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The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD (WEB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02099799
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : March 23, 2020
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
COPD currently afflicts 24 million US residents; the prevalence of COPD is high among Veterans. Persons with COPD have significant functional disability as a result of the disease. This project will determine whether a novel Internet-mediated walking program coupled with a pedometer can improve exercise capacity, improve health-related quality of life, and decrease the risk of acute exacerbations in persons with COPD. If successful, based on estimates that 33 to 64% of COPD patients are Internet users, the proposed exercise intervention could help over 8 million persons. The Veterans Health Administration (VHA) has a strong commitment to providing care to persons with COPD and supporting research directed at COPD-related disability. The 2012-2016 Strategic Plan of the VHA Office of Research and Development includes research in COPD rehabilitation. The proposed research addresses Rehabilitation R&D Service's current priority area of improving disabled Veterans' health-related quality of life by reducing disease burden and maximizing functional recovery.

Condition or disease Intervention/treatment Phase
COPD Emphysema Chronic Bronchitis Behavioral: Pedometer and Website Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Research assistant who assesses outcomes is blinded to randomization group.
Primary Purpose: Treatment
Official Title: The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD
Actual Study Start Date : November 17, 2015
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : February 7, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Pedometer and Internet Website
Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.
Behavioral: Pedometer and Website
Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.

No Intervention: Usual Care
Verbal instructions and written materials about exercise.

Primary Outcome Measures :
  1. 6-Minute Walk Test Distance [ Time Frame: 6 months ]
    In-clinic test that measures exercise capacity.

Secondary Outcome Measures :
  1. Health-related Quality of Life [ Time Frame: 6 months ]
    Questionnaires that assess quality of life.

  2. Number of Acute Exacerbations and Hospitalizations [ Time Frame: 6 months ]
    Assessed by patient report and review of medical records.

  3. Dyspnea [ Time Frame: 6 months ]
    Assessed by questionnaire that measure breathlessness and shortness of breath.

  4. Inflammatory Biomarkers IL-6 and CRP [ Time Frame: 6 months ]
    Participant has blood draw at in-clinic visits. Blood test measures markers of systemic inflammation.

  5. Engagement in Physical Activity [ Time Frame: 6 months ]
    Assessed by daily step counts on pedometer.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female subjects, greater than or equal to 40 years of age
  • Clinical diagnosis of COPD defined as either a ratio of FEV1 to forced vital capacity < 0.70 or chest CT evidence of emphysema. CT obtained as part of routine clinical care, independent of research study.
  • Medical clearance from healthcare provider to participate in an exercise program
  • Have an active email account and can check email at least weekly
  • Have access to a computer with Internet connection or willing to come to VABoston or Birmingham VA Medical Center to use study computers
  • Pedometer with >90% accuracy compared to manual counts on short clinic walk
  • Competent to provide informed consent
  • Willingness to make return visits and be available by telephone for duration of study

Exclusion Criteria:

  • COPD exacerbation in the previous 1 month
  • Unable to ambulate with or without assistance
  • Clinical signs of unstable cardiovascular disease or congestive heart failure
  • Hypoxemia during 6MWT, i.e. oxygen saturation <85% using supplemental oxygen
  • Unable to complete questionnaires
  • Unable to collect at least 5 of 7 days of baseline step counts
  • Participation in a pulmonary rehabilitation program at time of screening or within the previous 3 months
  • Participation in another exercise-related research study at time of screening
  • Plans to participate in an exercise-related research study in the next 6 months
  • Plans to enroll in a supervised exercise program, such as pulmonary rehabilitation, in the next 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02099799

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United States, Alabama
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: Marilyn L. Moy, MD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

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Responsible Party: VA Office of Research and Development Identifier: NCT02099799    
Other Study ID Numbers: O1150-R
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Physical Activity
COPD Self-Management
6-Minute Walk Test
COPD Exacerbation
Health-related Quality of Life
Additional relevant MeSH terms:
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Bronchitis, Chronic
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections