1. 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
- Author
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Akio Ishii, Ryo Takata, Yuho Miyamoto, Naoto Ikeda, Noriko Ishii, Shuhei Nishiguchi, Hiroki Nishikawa, Tomoyuki Takashima, Hirayuki Enomoto, Yoshiyuki Sakai, Chikage Nakano, Kunihiro Hasegawa, Yukihisa Yuri, Yoshinori Iwata, Nobuhiro Aizawa, Kazunori Yoh, Hiroko Iijima, and Takashi Nishimura
- Subjects
medicine.medical_specialty ,Physical exercise ,law.invention ,chronic pancreatitis ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Quality of life ,law ,Weight loss ,Clinical endpoint ,Medicine ,030212 general & internal medicine ,psychological stress ,Sleep disorder ,business.industry ,Gastroenterology ,abdominal pain ,medicine.disease ,Institutional review board ,Pancreatitis ,quality of life ,Physical therapy ,030211 gastroenterology & hepatology ,medicine.symptom ,business - 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.
- Published
- 2017