N/A
N=153
The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD
COPD · Emphysema · Chronic Bronchitis
Bottom Line
View on ClinicalTrials.gov: NCT02099799 ↗Enrolled (actual)
153
Serious AEs
32.0%
Results posted
Jan 2021
Primary outcome: Primary: 6-Minute Walk Test Distance — 25; 37 meters — p=0.189
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pedometer and Website (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6-Minute Walk Test Distance |
25; 37 | 0.189 |
| SECONDARY Health-related Quality of Life |
-13.0; -15.1 | 0.572 |
| SECONDARY Dyspnea |
-0.1; 0.0 | 0.799 |
| SECONDARY Engagement in Physical Activity |
673; -639 | <0.001 sig |
| SECONDARY Inflammatory Biomarker Number 1 |
95.0; 22.0 | 0.2265 |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT02099799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.