COVID-19 Acute Respiratory Distress SyndromeNCT05450120

Rehabilitation of Critically Ill Patients With SARS-CoV-2 Variants in ICU With Limited Resources

A study testing Functional Rehabilitation and Neuromuscular Electrical Stimulation in people with COVID-19 Acute Respiratory Distress Syndrome, run by Universidade Federal de Sao Carlos at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Acute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. Scientific evidence has considered neuromuscular electrical stimulation (NMES) as a promising approach for the early rehabilitation of patients during and/or after ICU. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19 Acute Respiratory Distress Syndrome
What is being tested?: Functional Rehabilitation and Neuromuscular Electrical Stimulation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 1 siteBrazil
Study dates: 1 May 2020to 1 Dec 2022
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects admitted in ICU for >72hs, undergoing orotracheal intubation and on mechanical ventilation for >48hs, with a diagnosis of Acute Respiratory Distress Syndrome (ARDS) according to Berlin definition secondary to COVID-19, with shock or organ failure, according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (7th Interim Edition) Guideline, and clinical stability:
mean arterial pressure < 60 mmHg;
heart rate >60 and <120 beats/minute;
respiratory rate <30 breaths/minute;
oxygen saturation ≥ 92%;
fraction of inspired oxygen (FiO2) ≤0.6;

Show all 11Show fewer

absence of vasopressor dose increase
absence of dysrhythmia (except for chronic atrial fibrillation);
controlled sepsis;
hemoglobin (Hb) > 8g m/d, plaquettes >20.000, Glucemia >70 e <180;
without NMBs

Who cannot join

Patients with movement resistance
Walking without assistance before the ICU (except using a cane)
Cognitive impairment before acute illness
Signs of intracranial hypertension, neuromuscular disease (myasthenia gravis, amyotrophic lateral sclerosis, Guillain-Barré) and stroke; hip fracture, unstable cervical spine, or pathological fracture
Prior hospitalization (30 days before ICU)
Readmission to the ICU, within the current hospitalization
Presence of an implanted cardiac pacemaker or defibrillator, pregnancy, acute myocardial infarction and, for the experimental group (EG), against indications for NMES (deep vein thrombosis, skin lesions, rhabdomyolysis).

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Santa Casa de Batatais
Batatais, São Paulo, 14300-029

Other trials in Brazil

About this study

Official title: Neuromuscular Electrical Stimulation and Functional Rehabilitation Protocol in Critically Ill Patients With SARS-CoV-2 Variants in ICUs With Limited Resources: A Randomized Clinical Trial

Neuromuscular electrostimulation can be an alternative form of muscle exercise that helps to gain strength in critically ill patients with COVID -19, due to the severe weakness that patients experience due to longer MV, analgesia and NMB duration. Thus, the general objective of evaluating the effects of an early rehabilitation protocol on the strength and functionality of patients affected by SARS-CoV-2 variants and specifically compare the effectiveness of NMES associated with the functional rehabilitation protocol(FR). Also, describe demographics, clinical status, ICU therapies, mortality estimates and Hospital outcomes, of every patients admitted in ICU during the observation periods.

Read the detailed description

Patients in both groups received the functional rehabilitation protocol adapted from the precoce mobilization protocol of Morris et al, 2008. The protocol was defined in 5 stages, with a period between the application of the stages according to the clinical conditions of the patient, in an interval maximum of 24 hours from the beginning of the application of the first stage. The steps included active assisted mobilization exercises, active with Proprioceptive Neuromuscular Facilitation (PNF) method diagonals for upper limbs and bridge exercises, bedside sitting, balance reactions, weight bearing, transfer to an armchair, passive and active orthostatism, static gait and ambulation. The experimental group also received a protocol of neuromuscular electrical stimulation (NMES), applied bilaterally for 30 minutes, using an electrical stimulator with rectangular pulse waves, symmetrical biphasic, applied to the quadriceps femoris and tibialis anterior muscle at the best motor point, activating fast fibers with a pulse time of less than 300 ms and slow pulses with a pulse time of more than 300 ms, with intensity adjusted to obtain visible muscle contraction and/or according to the patient's tolerance.

