The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD (NCT02099799) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD
United States153 participantsStarted 2015-11-17
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.