RT Journal Article SR Electronic T1 Clinical impact of physical exercise on sleep disorder as assessed by actigram in patients with chronic pancreatitis: a study protocol for a randomised controlled trial JF BMJ Open Gastroenterology FD BMJ Publishing Group Ltd SP e000193 DO 10.1136/bmjgast-2017-000193 VO 5 IS 1 A1 Kazunori Yoh A1 Hiroki Nishikawa A1 Hirayuki Enomoto A1 Yoshinori Iwata A1 Akio Ishii A1 Yukihisa Yuri A1 Noriko Ishii A1 Yuho Miyamoto A1 Kunihiro Hasegawa A1 Chikage Nakano A1 Ryo Takata A1 Takashi Nishimura A1 Nobuhiro Aizawa A1 Yoshiyuki Sakai A1 Naoto Ikeda A1 Tomoyuki Takashima A1 Hiroko Iijima A1 Shuhei Nishiguchi YR 2018 UL http://bmjopengastro.bmj.com//content/5/1/e000193.abstract AB Introduction In most chronic pancreatitis (CP) cases, malabsorption, pain, and weight loss are the leading clinical symptoms, which significantly worsen the quality of life (QOL) and decreased QOL in patients with CP can cause sleep disorder. There is a growing body of evidence that recognises the favourable effects of physical exercise (PE), however, there are limited data currently available concerning patients with CP undergoing PE. Actigram is a device for gathering objective sleep/awake data in the natural sleeping surroundings over an extended time period. In this study, we will aim to prospectively investigate the effect of PE on sleep disorder as assessed by actigram in patients with CP.Methods and analysis This study is a non-double-blind randomised controlled trial. Study participants will be randomised into the PE group and the control group. When registering patients, precise assessment for nutritional status and daily physical activities will be undertaken in each study patient. In the PE group, physical activities equal to or higher than walking for 60 min/day should be strongly recommended. Sleep quality using actigram will be prospectively compared in the two groups. The primary endpoint is the activity index in actigram at 12 weeks.Ethics and dissemination Ethical approval for the study was granted by the Institutional Review Board at Hyogo College of Medicine (approval number 2767). Results will be presented at relevant conferences and submitted to an appropriate journal following trial closure and analysis.Trial registration number UMIN000029265 (https://upload.umin.ac.jp/); Pre-results.