- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02675985
Early Intensive Physical Therapy in Subarachnoid Hemorrhage
June 25, 2021 updated by: University of Colorado, Denver
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Aurora, Colorado, United States, 80020
- UCH
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 83 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:
- 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%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
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Early Intensive Physical therapy in the ICU
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in Physical function in the ICU test (PFit)
Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment
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Every 7 days until hospital discharge or 28 days of study enrollment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Every 7 days until hospital discharge or 28 days of study enrollment
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Improvement in Timed up and Go (TUG)
Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment
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Every 7 days until hospital discharge or 28 days of study enrollment
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Improvement in Postural Assessment Scale for Stroke Patients
Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment
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Every 7 days until hospital discharge or 28 days of study enrollment
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Improvement in Medical Research Council (MRC) Muscle Sum Score
Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment
|
Every 7 days until hospital discharge or 28 days of study enrollment
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Improvement in Hand grip strength
Time Frame: Every 7 days until hospital discharge or 28 days of study enrollment
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Every 7 days until hospital discharge or 28 days of study enrollment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuro-Quality of Life (QOL)
Time Frame: Hospital Discharge only
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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.
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Hospital Discharge only
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amy J Nordon-Craft, University of Colorado, Denver
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-0829
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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