Tokyo, Feb. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060533) titled 'The Impact of Different Rehabilitation Methods During ICU Admission on Physical Function' on Jan. 31.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Nihon University Hospital

Condition: Condition - Critically ill patients requiring mechanical ventilation for 48 hours or more Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to introduce a functional extubation protocol based on the Functional Status Score for the ICU (FSS-ICU) for patients admitted to the ICU, and to examine changes in physical functional outcomes before and after its implementation. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - In the intervention group, a stepwise rehabilitation protocol based on the Functional Status Score for the ICU (FSS-ICU) is implemented for patients during their ICU stay. Rehabilitation is provided at least once daily and includes basic functional activities such as rolling, sitting up, sitting balance, standing, and walking. Progression of the intervention is determined based on hemodynamic and respiratory status and level of consciousness of the patient, following safety assessment by the treating physician and study investigator. The historical control group utilized data from ICU patients who underwent rehabilitation using the standard mobilization protocol prior to the introduction of the functional mobilization protocol. Rehabilitation was generally performed at least once daily, with safety confirmed using the same initiation and discontinuation criteria as the intervention group.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 18 years or older who were admitted to the emergency and critical care center of Nihon University hospital and required mechanical ventilation for 48 hours or longer. Key exclusion criteria - 1)Patients who are unable to understand instructions until ICU discharge due to severe impaired consciousness. 2)Patients admitted for cerebrovascular disease with motor paralysis. 3)Patients who develop severe complications during hospitalization. 4)Patients who required total assistance for all activities of daily living prior to hospital admission. 5)Patients who refused to participate in this study. Target Size - 124

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 09 Month 22 Day Date of IRB - 2025 Year 09 Month 22 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2026 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069037

Disclaimer: Curated by HT Syndication.