NCT03794921Completed
COPD Access to Pulmonary Rehabilitation Intervention
Leveraging Technology to Address Access and Adherence to Conventional Hospital-Based Pulmonary Rehabilitation in Veterans With COPD
Source: ClinicalTrials.gov · Last updated 2 Apr 2026
Brief summary (registry, in English)
Persons with COPD have significant functional disability but cannot access rehabilitative treatment at hospital-based conventional pulmonary rehabilitation (PR) programs. This project will determine whether an Internet-mediated, pedometer-based walking program can increase physical activity in persons with COPD who qualify for but cannot access PR, compared to usual care. This proposal has high potential to deliver an immediate solution to a pressing clinical need. 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 146 (actual)
- First submitted
- 18 Dec 2018
- Start date
- 17 Sept 2019
- Primary completion date
- 10 Sept 2024
- Lead sponsor
- VA Office of Research and Development
- Diseases
- COPD
- NCT number
- NCT03794921
What you commit to
- Study type: Interventional
- Participants enrolled: 146
- From 17 Sept 2019 to the primary completion date, 10 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- COPD exacerbation in the previous 1 month
- Participation in a pulmonary rehabilitation program at time of screening or within the previous 3 months
Lab values
- Inability to collect at least 7 of 10 days of baseline step counts
- Average baseline step counts of greater than or equal to 10,000 steps per week
- For those who wish to participate virtually.
- If participant has an in-person visit, oxygen will be assessed during the 6MWT to determine if subject's oxygen is stable during activity. If a participant has an in-person visit and oxygen is documented during the 6MWT and stays above 85%, he/she will be eligible to participate.
- If a participant uses an assistive walking device but we have previously shown that the Fitbit pedometer is accurate in him/her (before the study was transitioned to virtual) he/she will be allowed to participate in the study. If a participant has an in-person visit and Fitbit accuracy is documented during use of the assistive device he/she will be eligible to participate.
Other
- Prescribed supplemental oxygen for activity+
- Inability to ambulate with or without assistance
- Use of assistive device for walking such as cane or walker*
- Inability to complete questionnaires
- 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
Who the study is looking for
- Male and female subjects, greater than or equal to 40 years of age
- Clinical diagnosis of COPD defined as: 1 of the following as testing-based evidence of COPD (any documented FEV1/FVC < 0.70, chest CT evidence of emphysema) AND at least 2 of the following as clinical evidence of COPD (≥ 10 pack-year cigarette smoking history, taking an antimuscarinic inhaler such as ipratropium or tiotropium, diagnosis of COPD written in a provider's note or on problem list)
- Have declined participation in a conventional pulmonary rehabilitation program
- Medical clearance from healthcare provider to participate in an exercise program
- Have Internet connection and Bluetooth capability, and access to video platform Cisco Webex#
- Answer yes to "Does your shortness of breath interfere with your functioning?"
- Answer no to "Are you interested in joining PR now? If they answer yes, they will be ineligible and the PI will place a consult to PR for further evaluation
- Competent to provide informed consent
- Willingness to make return visits and be available by telephone for duration of study
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.