Intensive Care Unit Acquired WeaknessSTMNCT05053724
Efficacy of the "Start to Move" Protocol on Functionality, Delirium and Acquired Weakness in ICU
A study testing Star to move Protocol in people with Intensive Care Unit Acquired Weakness and Intensive Care Unit Delirium, run by Hospital Felix Bulnes at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Unit Acquired Weakness, Intensive Care Unit Delirium, Intensive Care Neuropathy
- What is being tested?
- Star to move Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChile
- Study dates
- 1 Jan 2018to 30 Nov 2019
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects admitted to ICU
- Adults ≥15 years
- IMV requirement >48 hours
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Sebastián Eduardo Soto López
Santiago, Santiago Metropolitan, 8240000
About this study
Official title: 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.
Read the 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.
- Conditions
- Intensive Care Unit Acquired Weakness, Intensive Care Unit Delirium, Intensive Care Neuropathy, Intensive Care Unit Syndrome, Mechanical Ventilation Complication
- Being tested
- Star to move Protocol
- Keywords
- Intensive Care Unit, Early mobilization, Physical therapy, ICU acquired weakness, Funcionality, Invasive mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Star to move ProtocolOther
Progressive physical therapy according to the Gosslink protocol called "Start to move".
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Star to move Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Number of days hospitalized in ICU, up to 45 days. From the date of admission to the ICU until the departure from the ICU.
Measured: 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.
Measured: 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: Measured at 28 days post ICU discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Jan 2018
- Primary completion10 Jul 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit Acquired WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Felix Bulnes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Soto López, Hospital Felix Bulnes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053724
- Sponsor's protocol ID
- starttomove
- Acronym
- STM
- Status last verified
- Sep 2021
- First submitted
- 28 May 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data were recorded using an Epidata form.
Publications
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.
PubMed 21475702Nordon-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.
PubMed 22282769Sommers 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.
PubMed 25681407Brower RG. Consequences of bed rest. Crit Care Med. 2009 Oct;37(10 Suppl):S422-8. doi: 10.1097/CCM.0b013e3181b6e30a.
PubMed 20046130Suetta 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.
PubMed 19661454Jones 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.
PubMed 15084522Puthucheary 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.
PubMed 24108501Kamdar 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.
PubMed 27538536Brummel 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.
PubMed 23182527Thrush 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.
PubMed 22956427de 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.
PubMed 20046115Kho 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.
PubMed 25307979Parry 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.
PubMed 22983782Charlson 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.
PubMed 3558716Schweickert 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.
PubMed 19446324
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the "Start to Move" Protocol on Functionality, Delirium and Acquired Weakness in ICU. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05053724
- Acronym / sponsor ID
- STM / starttomove
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hospital Felix BulnesUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Start to move group | Experimental | Other: Star to move ProtocolIn 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. |
| Conventional treatment group | Active comparator | Other: Star to move ProtocolIn 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects admitted to ICU
- Adults ≥15 years
- IMV requirement >48 hours
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Star to move ProtocolProgressive physical therapy according to the Gosslink protocol called "Start to move". | Other | Conventional treatment group, Start to move group |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
ICU stay (days)
Time frame: 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.
Mortality at 28 days, post ICU discharge
Time frame: Measured at 28 days post ICU discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Results publication: PubMed 21475702Schefold 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.
- Results publication: PubMed 22282769Nordon-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.
- Results publication: PubMed 25681407Sommers 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.
- Results publication: PubMed 20046130Brower RG. Consequences of bed rest. Crit Care Med. 2009 Oct;37(10 Suppl):S422-8. doi: 10.1097/CCM.0b013e3181b6e30a.
- Results publication: PubMed 19661454Suetta 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.
- Results publication: PubMed 15084522Jones 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.
- Results publication: PubMed 24108501Puthucheary 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.
- Results publication: PubMed 27538536Kamdar 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.
- Results publication: PubMed 23182527Brummel 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.
- Results publication: PubMed 22956427Thrush 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.
- Results publication: PubMed 20046115de 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.
- Results publication: PubMed 25307979Kho 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.
- Individual participant dataSharing planned: No. Data were recorded using an Epidata form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Star to move Protocol in people with Intensive Care Unit Acquired Weakness and Intensive Care Unit Delirium, run by Hospital Felix Bulnes at 1 site in Chile.
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 7 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: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.). The study lists 4 primary outcomes in all. 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 NCT05053724, which also lists 16 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 22 Sep 2021.