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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03347656
Recruitment Status : Unknown
Verified August 2020 by Matthias Eikermann, Beth Israel Deaconess Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : November 20, 2017
Last Update Posted : August 27, 2020
Sponsor:
Collaborators:
Massachusetts General Hospital
Technische Universität München
Information provided by (Responsible Party):
Matthias Eikermann, Beth Israel Deaconess Medical Center

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).

Condition or disease
Sarcopenia Stroke, Acute Muscle Weakness Critical Illness

Detailed Description:

The investigators have previously developed and validated the Surgical Intensive Care Unit Optimal Mobilization Score (SOMS), an algorithm to guide and facilitate early mobilization to advance mobility of surgical intensive care unit patients (NCT01363102). In addition, the investigators have established the use of bedside ultrasound technology to quantify cross sectional area of the rectus femoris muscle, which allows an objective, user-independent quantification of muscle wasting (NCT02270502).

This is a prospective, observational study to observe the relation between mobility dose, muscle wasting and patient outcomes in critically ill stroke patients.

Patients will be enrolled within 48 hours of ICU admission. The investigators will measure the dose of activity, that is duration and intensity of mobilization in critically ill patients with ischemic stroke and intracerebral hemorrhage. By mobility "dose" the investigators are referring to all provider-directed activities (by nursing, and physical therapists) meant to enhance the patient's mobility level. The investigators take into account mobility "dose", defined as a function of both the mobility level (e.g., sitting at the edge of the bed, ambulating) as well as its duration. Of note, there is so far no published data available that describes patients' mobility "dose" in such an integrative, semi-quantitative fashion.

The investigators use the existing mobility intensity quantification tool (MQS) (NCT03196960) and test the hypotheses that mobilization dose predicts muscle wasting in critically ill stroke patients, adverse hospital discharge disposition as well as 90 day Barthel Index. The investigators will apply hierarchical testing to evaluate the association between mobilization dose and discharge disposition as well as 90-day Barthel Index.

The Mobilization Quantification Score (MQS) is a composition of the validated ICU mobility score (SOMS), a 0 to 10 value scale that measures the mobility milestones in critically ill patients, multiplied by a for each level previously defined time unit (5 or 30 minutes correspond to one unit depending on mobilization level).

In order to capture the muscle status at ICU admission, determined by the first bedside ultrasound of the rectus femoris muscle after enrollment, and the change in rectus femoris muscle diameter throughout stay, the investigators will conduct repetitive measurements of the cross sectional area of the rectus femoris muscles (RF-CSA) of both legs. This longitudinal setting will allow to investigate muscle wasting due to immobilization and other severe illness related factors in the paretic and non-paretic limb.

The investigators will conduct a scheduled phone call 30 days and 90 days after hospital discharge by getting in contact with either the patient or a family member to obtain follow-up data. This conversation will include questions that allow to identify the Barthel Index at 30 days, the Barthel Index and GOS-E score at 90 days, and if the patient has been readmitted to a hospital within 30 days of hospital discharge and mortality.

Discharge disposition 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. The Barthel Index is a measure of functional disability originally designed to evaluate progress of rehabilitation in patients with stroke and neuromuscular disease. The GOS-E (Extended Glasgow Outcome Scale) is a global scale for functional outcome that rates patient status into eight categories: Dead Vegetative State, Upper and Lower Severe Disability, Upper and Lower Moderate Disability, Upper and Lower Good Recovery.

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Study Type : Observational
Actual Enrollment : 164 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Mobility Dose on Discharge Disposition in Critically Ill Stroke Patients
Actual Study Start Date : October 12, 2017
Actual Primary Completion Date : December 20, 2019
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Adverse Hospital Discharge Disposition [ Time Frame: patient will be followed until hospital discharge; assessed at hospital discharge; expected between study day 3 and 30 ]
    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.

