Neuromuscular Electrical Stimulation in Patients With COVID19 Associated Pneumonia

University of Turin

Status: Unknown

Conditions: COVID-19 Pneumonia

Treatments: Other: Physical Therapy Exercise; Other: Neuromuscular Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04382729

ESC270320

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age above 18 years
• respiratory (PaO2/FiO2 ratio > 180 mmHg) and hemodynamic stability for at least two days after withdrawal of mechanical ventilation and neuromuscular blocking agents

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 to transfer independently from bed to chair before hospital admission)
• presence of an implanted cardiac pacemaker or defibrillator

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

NMES Group

Experimental group

Treatment:

Other: Neuromuscular Electrical Stimulation

Control Group

Active Comparator group

Treatment:

Other: Physical Therapy Exercise