Conditions: COVID-19 Acute Respiratory Distress Syndrome
Being tested: Functional Rehabilitation, Neuromuscular Electrical Stimulation
Keywords: COVID-19, intensive care unit, early mobilization, rehabilitation, electrical stimulation, muscle weakness
Medical subject headings: COVID-19, Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Functional RehabilitationOther
Functional rehabilitation protocol
Neuromuscular Electrical StimulationOther
Neuromuscular electrical stimulation protocol

Study groups in NCT05450120
Study group	Role	What they receive
Functional Rehabilitation	Active comparator	Functional rehabilitation protocol Receives: Other: Functional Rehabilitation
NMES + Functional Rehabilitation	Experimental	Functional rehabilitation protocol associated with neuromuscular electrical stimulation Receives: Other: Functional Rehabilitation; Other: Neuromuscular Electrical Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Skeletal muscle strength
Improved skeletal muscle strength by modified Medical Research Council (mMRC)
Measured: 5 months
Functional independence
Improved level of functional independence by ICU Mobility Scale (IMS) and Functional Status Score for the ICU (FSS-ICU)
Measured: 5 months

Secondary outcomes (2)

Mechanical ventilation and hospitalization
Mechanical ventilation time, ICU and hospital stay.
Measured: 5 months
Survived and discharged
Proportion of patients who survived and were discharged.
Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20201 Dec 2022

First posted8 Jul 2022
Study start1 May 2020
Primary completion1 Oct 2020
Study completion1 Dec 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies 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
Masking: Single blind
Who is masked: Participant
Enrolment: 88 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05450120
Sponsor's protocol ID: 07351119.2.0000.5381
Status last verified: Aug 2022
First submitted: 5 Jul 2022
Last updated: 8 Aug 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Dhand UK. Clinical approach to the weak patient in the intensive care unit. Respir Care. 2006 Sep;51(9):1024-40; discussion 1040-1.
PubMed 16934166
Latronico N, Peli E, Botteri M. Critical illness myopathy and neuropathy. Curr Opin Crit Care. 2005 Apr;11(2):126-32. doi: 10.1097/01.ccx.0000155357.24360.89.
PubMed 15758592
Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
PubMed 12594312
Herridge MS. Legacy of intensive care unit-acquired weakness. Crit Care Med. 2009 Oct;37(10 Suppl):S457-61. doi: 10.1097/CCM.0b013e3181b6f35c.
PubMed 20046135
De Jonghe B, Sharshar T, Hopkinson N, Outin H. Paresis following mechanical ventilation. Curr Opin Crit Care. 2004 Feb;10(1):47-52. doi: 10.1097/00075198-200402000-00008.
PubMed 15166849
Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
PubMed 18511703
Latronico N, Bolton CF. Critical illness polyneuropathy and myopathy: a major cause of muscle weakness and paralysis. Lancet Neurol. 2011 Oct;10(10):931-41. doi: 10.1016/S1474-4422(11)70178-8.
PubMed 21939902
Latronico N. Critical illness polyneuropathy and myopathy 20 years later. No man's land? No, it is our land! Intensive Care Med. 2016 Nov;42(11):1790-1793. doi: 10.1007/s00134-016-4475-4. Epub 2016 Aug 8. No abstract available.
PubMed 27502507
Bolton CF, Gilbert JJ, Hahn AF, Sibbald WJ. Polyneuropathy in critically ill patients. J Neurol Neurosurg Psychiatry. 1984 Nov;47(11):1223-31. doi: 10.1136/jnnp.47.11.1223.
PubMed 6094735
Bonorino KC, Cani KC. Early mobilization in the time of COVID-19. Rev Bras Ter Intensiva. 2020 Oct-Dec;32(4):484-486. doi: 10.5935/0103-507X.20200086. No abstract available.
PubMed 33470350
Hodgson C, Needham D, Haines K, Bailey M, Ward A, Harrold M, Young P, Zanni J, Buhr H, Higgins A, Presneill J, Berney S. Feasibility and inter-rater reliability of the ICU Mobility Scale. Heart Lung. 2014 Jan-Feb;43(1):19-24. doi: 10.1016/j.hrtlng.2013.11.003. Epub 2013 Nov 19.
PubMed 24373338
Zanni JM, Korupolu R, Fan E, Pradhan P, Janjua K, Palmer JB, Brower RG, Needham DM. Rehabilitation therapy and outcomes in acute respiratory failure: an observational pilot project. J Crit Care. 2010 Jun;25(2):254-62. doi: 10.1016/j.jcrc.2009.10.010. Epub 2009 Nov 26.
PubMed 19942399
Bailey PP, Miller RR 3rd, Clemmer TP. Culture of early mobility in mechanically ventilated patients. Crit Care Med. 2009 Oct;37(10 Suppl):S429-35. doi: 10.1097/CCM.0b013e3181b6e227.
PubMed 20046131
Thomas P, Baldwin C, Bissett B, Boden I, Gosselink R, Granger CL, Hodgson C, Jones AY, Kho ME, Moses R, Ntoumenopoulos G, Parry SM, Patman S, van der Lee L. Physiotherapy management for COVID-19 in the acute hospital setting: clinical practice recommendations. J Physiother. 2020 Apr;66(2):73-82. doi: 10.1016/j.jphys.2020.03.011. Epub 2020 Mar 30.
PubMed 32312646
Stiller K. Physiotherapy in intensive care: towards an evidence-based practice. Chest. 2000 Dec;118(6):1801-13. doi: 10.1378/chest.118.6.1801. No abstract available.
PubMed 11115476

