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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-14

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Early Ambulation Standard of Care Subarachnoid Hemorrhage, Aneurysmal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early mobilization

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

Group Type EXPERIMENTAL

Early mobilization protocol

Intervention Type BEHAVIORAL

* 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

No early mobilization

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type BEHAVIORAL

During standard care, early mobilization does not take place in the intensive care unit; the patient receives only standard supportive care in bed rest.

Interventions

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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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No