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

Primary Purpose

COVID-19 Acute Respiratory Distress Syndrome

Status

Active

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Functional Rehabilitation

Neuromuscular Electrical Stimulation

About this trial

This is an interventional treatment trial for COVID-19 Acute Respiratory Distress Syndrome focused on measuring COVID-19, intensive care unit, early mobilization, rehabilitation, electrical stimulation, muscle weakness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Santa Casa de Batatais

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Functional Rehabilitation

NMES + Functional Rehabilitation

Arm Description

Functional rehabilitation protocol

Functional rehabilitation protocol associated with neuromuscular electrical stimulation

Outcomes

Primary Outcome Measures

Skeletal muscle strength

Improved skeletal muscle strength by modified Medical Research Council (mMRC)

Functional independence

Improved level of functional independence by ICU Mobility Scale (IMS) and Functional Status Score for the ICU (FSS-ICU)

Secondary Outcome Measures

Mechanical ventilation and hospitalization

Mechanical ventilation time, ICU and hospital stay.

Survived and discharged

Proportion of patients who survived and were discharged.

Full Information

NCT ID

NCT05450120

First Posted

July 5, 2022

Last Updated

August 5, 2022

Sponsor

Universidade Federal de Sao Carlos

1. Study Identification

Unique Protocol Identification Number

NCT05450120

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 1, 2020 (Actual)

Primary Completion Date

October 1, 2020 (Actual)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Federal de Sao Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Acute Respiratory Distress Syndrome

Keywords

COVID-19, intensive care unit, early mobilization, rehabilitation, electrical stimulation, muscle weakness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Functional Rehabilitation

Arm Type

Active Comparator

Arm Description

Functional rehabilitation protocol

Arm Title

NMES + Functional Rehabilitation

Arm Type

Experimental

Arm Description

Functional rehabilitation protocol associated with neuromuscular electrical stimulation

Intervention Type

Other

Intervention Name(s)

Functional Rehabilitation

Intervention Description

Functional rehabilitation protocol

Intervention Type

Other

Intervention Name(s)

Neuromuscular Electrical Stimulation

Intervention Description

Neuromuscular electrical stimulation protocol

Primary Outcome Measure Information:

Title

Skeletal muscle strength

Description

Improved skeletal muscle strength by modified Medical Research Council (mMRC)

Time Frame

5 months

Title

Functional independence

Description

Improved level of functional independence by ICU Mobility Scale (IMS) and Functional Status Score for the ICU (FSS-ICU)

Time Frame

5 months

Secondary Outcome Measure Information:

Title

Mechanical ventilation and hospitalization

Description

Mechanical ventilation time, ICU and hospital stay.

Time Frame

5 months

Title

Survived and discharged

Description

Proportion of patients who survived and were discharged.

Time Frame

5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacqueline Vianna, Phd

Organizational Affiliation

UFSCAR

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jamami, Phd

Organizational Affiliation

UFSCAR

Official's Role

Study Director

Facility Information:

Facility Name

Santa Casa de Batatais

City

Batatais

State/Province

São Paulo

ZIP/Postal Code

14300-029

Country

Brazil

12. IPD Sharing Statement

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

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