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Implication of exercise interventions on sleep disturbance in patients with pancreatic cancer: a study protocol for a randomised controlled trial
  1. Kazunori Yoh1,
  2. Hiroki Nishikawa1,2,
  3. Hirayuki Enomoto1,
  4. Noriko Ishii1,
  5. Yoshinori Iwata1,
  6. Akio Ishii1,
  7. Yukihisa Yuri1,
  8. Yuho Miyamoto1,
  9. Kunihiro Hasegawa1,
  10. Chikage Nakano1,
  11. Ryo Takata1,
  12. Takashi Nishimura1,
  13. Nobuhiro Aizawa1,
  14. Yoshiyuki Sakai1,
  15. Naoto Ikeda1,
  16. Tomoyuki Takashima1,
  17. Hiroko Iijima1,
  18. Shuhei Nishiguchi1,2
  1. 1 Department of Internal Medicine, Division of Hepatobiliary and Pancreatic Disease, Hyogo College of Medicine, Nishinomiya, Japan
  2. 2 Centre for Clinical Research and Education, Hyogo College of Medicine, Nishinomiya, Japan
  1. Correspondence to Dr Hirayuki Enomoto, Department of Hepatobiliary and Pancreatic disease, Department of Internal Medicine, Hyogo College of Medicine, Hyogo 663-8501, Japan; enomoto{at}hyo-med.ac.jp

Abstract

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.

  • pancreatic cancer
  • pancreas
  • nutritional status
  • quality of life

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors KY designed the study and wrote the initial draft of the manuscript. HN and HE contributed to the analysis and interpretation of data and assisted in the preparation of the manuscript. NI, YI, AI, YY, YM, KH, CN, RT, TN, NA, YS, NIk, TT, HI and SN contributed to data collection and interpretation, and critically reviewd the manuscript.

  • Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Provenance and peer review Not commissioned; externally peer reviewed.