Subarachnoid HemorrhageNCT02675985
Early Intensive Physical Therapy in Subarachnoid Hemorrhage
A study testing Physical Therapy in people with Subarachnoid Hemorrhage, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 14 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed by CT scan or MRI with subarachnoid hemorrhage and admitted to the neurological ICU >48 hours.
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Physical Therapy
- Keywords
- Physical Therapy, early intervention
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Early Intensive Physical therapy in the ICU
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Early intensive physical therapy will be the intervention arm. There is not a control group. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Physical function in the ICU test (PFit)
Measured: Every 7 days until hospital discharge or 28 days of study enrollment
Secondary outcomes (5)
Improvement in Activity Measure for Post-Acute Care (AM-PAC) mobility
Measured: Every 7 days until hospital discharge or 28 days of study enrollment
Improvement in Timed up and Go (TUG)
Measured: Every 7 days until hospital discharge or 28 days of study enrollment
Improvement in Postural Assessment Scale for Stroke Patients
Measured: Every 7 days until hospital discharge or 28 days of study enrollment
Improvement in Medical Research Council (MRC) Muscle Sum Score
Measured: Every 7 days until hospital discharge or 28 days of study enrollment
Improvement in Hand grip strength
Measured: Every 7 days until hospital discharge or 28 days of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startAug 2016
- Primary completion14 Nov 2017
- Study completion14 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy J Nordon-Craft, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675985
- Sponsor's protocol ID
- 15-0829
- Status last verified
- Jun 2021
- First submitted
- 2 Feb 2016
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 26651376Sottile 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.
PubMed 26038155Denehy 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.
PubMed 25319384Nordon-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.
PubMed 21934375Olkowski 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.
PubMed 22652987
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Intensive Physical Therapy for Patients With Subarachnoid Hemorrhage in a Neurological ICU
- ClinicalTrials.gov ID
- NCT02675985
- Acronym / sponsor ID
- 15-0829
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Physical Therapy, early intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 14 Nov 2017 (actual)
- Study completion
- 14 Nov 2017 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Physical TherapyEarly intensive physical therapy will be the intervention arm. There is not a control group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed by CT scan or MRI with subarachnoid hemorrhage and admitted to the neurological ICU >48 hours.
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyEarly Intensive Physical therapy in the ICU | Other | Intervention arm |
Primary outcome
Improvement in Physical function in the ICU test (PFit)
Time frame: Every 7 days until hospital discharge or 28 days of study enrollment
5 secondary outcomes
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
Improvement in Timed up and Go (TUG)
Time frame: Every 7 days until hospital discharge or 28 days of study enrollment
Improvement in Postural Assessment Scale for Stroke Patients
Time frame: Every 7 days until hospital discharge or 28 days of study enrollment
Improvement in Medical Research Council (MRC) Muscle Sum Score
Time frame: Every 7 days until hospital discharge or 28 days of study enrollment
Improvement in Hand grip strength
Time frame: Every 7 days until hospital discharge or 28 days of study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Background: PubMed 26651376Moss 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.
- Background: PubMed 26038155Sottile 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.
- Background: PubMed 25319384Denehy 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.
- Background: PubMed 21934375Nordon-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.
- Background: PubMed 22652987Olkowski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy J Nordon-Craft principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy in people with Subarachnoid Hemorrhage, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Physical function in the ICU test (PFit) (time frame: Every 7 days until hospital discharge or 28 days of study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02675985, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.