Acute Exacerbation of COPD and Physical Activity - Preliminary Study

August 2, 2021 updated by: 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.

Study Overview

Status

Terminated

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan - School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity during AECOPD
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sense of coherence
Time Frame: 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
Time Frame: 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
Time Frame: week 1 and week 15
Questionnaire assesses help seeking with respect to healthcare services.
week 1 and week 15
COPD Stigma Scale
Time Frame: week 1 and week 15
Questionnaire measures the stigma associated with having COPD.
week 1 and week 15

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Support for Exercise
Time Frame: week 1
Questionnaire measures social support, positive and negative social influences for physical activity and social support for exercise.
week 1
COPD symptoms
Time Frame: week 1
Questionnaire, the COPD Assessment Tests quantifies severity of the most recent exacerbation.
week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

June 3, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Actual)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • HUM00062912

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease

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