Effect of vibration therapy on physical function in critically ill adults (VTICIA trial): protocol for a single-blinded randomised controlled trial.

introductionVibration 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.