UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061817 |
|---|---|
| Receipt number | R000070501 |
| Scientific Title | Feasibility and Safety of Increased Early Mobilization Frequency During the Vasospasm Period After Aneurysmal Subarachnoid Hemorrhage: A Single-Center Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/06 |
| Last modified on | 2026/06/06 14:24:02 |
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Basic information
Public title
Study on the Feasibility and Safety of Early Mobilization Frequency in Patients With Aneurysmal Subarachnoid Hemorrhage
Acronym
SAFE-EM Study
Scientific Title
Feasibility and Safety of Increased Early Mobilization Frequency During the Vasospasm Period After Aneurysmal Subarachnoid Hemorrhage: A Single-Center Pilot Randomized Controlled Trial
Scientific Title:Acronym
SAFE-EM trial
Region
| Japan |
Condition
Condition
aneurysmal subarachnoid hemorrhage
Classification by specialty
| Neurosurgery | Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Achievement rate of twice-daily early mobilization in the intervention group
Key secondary outcomes
Incidence of symptomatic cerebral vasospasm (SCV)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University
Division name
Graduate School of Health Sciences
Zip code
113-0033
Address
3-2-12 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
te-takahashi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Oike |
Organization
Tsuchiura Kyodo General Hospital
Division name
Department of Rehabilitation
Zip code
300-0028
Address
4-1-1, Otsuno, Tsuchiura, Ibaraki
TEL
029-830-3711
Homepage URL
ek296988@yahoo.co.jp
Sponsor or person
Institute
Department of Rehabilitation, Tsuchiura Kyodo General Hospital
Institute
Department
Personal name
Kenji Oike
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsuchiura Kyodo General Hospital
Address
4-1-1, Otsuno, Tsuchiura, Ibaraki
Tel
029-830-3711
rehabilitaion@tkgh.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
| 2028 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 06 | Day |
Last modified on
| 2026 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070501
