RT Journal Article SR Electronic T1 Implication of exercise interventions on sleep disturbance in patients with pancreatic cancer: a study protocol for a randomised controlled trial JF BMJ Open Gastroenterology FD BMJ Publishing Group Ltd SP e000196 DO 10.1136/bmjgast-2017-000196 VO 5 IS 1 A1 Kazunori Yoh A1 Hiroki Nishikawa A1 Hirayuki Enomoto A1 Noriko Ishii A1 Yoshinori Iwata A1 Akio Ishii A1 Yukihisa Yuri 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/e000196.abstract AB Introduction and purpose Patients with pancreatic cancer (PC) have long been known to have high rates of depression. Depression in patients with PC can be linked to sleep disturbance. The American College of Sports Medicine notes that physical exercise is safe for most patients with cancer and physical inactivity should be avoided. However, clinical impacts of exercise interventions (EIs) on patients with PC have been poorly investigated. We aim to prospectively examine the effect of EIs on sleep disturbance in patients with PC using actigraphy, which is an objective measurement of motor activity and sleep.Methods and analysis This trial is a non-double blind randomised controlled trial. Standard therapy for each patient with PC will be allowed. When registering study subjects, a thorough assessment of the nutritional status and the daily physical activities performed will be undertaken individually for each participant. Study subjects will be randomly assigned into two groups: (1) the EI and standard therapy group or (2) the standard therapy group. In the EI and standard therapy group, physical activities equal to or higher than walking for 60 min/day will be strongly recommended. The primary outcome measure is the sleep-related variable using actigraphy (activity index) at 12 weeks.Ethics and dissemination The trial received approval from the Institutional Review Board at Hyogo College of Medicine (approval no. 2769). Final data will be publicly announced. A report releasing the study findings will be submitted for publication to an appropriate peer-reviewed journal.Trial registration number UMIN000029272; Pre-results.