Clinical Trial: Feasibility and Safety of Increased Early Mobilization Frequency During the Vasospasm Period After Aneurysmal Subarachnoid Hemorrhage: A Single-Center Pilot Randomized Controlled Trial (Japan)

Tokyo, June 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061817) titled 'Study on the Feasibility and Safety of Early Mobilization Frequency in Patients With Aneurysmal Subarachnoid Hemorrhage' on June 6.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Dose comparison

Primary Sponsor: Institute - Department of Rehabilitation, Tsuchiura Kyodo General Hospital

Condition: Condition - aneurysmal subarachnoid hemorrhage Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate, in patients after definitive treatment for aneurysmal subarachnoid hemorrhage during the vasospasm period, whether early mobilization twice daily is feasible and does not raise major safety concerns compared with standard early mobilization once daily, using a single-center pilot randomized controlled trial design. Basic objectives2 - Others

Intervention: Interventions/Control_1 - In the control group, early mobilization will be performed once daily according to the standardized early mobilization protocol of our hospital until day 14 after onset or discharge from the SCU, whichever occurs first. Interventions/Control_2 - In the intervention group, early mobilization will be performed twice daily according to the standardized early mobilization protocol of our hospital until day 14 after onset or discharge from the SCU, whichever occurs first. Each session will be separated by at least 3 hours in principle.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients aged 18 years or older 2. Patients diagnosed with aneurysmal subarachnoid hemorrhage (aSAH) who have undergone definitive treatment for a ruptured aneurysm 3. Patients judged by the attending physician to be eligible for early mobilization and who meet the early mobilization initiation criteria of our hospital 4. Patients who provide written informed consent, or whose legally acceptable representative provides written informed consent Key exclusion criteria - 1. Patients with untreated aneurysms, either ruptured or unruptured, for whom the attending physician considers early mobilization to pose safety concerns 2. Patients judged to be unable to undergo early mobilization because of hemodynamic instability or severe respiratory failure 3. Patients judged to be unable to undergo early mobilization because of conditions requiring sedation 4. Patients judged to be unable to undergo early mobilization because of increased intracranial pressure, uncontrolled intracranial bleeding, or severe stenosis or occlusion of the cerebral or cervical arteries 5. Patients or legally acceptable representatives who do not provide informed consent Target Size - 50

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 05 Month 08 Day Date of IRB - 2026 Year 05 Month 12 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2028 Year 09 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070501

Disclaimer: Curated by HT Syndication.