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Acute Exacerbation of COPD and Physical Activity - Preliminary Study

2. august 2021 oppdatert av: Janet L. Larson, University of Michigan
People with chronic obstructive pulmonary disease (COPD) are very sedentary and efforts to establish an active lifestyle are challenging because of periodic acute exacerbations of COPD that interrupt physical activity patterns and contribute to further decline in physical activity. The purpose of this preliminary research is to learn more about the experience of acute exacerbations of COPD (AECOPD) from the perspective of the patient and his/her family and to learn how AECOPDs affect physical activity.

Studieoversikt

Status

Avsluttet

Forhold

Detaljert beskrivelse

Individuals with chronic obstructive pulmonary disease (COPD) are very sedentary and their physical activity is often interrupted by acute exacerbations of COPD (AECOPD). Little is known about the expectations had by individuals with COPD and the effects of these expectations on their physical activity. To increase the understanding of these expectations in people with COPD, a study is proposed to explore their experience of daily fluctuations in symptoms and AECOPDs, focusing on how these experiences influence health promoting behaviors, especially physical activity (PA).

This study will involve an enrollment visit during which consent will be obtained, survey data will be administered (that they may take home), spirometry testing will be conducted, and a physical activity monitor (ActivPAL device) will be applied to be worn one week to allow us to understand their usual PA. A clinical ethnographic interview will then be conducted one week following enrollment, at which point the questionnaires and ActivPAL device will be collected. A second clinical ethnographic interview will be conducted one week following the first. Survey data will again collected at week 15 by mail.

Studietype

Observasjonsmessig

Registrering (Faktiske)

23

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan - School of Nursing

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

55 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

People with COPD, who have had an exaccerbation in the last year who live in the greater Ann Arbor area and their family members.

Beskrivelse

Inclusion Criteria:

  • People who have emphysema or chronic bronchitis as their primary health problem
  • People who have had a respiratory infection or an exacerbation of their COPD within the last year.
  • People who are 55 years or older
  • Family member of someone who meets the above criteria.

Exclusion Criteria:

  • Other lung diseases as their primary pulmonary problem.
  • Mobility problems that limit physical activity

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
People with COPD & recent exacerbation
The group consists of people with COPD who have had an exacerbation in the last year.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physical activity during AECOPD
Tidsramme: week 1
Subjects will be asked to report how they managed their physical activity during the last AECOPD. Current physical activity will be measured with accelerometry and by the CHAMPS questionnaire.
week 1

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sense of coherence
Tidsramme: week 1 and week 15
Questionnaire that measures one's global orientation to life and the extent to which one sees life as comprehensible, manageable and meaningful.
week 1 and week 15
Barriers efficacy scale
Tidsramme: week 1 week 15
Questionnaire that measures barriers to exercise and physical activity. The subjects reports the level of confidence they have that they can overcome each barrier.
week 1 week 15
Help seeking behavior
Tidsramme: week 1 and week 15
Questionnaire assesses help seeking with respect to healthcare services.
week 1 and week 15
COPD Stigma Scale
Tidsramme: week 1 and week 15
Questionnaire measures the stigma associated with having COPD.
week 1 and week 15

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Social Support for Exercise
Tidsramme: week 1
Questionnaire measures social support, positive and negative social influences for physical activity and social support for exercise.
week 1
COPD symptoms
Tidsramme: week 1
Questionnaire, the COPD Assessment Tests quantifies severity of the most recent exacerbation.
week 1

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Michigan

Etterforskere

  • Hovedetterforsker: Janet L Larson, PhD, University of Michigan - School of Nursing

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

1. februar 2013

Primær fullføring (Faktiske)

1. desember 2015

Studiet fullført (Faktiske)

1. juli 2021

Datoer for studieregistrering

Først innsendt

3. juni 2013

Først innsendt som oppfylte QC-kriteriene

3. juni 2013

Først lagt ut (Anslag)

6. juni 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. august 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. august 2021

Sist bekreftet

1. august 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HUM00062912

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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