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

This study is currently recruiting participants.
Verified September 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT02099799
First Posted: March 31, 2014
Last Update Posted: September 14, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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 Intervention
COPD Emphysema Chronic Bronchitis Behavioral: Pedometer and Website

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

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


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

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

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

  • 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.

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


Estimated Enrollment: 185
Actual Study Start Date: November 17, 2015
Estimated Study Completion Date: December 31, 2020
Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

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.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02099799


Contacts
Contact: Marilyn L Moy, MD (857) 203-6622 Marilyn.Moy@va.gov
Contact: Ana Kantorowski, MPH (857) 203-5229 ana.kantorowski@va.gov

Locations
United States, Alabama
Birmingham VA Medical Center, Birmingham, AL Recruiting
Birmingham, Alabama, United States, 35233
Contact: Amber Samuelson    205-933-8101 ext 5550    Amber.Samuelson@va.gov   
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: Maria Higgins    857-364-4802    maria.higgins@va.gov   
Principal Investigator: Marilyn L. Moy, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Marilyn L. Moy, MD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  More Information

Publications:
Moy ML, Collins RJ, Martinez CH, Kadri R, Roman P, Holleman RG, Kim HM, Nguyen HQ, Cohen MD, Goodrich DE, Giardino ND, Richardson CR. An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD: A Randomized Controlled Trial. Chest. 2015 Jul;148(1):128-137. doi: 10.1378/chest.14-1466.
Moy ML, Garshick E, Matthess KR, Lew R, Reilly JJ. Accuracy of uniaxial accelerometer in chronic obstructive pulmonary disease. J Rehabil Res Dev. 2008;45(4):611-7.
Moy ML, Danilack VA, Weston NA, Garshick E. Daily step counts in a US cohort with COPD. Respir Med. 2012 Jul;106(7):962-9. doi: 10.1016/j.rmed.2012.03.016. Epub 2012 Apr 20.
Moy ML, Teylan M, Weston NA, Gagnon DR, Garshick E. Daily step count predicts acute exacerbations in a US cohort with COPD. PLoS One. 2013 Apr 4;8(4):e60400. doi: 10.1371/journal.pone.0060400. Print 2013.
Moy ML, Teylan M, Weston NA, Gagnon DR, Danilack VA, Garshick E. Daily step count is associated with plasma C-reactive protein and IL-6 in a US cohort with COPD. Chest. 2014 Mar 1;145(3):542-550. doi: 10.1378/chest.13-1052.
Danilack VA, Weston NA, Richardson CR, Mori DL, Moy ML. Reasons persons with COPD do not walk and relationship with daily step count. COPD. 2014 Jun;11(3):290-9. doi: 10.3109/15412555.2013.841670. Epub 2013 Oct 23.
Moy ML, Teylan M, Danilack VA, Gagnon DR, Garshick E. An index of daily step count and systemic inflammation predicts clinical outcomes in chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Feb;11(2):149-57. doi: 10.1513/AnnalsATS.201307-243OC.
Moy ML, Janney AW, Nguyen HQ, Matthess KR, Cohen M, Garshick E, Richardson CR. Use of pedometer and Internet-mediated walking program in patients with chronic obstructive pulmonary disease. J Rehabil Res Dev. 2010;47(5):485-96.
Moy ML, Matthess K, Stolzmann K, Reilly J, Garshick E. Free-living physical activity in COPD: assessment with accelerometer and activity checklist. J Rehabil Res Dev. 2009;46(2):277-86.

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02099799     History of Changes
Other Study ID Numbers: O1150-R
First Submitted: March 20, 2014
First Posted: March 31, 2014
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Internet
6-Minute Walk Test
COPD Exacerbation
Health-related Quality of Life

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


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