The Investigation of the Impact of Early Mobilization on the Outcome in Patients With Aneurysmal Subarachnoid Hemorrhage.

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06436508
• Other study ID #: HunSAHEMob
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2024
• Source: University of Pecs
• Contact: Peter Csecsei, MD. PhD
• Phone: +0672535900
• Email: csecsei.peter[@]pte.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2026
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Early Ambulation
• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Intervention

Behavioral:
• Early mobilization protocol
Step 1 - Day 1: Bed rest, elevation of the head end to 30° Step 2 - Day 2: Bed rest, elevation of the head end to 60° Step 3 - Day 3: Bed rest, elevation of the head end to 80° Step 4 - Day 4: Sitting on the edge of the bed Step 5 - Day 5: Sitting in a chair, standing up Step 6 - Day 6: Walking with or without assistance Step 7 - Day 7: Walking with or without assistance from today
• Standard care
During standard care, early mobilization does not take place in the intensive care unit; the patient receives only standard supportive care in bed rest.

Locations

Country	Name	City	State
Hungary	National Institute of Mental Health, Neurology, and Neurosurgery	Budapest
Hungary	Central Hospital of B.A.Z. County	Miskolc	BAZ
Hungary	University of Pecs	Pécs	Baranya

Sponsors (3)

Lead Sponsor	Collaborator
University of Pecs	Borsod-Abaúj-Zemplén County Central Hospital and University Teaching Hospital, National Institute of Mental, Neurological and Neurosurgery

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability in early mobilization group (EM) vs. standard care group (SC) - modified Rankin score	Outcome assessments will include: Modified Rankin Scale; Disability is assessed by the modified Rankin Scale, dichotomized at a score of 0 to 3 versus 4 to 6 (6=death).Assessment is performed by a blinded investigator of the local study center by personal visit.	14 day; 3 months
Primary	Disability in early mobilization group (EM) vs. standard care group (SC) - Extended Glasgow Outcome Scale	Extended Glasgow Outcome Scale; Description of the neurological outcome by using extended Glasgow Outcome Score; Death; Vegetative sate; Lower severe disability; Upper severe disability; Lower moderate disability; Upper moderate disability; Lower good recovery; Upper good recovery; Assessment is performed by a blinded investigator of the local study center by personal visit.	14 day; 3 months
Secondary	Onset of delayed cerebral ischemia (DCI)	Occurence of DCI after aneurysmal subarachnoid hemorrhage	3-21 days
Secondary	Onset of severity of macrovascular vasospasm	based on cerebral vasospasm grade; Grade 0 All intracranial vessels show a physiological shape Grade 1 Vasospasm affects the A2, A1, and M2 segments Grade 2 Vasospasm expands to the M1 and terminal segment of the internal carotid artery Grade 3 Severe reduction in the intradural internal carotid artery with filiform A1 and M1 segments, which sometimes appears like a ghost (ghost sign)	Up to 14 days
Secondary	Stay in the Intensive Care Unit (ICU)	Length of stay in the Intensive Care Unit (ICU)	Up to 28 days
Secondary	Type of post-hospital discharge placement	home discharge, rehabilitation, chronic care, etc.	Up to 30 days
Secondary	Readmission to the ICU	repeated ICU treatment following ward discharge	Up to 30 days
Secondary	Occurrence of infection and its time in the intensive care unit	infection and its time in the intensive care unit	Up to 30 days
Secondary	Barthel score	For assessing activities of daily living in patients with aneurysmal subarachnoid hemorrhage; ordinal scale rates bowel function, bladder function, grooming, toilet use, feeding independence, transfer independence, mobility, dressing ability, stair use, and bathing ability to tabulate a composite score ranging from 0 to 100. Score of 100 represents totally independent.; Assessment is performed by a blinded investigator of the local study center by personal visit.	14 day; 3 months
Secondary	Functional Independence Measure (FIM) scale	The FIM's assessment of degree of disability depends on the patient's score in 18 categories, focusing on motor and cognitive function. Each category or item is rated on a 7-point scale (1 = <25% independence; total assistance required, 7 = 100% independence); Assessment is performed by a blinded investigator of the local study center by personal visit.	14 day
Secondary	Montreal Cognitive Assessment (MoCA)	MoCA scores range between 0 and 30.; The MoCA is used for assessment for detecting cognitive impairment. A score of 26 or over is considered to be normal.; Assessment is performed by a blinded investigator of the local study center by personal visit.	14 day; 3 months
Secondary	Hospital Anxiety and Depression Scale (HADS)	Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.; Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case.; Assessment is performed by a blinded investigator of the local study center by personal visit.	14 day; 3 months