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NCT Number: NCT03347656

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

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).

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Massachusetts General Hospital
  • Technical University of Munich

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Nov 20, 2017
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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