RT Journal Article
SR Electronic
T1 Protocol for long-term effect of pulmonary rehabilitation under nintedanib in idiopathic pulmonary fibrosis
JF ERJ Open Research
JO erjor
FD European Respiratory Society
SP 00321-2021
DO 10.1183/23120541.00321-2021
VO 7
IS 3
A1 Osamu Nishiyama
A1 Kensuke Kataoka
A1 Masahiko Ando
A1 Shinichi Arizono
A1 Akira Morino
A1 Koichi Nishimura
A1 Tomoya Ogawa
A1 Akira Shiraki
A1 Fumiko Watanabe
A1 Ryo Kozu
A1 Takashi Ogura
A1 Yasuhiro Kondoh
YR 2021
UL http://openres.ersjournals.com/content/7/3/00321-2021.abstract
AB Background Pulmonary rehabilitation causes short-term improvement in exercise capacity, dyspnoea 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 pulmonary rehabilitation is anticipated to contribute to the long-term maintenance of the pulmonary rehabilitation effects. The long-term effect of pulmonary rehabilitation under nintedanib treatment in IPF (FITNESS) study is a multicenter, randomised, prospective, parallel-group, open-label trial.Methods The study will enrol 84 patients with IPF who have been treated with nintedanib. Patients in the pulmonary rehabilitation group will receive a programmed short-term induction pulmonary rehabilitation programme, followed by a maintenance home-based pulmonary rehabilitation programme, 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 end-point of the study is to compare the change in the 6-min walk distance from the baseline to 12 months between the pulmonary rehabilitation and control groups. The main secondary end-point is endurance exercise time, measured using a bicycle ergometer.Discussion FITNESS is the first randomised controlled study to evaluate the long-term effects of pulmonary rehabilitation 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 pulmonary rehabilitation, thus leading to a comprehensive therapeutic approach of “nintedanib and pulmonary rehabilitation” in the antifibrotic era.FITNESS is the first randomised controlled study to evaluate the long-term effects of pulmonary rehabilitation in idiopathic pulmonary fibrosis treated with nintedanib. Effectiveness of this comprehensive therapeutic approach will be addressed. https://bit.ly/3zvoBTr