Early Ambulation, Standard of Care, Subarachnoid Hemorrhage, Aneurysmal
Conditions
Keywords
subarachnoid hemorrhage, early mobilization
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.
Interventions
BEHAVIORALEarly 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
BEHAVIORALStandard 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.
Sponsors
National Institute of Mental, Neurological and Neurosurgery
Borsod-Abaúj-Zemplén County Central Hospital and University Teaching Hospital
University of Pecs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability in early mobilization group (EM) vs. standard care group (SC) - modified Rankin score | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stay in the Intensive Care Unit (ICU) | Up to 28 days | Length of stay in the Intensive Care Unit (ICU) |
| Type of post-hospital discharge placement | Up to 30 days | home discharge, rehabilitation, chronic care, etc. |
| Readmission to the ICU | Up to 30 days | repeated ICU treatment following ward discharge |
| Occurrence of infection and its time in the intensive care unit | Up to 30 days | infection and its time in the intensive care unit |
| Onset of delayed cerebral ischemia (DCI) | 3-21 days | Occurence of DCI after aneurysmal subarachnoid hemorrhage |
| Functional Independence Measure (FIM) scale | 14 day | 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. |
| Montreal Cognitive Assessment (MoCA) | 14 day; 3 months | 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. |
| Hospital Anxiety and Depression Scale (HADS) | 14 day; 3 months | 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. |
| Barthel score | 14 day; 3 months | 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. |
| Onset of severity of macrovascular vasospasm | Up to 14 days | 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) |
Countries
Hungary
Contacts
Primary ContactPeter Csecsei, MD. PhD
Outcome results
None listed