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neuromuscular Electrical Stimulation and Functional Rehabilitation Protocol in Critically Ill Patients With SARS-CoV-2 Variants in ICUs With Limited Resources: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT05450120
Acronym / sponsor ID: 07351119.2.0000.5381
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Keywords: COVID-19, intensive care unit, early mobilization, rehabilitation, electrical stimulation, muscle weakness
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 88 participants (estimated)
Lead sponsor: Universidade Federal de Sao CarlosUniversity, hospital or other
Study start: 1 May 2020 (actual)
Primary completion: 1 Oct 2020 (actual)
Study completion: 1 Dec 2022 (estimated)
First posted: 8 Jul 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Functional Rehabilitation	Active comparator	Other: Functional RehabilitationFunctional rehabilitation protocol
NMES + Functional Rehabilitation	Experimental	Other: Functional Rehabilitation, Other: Neuromuscular Electrical StimulationFunctional rehabilitation protocol associated with neuromuscular electrical stimulation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Subjects admitted in ICU for >72hs, undergoing orotracheal intubation and on mechanical ventilation for >48hs, with a diagnosis of Acute Respiratory Distress Syndrome (ARDS) according to Berlin definition secondary to COVID-19, with shock or organ failure, according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (7th Interim Edition) Guideline, and clinical stability:
mean arterial pressure < 60 mmHg;
heart rate >60 and <120 beats/minute;
respiratory rate <30 breaths/minute;
oxygen saturation ≥ 92%;

Key exclusion criteria (7 listed)

Patients with movement resistance
Walking without assistance before the ICU (except using a cane)
Cognitive impairment before acute illness
Signs of intracranial hypertension, neuromuscular disease (myasthenia gravis, amyotrophic lateral sclerosis, Guillain-Barré) and stroke; hip fracture, unstable cervical spine, or pathological fracture
Prior hospitalization (30 days before ICU)

