Protocol for long-term effect of pulmonary rehabilitation under nintedanib in idiopathic pulmonary fibrosis
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 wo...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
European Respiratory Society
2021-08-01
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| Series: | ERJ Open Research |
| Online Access: | http://openres.ersjournals.com/content/7/3/00321-2021.full |
| _version_ | 1818887437849460736 |
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| author | Osamu Nishiyama Kensuke Kataoka Masahiko Ando Shinichi Arizono Akira Morino Koichi Nishimura Tomoya Ogawa Akira Shiraki Fumiko Watanabe Ryo Kozu Takashi Ogura Yasuhiro Kondoh |
| author_facet | Osamu Nishiyama Kensuke Kataoka Masahiko Ando Shinichi Arizono Akira Morino Koichi Nishimura Tomoya Ogawa Akira Shiraki Fumiko Watanabe Ryo Kozu Takashi Ogura Yasuhiro Kondoh |
| author_sort | Osamu Nishiyama |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-19T16:37:13Z |
| format | Article |
| id | doaj.art-e4db53a3c0f84f9eb986939f9606d22f |
| institution | Directory Open Access Journal |
| issn | 2312-0541 |
| language | English |
| last_indexed | 2024-12-19T16:37:13Z |
| publishDate | 2021-08-01 |
| publisher | European Respiratory Society |
| record_format | Article |
| series | ERJ Open Research |
| spelling | doaj.art-e4db53a3c0f84f9eb986939f9606d22f2022-12-21T20:13:56ZengEuropean Respiratory SocietyERJ Open Research2312-05412021-08-017310.1183/23120541.00321-202100321-2021Protocol for long-term effect of pulmonary rehabilitation under nintedanib in idiopathic pulmonary fibrosisOsamu Nishiyama0Kensuke Kataoka1Masahiko Ando2Shinichi Arizono3Akira Morino4Koichi Nishimura5Tomoya Ogawa6Akira Shiraki7Fumiko Watanabe8Ryo Kozu9Takashi Ogura10Yasuhiro Kondoh11 Dept of Respiratory Medicine and Allergology, Kindai University Faculty of Medicine, Osakasayama, Osaka, Japan Dept of Respiratory Medicine and Allergy, Tosei General Hospital, Seto, Aichi, Japan Dept of Advanced Medicine, Nagoya University Hospital, Nagoya, Aichi, Japan School of Rehabilitation Sciences, Seirei Christopher University, Hamamatsu, Shizuoka, Japan Dept of Physical Therapy, Hokkaido Chitose College of Rehabilitation, Chitose, Hokkaido, Japan Dept of Respiratory Medicine, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan Dept of Rehabilitation, Tosei General Hospital, Seto, Aichi, Japan Shiraki Medical Clinic, Ichinomiya, Aichi, Japan Dept of Rehabilitation, Tosei General Hospital, Seto, Aichi, Japan Dept of Rehabilitation Medicine, Nagasaki University Hospital, Nagasaki, Nagasaki, Japan Dept of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Kanagawa, Japan Dept of Respiratory Medicine and Allergy, Tosei General Hospital, Seto, Aichi, Japan 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.http://openres.ersjournals.com/content/7/3/00321-2021.full |
| spellingShingle | Osamu Nishiyama Kensuke Kataoka Masahiko Ando Shinichi Arizono Akira Morino Koichi Nishimura Tomoya Ogawa Akira Shiraki Fumiko Watanabe Ryo Kozu Takashi Ogura Yasuhiro Kondoh Protocol for long-term effect of pulmonary rehabilitation under nintedanib in idiopathic pulmonary fibrosis ERJ Open Research |
| title | Protocol for long-term effect of pulmonary rehabilitation under nintedanib in idiopathic pulmonary fibrosis |
| title_full | Protocol for long-term effect of pulmonary rehabilitation under nintedanib in idiopathic pulmonary fibrosis |
| title_fullStr | Protocol for long-term effect of pulmonary rehabilitation under nintedanib in idiopathic pulmonary fibrosis |
| title_full_unstemmed | Protocol for long-term effect of pulmonary rehabilitation under nintedanib in idiopathic pulmonary fibrosis |
| title_short | Protocol for long-term effect of pulmonary rehabilitation under nintedanib in idiopathic pulmonary fibrosis |
| title_sort | protocol for long term effect of pulmonary rehabilitation under nintedanib in idiopathic pulmonary fibrosis |
| url | http://openres.ersjournals.com/content/7/3/00321-2021.full |
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