Effects of Mobility Dose on Discharge Disposition in Critically Ill Stroke Patients

NCT03347656 | Completed

• 1 other identifier: 2017P000528
• Study Type: observational
• Target: 164
• Locations: 2 countries
• Sites: 3

Brief Summary

The primary aim of the study is to assess the mobility dose in neurocritical care patients with ischemic stroke or intracranial hemorrhage and its effects on discharge disposition and patient outcomes. The investigators hypothesize that patients' mobilization dose in the intensive care unit (ICU) predicts discharge disposition, 90 day Barthel Index and other outcomes like muscle wasting (expressed as decrease in rectus femoris cross sectional area (RF-CSA) in the paretic and non-paretic limb measured by bedside ultrasound), and ICU length of stay (LOS).

Conditions

Sarcopenia; Stroke, Acute; Muscle Weakness; Critical Illness

Keywords

Mobilization Therapy; Clitical Illness; Stroke; Intensive Care; Functional Mobility; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Adverse Hospital Discharge Disposition

  Adverse hospital discharge is defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility, or in-hospital mortality.

  patient will be followed until hospital discharge; assessed at hospital discharge; expected between study day 3 and 30

• 90 day Barthel Index (hierarchical testing)

  The Barthel Index is a measure of functional disability originally designed to evaluate progress of rehabilitation in patients with stroke and neuromuscular disease.

  90 days post discharge from hospital (collected through follow up phone call)

Secondary Outcomes (14)

• Rectus Femoris Muscle Cross Sectional Area Rectus Femoris Muscle Cross Sectional Area

  will be measured at least twice (on day of enrollement and before discharge); if stay longer than one week, ultrasound will be performed weekly (every 7 days); expected total time period of 3 to 30 days

• 30 day Barthel Index

  30 days post discharge from hospital (collected through follow up phone call)

• Neurological ICU length of stay

  admission until discharge from neurological ICU; an expected 3 to 20 days

• Neurological ICU length of stay until discharge readiness

  admission until discharge readiness from neurological ICU; an expected 3 to 20 days

• hospital length of stay

  admission until discharge from hospital: patient will be followed until discharge from hospital; an expected 3 to 30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

critically ill stroke patients recovering in the neurological intensive care unit

You may qualify if:

• Aged 18 years and older
• Admitted to the neurological intensive care service within the past 48 hours
• an expected ICU length of stay of at least 48h
• New onset ischemic stroke or non-traumatic intracerebral hemorrhage
• Baseline functional independence: Barthel-Index of 70 or above 2 weeks before admission (obtained retrospectively from patient or proxy)

You may not qualify if:

• Transfers from other institutions (hospitals, long-term rehabilitation facilities, skilled nursing facilities) with a stay \>48h at the outside institution
• absence of lower extremities
• not committed to full support
• exclusive or clinically predominant posterior circulation ischemic stroke
• subarachnoid hemorrhage, subdural and epidural hemorrhage

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Massachusetts General Hospital: collaborator
• Technical University of Munich: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Klinikum rechts der Isar of Technische Universität München

Munich, Bavaria, Germany

Location

Related Publications (7)

• Schaller SJ, Anstey M, Blobner M, Edrich T, Grabitz SD, Gradwohl-Matis I, Heim M, Houle T, Kurth T, Latronico N, Lee J, Meyer MJ, Peponis T, Talmor D, Velmahos GC, Waak K, Walz JM, Zafonte R, Eikermann M; International Early SOMS-guided Mobilization Research Initiative. Early, goal-directed mobilisation in the surgical intensive care unit: a randomised controlled trial. Lancet. 2016 Oct 1;388(10052):1377-1388. doi: 10.1016/S0140-6736(16)31637-3.

  PMID: 27707496 BACKGROUND

• Mueller N, Murthy S, Tainter CR, Lee J, Riddell K, Fintelmann FJ, Grabitz SD, Timm FP, Levi B, Kurth T, Eikermann M. Can Sarcopenia Quantified by Ultrasound of the Rectus Femoris Muscle Predict Adverse Outcome of Surgical Intensive Care Unit Patients as well as Frailty? A Prospective, Observational Cohort Study. Ann Surg. 2016 Dec;264(6):1116-1124. doi: 10.1097/SLA.0000000000001546.

  PMID: 26655919 BACKGROUND

• Lee JJ, Waak K, Grosse-Sundrup M, Xue F, Lee J, Chipman D, Ryan C, Bittner EA, Schmidt U, Eikermann M. Global muscle strength but not grip strength predicts mortality and length of stay in a general population in a surgical intensive care unit. Phys Ther. 2012 Dec;92(12):1546-55. doi: 10.2522/ptj.20110403. Epub 2012 Sep 13.

  PMID: 22976446 BACKGROUND

• Kasotakis G, Schmidt U, Perry D, Grosse-Sundrup M, Benjamin J, Ryan C, Tully S, Hirschberg R, Waak K, Velmahos G, Bittner EA, Zafonte R, Cobb JP, Eikermann M. The surgical intensive care unit optimal mobility score predicts mortality and length of stay. Crit Care Med. 2012 Apr;40(4):1122-8. doi: 10.1097/CCM.0b013e3182376e6d.

  PMID: 22067629 BACKGROUND

• Sainsbury A, Seebass G, Bansal A, Young JB. Reliability of the Barthel Index when used with older people. Age Ageing. 2005 May;34(3):228-32. doi: 10.1093/ageing/afi063.

  PMID: 15863408 BACKGROUND

• Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.

  PMID: 2240918 BACKGROUND

• Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573.

  PMID: 9726257 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Stroke; Muscle Weakness; Critical Illness

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes; Disease Attributes

Study Officials

• Balachundhar Subramaniam, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 20, 2017
• Study Start: October 12, 2017
• Primary Completion: December 20, 2019
• Study Completion: June 30, 2021
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

US (2); DE (1)