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Acute Exacerbation of COPD and Physical Activity - Preliminary Study

2. august 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

23

Kontakter og lokationer

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

Studiesteder

    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan - School of Nursing

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

55 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Efterforskere

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

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. februar 2013

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. juli 2021

Datoer for studieregistrering

Først indsendt

3. juni 2013

Først indsendt, der opfyldte QC-kriterier

3. juni 2013

Først opslået (Skøn)

6. juni 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • HUM00062912

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 .

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