Real-Time Support for Exercise Persistence in COPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Real-Time Support for Exercise Persistence in COPD

Conditions
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Pulmonary Disease, Chronic Obstructive, COPD, Emphysema, Chronic Bronchitis

Intervention / Treatment
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* Behavioral: Coached exercise persistence intervention
* Behavioral: Self-Monitored exercise persistence intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise behavior |  | 3 & 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Physical Activity, Adherence