Efficacy and safety of digital therapeutics for pulmonary rehabilitation in patients with COPD: A randomized controlled trial

Background and aims Pulmonary rehabilitation (PR) is widely acknowledged as a crucial non-pharmacological management of chronic obstructive pulmonary disease (COPD). Despite its clear benefits, PR remains underutilized globally, posing accessibility challenges for patients. To address this gap, we investigated the efficacy and safety of digital therapeutics (DTx), in PR for COPD patients. <bold>Methods:</bold> This trial was a prospective, parallel-group, randomized controlled trial conducted in multi-center. The research protocol was approved by the Korean Ministry of Food and Drug Safety (Approval No. 1431). The DTx group (DTxG) was provided with DTx utilizing the EASYBREATH app, or the control group (CG) receiving standard care. The DTxG underwent an eight-week PR program, with evaluations conducted at baseline, 4wks, 8wks. The CG received one PR session and was recommended to exercise and perform the same evaluation. <fig><object-id>erj;64/suppl_68/PA5193/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig> Results The change in 6MWD after 8 wks had a significant difference between the DTxG (62.87±51.70) and the CG (21.03±51.90) (P <.001). The DTxG showed a significant improvement in the change of mMRC, CAT scores, and SGRQ total score to CG after 8 wks. <bold>Conclusion:</bold> A comprehensive PR program using the DTx significantly improved exercise capacity, alleviated dyspnea, and enhanced the overall quality of life at 8 wks.