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A Sedentary Behaviour Reduction Intervention for People With COPD

2. juni 2020 opdateret af: Roger Goldstein, West Park Healthcare Centre

Get Up For Your Health: A Behaviour Change Intervention to Reduce Sedentary Behaviour for People With COPD

Chronic obstructive pulmonary disease (COPD) is a major cause of disability. Individuals with COPD are more likely to spend prolonged periods of time in sedentary behaviour (SB) and less in light physical activity compared to their healthy peers. SB is associated with exercise intolerance, reduced motivation to exercise, lower self-efficacy and more frequent acute exacerbations among people with COPD. To date, there is very limited information regarding behavioural approaches to reduce SB in people with COPD. The aim of this study is to examine the feasibility of a new 4-week theory-informed behaviour change intervention to reduce SB in individuals with COPD.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

21

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
      • Toronto, Ontario, Canada, M6M 2J5
        • West Park Healthcare Centre

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

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • A diagnosis of COPD confirmed by spirometry Forced expired volume to forced vital capacity ration (FEV1/FVC) less than 0.7
  • An ability to ambulate.
  • An ability to provide informed consent.

Exclusion Criteria:

  • Presence of co-existing conditions that may prevent participation in the intervention.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
This was a single arm study with all participants receiving the same intervention. Participants will receive a 4-week behaviour change intervention underpinned by the Theoretical Domains Framework (TDF) that aims to reduce sedentary behaviour.
Adfærdsmæssigt: Get Up For Your Health

The intervention is a 4-week behaviour change intervention underpinned by the Theoretical Domains Framework (TDF) that aims to reduce sedentary behaviour. The intervention consists of one individualized face-to-face session and 3 subsequent weekly points of contact (face-to-face meetings or phone calls).

Behaviour change techniques will be provided including education, verbal persuasion, environmental restructuring and goal-setting.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Enrollment rate
Tidsramme: 4 weeks
Enrollment rate is calculated as a percentage (number of people enrolled/ number of people approached)
4 weeks
Completion rate
Tidsramme: 4 weeks
Percentage of those enrolled who completed the program
4 weeks
Participants satisfaction
Tidsramme: 4 weeks
Participant satisfaction will be assessed on a percentage scale of 0 to 100, with 100 being the best possible score.
4 weeks
Adherence to wearing the activity monitor
Tidsramme: 4 weeks
Percentage of those who were able to provide data for at least 8 hours per day of wearing time during waking hours and for at least 4 days/week for the entire duration of the study
4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in sedentary time
Tidsramme: Baseline - week 4 (post-intervention)
To assess the change in sedentary time as measured using an accelerometer from baseline to post-intervention.
Baseline - week 4 (post-intervention)
Change in number of sit-to-stand transitions
Tidsramme: Baseline - week 4 (post-intervention)
To assess the change in the number of sit-to-stand transitions as measured using an accelerometer from baseline to post-intervention.
Baseline - week 4 (post-intervention)
Change in daily number of steps
Tidsramme: Baseline - week 4 (post-intervention)
To assess the change in the number of steps as measured using an accelerometer from baseline to post-intervention.
Baseline - week 4 (post-intervention)
Change in self-efficacy
Tidsramme: Baseline - week 4 (post-intervention)
To assess the change in self-efficacy to sit less using a scale adapted from the Multidimensional Self-Efficacy Scale over time from baseline to post-intervention. The scale consists of 9 items that measures 3 components of self-efficacy (task, coping and scheduling) with each item is measured on a scale of 0 (no confidence at all) up to 100 (complete confidence). The total score is the average of the scores of the 9 items.
Baseline - week 4 (post-intervention)
Change in outcome expectations
Tidsramme: Baseline - week 4 (post-intervention)
To assess the change in the outcome expectations using a 15-item scale adapted from the Multidimensional Outcome Expectations for Exercise Scale over time from baseline to post-intervention. The questionnaire is a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree), that assesses physical outcome expectations (6 items), social outcome expectations (4 items), and self-evaluative outcome expectations (5 items) with the higher the scores the more positive the outcome expectations are. The total score is the sum of the score of the 15 items.
Baseline - week 4 (post-intervention)
Change in knowledge of sedentary behaviour
Tidsramme: Baseline - week 4 (post-intervention)
To assess the change in sedentary behaviour using an 8-item True or False questionnaire with higher scores indicating better knowledge of sedentary behaviour
Baseline - week 4 (post-intervention)

Samarbejdspartnere og efterforskere

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

Sponsor

West Park Healthcare Centre

Efterforskere

  • Ledende efterforsker: Dina Brooks, PhD, McMaster University
  • Ledende efterforsker: Roger Goldstein, MD, West Park Healthcare Centre

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)

19. juni 2019

Primær færdiggørelse (Faktiske)

18. december 2019

Studieafslutning (Faktiske)

18. december 2019

Datoer for studieregistrering

Først indsendt

30. juni 2019

Først indsendt, der opfyldte QC-kriterier

30. juni 2019

Først opslået (Faktiske)

2. juli 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2020

Sidst verificeret

1. juni 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 19-012-WP

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

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 KOL

Kliniske forsøg med Get Up For Your Health

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