N/A
N=109
COPD Access to Pulmonary Rehabilitation Intervention
COPD
Bottom Line
View on ClinicalTrials.gov: NCT03794921 ↗Enrolled (actual)
109
Serious AEs
9.2%
Results posted
Apr 2026
Primary outcome: Primary: Physical Activity Measured as Change in Average Daily Step Count — 1302.34; -108.15 steps per day — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Every Step Counts (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Activity Measured as Change in Average Daily Step Count |
1302.34; -108.15 | 0.005 sig |
| SECONDARY Exercise Self-Regulatory Efficacy Measured as Change Score |
1.16; -0.86 | 0.661 |
| SECONDARY Disease Specific Health-Related Quality of Life Measured as Change Score |
-1.34; -2.30 | 0.739 |
| SECONDARY Shortness of Breath Rating as Perceived by the Participant Measured as Change Score |
-0.06; -0.01 | 0.847 |
| SECONDARY Depression Self-reported on Questionnaire Measured as Change Score |
-0.83; -1.35 | 0.691 |
| SECONDARY CHAMPS Physical Activity Questionnaire Measured as Change Score |
1567.28; 715.33; 885.45; 279.12 | 0.252 |
| SECONDARY Rapid Assessment of Physical Activity (RAPA) Questionnaire |
9; 10; 20; 6; 4; 5 | 0.001 sig |
| SECONDARY Healthcare Utilization Represented by Number of Hospitalizations Over Timeframe |
7; 3 | — |
| SECONDARY Healthcare Utilization Represented by Number of Acute Exacerbations Over Timeframe |
1; 3 | — |
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 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.
Eligibility Criteria
Inclusion Criteria are:
- 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
Exclusion Criteria are:
- COPD exacerbation in the previous 1 month
- 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
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT03794921). 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.