NCT01871246

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

August 10, 2021

Status Verified

August 1, 2021

Enrollment Period

2.8 years

First QC Date

June 3, 2013

Last Update Submit

August 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physical activity during AECOPD

    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 Outcomes (4)

  • Sense of coherence

    week 1 and week 15

  • Barriers efficacy scale

    week 1 week 15

  • Help seeking behavior

    week 1 and week 15

  • COPD Stigma Scale

    week 1 and week 15

Other Outcomes (2)

  • Social Support for Exercise

    week 1

  • COPD symptoms

    week 1

Study Arms (1)

People with COPD & recent exacerbation

The group consists of people with COPD who have had an exacerbation in the last year.

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan - School of Nursing

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Janet L Larson, PhD

    University of Michigan - School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 6, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2015

Study Completion

July 1, 2021

Last Updated

August 10, 2021

Record last verified: 2021-08

Locations