Early Intensive Physical Therapy in Subarachnoid Hemorrhage

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

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.

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage
• Intervention / Treatment: Other: Physical Therapy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80020
      • UCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Early intensive physical therapy will be the intervention arm. There is not a control group.	Other: Physical Therapy; Early Intensive Physical therapy in the ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in Physical function in the ICU test (PFit)	Every 7 days until hospital discharge or 28 days of study enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement in Activity Measure for Post-Acute Care (AM-PAC) mobility	Every 7 days until hospital discharge or 28 days of study enrollment
Improvement in Timed up and Go (TUG)	Every 7 days until hospital discharge or 28 days of study enrollment
Improvement in Postural Assessment Scale for Stroke Patients	Every 7 days until hospital discharge or 28 days of study enrollment
Improvement in Medical Research Council (MRC) Muscle Sum Score	Every 7 days until hospital discharge or 28 days of study enrollment
Improvement in Hand grip strength	Every 7 days until hospital discharge or 28 days of study enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Amy J Nordon-Craft, University of Colorado, Denver

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): November 14, 2017
• Study Completion (Actual): November 14, 2017

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Physical Therapy, early intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: 15-0829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No