BackgroundPulmonary rehabilitation (PR) causes short-term improvement in exercise capacity, dyspnea, and health-related quality of life in idiopathic pulmonary fibrosis (IPF); however, long-term maintenance of the improvement is difficult. Nintedanib, an antifibrotic drug, has been shown to delay the worsening of pulmonary function in IPF. Therefore, the concomitant use of nintedanib with PR is anticipated to contribute to the long-term maintenance of the PR effects. The long-term effect of PR under nintedanib treatment in IPF (FITNESS) study is a multicenter, randomised, prospective, parallel-group, open-label trial.MethodsThe study will enroll 82 patients with IPF who have been treated with nintedanib. Patients in the PR group will receive a programmed short-term induction PR program, followed by a maintenance home-based PR program, while patients in the control group will receive usual outpatient care. Patients in both groups will continue to receive nintedanib treatment throughout the study period. The primary endpoint of the study is to compare the change in the 6-min walk distance from the baseline to 12-months between the PR and control groups. The main secondary endpoint is endurance exercise time, measured using a bicycle ergometer.DiscussionFITNESS is the first randomised controlled study to evaluate the long-term effects of PR in IPF treated with nintedanib. This study will address the hypothesis that concomitant use of nintedanib contributes to the maintenance of long-term effects of PR, thus leading to a comprehensive therapeutic approach of “nintedanib and PR” in the antifibrotic era.
Long-term effect of home-based pulmonary rehabilitation in severe asthma
