Clinical trial NCT00373932: Real-Time Support for Exercise Persistence in COPD
Official title: Real-Time Support for Exercise Persistence in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
COPD
Emphysema
Chronic Bronchitis
Keywords: Exercise
Physical Activity
Adherence
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2006-09-08
Enrollment: 17
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Exercise behavior
timeFrame: 3 & 6 Months
Secondary outcomes:
measure: Self-efficacy for exercise
timeFrame: 3 & 6 Months
measure: Perception of support
timeFrame: 3 & 6 Months
measure: COPD exacerbation
timeFrame: 3 & 6 Months
measure: Exercise Performance
timeFrame: 3 & 6 months
measure: Health related quality of life
timeFrame: 3 & 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Huong Q. Nguyen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen HQ, Steele BG, Dougherty CM, Burr RL. Physical activity patterns of patients with cardiopulmonary illnesses. Arch Phys Med Rehabil. 2012 Dec;93(12):2360-6. doi: 10.1016/j.apmr.2012.06.022. Epub 2012 Jul 5.
citation: Nguyen HQ, Gill DP, Wolpin S, Steele BG, Benditt JO. Pilot study of a cell phone-based exercise persistence intervention post-rehabilitation for COPD. Int J Chron Obstruct Pulmon Dis. 2009;4:301-13. doi: 10.2147/copd.s6643. Epub 2009 Sep 1.