Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-05 @ 11:55 PM
Study NCT ID:
NCT03196960
Status:
UNKNOWN
Last Update Posted:
2018-09-06
First Post:
2017-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Mobility Dose in Surgical Intensive Care Unit Patients
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Effects of Mobility Dose in Surgical Intensive Care Unit Patients on Adverse Discharge Disposition
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MQS
Brief Summary:
The primary aim of this study is to assess if the mobility dose that patients receive in the surgical intensive care unit (SICU) predicts adverse discharge disposition (primary endpoint), and muscle wasting diagnosed by bedside ultrasound (secondary endpoint).
Detailed Description:
Our research group aims to better understand how patients on the SICU are mobilized and the impact it has on adverse discharge disposition and functional outcome after hospital discharge.
We 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 SICU patients (NCT01363102). In addition, we 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).
In this study we measure the dose of mobility, defined as a function of both the mobility provided by nursing and physical therapists (e.g., sitting at the edge of the bed, ambulating) as well as its duration. We will build on an existing mobility intensity quantification tool (NCT01674608) and add a domain that quantifies its duration in order to obtain a broad picture of the mobilization of patients on the SICU. The mobility dose is expressed by the mobility quantification score that has been developed by our team. We will then test the hypotheses that mobilization dose in the ICU predicts discharge disposition, 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. Further we will evaluate the association between mobility dose and cross sectional area of the rectus femoris muscle measured by bedside ultrasound as a potential reflection of ICU-acquired muscle weakness (exploratory outcome).
Mobilization Quantification score: MQS (Detailed table linked in reference section)
This score integrates the highest rated activities within each mobility session - from physical therapy and nursing. By multiplying the scale it gets greater and allows a better interpretation of mobility intensity. It adds value of mobility dose across sessions considering the entire spectrum of active participation of the patient over the day.
Some specifics:
* If patient achieves a level in between predefined MQS levels we score the closest lower level
* We collect mobility data for the night time by interviewing the day nurses and asking them about the patients' mobilization also during night time
* We round up the duration of each mobility session: Passive range of motion (PRM) conducted 4 times during the day counts as: 1\*4=4 (corresponding to 4 units/hours)
* For each session, we calculate the highest mobility level for the duration of the mobility session: e.g. Patient is standing for 5 minutes before s/he walks with 2 assists for 10 minutes: 3\*7=21 (adding up the duration of various activities within a session and multiplying it by the highest achieved mobility level). Sitting passively in the chair is an exception (see below).
Sitting:
* Sitting in the chair counts as a separate session. Per sitting session a maximum of 2 hours are counted. For example: if a patient was sitting for a duration of either 2, 4 or 5 hours, we would always count: 2\*4=8
* For patients stepping/shuffling/walking to the chair we use level 5 every time the patient is doing it. E.g. patient is shuffling to the chair, sitting for 2 hours and then walking back: 5\*1+2\*4+5\*1 =28
* Distinct sitting sessions are defined by the patient being back in bed in between the sessions of sitting in the chair. E.g. the patient gets actively to chair by stand-step/shuffle, sits in chair for 6 hours, during sitting session patient gets up twice and afterwards gets back to bed by stand-step/shuffle:
5\*1(to chair)+2\*4(sitting)+5\*1(back to bed)+5\*2(standing up 2x in between)=28
We 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 SICU patients (NCT01363102). In addition, we 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).
In this study we measure the dose of mobility, defined as a function of both the mobility provided by nursing and physical therapists (e.g., sitting at the edge of the bed, ambulating) as well as its duration. We will build on an existing mobility intensity quantification tool (NCT01674608) and add a domain that quantifies its duration in order to obtain a broad picture of the mobilization of patients on the SICU. The mobility dose is expressed by the mobility quantification score that has been developed by our team. We will then test the hypotheses that mobilization dose in the ICU predicts discharge disposition, 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. Further we will evaluate the association between mobility dose and cross sectional area of the rectus femoris muscle measured by bedside ultrasound as a potential reflection of ICU-acquired muscle weakness (exploratory outcome).
Mobilization Quantification score: MQS (Detailed table linked in reference section)
This score integrates the highest rated activities within each mobility session - from physical therapy and nursing. By multiplying the scale it gets greater and allows a better interpretation of mobility intensity. It adds value of mobility dose across sessions considering the entire spectrum of active participation of the patient over the day.
Some specifics:
* If patient achieves a level in between predefined MQS levels we score the closest lower level
* We collect mobility data for the night time by interviewing the day nurses and asking them about the patients' mobilization also during night time
* We round up the duration of each mobility session: Passive range of motion (PRM) conducted 4 times during the day counts as: 1\*4=4 (corresponding to 4 units/hours)
* For each session, we calculate the highest mobility level for the duration of the mobility session: e.g. Patient is standing for 5 minutes before s/he walks with 2 assists for 10 minutes: 3\*7=21 (adding up the duration of various activities within a session and multiplying it by the highest achieved mobility level). Sitting passively in the chair is an exception (see below).
Sitting:
* Sitting in the chair counts as a separate session. Per sitting session a maximum of 2 hours are counted. For example: if a patient was sitting for a duration of either 2, 4 or 5 hours, we would always count: 2\*4=8
* For patients stepping/shuffling/walking to the chair we use level 5 every time the patient is doing it. E.g. patient is shuffling to the chair, sitting for 2 hours and then walking back: 5\*1+2\*4+5\*1 =28
* Distinct sitting sessions are defined by the patient being back in bed in between the sessions of sitting in the chair. E.g. the patient gets actively to chair by stand-step/shuffle, sits in chair for 6 hours, during sitting session patient gets up twice and afterwards gets back to bed by stand-step/shuffle:
5\*1(to chair)+2\*4(sitting)+5\*1(back to bed)+5\*2(standing up 2x in between)=28
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: