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

Not Applicable

Recruiting

• Conditions: Early Ambulation; Standard of Care; Subarachnoid Hemorrhage, Aneurysmal
• Interventions: Behavioral: Early mobilization protocol; Behavioral: Standard care

• Registration Number: NCT06436508
• Lead Sponsor: University of Pecs

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-14
• Study First Submitted: 2024-02-27
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-05-30
• Study First Posted: 2024-05-31
• Last Update Posted: 2024-05-31
• Primary Completion: 2025-01-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early mobilization	Early mobilization protocol	This group is mobilized in the intensive care unit by the institutional physiotherapist with the assistance of specialized personnel. Mobilization is carried out according to the Early Mobilization Protocol (EMP) 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 bed rest	Standard care	No early mobilization

Primary Outcome Measures

Name	Time	Method
Disability in early mobilization group (EM) vs. standard care group (SC) - Extended Glasgow Outcome Scale	14 day; 3 months	Extended Glasgow Outcome Scale; Description of the neurological outcome by using extended Glasgow Outcome Score; 1. Death; 2. Vegetative sate; 3. Lower severe disability; 4. Upper severe disability; 5. Lower moderate disability; 6. Upper moderate disability; 7. Lower good recovery; 8. Upper good recovery; Assessment is performed by a blinded investigator of the local study center by personal visit.
Disability in early mobilization group (EM) vs. standard care group (SC) - modified Rankin score	14 day; 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Occurrence of infection and its time in the intensive care unit	Up to 30 days	infection and its time in the intensive care unit
Readmission to the ICU	Up to 30 days	repeated ICU treatment following ward discharge
Onset of delayed cerebral ischemia (DCI)	3-21 days	Occurence of DCI after aneurysmal subarachnoid hemorrhage
Type of post-hospital discharge placement	Up to 30 days	home discharge, rehabilitation, chronic care, etc.
Onset of severity of macrovascular vasospasm	Up to 14 days	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)
Stay in the Intensive Care Unit (ICU)	Up to 28 days	Length of stay in the Intensive Care Unit (ICU)
Barthel score	14 day; 3 months	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.
Montreal Cognitive Assessment (MoCA)	14 day; 3 months	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.
Functional Independence Measure (FIM) scale	14 day	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.
Hospital Anxiety and Depression Scale (HADS)	14 day; 3 months	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.

Trial Locations

Locations (3)

University of Pecs; 🇭🇺 Pécs, Baranya, Hungary

Central Hospital of B.A.Z. County; 🇭🇺 Miskolc, BAZ, Hungary

National Institute of Mental Health, Neurology, and Neurosurgery; 🇭🇺 Budapest, Hungary