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

University of Pecs

Status: Enrolling

Conditions: Standard of Care; Subarachnoid Hemorrhage, Aneurysmal; Early Ambulation

Treatments: Behavioral: Early mobilization protocol; Behavioral: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT06436508

HunSAHEMob

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Early mobilization

Experimental group

Description:

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

Treatment:

Behavioral: Early mobilization protocol

Standard bed rest

Active Comparator group

Description:

No early mobilization

Treatment:

Behavioral: Standard care