Early Intensive Physical Therapy in Subarachnoid Hemorrhage

NCT ID: NCT02675985

Last Updated: 2021-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-11-14

Brief Summary

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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.

Detailed Description

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Conditions

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Subarachnoid Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention arm

Early intensive physical therapy will be the intervention arm. There is not a control group.

Group Type EXPERIMENTAL

Physical Therapy

Intervention Type OTHER

Early Intensive Physical therapy in the ICU

Interventions

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Physical Therapy

Early Intensive Physical therapy in the ICU

Intervention Type OTHER

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy J Nordon-Craft

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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UCH

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26651376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26038155 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25319384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21934375 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22652987 (View on PubMed)

Other Identifiers

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15-0829

Identifier Type: -

Identifier Source: org_study_id

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