Acute Exacerbation of COPD and Physical Activity - Prelim... | NCT01871246

Studies
Acute Exacerbation of COPD and Physical Activity - Preliminary Study

NCT01871246

Sponsor

University of Michigan

Status

Terminated

Last Update Posted

Aug 10, 2021Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was not funded and we ran out of resources to complete the data analysis. This was a qualitative study and requires substantial time and effort to conduct data analysis.

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Jul 1, 2021Actual

First Submitted Date

Jun 3, 2013

First Submission Date that Met QC Criteria

Jun 3, 2013

First Posted Date

Jun 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2021

Last Update Posted Date

Aug 10, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
People with COPD & recent exacerbation		The group consists of people with COPD who have had an exacerbation in the last year.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Barriers efficacy scale

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janet L Larson, PhD	University of Michigan - School of Nursing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan - School of Nursing		Ann Arbor	Michigan	48109	United States

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided