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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Intensive Care Unit Acquired Weakness, Intensive Care Unit Delirium, Intensive Care Neuropathy, Intensive Care Unit Syndrome, Mechanical Ventilation Complication

Intervention / Treatment
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* Other: Star to move Protocol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Methods: Randomized, single-blind, controlled clinical trial. Computational random assignment of the intervention using sealed envelopes (1:1), non-probabilistic, consecutive sampling of subjects admitted to Clínica Ensenada ICU between January 2018 - July 2019 and who met selection criteria. Participants: All subjects admitted to Clínica Ensenada ICU, adults ≥15 years with invasive mechanical ventilation requirement >48 hours were recruited. Subjects with neuromuscular disease; psychiatric history (attempted autolysis, schizophrenia, senile dementia or others, who due to their condition are not able to follow a logical sequential order, which could bias the evaluation 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); and not consenting to participate in the study were excluded.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Start to move group<br>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<br>* Progressive physical therapy according to the Gosslink protocol called Start to move.<br>|
| Active Comparator: Conventional treatment group<br>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<br>* Progressive physical therapy according to the Gosslink protocol called Start to move.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of ICU-acquired weakness | 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) | 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) | 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 | 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) | 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) | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Unit, Early mobilization, Physical therapy, ICU acquired weakness, Funcionality, Invasive mechanical ventilation