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Fit For Function: A Community Wellness Program for Persons With Stroke

25. juni 2019 opdateret af: McMaster University
Building on an earlier pilot study, this randomized controlled trial will compare the effectiveness of a 12 week community YMCA-based wellness program specifically designed for people with stroke (Fit for Function) to a standard YMCA membership.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The program will be delivered through a partnership between McMaster University, the YMCA and Hamilton Health Sciences/ the Brant Community Healthcare System/ the Niagara Health System. Participants will exercise three times a week and receive weekly education about how to take care of themselves after a stroke. The YMCA staff who deliver the program will have specialized training about how to help people with a stroke exercise safely and effectively. The hospital within each region will provide specialized on-site physiotherapy consultative support. The comparator standard YMCA membership will include typical sessions with a wellness coach who has basic safety training regarding stroke and exercise.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

218

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Brantford, Ontario, Canada
        • The Brantford Family YMCA
      • Hamilton, Ontario, Canada, L8P 2Z1
        • Downtown Hamilton YMCA
      • St. Catharines, Ontario, Canada, L2N 7P9
        • The Walker Family YMCA

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:

  • diagnosed with stroke
  • 18 years of age or older
  • community dwelling
  • able to walk 10m independently, with or without an assistive device
  • medically approved by a physician to participate
  • able to tolerate 60 minutes of activity with rest intervals
  • able to independently follow instructions

Exclusion Criteria:

  • involved in an active rehabilitation program

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Fit For Function Program
A 12-week YMCA-based wellness program for persons with stroke, consisting of 2 group exercise sessions, one gym exercise session and one education session per week with trained instructors.
Andet: Fit For Function Program
A 12-week YMCA-based wellness program for persons with stroke, consisting of 2 group exercise sessions, one gym exercise session and one education session per week with trained instructors
Aktiv komparator: Standard YMCA membership
A 12 week standard YMCA membership.
Andet: Standard YMCA membership
A 12 week standard YMCA membership.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the Reintegration to Normal Living Index (RNL) from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
This measure assesses the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities.
baseline, 12 weeks, 24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in The Rapid Assessment of Physical Activity (RAPA) score from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
This is a 9-item measure that assesses frequency and intensity of aerobic physical activity and frequency of strengthening and flexibility exercises.
baseline, 12 weeks, 24 weeks
Change in The Short Portable Performance Tests (SPPT) score from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
This test is used to quantify lower extremity function by evaluating the time to walk 8 feet, standing balance and repeated chair stands.
baseline, 12 weeks, 24 weeks
Change in The Six Minute Walk Test (6MWT) from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
This test is an indicator of exercise capacity and measures the distance walked in 6 minutes.
baseline, 12 weeks, 24 weeks
Change in Strength: Grip and Knee extension from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
Hand-held dynamometry will measure the average strength of three trials.
baseline, 12 weeks, 24 weeks
Change in The EQ-5D score from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
This is a generic utility-based health related quality of life questionnaire.
baseline, 12 weeks, 24 weeks
Change in The Patient Activation Measure (PAM) score from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
This is a 13-item measure of the patient's level of knowledge, skill and confidence for self-management.
baseline, 12 weeks, 24 weeks
Change in The Body Mass Index (BMI) score from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
The BMI will be calculated from measurements of body mass and height as an indicator of cardiovascular health.
baseline, 12 weeks, 24 weeks
Change in Blood lipid levels from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
12 hour fasting levels of lipids will be used as an indicator of cardiovascular health.
baseline, 12 weeks, 24 weeks
Change in blood glucose levels from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
12 hour fasting levels of glucose in blood will be used as an indicator of cardiovascular health.
baseline, 12 weeks, 24 weeks
Change in blood inflammatory markers from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
12 hour fasting levels of inflammatory markers in blood will be used as an indicator of cardiovascular health.
baseline, 12 weeks, 24 weeks
Healthcare Utilization Questionnaire
Tidsramme: 0- 24 weeks
An indicator of healthcare resource utilization (hospitalizations, medical appointments and investigations, medication use) for economic analysis.
0- 24 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

McMaster University

Samarbejdspartnere

Canadian Institutes of Health Research (CIHR)
Hamilton Health Sciences Corporation
YMCA of Hamilton/Burlington/Brant
YMCA of Niagara
Brant Community Healthcare System
Niagara Health System

Efterforskere

  • Ledende efterforsker: Julie Richardson, PhD, McMaster University
  • Ledende efterforsker: Ada Tang, PhD, McMaster University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

1. maj 2014

Primær færdiggørelse (Faktiske)

1. november 2018

Studieafslutning (Faktiske)

1. november 2018

Datoer for studieregistrering

Først indsendt

14. oktober 2014

Først indsendt, der opfyldte QC-kriterier

3. marts 2016

Først opslået (Skøn)

9. marts 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2019

Sidst verificeret

1. juni 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FFF133486

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

Results will be communicated to the Central South Regional Stroke Network and the Ontario Stroke System. Results will also be disseminated through professional organizations, the Ontario Ministry of Health and Long Term Care, peer reviewed conferences, provincial and national stroke forums, journal articles and special interest groups like the Stroke Recovery Group.

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 .

Kliniske forsøg med Cerebrovaskulær ulykke

Kliniske forsøg med Fit For Function Program

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner