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Effect of physical exercise on sarcopaenia in patients with overt hepatic encephalopathy: 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}


Introduction Limited data are currently available for patients with overt hepatic encephalopathy (OHE)) receiving physical exercise (PE). The aim of the current study is to prospectively examine the effect of PE on sarcopaenia in patients with OHE.

Methods and analysis At the time of patient recruitment, a precise assessment for nutritional status and daily physical activities will be performed in each subject. Study participants will be randomly assigned into two groups: (1) the PE group and (2) the control group. In the PE group, we will conduct guidance to study participants once a month at the outpatient nutrition guidance room. We will also instruct them to do exercise with >3 metabolic equivalents (mets; energy consumption in physical activities/resting metabolic rate) for 60 min per day and to do exercise >23 mets per week. Improvement of sarcopaenia as defined by muscle mass and muscle strength at 3 months after the randomisation will be the primary endpoint. Sarcopaenia will be defined based on the current Japanese guidelines. We prospectively compared the improvement of sarcopaenia in the two groups.

Ethics and dissemination This study has received approval from the Institutional Review Board at Hyogo college of medicine (approval no. 2768). Final data will be publicly disseminated irrespective of the study results. A report releasing study results will be submitted for publication in an appropriate journal after completion of data collection.

Trial registration number UMIN000029248; Pre-results. No patient is registered at the submission of our manuscript.

  • liver
  • liver cirrhosis
  • hepatic encephalopathy
  • malnutrition

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  • Contributors KY, HN and HE: analysed data and wrote the article. SN: supervised the randomised trial. Other authors: recruited candidates and collected relevant data.

  • Competing interests None declared.

  • Ethics approval Institutional Review Board at Hyogo College of Medicine (approval no. 2768).

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

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