
|
|
|
Eksperimentel: aerobic exercise and resistance training
patients will undergo a combination of aerobic exercise and resistance training on an alternating schedule three time per week
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
change in walking speed over 20 weeks
Tidsramme: 10 and 20 weeks
|
repeated measures analysis
|
10 and 20 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
change in short physical performance battery over 20 weeks
Tidsramme: 10 and 20 weeks
|
repeated measures analysis
|
10 and 20 weeks
|
|
change in EuroQOL-5D-5L over 20 weeks
Tidsramme: 10 and 20 weeks
|
Health-related quality of life.
Repeated measures analysis
|
10 and 20 weeks
|
|
change in dialysis recovery time over 20 weeks
Tidsramme: 10 and 20 weeks
|
repeated measures analysis
|
10 and 20 weeks
|
|
change in Nottingham extended activities of daily living index over 20 weeks
Tidsramme: 10 and 20 weeks
|
repeated measures analysis
|
10 and 20 weeks
|
|
change in body anthropometry and composition over 20 weeks.
Tidsramme: 10 and 20 weeks
|
weight, waist-hip ratio, bioimpedance analysis-determined fat-free mass, percentage body fat, phase angle.
Repeated measures analysis
|
10 and 20 weeks
|
|
change in inflammation measures over 20 weeks
Tidsramme: 10 and 20 weeks
|
serum albumin, C-reactive protein, interleukin-6 and tumor necrosis factor-alpha.
Repeated measures analysis
|
10 and 20 weeks
|
|
hospitalization
Tidsramme: continuous over 20 weeks
|
continuous over 20 weeks
|
|
|
death
Tidsramme: continuous over 20 weeks
|
continuous over 20 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. oktober 2013
Primær færdiggørelse (Forventet)
1. juni 2017
Studieafslutning (Forventet)
1. september 2017
Datoer for studieregistrering
Først indsendt
8. oktober 2013
Først indsendt, der opfyldte QC-kriterier
9. oktober 2013
Først opslået (Skøn)
14. oktober 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13-468
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 .