Neuromuscular Electrical Stimulation in Patients With COVID19 Associated Pneumonia

Last updated: May 8, 2020
Sponsor: University of Turin, Italy
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Pneumonia

Corona Virus

Treatment

N/A

Clinical Study ID

NCT04382729
ESC270320
  • Ages > 18
  • All Genders

Study Summary

Neuromuscular electrical stimulation (NMES) has been considered as a promising approach for the early rehabilitation of patients in and/or after the intensive care unit (ICU). Aim of this study is to evaluate the NMES effect on physical function of COVID-19 patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age above 18 years

  • respiratory (PaO2/FiO2 ratio > 180 mmHg) and hemodynamic stability for at least twodays after withdrawal of mechanical ventilation and neuromuscular blocking agents

Exclusion

Exclusion Criteria:

  • pregnancy

  • known or suspected malignancy in the lower limbs

  • body mass index equal or greater than 35 kg/m2

  • conditions preventing NMES treatment (e.g., deep vein thrombosis, skin lesions,rhabdomyolysis)

  • conditions preventing the outcome assessment (e.g., amputation or inability totransfer independently from bed to chair before hospital admission)

  • presence of an implanted cardiac pacemaker or defibrillator

Study Design

Total Participants: 80
Study Start date:
April 17, 2020
Estimated Completion Date:
July 31, 2020

Study Description

This prospective, randomized, controlled, parallel-group, single-blind trial will include 80 patients who had undergone mechanical or non-invasive ventilation following pneumonia-induced respiratory failure. Patients are randomized to a control group (routine physical therapy for 3 weeks) or a NMES group (routine physical therapy plus NMES of quadriceps and gastrocnemius muscles for 3 weeks). The primary outcome is physical performance assessed through the Short Physical Performance Battery (SPPB). Secondary outcomes include independence level, perceived fatigue, muscle strength, rectus femoris thickness, and walking performance. The SPBB and walking performance will be assessed once (after the 3-week intervention period), while all other outcomes will be assessed twice (before and after the intervention).

NMES is a simple and non-invasive technique for muscle strengthening that is usually well tolerated, does not produce adverse effects, requires no or little cooperation from patients and is quite inexpensive. Therefore, proving the effectiveness of NMES therapy for physical and muscle function in COVID-19 patients could support its systematic incorporation in post-ICU rehabilitation protocols of patients presenting with post-intensive care syndrome.

Connect with a study center

  • San Luigi Gonzaga Hospital

    Orbassano, TO 10043
    Italy

    Active - Recruiting

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