Physical Activity Coaching in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

— PACC  

Official title:

Physical Activity Coaching in COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349608
• Other study ID #: 11-000356
• Status: Completed
• Phase: N/A
• First received: May 2, 2011
• Last updated: April 1, 2013
• Start date: April 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Health Behavior
• Lung Diseases
• Lung Diseases, Obstructive
• Physical Activity
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Telephonic 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of telephone-based health coaching in COPD.	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	No