Chronic Obstructive Pulmonary Disease Access and Adherence to Pulmonary Rehabilitation Intervention (CAPRI): Protocol for a randomized controlled trial and adaptations during the COVID-19 pandemic

BACKGROUND: Pulmonary rehabilitation (PR) is the standard of care for chronic obstructive pulmonary disease (COPD) management. However, significant barriers limit access and adherence to PR and alternatives are needed. The purpose of this randomized controlled trial is to test the efficacy of a web-based, pedometer-mediated intervention to increase physical activity (PA) for persons with COPD who decline PR or meet U.S. guidelines for referral to PR but have not participated (CAPRI-1). In addition, we will test whether the intervention maintains PA following PR in an exploratory aim (CAPRI-2). METHODS: Participants with COPD (N = 120) will be recruited and randomized 1:1 to a 12-week web-based, pedometer-mediated intervention or usual care (UC) (CAPRI-1). The intervention provides: 1) objective monitoring of walking and iterative feedback, 2) individualized step-count goals, 3) motivational messages and educational content, and 4) an online community. The primary outcome is change in daily step count from baseline to 12 weeks. Secondary outcomes include: (a) exercise capacity; (b) self-reported PA; (c) PA intensity; (d) exercise self-regulatory efficacy, (e) health-related quality of life, (f) dyspnea, (g) depression symptoms, and (h) healthcare utilization. CAPRI-2 will test whether participants (N = 96) assigned to the intervention following PR completion show greater maintenance of daily step count compared to UC at 3, 6, 9, and 12 months. DISCUSSION: If the intervention is efficacious, it may be an alternative for those who cannot attend PR or a maintenance program following completion of conventional PR. We also present adaptations made to the protocol in response to the COVID-19 pandemic.