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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Subarachnoid Hemorrhage, Aneurysmal; Early Ambulation; Standard of Care
• Intervention / Treatment: Behavioral: Early mobilization protocol; Behavioral: Standard care

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Csecsei, MD. PhD; Phone Number: +0672535900; Email: csecsei.peter@pte.hu

Study Locations

• Hungary
  • Budapest, Hungary, 1145
    • Recruiting
    • National Institute of Mental Health, Neurology, and Neurosurgery
    • Contact: Sandor Nardai, MD. PhD
  • BAZ
    • Miskolc, BAZ, Hungary, 3526
      • Recruiting
      • Central Hospital of B.A.Z. County
      • Contact: Csaba Olah, MD. PhD
  • Baranya
    • Pécs, Baranya, Hungary, 7624
      • Recruiting
      • University of Pecs
      • Contact: Peter Csecsei, MD. PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Active Comparator: Standard bed rest; No early mobilization	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of delayed cerebral ischemia (DCI)	Occurence of DCI after aneurysmal subarachnoid hemorrhage	3-21 days
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
Stay in the Intensive Care Unit (ICU)	Length of stay in the Intensive Care Unit (ICU)	Up to 28 days
Type of post-hospital discharge placement	home discharge, rehabilitation, chronic care, etc.	Up to 30 days
Readmission to the ICU	repeated ICU treatment following ward discharge	Up to 30 days
Occurrence of infection and its time in the intensive care unit	infection and its time in the intensive care unit	Up to 30 days
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Pecs
• Collaborators: National Institute of Mental, Neurological and Neurosurgery; Borsod-Abaúj-Zemplén County Central Hospital and University Teaching Hospital
• Investigators: Principal Investigator: Peter Csecsei, MD. PhD, University of Pecs

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: subarachnoid hemorrhage; early mobilization
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: HunSAHEMob

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Investigators will use external resources for an appropriate repository for their data
• IPD Sharing Time Frame: After study completion for 3 years.
• IPD Sharing Access Criteria: upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No