Acute Exacerbation of COPD and Physical Activity - Preliminary Study

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Acute Exacerbation of COPD and Physical Activity - Preliminary Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01871246
• Other study ID #: HUM00062912
• Status: Terminated
• Start date: February 2013
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: July 1, 2021
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	University of Michigan - School of Nursing	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social Support for Exercise	Questionnaire measures social support, positive and negative social influences for physical activity and social support for exercise.	week 1
Other	COPD symptoms	Questionnaire, the COPD Assessment Tests quantifies severity of the most recent exacerbation.	week 1
Primary	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	Sense of coherence	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
Secondary	Barriers efficacy scale	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
Secondary	Help seeking behavior	Questionnaire assesses help seeking with respect to healthcare services.	week 1 and week 15
Secondary	COPD Stigma Scale	Questionnaire measures the stigma associated with having COPD.	week 1 and week 15