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Completed

NCT Number: NCT00373932

Real-Time Support for Exercise Persistence in COPD

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).

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Behavior Bronchial Diseases Bronchitis Bronchitis, Chronic COPD Chronic Bronchitis Chronic Disease Disease Attributes Emphysema Infections Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coached exercise persistence intervention

Behavioral

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

Self-Monitored exercise persistence intervention

Behavioral

Self-monitoring of symptoms and exercise using a mobile device

Primary outcomes

  1. Exercise behavior

    Time frame: 3 & 6 Months

Secondary outcomes

  1. Self-efficacy for exercise

    Time frame: 3 & 6 Months

  2. Perception of support

    Time frame: 3 & 6 Months

  3. COPD exacerbation

    Time frame: 3 & 6 Months

  4. Exercise Performance

    Time frame: 3 & 6 months

  5. Health related quality of life

    Time frame: 3 & 6 months

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 8, 2006
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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