Late Breaking Abstract - Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in Idiopathic Pulmonary Fibrosis (FITNESS study)

Background: Pulmonary rehabilitation (PR) causes short-term improvement in exercise capacity, in IPF, but long-term maintenance is difficult. Nintedanib has been shown to slow the worsening of pulmonary function in IPF. The concomitant use of nintedanib with PR may contribute to the long-term maintenance of PR effects. Methods: This is a multicenter, randomized, prospective, parallel-group, open-label trial. Patients in the PR group will receive a programmed short-term PR induction, followed by home-based PR maintenance. Patients in the control group will receive usual outpatient care. Patients in both groups will continue to receive nintedanib. The primary endpoint is the change in the 6-minute walk distance (6MWD) from baseline to 12-months in the two groups. The main secondary endpoint is the change in endurance exercise time, measured using a bicycle ergometer. Results: Of the 88 randomized subjects, 74 completed the study (PR group n=38, control group n=36). In the primary-endpoint analysis, the change in 6MWD was -24 m in the PR group and -37 m in the control group (p=0.1502). In the main secondary-endpoint analysis, the change in endurance time was 93 sec in the PR group and -99 sec in the control group (p=0.0032). Conclusions: A long-term PR program in combination with nintedanib in patients with IPF did not improve 6MWD but did improve endurance exercise time. Acknowledgment: This study was supported by Boehringer Ingelheim.