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
Functional RehabilitationFunctional rehabilitation protocol	Other	Functional Rehabilitation, NMES + Functional Rehabilitation
Neuromuscular Electrical StimulationNeuromuscular electrical stimulation protocol	Other	NMES + Functional Rehabilitation

Primary outcome

Skeletal muscle strength
Time frame: 5 months
Improved skeletal muscle strength by modified Medical Research Council (mMRC)
Functional independence
Time frame: 5 months
Improved level of functional independence by ICU Mobility Scale (IMS) and Functional Status Score for the ICU (FSS-ICU)

2 secondary outcomes

Mechanical ventilation and hospitalization
Time frame: 5 months
Survived and discharged
Time frame: 5 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
Background: PubMed 16934166Dhand UK. Clinical approach to the weak patient in the intensive care unit. Respir Care. 2006 Sep;51(9):1024-40; discussion 1040-1.
Background: PubMed 15758592Latronico N, Peli E, Botteri M. Critical illness myopathy and neuropathy. Curr Opin Crit Care. 2005 Apr;11(2):126-32. doi: 10.1097/01.ccx.0000155357.24360.89.
Background: PubMed 12594312Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
Background: PubMed 20046135Herridge MS. Legacy of intensive care unit-acquired weakness. Crit Care Med. 2009 Oct;37(10 Suppl):S457-61. doi: 10.1097/CCM.0b013e3181b6f35c.
Background: PubMed 15166849De Jonghe B, Sharshar T, Hopkinson N, Outin H. Paresis following mechanical ventilation. Curr Opin Crit Care. 2004 Feb;10(1):47-52. doi: 10.1097/00075198-200402000-00008.
Background: PubMed 18511703Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
Background: PubMed 21939902Latronico N, Bolton CF. Critical illness polyneuropathy and myopathy: a major cause of muscle weakness and paralysis. Lancet Neurol. 2011 Oct;10(10):931-41. doi: 10.1016/S1474-4422(11)70178-8.
Background: PubMed 27502507Latronico N. Critical illness polyneuropathy and myopathy 20 years later. No man's land? No, it is our land! Intensive Care Med. 2016 Nov;42(11):1790-1793. doi: 10.1007/s00134-016-4475-4. Epub 2016 Aug 8. No abstract available.
Background: PubMed 6094735Bolton CF, Gilbert JJ, Hahn AF, Sibbald WJ. Polyneuropathy in critically ill patients. J Neurol Neurosurg Psychiatry. 1984 Nov;47(11):1223-31. doi: 10.1136/jnnp.47.11.1223.
Background: PubMed 33470350Bonorino KC, Cani KC. Early mobilization in the time of COVID-19. Rev Bras Ter Intensiva. 2020 Oct-Dec;32(4):484-486. doi: 10.5935/0103-507X.20200086. No abstract available.
Background: PubMed 24373338Hodgson C, Needham D, Haines K, Bailey M, Ward A, Harrold M, Young P, Zanni J, Buhr H, Higgins A, Presneill J, Berney S. Feasibility and inter-rater reliability of the ICU Mobility Scale. Heart Lung. 2014 Jan-Feb;43(1):19-24. doi: 10.1016/j.hrtlng.2013.11.003. Epub 2013 Nov 19.
Background: PubMed 19942399Zanni JM, Korupolu R, Fan E, Pradhan P, Janjua K, Palmer JB, Brower RG, Needham DM. Rehabilitation therapy and outcomes in acute respiratory failure: an observational pilot project. J Crit Care. 2010 Jun;25(2):254-62. doi: 10.1016/j.jcrc.2009.10.010. Epub 2009 Nov 26.

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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.

Jacqueline Vianna, Phd principal investigator

UFSCAR

Jamami, Phd study director

UFSCAR

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 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: status not confirmed, as of the sponsor's last update on 8 Aug 2022. 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 Brazil. 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?

Results are not available in the source record.

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?

Skeletal muscle strength (time frame: 5 months). The study lists 2 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 NCT05450120, which also lists 24 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 8 Aug 2022.