Real-Time Support for Exercise Persistence in COPD

COPD Clinical Trial

Official title:

Real-Time Support for Exercise Persistence in COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373932
• Other study ID #: 29494-V2
• Secondary ID: R03NR009361-01A1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 6, 2006
• Last updated: December 3, 2009
• Start date: May 2006
• Est. completion date: December 2008

Study information

• Verified date: December 2009
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

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

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.
• Self-Monitored exercise persistence intervention
Self-monitoring of symptoms and exercise using a mobile device

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise behavior		3 & 6 Months	No
Secondary	Self-efficacy for exercise		3 & 6 Months	No
Secondary	Perception of support		3 & 6 Months	No
Secondary	COPD exacerbation		3 & 6 Months	No
Secondary	Exercise Performance		3 & 6 months	No
Secondary	Health related quality of life		3 & 6 months	No