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Muscle WeaknessmSOMSNCT01363102

Systematic Team Approach to Guide Early Mobilization in Surgical Intensive Care Unit Patients

A study testing SOMS in people with Muscle Weakness and Critical Illness, run by Massachusetts General Hospital at 5 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigators hypothesize that by applying a validated algorithm to accomplish early mobilization in surgical intensive care unit (ICU) patients, these patients will achieve a higher level of mobility which translates to shorter ICU length of stay and improved functional status at discharge. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
SOMS
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
5 sitesin 3 countries
Study dates
Jun 2011to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (18 years of age or greater)
  • Who have been on mechanical ventilation for less than 48 hours and are expected to continue for at least 24 more hours
  • Who meet criteria for baseline functional independence (Barthel Index greater than or equal to 70 obtained from a proxy describing patient function 2 weeks before admission

Who cannot join

  • Irreversible disorders with 6-month mortality greater than 50%
  • Rapidly developing neuromuscular disease
  • Cardiopulmonary arrest
  • Motor component of Glascow Coma Scale <5
  • Elevated intracranial pressure
  • Ruptured/leaking aortic aneurysm
Show all 12Show fewer
  • Acute MI before peak troponin has been reached
  • Absent lower limbs
  • Pregnancy
  • Unstable fractures contributing to likely immobility
  • Hospitalization prior to ICU admission >5 days
  • Enrollment in another clinical trial

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

United States3 sites

  • The Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of Massachusetts

    Worcester, Massachusetts, 01605

Other trials in United States

Austria1 site

  • University of Salzburg

    Salzburg, A-5020

Other trials in Austria

Germany1 site

  • Technische Universität München

    München, Bavaria, D-81675

Other trials in Germany

About this study

Official title: Effects of a Systematic Team Approach to Guide Early Mobilization in Surgical ICU Patients

The investigators hypothesize that by applying a validated algorithm to accomplish early mobilization in surgical intensive care unit (ICU) patients, these patients will achieve a higher level of mobility which translates to shorter ICU length of stay and improved functional status at discharge. Additionally, the investigators hypothesize that genetic polymorphisms related to muscle strength and sleep will also explain some variance in these outcome variables.

Read the detailed description

The trauma literature consistently shows that early mobilization improves patients' outcome after a localized trauma such as hip fracture, or blunt solid organ injuries. In addition, in critically ill patients on the medical ICU, early mobilization improves patients' functional outcome and decreases ICU length of stay (1). This study evaluates if critically ill patients in a surgical ICU can safely and effectively be mobilized early after trauma and surgery. The investigators propose to conduct a randomized controlled study in surgical intensive care unit patients to evaluate the effects of mSOMS guided early mobilization. Additionally, the study will examine known genetic polymorphisms as related to sleep quality and muscle strength and how it relates to early mobilization of surgical ICU patients. In particular, the study will focus on the following polymorphisms: CLOCK, NPAS2, PER2 and PER3, PDE4D,MUC1, ATP2B1, DCDC5, TRPM6, SHROOM3, and MDS1 genes.

Being tested
SOMS
Keywords
Muscle strength, functional mobility, outcome, intensive care unit, quality of life
Medical subject headings
Muscle Weakness, Critical Illness, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOMSProcedure or surgery

    Also called Early Mobilization

    Apply a number to mobilization goal for patient

Study groups in NCT01363102
Study groupRoleWhat they receive
Control groupNo interventionGroup will undergo usual mobilization per standard SICU care
Study GroupExperimentalPatient mobilization discussed on rounds, SOMS score goal created, specific attempt to mobilize patient and achieve goal throughout day.
Receives: Procedure: SOMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average achieved SOMS level

    Achieved SOMS level will be assessed daily and average values be taken for comparison between groups.

    Measured: Average SOMS level from time to inclusion to ICU discharge readiness, an expected time of one to two weeks (expected time of one to two weeks).

Secondary outcomes (6)

  1. SICU length of stay

    Time from study inclusion to SICU discharge readiness, an expected time of one to two weeks.

    Measured: Patients will be followed until SICU discharge, an expected 2 days to 2 weeks

  2. The "mini" modified Functional Independence Measure (mmFIM) level

    Using the modified Functional Independence Measure (mmFIM), the levels of the locomotion and transfer mobility domain at hospital discharge (4 point NRS) will be compared between groups.

    Measured: mmFIM will be measured twice, at ICU discharge readiness and hospital discharge readiness, an expected average of one to two and three weeks, respectively.

  3. Quality of life following hospital discharge

    SF 36 score

    Measured: three months after hospital discharge

  4. Muscle strength

    Medical Research Council (MRC) scale.

    Measured: ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively.

  5. Side effects of mobilization therapy

    Number of unfavorable signs and symptoms or unintended deterioration of clinical status associated with mobilization therapy, including, but not limited to, unplanned extubation or dislodgment of drains, arterial catheters, venous devices, or other medical equipment. The relationship of any untoward event to mobilization therapy was assessed by the clinician and reported as unrelated, unlikely, possibly, or definitely related. AE were also categorized by intensity as mild, moderate, or severe

    Measured: during and 30 minutes after mobilization therapy during SICU stay, approximately 1 to 2 weeks.

  6. Genetic Polymorphisms as related to the other outcomes

    Since Sleep duration has a genetic component corresponding to 40% heritability, we are going to conduct an analysis of known polymorphisms that are related to different variables of sleep quality and how it relates to muscle strength and mobility. In particular we will focus on polymorphisms in CLOCK, NPAS2, PER2 and PER3, PDE4D,MUC1, ATP2B1, DCDC5, TRPM6, SHROOM3, and MDS1 genes, which are associated with sleepiness, sleep phase, inertia, and potentially with respiratory muscle weakness and duration.

    Measured: 5 minutes to collect sample

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionJul 2015
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01363102
Sponsor's protocol ID
11112010
Acronym
mSOMS
Status last verified
Mar 2016
First submitted
23 May 2011
Last updated
17 Mar 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22067629

  • 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.

    PubMed 27707496

  • Meyer MJ, Stanislaus AB, Lee J, Waak K, Ryan C, Saxena R, Ball S, Schmidt U, Poon T, Piva S, Walz M, Talmor DS, Blobner M, Latronico N, Eikermann M. Surgical Intensive Care Unit Optimal Mobilisation Score (SOMS) trial: a protocol for an international, multicentre, randomised controlled trial focused on goal-directed early mobilisation of surgical ICU patients. BMJ Open. 2013 Aug 19;3(8):e003262. doi: 10.1136/bmjopen-2013-003262.

    PubMed 23959756

Questions about this trial

What is this clinical trial studying?

A study testing SOMS in people with Muscle Weakness and Critical Illness, run by Massachusetts General Hospital at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average achieved SOMS level (time frame: Average SOMS level from time to inclusion to ICU discharge readiness, an expected time of one to two weeks (expected time of one to two weeks).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01363102, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016; AzTrials last refreshed its copy on 26 Oct 2026.

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