Early Intensive Physical Therapy in Subarachnoid Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

Official title:

Effects of Early Intensive Physical Therapy for Patients With Subarachnoid Hemorrhage in a Neurological ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675985
• Other study ID #: 15-0829
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: November 14, 2017

Study information

• Verified date: June 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 14, 2017
• Est. primary completion date: November 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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%

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Other:
• Physical Therapy
Early Intensive Physical therapy in the ICU

Locations

Country	Name	City	State
United States	UCH	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neuro-Quality of Life (QOL)	Neuro-QOL measures 17 domains of health related quality of life for adults through self-report.. We will use the short form versions for applied cognition, lower extremity mobility and Upper extremity function and Satisfaction with social roles/activities.	Hospital Discharge only
Primary	Improvement in Physical function in the ICU test (PFit)		Every 7 days until hospital discharge or 28 days of study enrollment
Secondary	Improvement in Activity Measure for Post-Acute Care (AM-PAC) mobility		Every 7 days until hospital discharge or 28 days of study enrollment
Secondary	Improvement in Timed up and Go (TUG)		Every 7 days until hospital discharge or 28 days of study enrollment
Secondary	Improvement in Postural Assessment Scale for Stroke Patients		Every 7 days until hospital discharge or 28 days of study enrollment
Secondary	Improvement in Medical Research Council (MRC) Muscle Sum Score		Every 7 days until hospital discharge or 28 days of study enrollment
Secondary	Improvement in Hand grip strength		Every 7 days until hospital discharge or 28 days of study enrollment