- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01349608
Physical Activity Coaching in Chronic Obstructive Pulmonary Disease (COPD) (PACC)
April 1, 2013 updated by: Roberto P. Benzo, Mayo Clinic
Physical Activity Coaching in COPD
This study is designed to explore a new approach to help people with chronic obstructive pulmonary disease (COPD) become more physically active.
Through weekly telephone sessions with a health coach utilizing motivational interviewing, participants will be empowered to set goals for increased physical activity (emphasis on walking).
The objective of the study is to determine if telephone-based health coaching is a reasonable and effective way to increase physical activity, as measured by a gold-standard activity monitor, in people with COPD.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
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
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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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
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women age 40 years and older
- Current or former cigarette smoker of at least 10 pack-years
- Diagnosis of COPD stage II to IV COPD as documented by pulmonary function testing (FEV1 <80% predicted, FEV1/FVC ration <0.71) within the past 24 months
- Able to ambulate independently or with a walking aid (wheeled or standard walker or cane)
Exclusion Criteria:
- Unable to walk without assistance of another person
- patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not able to be contacted by telephone
- patients with an inability to provide good data or follow commands (patients who are disoriented or have a severe neurologic/psychiatric condition)
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Health coaching
|
Participants will be given a pedometer and activity log to use daily to track their physical activity accomplishments.
Weekly, they will participate in a health coaching telephone session to discuss physical activity and set goals.
The health coach is knowledgable in COPD care and will utilize a motivational interviewing approach to support the self-efficacy of the participants to be more active.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of telephone-based health coaching in COPD.
Time Frame: 3 Months
|
Determine the effectiveness of a telephone-based health coaching intervention on daily physical activity level, as measured by a gold-standard activity monitor and daily pedometer record, acceptability of intervention through qualitative interviews with participants, and health-related quality of life as measured by questionnaires.
|
3 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
May 2, 2011
First Submitted That Met QC Criteria
May 5, 2011
First Posted (Estimate)
May 6, 2011
Study Record Updates
Last Update Posted (Estimate)
April 4, 2013
Last Update Submitted That Met QC Criteria
April 1, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-000356
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.
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