  2. 90 day Barthel Index (hierarchical testing) [ Time Frame: 90 days post discharge from hospital (collected through follow up phone call) ]
    The Barthel Index is a measure of functional disability originally designed to evaluate progress of rehabilitation in patients with stroke and neuromuscular disease.


Secondary Outcome Measures :
  1. Rectus Femoris Muscle Cross Sectional Area Rectus Femoris Muscle Cross Sectional Area [ Time Frame: 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 ]
    Rectus femoris cross sectional area will be measured by bedside ultrasound, raw numbers as well as change over time will be respected

  2. 30 day Barthel Index [ Time Frame: 30 days post discharge from hospital (collected through follow up phone call) ]
    The Barthel Index is a measure of functional disability originally designed to evaluate progress of rehabilitation in patients with stroke and neuromuscular disease.

  3. Neurological ICU length of stay [ Time Frame: admission until discharge from neurological ICU; an expected 3 to 20 days ]
    number of days patient stays on the neurological ICU

  4. Neurological ICU length of stay until discharge readiness [ Time Frame: admission until discharge readiness from neurological ICU; an expected 3 to 20 days ]
    number of days patient stays on the neurological ICU until time point from which patient is stable for discharge from ICU

  5. hospital length of stay [ Time Frame: admission until discharge from hospital: patient will be followed until discharge from hospital; an expected 3 to 30 days ]
    number of days patients stays in hospital during index admission

  6. FIM Score at ICU discharge [ Time Frame: assessed at discharge from neurological ICU; expected between study day 3 and 20 ]
    Functional independence measure score in the domains transfer and locomotion at ICU discharge

  7. Days on sedation [ Time Frame: during hospital stay; an expected 0 to 30 days ]
    number of days patient receives sedatives

  8. mortality [ Time Frame: during ICU stay, hospital stay or within the 30day or 90day follow up period (follow up data collected through phone call ]
    we will distinguish between ICU mortality, hospital mortality and mortality within 30 or 90 days after discharge from hospital

  9. ICU readmission [ Time Frame: during hospital stay; expected to be assessed between study day 3 and 30 ]
    readmission to the ICU after discharge from ICU but within hospital stay

  10. 30-day hospital readmission [ Time Frame: 30 days after discharge from hospital, obtained through follow up phone call ]
    readmission to a hospital within 30 days after discharge from index stay

  11. 90-day GOS-E (Extended Glasgow Outcomes Scale) [ Time Frame: obtained 90 days after discharge from hospital through follow up phone call ]
    The GOS-E is a global scale for functional outcome that rates patient status into eight categories: Dead Vegetative State, Upper and Lower Severe Disability, Upper and Lower Moderate Disability, Upper and Lower Good Recovery

  12. Total costs of care [ Time Frame: during hospital stay ]
    total costs of care

  13. Falls [ Time Frame: during hospital stay; expected to be assessed between study day 3 and 30 ]
    number of falls

  14. Delirium-free days [ Time Frame: CAM-ICU will be evaluated daily during hospital stay; an expected 0 to 30 days ]
    defined by CAM-ICU (Confusion Assessment Method)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
critically ill stroke patients recovering in the neurological intensive care unit
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347656


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deconess Medical Center
Boston, Massachusetts, United States, 02215
Germany
Klinikum rechts der Isar of Technische Universität München
Munich, Bavaria, Germany
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Technische Universität München
Investigators
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Principal Investigator: Matthias Eikermann, MD, PhD Beth Israel Deaconess Medical Center
Publications:

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Responsible Party: Matthias Eikermann, Professor of Anesthesia, Harvard Medical School, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03347656    
Other Study ID Numbers: 2017P000528
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthias Eikermann, Beth Israel Deaconess Medical Center:
Mobilization Therapy
Clitical Illness
Stroke
Intensive Care
Functional Mobility
Quality of Life
Additional relevant MeSH terms:
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Muscle Weakness
Stroke
Sarcopenia
Critical Illness
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Atrophy
Pathological Conditions, Anatomical
Muscular Diseases
Musculoskeletal Diseases