Protocol for long-term effect of pulmonary rehabilitation under nintedanib in idiopathic pulmonary fibrosis

Abstract

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.

Benefits of Pulmonary Rehabilitation in Patients with Idiopathic Pulmonary Fibrosis Receiving Antifibrotic Drug Treatment

“…Both AFD and PR are treatments that should be continued as long as possible unless there is a reason to stop. Currently, a randomized controlled study to evaluate the 12-month effects of pulmonary rehabilitation in IPF treated with nintedanib is ongoing [32]. That study may reveal the contribution of concomitant use of nintedanib to the maintenance of long-term effects of pulmonary rehabilitation.…”

Long-term effect of pulmonary rehabilitation in idiopathic pulmonary fibrosis: a randomised controlled trial

“…For the achieved target sample size of 84 patients, a statistical power of ≥90% (at p<0.05) was calculated to be sufficient for detecting a statistically significant difference between the treatment groups. 18 The sample size for this study was similar to that of the previous HOPE IPF study. 30…”

“…Both groups continued to receive nintedanib. The purpose, design and methods of the study, which were previously reported 18 and the final protocol, are available in online supplemental appendix.…”

“…The detailed rehabilitation programme is described in a previous report 18 and will be briefly introduced. During the first 12 weeks after the start of the pulmonary rehabilitation programme, induction pulmonary rehabilitation was performed during two outpatient visits per week (24 sessions) under the supervision of a cardiorespiratory physiotherapist.…”