Back to resultsEarly Intensive Physical Therapy in Subarachnoid Hemorrhage
Primary Purpose
Subarachnoid Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Subarachnoid Hemorrhage focused on measuring Physical Therapy, early intervention
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:
- intracranial pressure ≤ 15 mm Hg
- Cerebral perfusion pressure >50 or <70 mm Hg
- Mean arterial pressure ≥ 80 and ≤ 110
- Heart rate ≥40 and <140 bpm
- Pulse oximetry >88%
Sites / Locations
- UCH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention arm
Arm Description
Early intensive physical therapy will be the intervention arm. There is not a control group.
Outcomes
Primary Outcome Measures
Improvement in Physical function in the ICU test (PFit)
Secondary Outcome Measures
Improvement in Activity Measure for Post-Acute Care (AM-PAC) mobility
Improvement in Timed up and Go (TUG)
Improvement in Postural Assessment Scale for Stroke Patients
Improvement in Medical Research Council (MRC) Muscle Sum Score
Improvement in Hand grip strength
Full Information
NCT ID
NCT02675985
First Posted
February 2, 2016
Last Updated
June 25, 2021
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT02675985
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
November 14, 2017 (Actual)
Study Completion Date
November 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage
Keywords
Physical Therapy, early intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Early intensive physical therapy will be the intervention arm. There is not a control group.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
Early Intensive Physical therapy in the ICU
Primary Outcome Measure Information:
Title
Improvement in Physical function in the ICU test (PFit)
Time Frame
Every 7 days until hospital discharge or 28 days of study enrollment
Secondary Outcome Measure Information:
Title
Improvement in Activity Measure for Post-Acute Care (AM-PAC) mobility
Time Frame
Every 7 days until hospital discharge or 28 days of study enrollment
Title
Improvement in Timed up and Go (TUG)
Time Frame
Every 7 days until hospital discharge or 28 days of study enrollment
Title
Improvement in Postural Assessment Scale for Stroke Patients
Time Frame
Every 7 days until hospital discharge or 28 days of study enrollment
Title
Improvement in Medical Research Council (MRC) Muscle Sum Score
Time Frame
Every 7 days until hospital discharge or 28 days of study enrollment
Title
Improvement in Hand grip strength
Time Frame
Every 7 days until hospital discharge or 28 days of study enrollment
Other Pre-specified Outcome Measures:
Title
Neuro-Quality of Life (QOL)
Description
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.
Time Frame
Hospital Discharge only
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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:
intracranial pressure ≤ 15 mm Hg
Cerebral perfusion pressure >50 or <70 mm Hg
Mean arterial pressure ≥ 80 and ≤ 110
Heart rate ≥40 and <140 bpm
Pulse oximetry >88%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy J Nordon-Craft
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCH
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80020
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26651376
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.
Results Reference
background
PubMed Identifier
26038155
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.
Results Reference
background
PubMed Identifier
25319384
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.
Results Reference
background
PubMed Identifier
21934375
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.
Results Reference
background
PubMed Identifier
22652987
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.
Results Reference
background
Learn more about this trial
Early Intensive Physical Therapy in Subarachnoid Hemorrhage
We'll reach out to this number within 24 hrs