Real-Time Support for Exercise Persistence in COPD

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT00373932

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this exploratory study is to determine the feasibility, acceptability, and efficacy of an exercise persistence intervention for patients with chronic obstructive pulmonary disease (COPD) following pulmonary rehabilitation (PR).

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive COPD Emphysema Chronic Bronchitis	Behavioral: Coached exercise persistence intervention Behavioral: Self-Monitored exercise persistence intervention	Phase 1/Phase 2

Detailed Description

Exercise, a cornerstone of PR, is effective in improving dyspnea, functioning, and health related quality of life (HRQL) in patients with COPD. However, these improvements gradually dissipate following program completion. There are currently few successful interventions that support patients' persistence with community-based exercise after PR and that have closely monitored the potentially negative impact that COPD exacerbations have on exercise behaviors. Emerging technologies such as wirelessly enabled personal digital assistants (PDA) may provide an innovative means to support exercise persistence through real-time collaborative monitoring of exercise and signs and symptoms of COPD exacerbations and reinforcement to enhance exercise self-efficacy. Patient graduates of two PR programs who have COPD (n=20) will first undergo a 2-week run-in prior to being randomized to either the MOBILE (Mobilizing Support for Long-term Exercise) intervention or attention control for 6 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Official Title:

Real-Time Support for Exercise Persistence in COPD

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MOBILE-A Coached exercise persistence intervention	Behavioral: Coached exercise persistence intervention Collaborative symptom and exercise monitoring and weekly reinforcement for exercise persistence from nurse coach via a mobile device and telephone.
Active Comparator: MOBILE-B Self-monitored exercise persistence intervention	Behavioral: Self-Monitored exercise persistence intervention Self-monitoring of symptoms and exercise using a mobile device

Arm

Intervention/Treatment

Experimental: MOBILE-A

Coached exercise persistence intervention

Behavioral: Coached exercise persistence intervention

Collaborative symptom and exercise monitoring and weekly reinforcement for exercise persistence from nurse coach via a mobile device and telephone.

Active Comparator: MOBILE-B

Self-monitored exercise persistence intervention

Behavioral: Self-Monitored exercise persistence intervention

Self-monitoring of symptoms and exercise using a mobile device

Outcome Measures

Primary Outcome Measures

Exercise behavior [3 & 6 Months]

Secondary Outcome Measures

Self-efficacy for exercise [3 & 6 Months]
Perception of support [3 & 6 Months]
COPD exacerbation [3 & 6 Months]
Exercise Performance [3 & 6 months]
Health related quality of life [3 & 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Moderate to severe COPD (FEV1/FVC <70% and FEV1%<80%)
Ability to speak, read and write English
Age 40 or older
Willingness to complete a 6 month program

Exclusion Criteria:

Illnesses such as bronchiectasis, active malignancies or other end stage diseases
Plans to continue in a maintenance program after rehabilitation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington	Seattle	Washington	United States	98195

Sponsors and Collaborators

University of Washington
National Institutes of Health (NIH)

Investigators

Principal Investigator: Huong Q. Nguyen, PhD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00373932

Other Study ID Numbers:

29494-V2
R03NR009361-01A1

First Posted:

Sep 8, 2006

Last Update Posted:

Dec 7, 2009

Last Verified:

Dec 1, 2009

Keywords provided by , ,

Exercise

Physical Activity

Adherence

Additional relevant MeSH terms:

Bronchitis

Bronchitis, Chronic

Pulmonary Disease, Chronic Obstructive

Emphysema

Study Results

No Results Posted as of Dec 7, 2009