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
Brief Summary

Acute rehabilitation in critically ill patients can improve post-intensive care unit(post-ICU) physical function. Scientific evidence has considered neuromuscular electricalstimulation (NMES) as a promising approach for the early rehabilitation of patientsduring and/or after ICU.Neuromuscular electrostimulation can be an alternative form of muscle exercise that helpsto gain strength in critically ill patients with COVID -19, due to the severe weaknessthat patients experience due to longer MV, analgesia and NMB duration. Thus, the generalobjective of evaluating the effects of an early rehabilitation protocol on the strengthand functionality of patients affected by SARS-CoV-2 variants and specifically comparethe effectiveness of NMES associated with the functional rehabilitation protocol(FR).Also, describe demographics, clinical status, ICU therapies, mortality estimates andHospital outcomes, of every patients admitted in ICU during the observation periods.

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.

Unknown status
COVID-19 Acute Respiratory Distress Syndrome

Other: Functional Rehabilitation

Functional rehabilitation protocol

Other: Neuromuscular Electrical Stimulation

Neuromuscular electrical stimulation protocol

Eligibility Criteria

Inclusion Criteria:

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;

- 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

Exclusion Criteria:

- 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).

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Brazil
Locations

Santa Casa de Batatais
Batatais, São Paulo, Brazil

Universidade Federal de Sao Carlos
NCT Number
Keywords
Covid-19
Intensive care unit
Early mobilization
Rehabilitation
electrical stimulation
Muscle Weakness
MeSH Terms
COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury