直近一年間の累計
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ID 117420
著者
中西, 信人 Tokushima University
Doi, Satoshi Tokushima University
Kawahara, Yoshimi Tokushima University
Shiraishi, Mie Tokushima University
資料タイプ
学術雑誌論文
抄録
Introduction
Vibration therapy has been used as an additional approach in passive rehabilitation. Recently, it has been demonstrated to be feasible and safe for critically ill patients, whose muscle weakness and intensive care unit (ICU)-acquired weakness are serious problems. However, the effectiveness of vibration therapy in this population is unclear.
Methods and analysis
This study will enrol 188 adult critically ill patients who require further ICU stay after they can achieve sitting at the edge of the bed or wheelchair. The sample size calculation is based on a 15% improvement of Functional Status Score for the ICU. They will be randomised to vibration therapy coupled with protocolised mobilisation or to protocolised mobilisation alone; outcomes will be compared between the two groups. Therapy will be administered using a low-frequency vibration device (5.6–13 Hz) for 15 min/day from when the patient first achieves a sitting position and onward until discharge from the ICU. Outcome assessments will be blinded to the intervention. Primary outcome will be measured using the Functional Status Score for the ICU during discharge. Secondary outcomes will be identified as follows: delirium, Medical Research Council Score, ICU-acquired weakness, the change of biceps brachii and rectus femoris muscle mass measured by ultrasound, ICU mobility scale and ventilator-free and ICU-free days (number of free days during 28 days after admission). For safety assessment, vital signs will be monitored during the intervention.
Ethics and dissemination
This study has been approved by the Clinical Research Ethics Committee of Tokushima University Hospital. Results will be disseminated through publication in a peer-reviewed journal and presented at conferences.
Trial registration number
UMIN000039616.
掲載誌名
BMJ Open
ISSN
20446055
出版者
BMJ Publishing Group
11
3
開始ページ
e043348
発行日
2021-03-02
権利情報
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, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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言語
eng
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部局
病院