Status:
COMPLETED
COPD Access to Pulmonary Rehabilitation Intervention
Lead Sponsor:
VA Office of Research and Development
Conditions:
COPD
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Persons with COPD have significant functional disability but cannot access rehabilitative treatment at hospital-based conventional pulmonary rehabilitation (PR) programs. This project will determine w...
Detailed Description
Conventional pulmonary rehabilitation (PR) programs are highly effective and the standard of care in patients with chronic obstructive pulmonary disease (COPD). PR faces two significant problems: (1) ...
Eligibility Criteria
Inclusion
- 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 (FVC) \< 0.70 or chest CT evidence of emphysema or prior documentation of FEV1/FVC ratio of \< 0.7 and clinical evidence of COPD
- defined as 10 pack-year cigarette smoking history
- dyspnea
- or on bronchodilators
- Have declined participation in or cannot access a conventional pulmonary rehabilitation program
- Medical clearance from healthcare provider to participate in an exercise program
- Have access to a computer with Internet connection, a USB port or Bluetooth capability, and Windows XP/Vista/7/8/10 or higher, or Mac OSX 10.5 or higher operating system, or willing to come to VA Medical Center to use study computers
- Competent to provide informed consent
- Willingness to make return visits and be available by telephone for duration of study
Exclusion
- COPD exacerbation in the previous 1 month
- Inability to ambulate with or without assistance (if remote)
- On supplemental oxygen (if remote)
- Use of walking assistive device (if remote)
- Inability to complete questionnaires
- Inability to collect at least 7 of 10 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 3 months
- Average baseline step counts of greater than or equal to 10,000 steps per week
Key Trial Info
Start Date :
September 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03794921
Start Date
September 2 2019
End Date
March 31 2025
Last Update
June 19 2025
Active Locations (1)
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1
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817