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Impact of Structured Physical Activity Education Delivery in Patients With Type 2 Diabetes Mellitus

15. august 2016 opdateret af: Dr. Andrew Wozniak, Royal Victoria Hospital, Canada

Impact of Structured Physical Activity Education Delivery on Hemoglobin A1c Levels, Blood Pressure, Lipid Profile, Body Mass Index, Waist Circumference, and Adherence to Canadian Diabetes Association Clinical Practice Guidelines Weekly Physical Activity Recommendations for Patients With Type 2 Diabetes Mellitus: A Pilot Study.

The objective of this study is to assess whether a structured exercise program compared to routine recommendation for exercise has any positive impact on disease outcome in patients with type 2 diabetes.

This study aims to assess whether a structured exercise program has an impact on the following determinants of the disease in type 2 diabetes: HbA1C, blood pressure, lipids, body mass index and waist circumference. It also aims to assess the compliance and retention of patients with type 2 diabetes in a structured exercise program.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

5

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
      • Barrie, Ontario, Canada, L4M 6L2
        • Barrie and Community Family Health Team Diabetes Program

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 64 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Man or woman with type 2 diabetes
  • Ready to begin regular physical activity
  • Age equal to or greater than 18
  • Age equal to or less than 64.

Exclusion Criteria:

  • Any vascular disease
  • Exhibits symptoms of coronary artery disease (CAD)
  • History of losing balance because of dizziness
  • History of losing consciousness
  • Has a bone or joint problem that could be made worse by a change in physical activity
  • Pregnant
  • Has been excluded by the Patient's Physician for any other health-related reason not stated under these exclusion criteria.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Unstructured Physical Activity and Exercise Education Delivery
50 subjects will receive the standard approach to physical activity and exercise education from a Certified Diabetes Educator.
Adfærdsmæssigt: Unstructured Physical Activity and Exercise Education
Eksperimentel: Structured Physical Activity and Exercise Education Delivery
50 subjects will receive physical activity and exercise education and behaviour counseling from a qualified Exercise Specialist (Registered Kinesiologist). These subjects will receive access to a community health and fitness centre as well as exercise instruction and on-going support and motivation from a YMCA Wellness Coach who focuses on establishing healthy behaviors towards the attainment of personal goals. Subjects will be requested to complete a lifestyle questionnaire at each appointment with their Wellness Coach. Subjects will receive a Physical Activity and Exercise Journal that will help them keep track of their weekly physical activity and exercise activities.
Adfærdsmæssigt: Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Mean Change in Hemoglobin A1c (HbA1c) Levels
Tidsramme: Baseline and 12 months
Baseline and 12 months
Mean Change in Systolic Blood Pressure
Tidsramme: Baseline and 12 months
Baseline and 12 months
Mean Change in Waist Circumference
Tidsramme: Baseline and 12 months
Baseline and 12 months
Mean Change in Body Mass Index
Tidsramme: Baseline and 12 months
Baseline and 12 months
Mean Change in Serum Total Cholesterol
Tidsramme: Baseline and 12 months
Baseline and 12 months
Mean Change in HDL-C
Tidsramme: Baseline and 12 months
Baseline and 12 months
Mean Change in LDL-C
Tidsramme: Baseline and 12 months
Baseline and 12 months
Mean Change in Triglycerides (TGs)
Tidsramme: Baseline and 12 months
Baseline and 12 months
Mean Change in Total Cholesterol: HDL-C Ratio
Tidsramme: Baseline and 12 months
Baseline and 12 months
Mean Change in Diastolic Blood Pressure
Tidsramme: Baseline and 12 months
Baseline and 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations
Tidsramme: Baseline and 12 months
The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 150 minutes per week of aerobic exercise.
Baseline and 12 months
Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations
Tidsramme: Baseline and 12 months
The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 2 sessions per week of resistance exercise.
Baseline and 12 months

Samarbejdspartnere og efterforskere

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

Sponsor

Royal Victoria Hospital, Canada

Efterforskere

  • Ledende efterforsker: Dr. Andrew Wozniak, MD, CCFP, Barrie and Community Family Health Team

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

1. april 2014

Primær færdiggørelse (Faktiske)

1. september 2015

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

3. marts 2014

Først indsendt, der opfyldte QC-kriterier

20. marts 2014

Først opslået (Skøn)

21. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AW-100-SD

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 Type 2 diabetes mellitus

Kliniske forsøg med Unstructured Physical Activity and Exercise Education

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in China

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner