Efficacy of the "Start to Move" Protocol on Functionality, Delirium and Acquired Weakness in ICU (STM)

September 20, 2021 updated by: Sebastian Soto López, Hospital Felix Bulnes

Efficacy of the "Start to Move" Protocol on Functionality, Delirium and Acquired Weakness in ICU. Randomized Clinical Trial.

Background: ICU hospitalization is associated with loss of strength, functionality and delirium. The "Start to Move protocol" demonstrated efficacy in improving and minimizing such effects.

Aim: To evaluate the effectiveness of the "Start to move protocol" compared with conventional treatment in ICU subjects on functionality, weakness acquired in the Intensive Care Unit (ICU-AW), incidence of delirium, days of invasive mechanical ventilation (IMV), ICU stay and 28-day mortality.

Methods: Randomized controlled clinical trial. Including adults ≥15 years with IMV >48 hours, randomized into Start to move and conventional treatment groups.Functionality, ICU-AW incidence, delirium incidence, IMV days, ICU stay and mortality-28 days were analyzed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction:

Individuals hospitalized in Intensive Care Units are subjected to a prolonged state of rest and to various factors that directly or indirectly affect the muscular and organic structure, which can result in ICU-acquired weakness (ICU-AW) and a limitation in functional performance.

These factors can be divided into metabolic, pharmacological and organic, where sustained hyperglycemia, corticosteroid use, sedation-analgesia, neuromuscular blockade and multiorgan failure associated with sepsis or septic shock stand out. This state translates into a direct loss of muscle mass, specifically of type II fibers, physiologically explained by an increase in the myosin protein degradation process, a decrease in protein synthesis and an increase in proinflammatory cells that favor the weakness of the critically ill patient.

Brower et al. studied that the effects of prolonged rest produce a deconditioning and atrophy of the musculature. After 14 days of immobilization, young people and adults are exposed to a 9% loss of quadriceps muscle mass, which translates into a loss of muscle strength of up to 27%.In subjects subjected to invasive mechanical ventilation, it has been shown that the cross-sectional area of the quadriceps muscle can decrease up to 12.5% in the first week of their stay in the ICU, which can increase up to 15.7% if they present multiorgan failure versus a 3% loss in subjects with single organ failure.

ICU-AW and loss of function are also directly related to the prolonged use of sedoanalgesia, neuromuscular blockade and a higher incidence of delirium in the ICU. The presence of delirium is related to low participation in physical therapies, either by decreased cooperation and/or psychomotor agitation, thus directly influencing muscle status and subsequent functional recovery.

Brummel et al. report that delirium is common in the ICU, affecting between 60-80% of subjects undergoing IMV and between 20-50% of subjects on noninvasive mechanical ventilation, increasing the risk of removal of invasive elements, accidental extubations and the need for physical restraints that may delay the onset of functional recovery.

To demonstrate the consequences of prolonged rest and quantify ICU-AW, the Medical Research Council (MRC) assessment scale is used, a validated tool which analytically measures the strength of six muscle groups bilaterally with a score of 30 points per hemibody, obtaining a total of 60 points. A score of 48 points or less determines the presence of ICU-AW.

On the other hand, the validated Functional Status Scale - Intensive Care Unit (FSS-ICU), which measures functional milestones with a score between 0 and 35 points, is commonly used to assess the functionality of the critically ill patient 12.

The aim of our study is to evaluate the effectiveness of the Start to move protocol compared to conventional ICU treatment on functionality, ICU-Aw, incidence of delirium, days of mechanical ventilation, ICU stay and 28-day mortality, Clínica Ensenada 2018 - 2019.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 8240000
        • Sebastián Eduardo Soto López

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects admitted to ICU
  • Adults ≥15 years
  • IMV requirement >48 hours

Exclusion Criteria:

  • Neuromuscular disease
  • Psychiatric history (attempted autolysis, schizophrenia, senile dementia or others, who due to their condition are unable to follow simple orders, which could bias the assessment and functional treatment)
  • Limb amputation
  • Pregnancy
  • Cardiorespiratory arrest with severe hypoxic-ischemic brain damage
  • Total dependence prior to hospitalization, according to Barthel index (<20 points);
  • Subject without consenting to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Start to move group
In the Start to move group, physical therapy was included according to the Gosselink protocol, which establishes 6 levels of care divided according to system stability and state of consciousness. At level 0, no physical mobilization therapy was applied due to systemic lability. From level 1 to 5, passive mobilizations, use of muscle electrostimulation, active mobilizations and exercises against resistance, application of conventional cycloergometer, up to walking with assistance if the subject is able to perform it.
Other: Star to move Protocol
Progressive physical therapy according to the Gosslink protocol called "Start to move".
Active Comparator: Conventional treatment group
In the conventional treatment group, passive mobilization, active-assisted mobilization and exercises against resistance, facilitation of high functional positions such as sedentary, bipedal and walking were applied, according to conventional treatment protocol.
Other: Star to move Protocol
Progressive physical therapy according to the Gosslink protocol called "Start to move".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of ICU-acquired weakness
Time Frame: It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.
ICU-AW was measured through the MRC scale of 60 points, where scores below 48 points indicate ICU-AW and more than 48 points the greater the strength of the subject.
It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.
Change of Functionality of the Critically Ill Patient (Intra-hospital)
Time Frame: It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.
Through the FSS-ICU evaluation scale, a score of 0 to 35 points is made to evaluate the motor function of the critical patient, where the higher the score, the greater the subject's functionality.
It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.
Change of Functionality of the Critically Ill Patient (pre-hospitalization)
Time Frame: It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.
Evaluation of the Barthel index of a family member, of the baseline state of the patient, before hospitalization. The total score is 100 points, the higher the score, the better the patient's baseline functionality.
It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.
Change of Delirium
Time Frame: It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.
It is measured using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale to determine the presence of delirium. It does not have a score, if it meets criteria the subject will have delirium.
It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU stay (days)
Time Frame: It is measured in the 24 hours prior to discharge from the ICU.
Number of days hospitalized in ICU, up to 45 days. From the date of admission to the ICU until the departure from the ICU.
It is measured in the 24 hours prior to discharge from the ICU.
Days of invasive mechanical ventilation (IMV)
Time Frame: It is measured in the 24 hours prior to discharge from the ICU.
Number of days of invasive mechanical ventilation during hospitalization, up to 45 days. From the day of intubation until weaning from invasive mechanical ventilation.
It is measured in the 24 hours prior to discharge from the ICU.
Mortality at 28 days, post ICU discharge
Time Frame: Measured at 28 days post ICU discharge.
The patient's death is verified according to the medical record (during hospitalization) or through a telephone number to a family member (outside the hospital).
Measured at 28 days post ICU discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Felix Bulnes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

July 10, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

September 20, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • starttomove

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data were recorded using an Epidata form.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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