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

NCT05053724 | Completed

• 1 other identifier: starttomove
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Intensive Care Unit; Early mobilization; Physical therapy; ICU acquired weakness; Funcionality; Invasive mechanical ventilation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• ICU stay (days)

  It is measured in the 24 hours prior to discharge from the ICU.

• Days of invasive mechanical ventilation (IMV)

  It is measured in the 24 hours prior to discharge from the ICU.

• Mortality at 28 days, post ICU discharge

  Measured at 28 days post ICU discharge.

Study Arms (2)

Start to move group

EXPERIMENTAL

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

Conventional treatment group

ACTIVE COMPARATOR

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

Interventions

Star to move Protocol OTHER

Progressive physical therapy according to the Gosslink protocol called "Start to move".

Conventional treatment group; Start to move group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Felix Bulnes: lead

Study Sites (1)

Sebastián Eduardo Soto López

Santiago, Santiago Metropolitan, 8240000, Chile

Location

Related Publications (16)

• 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. doi: 10.1007/s13539-010-0010-6. Epub 2010 Dec 17.

  PMID: 21475702 RESULT

• 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.

  PMID: 22282769 RESULT

• 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;29(11):1051-63. doi: 10.1177/0269215514567156. Epub 2015 Feb 13.

  PMID: 25681407 RESULT

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

  PMID: 20046130 RESULT

• 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: 10.1152/japplphysiol.00290.2009. Epub 2009 Aug 6.

  PMID: 19661454 RESULT

• 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. doi: 10.1096/fj.03-1228fje. Epub 2004 Apr 14.

  PMID: 15084522 RESULT

• 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 skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.

  PMID: 24108501 RESULT

• 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/s13054-016-1433-z.

  PMID: 27538536 RESULT

• 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.

  PMID: 23182527 RESULT

• 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. Epub 2012 Sep 6.

  PMID: 22956427 RESULT

• 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.

  PMID: 20046115 RESULT

• 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. doi: 10.1016/j.jcrc.2014.09.014. Epub 2014 Sep 22.

  PMID: 25307979 RESULT

• 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 Sep 13;2(5):e001891. doi: 10.1136/bmjopen-2012-001891. Print 2012.

  PMID: 22983782 RESULT

• 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. doi: 10.1016/0021-9681(87)90171-8.

  PMID: 3558716 RESULT

• 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, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.

  PMID: 19446324 RESULT

• Soto S, Adasme R, Vivanco P, Figueroa P. Efficacy of the "Start to move" protocol on functionality, ICU-acquired weakness and delirium: A randomized clinical trial. Med Intensiva (Engl Ed). 2024 Apr;48(4):211-219. doi: 10.1016/j.medine.2024.01.003. Epub 2024 Feb 23.

  PMID: 38402053 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study was conducted in a single 12-bed ICU clinical center, during 2018-2019. Subjects who met the inclusion criteria were asked for informed consent from the responsible guardian and were subsequently randomized (1:1) into Start to move group and conventional treatment group. Sequentially numbered sealed envelopes were used for allocation, which were accessed only by research personnel not participating in the clinical trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: September 22, 2021
• Study Start: January 1, 2018
• Primary Completion: July 10, 2019
• Study Completion: November 30, 2019
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)