Effect of vibration therapy on physical function in critically ill adults (VTICIA trial): protocol for a single-blinded randomised controlled trial
Autor: | Nobuto Nakanishi, Yoshimi Kawahara, Mie Shiraishi, Satoshi Doi, Jun Oto |
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Jazyk: | angličtina |
Rok vydání: | 2021 |
Předmět: |
Adult
intensive & critical care medicine.medical_specialty Weakness Critical Illness medicine.medical_treatment Population Vital signs Sitting Vibration Rehabilitation Medicine law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Activities of Daily Living Humans Medicine 030212 general & internal medicine education adult intensive & critical care Physical Therapy Modalities Randomized Controlled Trials as Topic education.field_of_study Rehabilitation business.industry 030208 emergency & critical care medicine General Medicine Intensive care unit Intensive Care Units Physical therapy Delirium medicine.symptom business |
Zdroj: | BMJ Open, Vol 11, Iss 3 (2021) BMJ Open |
ISSN: | 2044-6055 |
Popis: | 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 analysisThis 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 disseminationThis 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 numberUMIN000039616. |
Databáze: | OpenAIRE |
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