Clinical trial NCT01656317: Rehabilitation of Patients After Subarachnoid Hemorrhage
Official title: Effect of Early Rehabilitation in Patients With Acute Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SAH
Keywords: SAH
Early rehabilitation
Mobilisation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2012-08-02
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study's main objective will be to assess which effect early initiated rehabilitation has on the frequency of complications and the level of physical and cognitive functioning after aneurysmal subarachnoid hemorrhage (SAH).

To this end the following aspects will be investigated:

The frequency of complications (with special emphasis on pulmonary complications,thromboembolic events, cerebral vasospasm, unintended discontinuation of drains and lines)

* Length of stay in hospitals and socio-economic impact
* Physical and cognitive function in the early and chronic phase after SAH
* Health-related quality of life and participation in society in the chronic phase

Detailed description: Oslo University Hospital (OUS) is the primary hospital for Health Region South-East regarding treatment of patients with SAH. Approximately 120 patients are referred annually. OUS,Rikshospitalet, Dept of Neurosurgery offers 24/7 service of surgical and vascular aneurysm repair performed by a dedicated vascular team.

Patients admitted in 2012 are treated in accordance to the standard institutional protocol plus an early rehabilitation model adapted to SAH, while patients admitted in 2011 who did not receive any early rehabilitation, but apart from that were treated identically, serve as a control group.

All patients admitted to the intermediate unit at OUS in 2011 and 2012 with aneurysmal SAH and repaired aneurysm will be invited to participate in this study. Examination of the patients from both 2011 and 2012 will be performed as part of routine, neurosurgical follow- up which is in the early phase at 3-6 months and in the chronic phase at least 12 months post SAH. Exclusion criteria for participation in the study: unsecured ruptured aneurysm, symptomatic aneurysm without rupture, previous SAH or brain injury, diagnosis of a neurodegenerative disorder, patients from other health regions or tourists, patients that were treated at the intensive care unit (ICU )only.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to the intermediate unit at OUS in 2011 and 2012 with aneurysmal SAH and repaired aneurysm will be invited to participate in this study.

Exclusion Criteria:

* Unsecured ruptured aneurysm,
* Symptomatic aneurysm without rupture
* Previous SAH or brain injury, diagnosis of a neurodegenerative disorder
* Patients from other health regions or tourists
* Patients that were treated at the intensive care unit (ICU )only.

Primary outcomes:
measure: Glasgow Coma Scale (GCS)
timeFrame: up to 10 weeks
Secondary outcomes:
measure: Glasgow Outcome Scale Extended (GOSE)
timeFrame: 3-6 months and 12 months after SAH
measure: Functional Independence Measure (FIM)
timeFrame: 3-6 months and 12 months after SAH
measure: Coma Recovery Scale (CRS)
timeFrame: 3-6 and 12 months after SAH
measure: Disability Rating Scale (DRS)
timeFrame: 3-6 and 12 months after SAH
measure: High Level Mobility Assessment Tool (HIMAT)
timeFrame: 3-6 and 12 months after SAH
Other outcomes:
measure: Pain score on the Visual Analog Scale
timeFrame: 3-6 and 12 months after SAH
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Tanja Karic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karic T, Roe C, Nordenmark TH, Becker F, Sorteberg W, Sorteberg A. Effect of early mobilization and rehabilitation on complications in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2017 Feb;126(2):518-526. doi: 10.3171/2015.12.JNS151744. Epub 2016 Apr 8.