## Protocol Section
### Identification Module
**NCT ID:** NCT06436508

**Brief Title:** 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.

#### Organization Study ID Info
**ID:** HunSAHEMob
#### Organization
**Class:** OTHER
**Full Name:** University of Pecs
### Status Module
#### Completion Date
**Date:** 2026-03-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-01-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-06-14

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-02-27
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** National Institute of Mental, Neurological and Neurosurgery

**Class:** UNKNOWN

**Name:** Borsod-Abaúj-Zemplén County Central Hospital and University Teaching Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Pecs

#### Responsible Party

**Investigator Affiliation:** University of Pecs

**Investigator Full Name:** Péter Csécsei

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Early Ambulation

- Standard of Care

- Subarachnoid Hemorrhage, Aneurysmal

**Keywords:**

- subarachnoid hemorrhage

- early mobilization

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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

**Intervention Names:**

- Behavioral: Early mobilization protocol

**Label:** Early mobilization

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** No early mobilization

**Intervention Names:**

- Behavioral: Standard care

**Label:** Standard bed rest

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Early mobilization

**Description:** * 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

**Name:** Early mobilization protocol

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Standard bed rest

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

**Name:** Standard care

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Disability in early mobilization group (EM) vs. standard care group (SC) - modified Rankin score

**Time Frame:** 14 day; 3 months

**Description:** 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.

**Measure:** Disability in early mobilization group (EM) vs. standard care group (SC) - Extended Glasgow Outcome Scale

**Time Frame:** 14 day; 3 months

#### Secondary Outcomes

**Description:** Occurence of DCI after aneurysmal subarachnoid hemorrhage

**Measure:** Onset of delayed cerebral ischemia (DCI)

**Time Frame:** 3-21 days

**Description:** 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)

**Measure:** Onset of severity of macrovascular vasospasm

**Time Frame:** Up to 14 days

**Description:** Length of stay in the Intensive Care Unit (ICU)

**Measure:** Stay in the Intensive Care Unit (ICU)

**Time Frame:** Up to 28 days

**Description:** home discharge, rehabilitation, chronic care, etc.

**Measure:** Type of post-hospital discharge placement

**Time Frame:** Up to 30 days

**Description:** repeated ICU treatment following ward discharge

**Measure:** Readmission to the ICU

**Time Frame:** Up to 30 days

**Description:** infection and its time in the intensive care unit

**Measure:** Occurrence of infection and its time in the intensive care unit

**Time Frame:** Up to 30 days

**Description:** 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.

**Measure:** Barthel score

**Time Frame:** 14 day; 3 months

**Description:** 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.

**Measure:** Functional Independence Measure (FIM) scale

**Time Frame:** 14 day

**Description:** 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.

**Measure:** Montreal Cognitive Assessment (MoCA)

**Time Frame:** 14 day; 3 months

**Description:** 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.

**Measure:** Hospital Anxiety and Depression Scale (HADS)

**Time Frame:** 14 day; 3 months

### Eligibility Module

**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)

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** csecsei.peter@pte.hu

**Name:** Peter Csecsei, MD. PhD

**Phone:** +0672535900

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Pécs

**Contacts:**

***Contact 1:***

- **Name:** Peter Csecsei, MD. PhD

- **Role:** CONTACT

**Country:** Hungary

**Facility:** University of Pecs

**State:** Baranya

**Status:** RECRUITING

**Zip:** 7624

**Location 2:**

**City:** Miskolc

**Contacts:**

***Contact 1:***

- **Name:** Csaba Olah, MD. PhD

- **Role:** CONTACT

**Country:** Hungary

**Facility:** Central Hospital of B.A.Z. County

**State:** BAZ

**Status:** RECRUITING

**Zip:** 3526

**Location 3:**

**City:** Budapest

**Contacts:**

***Contact 1:***

- **Name:** Sandor Nardai, MD. PhD

- **Role:** CONTACT

**Country:** Hungary

**Facility:** National Institute of Mental Health, Neurology, and Neurosurgery

**Status:** RECRUITING

**Zip:** 1145

#### Overall Officials

**Official 1:**

**Affiliation:** University of Pecs

**Name:** Peter Csecsei, MD. PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** upon reasonable request

**Description:** Investigators will use external resources for an appropriate repository for their data

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

**Time Frame:** After study completion for 3 years.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020300

- Term: Intracranial Hemorrhages

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: HIGH

- As Found: Hemorrhage

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M16135

- Name: Subarachnoid Hemorrhage

- Relevance: HIGH

- As Found: Subarachnoid Hemorrhage

- ID: M22113

- Name: Intracranial Hemorrhages

- Relevance: LOW

- As Found: Unknown

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013345

- Term: Subarachnoid Hemorrhage

- ID: D000006470

- Term: Hemorrhage

### Misc Info Module

- Version Holder: 2024-05-31
