Clinical trial NCT06436508: The Investigation of the Impact of Early Mobilization on the Outcome in Patients With Aneurysmal Subarachnoid Hemorrhage.
Official title: The Investigation of the Impact of Early Mobilization on the Outcome, the Appearance of Early Ischemic Damage, the Functional Status, and the Length of Intensive Care Treatment in Patients With Aneurysmal Subarachnoid Hemorrhage.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Ambulation
Standard of Care
Subarachnoid Hemorrhage, Aneurysmal
Keywords: subarachnoid hemorrhage
early mobilization
Lead sponsor: University of Pecs
Sponsor class: OTHER
Collaborators: name: National Institute of Mental, Neurological and Neurosurgery
name: Borsod-Abaúj-Zemplén County Central Hospital and University Teaching Hospital
First posted: 2024-05-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the randomized clinical trial is to examine the effect of early mobilization on primary and secondary outcomes in patients with subarachnoid hemorrhage caused by aneurysm rupture.

Researchers will compare early mobiliziation vs. standrad bed rest care.


Eligibility criteria: Inclusion Criteria:

* Age \>18 ys
* Premorbid modified Rankin Scale score of 0-2
* WFNS I-IV at enrollment
* Aneurysm occlusion has occurred through open or endovascular means
* Minimum 24 hours elapsed after aneurysm occlusion
* The patient has not received thrombolytic therapy
* Vital parameters are appropriate (mean arterial pressure \[MAP\] \>80 or \>110 mm Hg)
* Signed patient information and consent form
* Enrollment occurs within 72 hours following ictus

Exclusion Criteria:

* Age under 18 years
* Traumatic subarachnoid hemorrhage
* Incapacitated or limited capacity for action before ictus
* Confirmed pregnancy
* Aneurysm multiplicity (unless all aneurysms are treated)

Primary outcomes:
measure: Disability in early mobilization group (EM) vs. standard care group (SC) - modified Rankin score
timeFrame: 14 day; 3 months
measure: Disability in early mobilization group (EM) vs. standard care group (SC) - Extended Glasgow Outcome Scale
timeFrame: 14 day; 3 months
Secondary outcomes:
measure: Onset of delayed cerebral ischemia (DCI)
timeFrame: 3-21 days
measure: Onset of severity of macrovascular vasospasm
timeFrame: Up to 14 days
measure: Stay in the Intensive Care Unit (ICU)
timeFrame: Up to 28 days
measure: Type of post-hospital discharge placement
timeFrame: Up to 30 days
measure: Readmission to the ICU
timeFrame: Up to 30 days
measure: Occurrence of infection and its time in the intensive care unit
timeFrame: Up to 30 days
measure: Barthel score
timeFrame: 14 day; 3 months
measure: Functional Independence Measure (FIM) scale
timeFrame: 14 day
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 14 day; 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 14 day; 3 months
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pecs
state: Baranya
city: Miskolc
country: Hungary
facility: Central Hospital of B.A.Z. County
state: BAZ
city: Budapest
country: Hungary
facility: National Institute of Mental Health, Neurology, and Neurosurgery
Study officials:
affiliation: University of Pecs
name: Peter Csecsei, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: