Early Intensive Physical Therapy in Subarachnoid Hemorrhage

NCT02675985 | Completed

• 1 other identifier: 15-0829
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage

Keywords

Physical Therapy, early intervention

Outcome Measures

Primary Outcomes (1)

• Improvement in Physical function in the ICU test (PFit)

  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

  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 Outcomes (1)

• Neuro-Quality of Life (QOL)

  Hospital Discharge only

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Other: Physical Therapy

Interventions

Physical Therapy OTHER

Early Intensive Physical therapy in the ICU

Intervention arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed by CT scan or MRI with subarachnoid hemorrhage and admitted to the neurological ICU \>48 hours.

You may not qualify if:

• 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%

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

UCH

Aurora, Colorado, 80020, United States

Location

Related Publications (5)

• 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.

  PMID: 26651376 BACKGROUND

• 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.

  PMID: 26038155 BACKGROUND

• 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.

  PMID: 25319384 BACKGROUND

• 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.

  PMID: 21934375 BACKGROUND

• 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.

  PMID: 22652987 BACKGROUND

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Amy J Nordon-Craft

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 5, 2016
• Study Start: August 1, 2016
• Primary Completion: November 14, 2017
• Study Completion: November 14, 2017
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)