Clinical trial NCT02675985: Early Intensive Physical Therapy in Subarachnoid Hemorrhage
Official title: Effects of Early Intensive Physical Therapy for Patients With Subarachnoid Hemorrhage in a Neurological ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subarachnoid Hemorrhage
Keywords: Physical Therapy, early intervention
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety and feasibility of early intensive physical therapy for patients diagnosed with subarachnoid hemorrhage. Intervention will begin in the neurological Intensive Care Unit (ICU) and continue for 30 days or hospital discharge.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed by CT scan or MRI with subarachnoid hemorrhage and admitted to the neurological ICU \>48 hours.

Exclusion Criteria:

* Significant language barrier that would limit the ability to participate in the physical therapy program
* Severe baseline physical or cognitive impairment that would impair their ability to participate in the protocol
* Patients whose vital signs are outside the accepted starting and stopping criteria outlined below:

  1. intracranial pressure ≤ 15 mm Hg
  2. Cerebral perfusion pressure \>50 or \<70 mm Hg
  3. Mean arterial pressure ≥ 80 and ≤ 110
  4. Heart rate ≥40 and \<140 bpm
  5. Pulse oximetry \>88%

Primary outcomes:
measure: Improvement in Physical function in the ICU test (PFit)
timeFrame: Every 7 days until hospital discharge or 28 days of study enrollment
Secondary outcomes:
measure: Improvement in Activity Measure for Post-Acute Care (AM-PAC) mobility
timeFrame: Every 7 days until hospital discharge or 28 days of study enrollment
measure: Improvement in Timed up and Go (TUG)
timeFrame: Every 7 days until hospital discharge or 28 days of study enrollment
measure: Improvement in Postural Assessment Scale for Stroke Patients
timeFrame: Every 7 days until hospital discharge or 28 days of study enrollment
measure: Improvement in Medical Research Council (MRC) Muscle Sum Score
timeFrame: Every 7 days until hospital discharge or 28 days of study enrollment
measure: Improvement in Hand grip strength
timeFrame: Every 7 days until hospital discharge or 28 days of study enrollment
Other outcomes:
measure: Neuro-Quality of Life (QOL)
timeFrame: Hospital Discharge only
Locations:
city: Aurora
country: United States
facility: UCH
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Amy J Nordon-Craft
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moss M, Nordon-Craft A, Malone D, Van Pelt D, Frankel SK, Warner ML, Kriekels W, McNulty M, Fairclough DL, Schenkman M. A Randomized Trial of an Intensive Physical Therapy Program for Patients with Acute Respiratory Failure. Am J Respir Crit Care Med. 2016 May 15;193(10):1101-10. doi: 10.1164/rccm.201505-1039OC.
citation: Sottile PD, Nordon-Craft A, Malone D, Schenkman M, Moss M. Patient and family perceptions of physical therapy in the medical intensive care unit. J Crit Care. 2015 Oct;30(5):891-5. doi: 10.1016/j.jcrc.2015.04.119. Epub 2015 May 8.
citation: Denehy L, Nordon-Craft A, Edbrooke L, Malone D, Berney S, Schenkman M, Moss M. Outcome measures report different aspects of patient function three months following critical care. Intensive Care Med. 2014 Dec;40(12):1862-9. doi: 10.1007/s00134-014-3513-3. Epub 2014 Oct 16.
citation: Nordon-Craft A, Schenkman M, Ridgeway K, Benson A, Moss M. Physical therapy management and patient outcomes following ICU-acquired weakness: a case series. J Neurol Phys Ther. 2011 Sep;35(3):133-40. doi: 10.1097/NPT.0b013e3182275905.
citation: Olkowski BF, Devine MA, Slotnick LE, Veznedaroglu E, Liebman KM, Arcaro ML, Binning MJ. Safety and feasibility of an early mobilization program for patients with aneurysmal subarachnoid hemorrhage. Phys Ther. 2013 Feb;93(2):208-15. doi: 10.2522/ptj.20110334. Epub 2012 May 31.