Real-Time Support for Exercise Persistence in COPD

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00373932
First received: September 6, 2006
Last updated: December 3, 2009
Last verified: December 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Real-Time Support for Exercise Persistence in COPD

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Exercise behavior [ Time Frame: 3 & 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-efficacy for exercise [ Time Frame: 3 & 6 Months ] [ Designated as safety issue: No ]
  • Perception of support [ Time Frame: 3 & 6 Months ] [ Designated as safety issue: No ]
  • COPD exacerbation [ Time Frame: 3 & 6 Months ] [ Designated as safety issue: No ]
  • Exercise Performance [ Time Frame: 3 & 6 months ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: 3 & 6 months ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: May 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373932

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Huong Q. Nguyen, PhD University of Washington
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Huong Q. Nguyen, PhD, University of Washington
ClinicalTrials.gov Identifier: NCT00373932     History of Changes
Other Study ID Numbers: 29494-V2, R03NR009361-01A1
Study First Received: September 6, 2006
Last Updated: December 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Exercise
Physical Activity
Adherence

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Chronic Disease
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Tract Infections
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014