A Sedentary Behaviour Reduction Intervention for People With COPD
2. juni 2020 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
21
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ontario
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Toronto, Ontario, Canada, M6M 2J5
- West Park Healthcare Centre
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Enrollment rate
Tidsramme: 4 weeks
|
Enrollment rate is calculated as a percentage (number of people enrolled/ number of people approached)
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4 weeks
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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
|
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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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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Baseline - week 4 (post-intervention)
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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.
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Baseline - week 4 (post-intervention)
|
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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)
|
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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.
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Baseline - week 4 (post-intervention)
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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.
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Baseline - week 4 (post-intervention)
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Change in knowledge of sedentary behaviour
Tidsramme: Baseline - week 4 (post-intervention)
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To assess the change in sedentary behaviour using an 8-item True or False questionnaire with higher scores indicating better knowledge of sedentary behaviour
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Baseline - week 4 (post-intervention)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Dina Brooks, PhD, McMaster University
- Hovedetterforsker: Roger Goldstein, MD, West Park Healthcare Centre
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. juni 2019
Primær fullføring (Faktiske)
18. desember 2019
Studiet fullført (Faktiske)
18. desember 2019
Datoer for studieregistrering
Først innsendt
30. juni 2019
Først innsendt som oppfylte QC-kriteriene
30. juni 2019
Først lagt ut (Faktiske)
2. juli 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. juni 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juni 2020
Sist bekreftet
1. juni 2020
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 19-012-WP
Plan for individuelle deltakerdata (IPD)
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NEI
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Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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