Evaluation of a Smartphone App for Pulmonary Rehabilitation in COPD - A Multicenter Randomized Controlled Trial

<bold>Background:</bold> Pulmonary rehabilitation (PR) is an essential component of COPD management. However, access to traditional face-to-face PR programs is limited. Therefore, tele-PR interventions are gaining interest. <bold>Methods:</bold> This multicenter, randomized, controlled trial recruited COPD patients from 18 sites in Germany and Switzerland, aiming to evaluate the impact of 12 weeks of the fully automated Kaia COPD app (intervention group, IVG) on health-related quality of life, measured by COPD Assessment Test (CAT), and exercise capacity, assessed by 1-Minute-Sit-to-Stand-Test (1MSTST) (co-primary outcomes), compared to a control group (CTG) receiving ’enhanced standard of care’. <bold>Results:</bold> A total of 278 subjects were included in the study with median age 65 years, FEV1: 48% predicted, and 49% female. In the intention to treat analysis at week 12, CAT improved from baseline median -4 points vs -3 points in the IVG vs CTG groups, respectively (difference: 1 point [−1, 2]; p=0.7); 1MSTST improved by 1 vs 2 repetitions, respectively (difference: 1 repetition [−2.5, 2]; p=0.12). A subgroup analysis of the IVG, showed that patients with a high app adherence (≥3 days/week for ≥75% of the first 12 weeks), improved 1MSTST vs non-adherent users by 2 more repetitions (1, 3); p=0.006. App use did not raise any safety concerns. <bold>Conclusion:</bold> Overall, app-based PR did not improve outcomes in COPD. However, adherent app users had an improvement in exercise capacity vs non-adherent users. This study supports the use of the Kaia COPD app for the management of COPD, addressing the healthcare challenge of access to PR interventions.