Protocol for long-term effect of pulmonary rehabilitation under nintedanib in IPF
- Osamu Nishiyama1,11,
- Kensuke Kataoka2,11,
- Masahiko Ando3,
- Shinichi Arizono4,
- Akira Morino5,
- Koichi Nishimura6,
- Tomoya Ogawa7,
- Akira Shiraki8,
- Fumiko Watanabe7,
- Ryo Kozu9,
- Takashi Ogura10 and
- Yasuhiro Kondoh2⇑
- 1Department of Respiratory Medicine and Allergology, Kindai University Faculty of Medicine, Osakasayama, Osaka, Japan
- 2Department of Respiratory Medicine and Allergy, Tosei General Hospital, Seto, Aichi, Japan
- 3Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Aichi, Japan
- 4School of Rehabilitation Sciences, Seirei Christopher University, Hamamatsu, Shizuoka, Japan
- 5Department of Physical Therapy, Hokkaido Chitose College of Rehabilitation, Chitose, Hokkaido, Japan
- 6Department of Respiratory Medicine, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan
- 7Department of Rehabilitation, Tosei General Hospital, Seto, Aichi, Japan
- 8Shiraki Medical Clinic, Ichinomiya, Aichi, Japan
- 9Department of Rehabilitation Medicine, Nagasaki University Hospital, Nagasaki, Nagasaki, Japan
- 10Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Kanagawa, Japan
- 11Equally contributing author
- Yasuhiro Kondoh (konyasu2003{at}yahoo.co.jp)
Abstract
Background Pulmonary 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.
Methods The 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.
Discussion FITNESS 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.
Footnotes
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Competing interests: Osamu Nishiyama reports support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.) from Nippon Boehringer and Ingelheim Co., Ltd. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Nippon Boehringer and Ingelheim Co., Ltd. in the last 36 months, outside the submitted work.
Competing interests: Kensuke Kataoka reports support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.) from Nippon Boehringer and Ingelheim Co., Ltd. Personal payment for lectures from Nippon Boehringer Ingelheim Co., Ltd. in the last 36 months, outside the submitted work.
Competing interests: Masahiko Ando reports support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.) from Nippon Boehringer and Ingelheim Co., Ltd.
Competing interests: Shinichi Arizono reports support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.) from Nippon Boehringer and Ingelheim Co., Ltd.
Competing interests: Akira Morino reports support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.) from Nippon Boehringer and Ingelheim Co., Ltd.
Competing interests: Koichi Nishimura reports support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.) from Nippon Boehringer and Ingelheim Co., Ltd.
Competing interests: Tomoya Ogawa reports support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.) from Nippon Boehringer and Ingelheim Co., Ltd.
Competing interests: Akira Shiraki reports support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.) from Nippon Boehringer and Ingelheim Co., Ltd.
Competing interests: Fumiko Watanabe reports support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.) from Nippon Boehringer and Ingelheim Co., Ltd.
Competing interests: Ryo Kozu reports support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.) from Nippon Boehringer and Ingelheim Co., Ltd.
Competing interests: Takashi Ogura reports support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.) from Nippon Boehringer and Ingelheim Co., Ltd. Honoraria for lectures from Nippon Boehringer, Ingelheim Co., Ltd. Shionogi Co,Ltd, Astellas Co., and Bristol-Myers Squibb Co. Support for attending meetings and travel from Taiho PHARMACEUTICAL CO., LTD,in the last 36 months, outside the submitted work.
Competing interests: Yasuhiro Kondoh reports support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.) from Nippon Boehringer and Ingelheim Co., Ltd. Consulting fees from Asahi Kasei Pharma Corp., Shionogi & Co.Ltd., Boehringer Ingelheim Co., Ltd., Janssen Pharmaceutical K.K., Healios K.K., Taiho Pharmaceutical Co., Ltd. outside the submitted work within the last 36 months. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Asahi Kasei Pharma Corp., Shionogi & Co.Ltd., Boehringer Ingelheim Co., Ltd., AstraZaneca K.K., Eisai inc., KYORIN Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma and Novartis Pharma K.K., outside the submitted work within the last 36 months.
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- Received May 7, 2021.
- Accepted June 14, 2021.
- Copyright ©The authors 2021
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