Early AmbulationNCT06436508
The Investigation of the Impact of Early Mobilization on the Outcome in Patients With Aneurysmal Subarachnoid Hemorrhage.
A study testing Early mobilization protocol in people with Early Ambulation and Standard of Care, run by University of Pecs at 3 sites in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Early Ambulation, Standard of Care, Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- Early mobilization protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesHungary
- Study dates
- 14 Jun 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Hungary3 sites, 3 recruiting
- Recruiting
National Institute of Mental Health, Neurology, and Neurosurgery
Budapest, 1145
Sandor Nardai, MD. PhD
- Recruiting
Central Hospital of B.A.Z. County
Miskolc, BAZ, 3526
Csaba Olah, MD. PhD
- Recruiting
University of Pecs
Pécs, Baranya, 7624
Peter Csecsei, MD. PhD
About this study
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.
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.
- Being tested
- Early mobilization protocol, Standard care
- Keywords
- subarachnoid hemorrhage, early mobilization
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilization protocolBehavioural
- 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 careBehavioural
During standard care, early mobilization does not take place in the intensive care unit; the patient receives only standard supportive care in bed rest.
| Study group | Role | What they receive |
|---|---|---|
| Early mobilization | Experimental | 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 Receives: Behavioral: Early mobilization protocol |
| Standard bed rest | Active comparator | No early mobilization Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 day; 3 months
Secondary outcomes (10)
Onset of delayed cerebral ischemia (DCI)
Occurence of DCI after aneurysmal subarachnoid hemorrhage
Measured: 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)
Measured: Up to 14 days
Stay in the Intensive Care Unit (ICU)
Length of stay in the Intensive Care Unit (ICU)
Measured: Up to 28 days
Type of post-hospital discharge placement
home discharge, rehabilitation, chronic care, etc.
Measured: Up to 30 days
Readmission to the ICU
repeated ICU treatment following ward discharge
Measured: Up to 30 days
Occurrence of infection and its time in the intensive care unit
infection and its time in the intensive care unit
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 day; 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start14 Jun 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early AmbulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental, Neurological and Neurosurgery, Borsod-Abaúj-Zemplén County Central Hospital and University Teaching Hospital
- Responsible party
- Principal investigator, Péter Csécsei, University of Pecs
- Investigators
- Peter Csecsei, MD. PhD, Principal investigator, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436508
- Sponsor's protocol ID
- HunSAHEMob
- Status last verified
- May 2024
- First submitted
- 27 Feb 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will use external resources for an appropriate repository for their data
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06436508
- Acronym / sponsor ID
- HunSAHEMob
- Keywords
- subarachnoid hemorrhage, early mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Collaborators
- National Institute of Mental, Neurological and Neurosurgery, Borsod-Abaúj-Zemplén County Central Hospital and University Teaching Hospital
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early mobilization | Experimental | Behavioral: Early mobilization protocolThis 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 | Active comparator | Behavioral: Standard careNo early mobilization |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- Age under 18 years
- Traumatic subarachnoid hemorrhage
- Incapacitated or limited capacity for action before ictus
- Confirmed pregnancy
- Aneurysm multiplicity (unless all aneurysms are treated)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Early mobilization |
| Standard careDuring standard care, early mobilization does not take place in the intensive care unit; the patient receives only standard supportive care in bed rest. | Behavioural | Standard bed rest |
Primary outcome
Disability in early mobilization group (EM) vs. standard care group (SC) - modified Rankin score
Time frame: 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.
Disability in early mobilization group (EM) vs. standard care group (SC) - Extended Glasgow Outcome Scale
Time frame: 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.
10 secondary outcomes
Onset of delayed cerebral ischemia (DCI)
Time frame: 3-21 days
Onset of severity of macrovascular vasospasm
Time frame: Up to 14 days
Stay in the Intensive Care Unit (ICU)
Time frame: Up to 28 days
Type of post-hospital discharge placement
Time frame: Up to 30 days
Readmission to the ICU
Time frame: Up to 30 days
Occurrence of infection and its time in the intensive care unit
Time frame: Up to 30 days
Barthel score
Time frame: 14 day; 3 months
Functional Independence Measure (FIM) scale
Time frame: 14 day
Montreal Cognitive Assessment (MoCA)
Time frame: 14 day; 3 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: 14 day; 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: Yes. Investigators will use external resources for an appropriate repository for their data
Related trials for Early Ambulation
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RecruitingObservational study
Dosage of Early Rehabilitation of ICU Patients
Critical Care, Intensive Care, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Csecsei, MD. PhD principal investigator
University of Pecs
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early mobilization protocol in people with Early Ambulation and Standard of Care, run by University of Pecs at 3 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Csecsei, MD. PhD (+0672535900, csecsei.peter@pte.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability in early mobilization group (EM) vs. standard care group (SC) - modified Rankin score (time frame: 14 day; 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.