Neuromuscular Electrical Stimulation in Patients With COVID19 Associated Pneumonia

COVID-19 Pneumonia Clinical Trial

Official title: Effects of Neuromuscular Electrical Stimulation Therapy on Physical Function in Patients With COVID-19 Associated Pneumonia: Study Protocol of a Randomized Controlled Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Pneumonia

• NCT number: NCT04382729
• Study type: Interventional
• Source: University of Turin, Italy
• Contact: Marco Alessandro Minetto, MD, PhD
• Phone: +39 011 6705472?
• Email: marco.minetto@unito.it
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2020
• Completion date: July 2020