作者
Kensuke Kataoka,Osamu Nishiyama,Takashi Ogura,Yuichi Mori,Ryo Kozu,Shinichi Arizono,Tohru Tsuda,Haruaki Tomioka,Keisuke Tomii,Koji Sakamoto,Hiroshi Ishimoto,Michiko Kagajo,Hiroyuki Ito,Kazuya Ichikado,Hajime Sasano,Eda S,Machiko Arita,Yasuhiro Gotô,Osamu Hataji,Satoshi Fuke,Ryota Shintani,Hirotsugu Hasegawa,Masahiko Ando,Tomoya Ogawa,Masashi Shiraishi,Fumio Watanabe,Koichi Nishimura,Takuma Sasaki,Shunichi Miyazaki,Hideo Sasaki,Yasuhiro Kondoh
摘要
Background Idiopathic pulmonary fibrosis (IPF) is characterised by worsening dyspnoea and exercise intolerance. Research question Does a long-term pulmonary rehabilitation improve exercise tolerance in patients with IPF treated with standard antifibrotic drugs, which are expected to reduce disease progression? Methods This open-label randomised controlled trial was performed at 19 institutions. Stable patients receiving nintedanib were randomised into pulmonary rehabilitation and control groups (1:1). The pulmonary rehabilitation group underwent initial rehabilitation which included twice-weekly sessions of monitored exercise training for 12 weeks, followed by an at-home rehabilitation programme for 40 weeks. The control group received usual care only, without pulmonary rehabilitation. Both groups continued to receive nintedanib. The primary and main secondary outcomes were change in 6 min walking distance (6MWD) and change in endurance time (using cycle ergometry) at week 52. Results Eighty-eight patients were randomised into pulmonary rehabilitation (n=45) and control (n=43) groups. Changes in 6MWD were −33 m (95% CI −65 to −1) and −53 m (95% CI −86 to −21) in the pulmonary rehabilitation and control groups, respectively, with no statistically significant difference (mean difference, 21 m (95% CI −25 to 66), p=0.38). Changes in endurance time were significantly better in the pulmonary rehabilitation (64 s, 95% CI −42.3 to 171)) than in the control (−123 s (95% CI −232 to −13)) group (mean difference, 187 s (95% CI 34 to 153), p=0.019). Interpretation Although pulmonary rehabilitation in patients taking nintedanib did not improve 6MWD in the long term, it led to prolonged improvement in endurance time. Trial registration number UMIN000026376.