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  • 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

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Pancreatitis
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
  1. Kazunori Yoh1,
  2. Hiroki Nishikawa1,2,
  3. Hirayuki Enomoto1,
  4. Yoshinori Iwata1,
  5. Akio Ishii1,
  6. Yukihisa Yuri1,
  7. Noriko Ishii1,
  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. 1Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan
  2. 2Center for Clinical Research and Education, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan
  1. Correspondence to Dr Hirayuki Enomoto; enomoto{at}hyo-med.ac.jp

Abstract

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.

  • abdominal pain
  • chronic pancreatitis
  • quality of life
  • psychological stress

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/

https://doi.org/10.1136/bmjgast-2017-000193

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    Footnotes

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

    • Ethics approval The Institutional Review Board at Hyogo College of Medicine (approval number 2767).

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