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

Mechanical Ventilation Complication Clinical Trial

— STM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05053724
• Other study ID #: starttomove
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: September 2021
• Source: Hospital Felix Bulnes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: November 30, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Intensive Care Neuropathy
• Intensive Care Unit Acquired Weakness
• Intensive Care Unit Delirium
• Intensive Care Unit Syndrome
• Mechanical Ventilation Complication

Intervention

Other:
• Star to move Protocol
Progressive physical therapy according to the Gosslink protocol called "Start to move".

Locations

Country	Name	City	State
Chile	Sebastián Eduardo Soto López	Santiago	Región Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Felix Bulnes

Country where clinical trial is conducted

Chile, 

References & Publications (15)

Brower RG. Consequences of bed rest. Crit Care Med. 2009 Oct;37(10 Suppl):S422-8. doi: 10.1097/CCM.0b013e3181b6e30a. Review. — View Citation

Brummel NE, Girard TD. Preventing delirium in the intensive care unit. Crit Care Clin. 2013 Jan;29(1):51-65. doi: 10.1016/j.ccc.2012.10.007. Review. — View Citation

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. — View Citation

de Jonghe B, Lacherade JC, Sharshar T, Outin H. Intensive care unit-acquired weakness: risk factors and prevention. Crit Care Med. 2009 Oct;37(10 Suppl):S309-15. doi: 10.1097/CCM.0b013e3181b6e64c. Review. — View Citation

Jones SW, Hill RJ, Krasney PA, O'Conner B, Peirce N, Greenhaff PL. Disuse atrophy and exercise rehabilitation in humans profoundly affects the expression of genes associated with the regulation of skeletal muscle mass. FASEB J. 2004 Jun;18(9):1025-7. Epub — View Citation

Kamdar BB, Combs MP, Colantuoni E, King LM, Niessen T, Neufeld KJ, Collop NA, Needham DM. The association of sleep quality, delirium, and sedation status with daily participation in physical therapy in the ICU. Crit Care. 2016 Aug 18;19:261. doi: 10.1186/ — View Citation

Kho ME, Truong AD, Zanni JM, Ciesla ND, Brower RG, Palmer JB, Needham DM. Neuromuscular electrical stimulation in mechanically ventilated patients: a randomized, sham-controlled pilot trial with blinded outcome assessment. J Crit Care. 2015 Feb;30(1):32-9 — View Citation

Nordon-Craft A, Moss M, Quan D, Schenkman M. Intensive care unit-acquired weakness: implications for physical therapist management. Phys Ther. 2012 Dec;92(12):1494-506. doi: 10.2522/ptj.20110117. Epub 2012 Jan 26. Review. — View Citation

Parry SM, Berney S, Koopman R, Bryant A, El-Ansary D, Puthucheary Z, Hart N, Warrillow S, Denehy L. Early rehabilitation in critical care (eRiCC): functional electrical stimulation with cycling protocol for a randomised controlled trial. BMJ Open. 2012 Se — View Citation

Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute — View Citation

Schefold JC, Bierbrauer J, Weber-Carstens S. Intensive care unit-acquired weakness (ICUAW) and muscle wasting in critically ill patients with severe sepsis and septic shock. J Cachexia Sarcopenia Muscle. 2010 Dec;1(2):147-157. Epub 2010 Dec 17. — View Citation

Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critic — View Citation

Sommers J, Engelbert RH, Dettling-Ihnenfeldt D, Gosselink R, Spronk PE, Nollet F, van der Schaaf M. Physiotherapy in the intensive care unit: an evidence-based, expert driven, practical statement and rehabilitation recommendations. Clin Rehabil. 2015 Nov; — View Citation

Suetta C, Hvid LG, Justesen L, Christensen U, Neergaard K, Simonsen L, Ortenblad N, Magnusson SP, Kjaer M, Aagaard P. Effects of aging on human skeletal muscle after immobilization and retraining. J Appl Physiol (1985). 2009 Oct;107(4):1172-80. doi: 10.11 — View Citation

Thrush A, Rozek M, Dekerlegand JL. The clinical utility of the functional status score for the intensive care unit (FSS-ICU) at a long-term acute care hospital: a prospective cohort study. Phys Ther. 2012 Dec;92(12):1536-45. doi: 10.2522/ptj.20110412. Epu — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.