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

August 5, 2022 updated by: Jacqueline R F Vianna, Universidade Federal de Sao Carlos

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

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Functional Rehabilitation
Functional rehabilitation protocol
Other: Functional Rehabilitation
Functional rehabilitation protocol
Experimental: NMES + Functional Rehabilitation
Functional rehabilitation protocol associated with neuromuscular electrical stimulation
Other: Functional Rehabilitation
Functional rehabilitation protocol
Other: Neuromuscular Electrical Stimulation
Neuromuscular electrical stimulation protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal muscle strength
Time Frame: 5 months
Improved skeletal muscle strength by modified Medical Research Council (mMRC)
5 months
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)
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical ventilation and hospitalization
Time Frame: 5 months
Mechanical ventilation time, ICU and hospital stay.
5 months
Survived and discharged
Time Frame: 5 months
Proportion of patients who survived and were discharged.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Sao Carlos

Investigators

  • Principal Investigator: Jacqueline Vianna, Phd, Ufscar
  • Study Director: Jamami, Phd, Ufscar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

October 1, 2020

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

July 5, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07351119.2.0000.5381

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19 Acute Respiratory Distress Syndrome

Clinical Trials on Functional Rehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe