Try our beta test site

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by VA Office of Research and Development
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02099799
First received: March 20, 2014
Last updated: October 13, 2016
Last verified: October 2016
  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
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD

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

Primary Outcome Measures:
  • 6-Minute Walk Test Distance [ Time Frame: 12 months ]
    In-clinic test that measures exercise capacity.


Secondary Outcome Measures:
  • Health-related Quality of Life [ Time Frame: 12 months ]
    Questionnaires that assess quality of life.

  • Number of Acute Exacerbations and Hospitalizations [ Time Frame: 12 months ]
    Assessed by patient report and review of medical records.

  • Dyspnea [ Time Frame: 12 months ]
    Assessed by questionnaire that measure breathlessness and shortness of breath.

  • Inflammatory Biomarkers IL-6 and CRP [ Time Frame: 12 months ]
    Participant has blood draw at in-clinic visits. Blood test measures markers of systemic inflammation.

  • Engagement in Physical Activity [ Time Frame: 12 months ]
    Assessed by daily step counts on pedometer.


Estimated Enrollment: 185
Study Start Date: November 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Active Comparator: Usual Care
Verbal instructions and written materials about exercise.
Behavioral: Usual Care
Verbal instructions and written materials about exercise.

  Show Detailed Description

  Eligibility

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
  • 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
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: 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: Donna Kantarges    617-323-7700 ext 5151    donna.kantarges@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:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02099799     History of Changes
Other Study ID Numbers: O1150-R
Study First Received: March 20, 2014
Last Updated: October 13, 2016
Individual Participant Data  
Plan to Share IPD: 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

ClinicalTrials.gov processed this record on March 29, 2017